1. EMERYVILLE, Calif., April 08, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that Stephen J. Farr, Ph.D., President and Chief Executive Officer, and Michael Smith, Executive Vice President, Chief Financial Officer, and Treasurer, will participate in a fireside chat on Monday, April 12, 2021, at the 20th Annual Needham Virtual Healthcare Conference.

    Zogenix Presentation Details
    Date:  Monday, April 12, 2021
    Time: 11:00 AM Eastern Time

    The presentation will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com.

    About Zogenix
    Zogenix is a global biopharmaceutical company committed…

    EMERYVILLE, Calif., April 08, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that Stephen J. Farr, Ph.D., President and Chief Executive Officer, and Michael Smith, Executive Vice President, Chief Financial Officer, and Treasurer, will participate in a fireside chat on Monday, April 12, 2021, at the 20th Annual Needham Virtual Healthcare Conference.

    Zogenix Presentation Details

    Date:  Monday, April 12, 2021
    Time: 11:00 AM Eastern Time

    The presentation will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare epilepsy, and one for MT1621, an investigational therapy for the treatment of a rare genetic disorder called TK2 deficiency. Zogenix is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 | zogenix.com

    Investors

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 | 

    Media

    Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |



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  2. EMERYVILLE, Calif., March 25, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that Stephen J. Farr, Ph.D., President and Chief Executive Officer, and Michael Smith, Executive Vice President, Chief Financial Officer, and Treasurer, will participate in a fireside chat on Wednesday, March 31, 2021, at the Stifel 3rd Annual CNS Day.

    Zogenix Presentation Details
    Date: Wednesday, March 31, 2021
    Time: 2:30 PM Eastern Time

    The presentation will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com.

    About Zogenix
    Zogenix is a global biopharmaceutical company committed to developing and commercializing…

    EMERYVILLE, Calif., March 25, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that Stephen J. Farr, Ph.D., President and Chief Executive Officer, and Michael Smith, Executive Vice President, Chief Financial Officer, and Treasurer, will participate in a fireside chat on Wednesday, March 31, 2021, at the Stifel 3rd Annual CNS Day.

    Zogenix Presentation Details
    Date: Wednesday, March 31, 2021
    Time: 2:30 PM Eastern Time

    The presentation will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare epilepsy, and one for MT1621, an investigational therapy for the treatment of a rare genetic disorder called TK2 deficiency. Zogenix is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 | 

    Investors

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 | 

    Media

    Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |



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  3. EMERYVILLE, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that Michael Smith, Executive Vice President, Chief Financial Officer, and Treasurer, will present a corporate overview and participate in a fireside chat on Wednesday, March 3, 2021, at the Raymond James Institutional Investors Conference.

    Zogenix Presentation Details
    Date:Wednesday, March 3, 2021
    Time: 3:50 PM Eastern Time

    The presentation will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com.

    About Zogenix
    Zogenix is a global biopharmaceutical company committed to developing and commercializing…

    EMERYVILLE, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that Michael Smith, Executive Vice President, Chief Financial Officer, and Treasurer, will present a corporate overview and participate in a fireside chat on Wednesday, March 3, 2021, at the Raymond James Institutional Investors Conference.

    Zogenix Presentation Details
    Date:Wednesday, March 3, 2021
    Time: 3:50 PM Eastern Time

    The presentation will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare epilepsy, and one for MT1621, an investigational therapy for the treatment of a rare genetic disorder called TK2 deficiency. Zogenix is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 | 

    Investors

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 | 

    Media

    Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |



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    • Positive momentum continues for U.S. launch of FINTEPLA® (fenfluramine) oral solution in Dravet syndrome, with total net product sales of $8.1 million in the fourth quarter; total net sales of $9.6 million since launch in July 2020

    • As of December 31, 2020, over 550 Dravet syndrome patients referred to the FINTEPLA REMS program, with 416 patients receiving reimbursed therapy, approximately 60% of whom were new to FINTEPLA
    • FINTEPLA for Dravet syndrome approved by European Commission in December 2020 and launched in Germany this month
    • On track to submit applications for FINTEPLA in Lennox-Gastaut syndrome in the U.S. in Q3 2021 and in Europe in Q4 2021
    • Planned New Drug Application (NDA) submission in first half of 2022 for MT1621 in TK2 deficiency
    • Positive momentum continues for U.S. launch of FINTEPLA® (fenfluramine) oral solution in Dravet syndrome, with total net product sales of $8.1 million in the fourth quarter; total net sales of $9.6 million since launch in July 2020



    • As of December 31, 2020, over 550 Dravet syndrome patients referred to the FINTEPLA REMS program, with 416 patients receiving reimbursed therapy, approximately 60% of whom were new to FINTEPLA

    • FINTEPLA for Dravet syndrome approved by European Commission in December 2020 and launched in Germany this month

    • On track to submit applications for FINTEPLA in Lennox-Gastaut syndrome in the U.S. in Q3 2021 and in Europe in Q4 2021

    • Planned New Drug Application (NDA) submission in first half of 2022 for MT1621 in TK2 deficiency

    • Ended 2020 with $505.1 million in cash, cash equivalents and marketable securities



    EMERYVILLE, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today provided a corporate update and announced financial results for the fourth quarter and full-year ended December 31, 2020. The Company will host a conference call today, Thursday, February 25, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

    "We are very pleased to have concluded 2020 with strong momentum across all of our programs, especially the robust U.S. launch of FINTEPLA® in Dravet syndrome, where we saw strong adoption by existing and new prescribing physicians and patients, and partnerships with U.S. payors to provide optimal access for all appropriate patients," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "We expect several additional key catalysts for FINTEPLA in Dravet syndrome in the year ahead in the U.S. and in Europe, where we recently launched FINTEPLA in Germany and are actively preparing for additional European country launches and, with our partner Nippon Shinyaku, are preparing to submit a J-NDA in the second half of the year."

    "Our goal is also to continue expanding the eligible patient population for FINTEPLA in other indications, based on strong safety and efficacy data from our clinical trials," continued Dr. Farr. "In the U.S. and Europe, we are advancing FINTEPLA for multiple other treatment-resistant epilepsies, including Lennox-Gastaut syndrome (LGS), for which we anticipate submitting global regulatory filings. We are also planning to initiate a Phase 3 trial for CDKL5 in the second half of 2021, and assess additional severe, treatment-resistant epilepsies through the initiation of other investigator-initiated clinical studies."

    Corporate Update

    • FINTEPLA for the treatment of seizures associated with Dravet syndrome:



      ° As of December 31, 2020, 492 prescribers had successfully completed the Risk Evaluation and Mitigation Strategy (REMS) certification process



      ° As of December 31, 2020, over 550 Dravet syndrome patients had been referred to the FINTEPLA REMS program to become eligible to receive therapy, and 416 patients were receiving reimbursed therapy, of which approximately 60% were new to FINTEPLA



      ° Received European Commission approval on December 21, 2020; FINTEPLA commercially available in Germany as of February 1, 2021



      ° Received temporary authorisation to use in France from the French National Agency for Medicines and Health Products Safety in January 2021; expect patients to begin treatment with FINTEPLA in France during current quarter



      ° Anticipate submission of a Japan-NDA to Japan's Pharmaceutical and Medical Devices Agency in the second half of 2021



      °  Presented new long-term (3 year) safety and efficacy data for FINTEPLA in Dravet syndrome at American Epilepsy Society (AES) Annual Meeting in December 2020, which demonstrated durable effectiveness in significantly reducing seizures



    • FINTEPLA for the treatment of seizures associated with LGS:



      ° Completed all required studies for submission. Compilation of data package is ongoing with anticipated filing of sNDA in the third quarter of 2021



      ° Anticipate submitting Marketing Authorization Application with European Medicines Agency in fourth quarter of 2021



      ° Presented full results from Phase 3 study of FINTEPLA in LGS and its efficacy in reducing convulsive seizure frequency at AES Annual Meeting



    • FINTEPLA for the treatment of seizures associated with CDKL5 Deficiency Disorder:



      ° New data presented from investigator-initiated study in CDKL5 Deficiency Disorder, an infantile-onset genetic seizure disorder, at AES Annual Meeting



      ° Anticipate initiating a Phase 3 study of FINTEPLA for the treatment of CDKL5 Deficiency Disorder during the second half of 2021



    • MT1621 for the treatment of TK2d:



      ° Studies are proceeding as planned and Company anticipates the submission of an NDA in the first half of 2022



    • Tevard Research Collaboration:



      ° Zogenix and Tevard collaborating to identify and develop novel tRNA-based gene therapies for Dravet syndrome and other genetic epilepsies

    Fourth Quarter 2020 Financial Results

    • The Company recorded $8.5 million in revenue for the fourth quarter ended December 31, 2020. This included total net product sales of FINTEPLA of $8.1 million, in addition to $0.4 million in revenue as a result of the March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded $1.9 million in revenue for the corresponding period of 2019.

    • Research and development expenses for the fourth quarter ended December 31, 2020, totaled $36.0 million, compared to $35.8 million in the fourth quarter ended December 31, 2019.

    • Selling, general and administrative expenses for the fourth quarter ended December 31, 2020, totaled $29.2 million, up from $18.7 million in the fourth quarter ended December 31, 2019. The increase was driven by commercial launch in the U.S. and launch preparations Europe.

    • Net loss for the fourth quarter ended December 31, 2020, was $70.2 million, or a net loss of $1.26 per share, compared with a net loss of $56.1 million, or a net loss of $1.26 per share, in the fourth quarter ended December 31, 2019.

    Year Ended December 31, 2020 Financial Results Compared to Year Ended December 31, 2019

    • The Company recorded $13.6 million in revenue for the year ended December 31, 2020. This included total net product sales of FINTEPLA of $9.6 million, in addition to $4.0 million in revenue as a result of the March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded in $3.6 million revenue for the corresponding period of 2019.



    • Research and development expenses for the year ended December 31, 2020, totaled $138.0 million, up from $115.6 million in the year ended December 31, 2019, as the Company expanded clinical activities in LGS and MT1621, partially offset by decreased spending in Dravet syndrome.



    • Selling, general and administrative expenses for the year ended December 31, 2020, totaled $99.6 million, up from $60.8 million in the year ended December 31, 2019, as the Company continued investment related to the launch of FINTEPLA for the treatment of Dravet syndrome in the U.S. and prepared for prospective launch in Europe.



    • Net loss for the year ended December 31, 2020, was $209.4 million, or a net loss of $3.90 per share, compared with a net loss of $419.5 million, or a net loss of $9.74 per share, in the year ended December 31, 2019.  The decrease in net loss was primarily attributable to the 2019 acquisition of Modis.



    • As of December 31, 2020, the Company had $505.1 million in cash, cash equivalents, and marketable securities, compared to $251.2 million at December 31, 2019. 
    Conference Call Details

    Thursday, February 25, at 4:30 PM Eastern Time / 1:30 PM Pacific Time

    Toll Free:                877-407-9716
    International:                201-493-6779
    Conference ID:        13715661
    Webcast:               http://public.viavid.com/index.php?id=143250

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare epilepsy, and one for MT1621, an investigational therapy for the treatment of a rare genetic disorder called TK2 deficiency. Zogenix is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.

    Forward Looking Statements

    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include timing of commercial launch of FINTEPLA for the treatment of Dravet syndrome in additional countries in Europe, including France; Zogenix's expectations on the submission of a J-NDA by Nippon Shinyaku in Japan; the timing and ability of Zogenix to complete regulatory submissions in the United States and the European Union for FINTEPLA in LGS; Zogenix's plans to expand FINTEPLA in other indications including the timing or success of a Phase 3 clinical trial in CDKL5 deficiency disorder and investigator-initiated clinical trials in other indications; Zogenix's belief that the recent Type B meeting with the FDA supports an NDA submission for MT1621 in TK2 deficiency and the timing of such submission. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA in the U.S. and Europe, including due to the costs and procedures related to the REMS certification process or controlled access program; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to commercialize FINTEPLA and may delay Zogenix's development plans for FINTEPLA and MT1621; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA or MT1621 that could limit development or commercialization, or that could result in recalls or product liability claims; additional data from Zogenix's ongoing studies may contradict or undermine the data previously reported; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 | 

    Investors

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 | 

    Media

    Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |



    Zogenix, Inc.


    Condensed Consolidated Balance Sheets (Unaudited)

    (in thousands)

     December 31,
     2020 2019
    Assets   
    Current assets:   
    Cash and cash equivalents$166,916  $62,070 
    Marketable securities 338,193   189,085 
    Accounts receivable, net 3,824   - 
    Inventory 1,026   - 
    Prepaid expenses 7,279   8,593 
    Acquisition holdback placed in escrow -   25,000 
    Other current assets 4,936   2,491 
    Total current assets 522,174   287,239 
    Property and equipment, net 8,724   9,424 
    Operating lease right-of-use assets 7,748   7,774 
    Intangible asset, net 98,558   102,500 
    Goodwill 6,234   6,234 
    Other non-current assets 7,692   1,079 
    Total assets$651,130  $414,250 
        
    Liabilities and stockholders' equity   
    Current liabilities:   
    Accounts payable$11,945  $7,979 
    Accrued and other current liabilities 54,964   30,117 
    Acquisition holdback liability -   24,444 
    Deferred revenue, current 5,318   5,927 
    Current portion of operating lease liabilities 1,688   1,322 
    Current portion of contingent consideration 8,800   25,600 
    Total current liabilities 82,715   95,389 
    Deferred revenue, non-current 5,479   7,425 
    Operating lease liabilities, net of current portion 10,314   10,752 
    Contingent consideration, net of current portion 33,600   38,200 
    Deferred tax liability -   17,425 
    Convertible Senior Notes 149,353   - 
    Total liabilities 281,461   169,191 
    Stockholders' equity:   
    Common stock 56   45 
    Additional paid-in capital 1,694,524   1,360,092 
    Accumulated other comprehensive (loss) income (71)  379 
    Accumulated deficit (1,324,840)  (1,115,457)
    Total stockholders' equity 369,669   245,059 
    Total liabilities and stockholders' equity$651,130  $414,250 



    Zogenix, Inc.

    Condensed Consolidated Statements of Operations (Unaudited)

    (in thousands, except per share amounts)

     Three Months Ended

    December 31,
     Twelve Months Ended

    December 31,
     20202019 20202019
    Revenues:     
    Net product sales$8,067 $-  $9,587 $- 
    Collaboration revenue 435  1,949   4,056  3,648 
    Total revenues 8,502  1,949   13,643  3,648 
          
    Operating costs and expenses:     
    Cost of product sales (excluding intangible asset amortization) 402  -   542  - 
    Research and development 35,964  35,820   138,002  115,639 
    Selling, general and administrative 29,242  18,653   99,574  60,792 
    Intangible asset amortization 1,971  -   3,942  - 
    Acquired IPR&D and related costs 6,200  2,000   10,700  251,438 
    Change in fair value of contingent consideration 2,500  2,900   8,600  5,600 
    Total operating expenses 76,279  59,373   261,360  433,469 
    Loss from operations (67,777) (57,424)  (247,717) (429,821)
    Other income (expense):     
    Interest income 387  1,283   2,891  9,802 
    Interest expense (3,759) -   (3,759) - 
    Other income, net 979  81   21,777  516 
    Loss from operations before income taxes (70,170) (56,060)  (226,808) (419,503)
    Income tax benefit -  -   (17,425) - 
    Net loss$(70,170)$(56,060) $(209,383)$(419,503)
          
    Net loss per share, basic and diluted$(1.26)$(1.26) $(3.90)$(9.74)


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  4. EMERYVILLE, Calif., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that Stephen J. Farr, Ph.D., will participate in a fireside chat on Friday, February 26, 2021, at the 10th Annual SVB Leerink Global Healthcare Conference.

    Zogenix Fireside Chat Details
    Date:Friday, February 26, 2021
    Time:1:00 PM Eastern Time

    The fireside chat will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com.

    About Zogenix
    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases…

    EMERYVILLE, Calif., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that Stephen J. Farr, Ph.D., will participate in a fireside chat on Friday, February 26, 2021, at the 10th Annual SVB Leerink Global Healthcare Conference.

    Zogenix Fireside Chat Details

    Date:Friday, February 26, 2021
    Time:1:00 PM Eastern Time

    The fireside chat will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare epilepsy, and one for MT1621, an investigational therapy for the treatment of a rare genetic disorder called TK2 deficiency (being developed through its subsidiary Modis Therapeutics). Zogenix is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for genetic rare epilepsies.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 | 

    Investors

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 | 

    Media

    Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |

     



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  5. EMERYVILLE, Calif., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that it will report its financial results for the fourth quarter and full-year ended December 31, 2020 and host a corporate update conference call and webcast after the market close, on Thursday, February 25, 2021, at 4:30 PM Eastern Time.

    Conference Call Details
    Thursday, February 25, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
    Toll Free:877-407-9716
    International:201-493-6779
    Conference ID:13715661
    Webcast:http://public.viavid.com/index.php?id=143250

    About Zogenix
    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential…

    EMERYVILLE, Calif., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that it will report its financial results for the fourth quarter and full-year ended December 31, 2020 and host a corporate update conference call and webcast after the market close, on Thursday, February 25, 2021, at 4:30 PM Eastern Time.

    Conference Call Details

    Thursday, February 25, at 4:30 PM Eastern Time / 1:30 PM Pacific Time

    Toll Free:877-407-9716
    International:201-493-6779
    Conference ID:13715661
    Webcast:http://public.viavid.com/index.php?id=143250

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare epilepsy, and one for MT1621, an investigational therapy for the treatment of a rare genetic mitochondrial depletion disorder called TK2 deficiency. Zogenix is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for genetic rare epilepsies.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 | 

    Investors

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 | 

    Media

    Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |



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    • FINTEPLA offers a new treatment option for patients in Germany with Dravet syndrome, a rare, devastating, infant-onset epilepsy marked by frequent seizures, medical emergencies, and developmental impairments
    • FINTEPLA was approved by the European Commission in December 2020 based on data from two Phase 3 studies demonstrating it safely and significantly reduced convulsive seizure frequency for Dravet syndrome patients whose seizures were not adequately controlled on their existing medications

    EMERYVILLE, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, announced today that FINTEPLA® (fenfluramine) oral solution is now available in Germany for the treatment of…

    • FINTEPLA offers a new treatment option for patients in Germany with Dravet syndrome, a rare, devastating, infant-onset epilepsy marked by frequent seizures, medical emergencies, and developmental impairments
    • FINTEPLA was approved by the European Commission in December 2020 based on data from two Phase 3 studies demonstrating it safely and significantly reduced convulsive seizure frequency for Dravet syndrome patients whose seizures were not adequately controlled on their existing medications

    EMERYVILLE, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, announced today that FINTEPLA® (fenfluramine) oral solution is now available in Germany for the treatment of seizures associated with Dravet syndrome in patients aged two years and older, as an add-on therapy to existing anti-epileptic medications. Dravet syndrome is a rare, lifelong epilepsy that begins in infancy and is marked by severe refractory seizures, frequent medical emergencies, significant cognitive and behavioral impairments, and an increased risk of sudden premature death (SUDEP).

    "Patients with Dravet syndrome experience severe and often prolonged seizures that are highly resistant to existing anti-convulsant medications. Despite treatment with one or more of the currently available medications, most patients' seizures are not adequately controlled," said Dr. Jens Grünert, Medical Director, Zogenix Germany. "With the launch of FINTEPLA in Germany, physicians and caregivers here can now access an urgently needed, effective and generally well-tolerated new treatment option to help reach their goals of reducing the devastating seizures and improving outcomes and quality of life for patients and their families."

    FINTEPLA will be available in Germany starting on 1 February 2021 under a controlled access program requested by the European Medicines Agency. In Germany, physicians will register for an identification number before being able to prescribe FINTEPLA via the following website: www.fenfluramin-wichtige-infos.de/verschreiber. Further details regarding prescribing and patient monitoring requirements can be found on the European Medicines Agency website: https://www.ema.europa.eu/en/medicines/human/EPAR/fintepla.

    The approval of FINTEPLA by the European Commission in December 2020 was based on positive safety and efficacy results from two randomized, international, multi-center, placebo-controlled Phase 3 trials (Study 1 and Study 2), as well as data from an interim analysis of a long-term, open-label extension study in 330 Dravet syndrome patients treated up to 3 years. In the studies, most patients given FINTEPLA in addition to their existing regimen of antiepileptic therapies, experienced a statistically significant and clinically meaningful reduction in convulsive seizure frequency. The most commonly reported adverse events that occurred in patients included decreased appetite, diarrhea, pyrexia, fatigue, upper respiratory tract infection, lethargy, somnolence and bronchitis.

    About FINTEPLA®

    In 2020, FINTEPLA (fenfluramine) oral solution was approved by the U.S. Food & Drug Administration (FDA), and by the European Commission as an add on therapy to other anti-epileptic medicines, for the treatment of seizures associated with Dravet syndrome in patients aged two years and older. In addition, Zogenix recently reported positive results of a third Phase 3 study of FINTEPLA in Dravet syndrome to support planned registration in Japan, which corroborated the statistically significant and clinically meaningful convulsive seizure reductions seen in earlier multinational Phase 3 studies. FINTEPLA is also being studied for the potential treatment of seizures associated with other rare epilepsies.

    About Dravet Syndrome

    Dravet syndrome is a rare, devastating and life-long form of epilepsy that generally begins in infancy and is marked by frequent, treatment-resistant seizures, significant developmental, motor, and behavioral impairments, and an increased risk of sudden unexpected death in epilepsy (SUDEP). Affecting one in 15,700 live births in the U.S. and approximately one in 20,000 to 40,000 live births in Europe, most patients follow a course of developmental delay with cognitive, motor and behavioral deficits that persist into adulthood. Dravet syndrome severely impacts quality of life for patients, families and caregivers due to the high physical, emotional, caregiving, and financial burden associated with the disease.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare epilepsy, and one for MT1621, an investigational therapy for the treatment of a rare genetic disorder called TK2 deficiency (being developed through its subsidiary Modis Therapeutics). Zogenix is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for genetic rare epilepsies.

    Forward-Looking Statement

    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the potential that fenfluramine oral solution will be an important new treatment option for Dravet syndrome patients and Zogenix's plans to commercialize fenfluramine in Europe. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: Zogenix's ability to successfully launch FINTEPLA, including launching a controlled access program implemented due to risks related to valvular heart disease and pulmonary arterial hypertension; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to commercialize FINTEPLA in Europe and Zogenix's ability to generate product revenue in Europe; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA in Europe; unexpected adverse side effects or inadequate therapeutic efficacy of fenfluramine that could limit commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 | 

    Investors

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 | 

    Media

    In Europe: Kerry Lloyd-Jones, Account Director, Porter Novelli

    +44 (0) 7949 794 290 |

    In the US: Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |



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    • Total FINTEPLA® preliminary, unaudited net product sales of approximately $8.1 million for the fourth quarter
    • As of December 31, 2020, 492 healthcare prescribers had completed FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) certification process
    • As of December 31, 2020, more than 550 patients had been prescribed FINTEPLA and were enrolled in the REMS program, and 416 patients were receiving reimbursed therapy
    • Cash, cash equivalents and marketable securities at December 31, 2020, were approximately $505.8 million

    EMERYVILLE, Calif., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today reported select preliminary, unaudited financial results…

    • Total FINTEPLA® preliminary, unaudited net product sales of approximately $8.1 million for the fourth quarter

    • As of December 31, 2020, 492 healthcare prescribers had completed FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) certification process
    • As of December 31, 2020, more than 550 patients had been prescribed FINTEPLA and were enrolled in the REMS program, and 416 patients were receiving reimbursed therapy
    • Cash, cash equivalents and marketable securities at December 31, 2020, were approximately $505.8 million

    EMERYVILLE, Calif., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today reported select preliminary, unaudited financial results for the fourth quarter and full-year 2020. In addition, the Company highlighted its key 2021 corporate objectives.

    "2020 marked a year of tremendous achievements for Zogenix, highlighted by the successful commercial launch of FINTEPLA® in Dravet syndrome in the U.S.," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "We are extremely pleased with our launch progress and believe our strong results in the fourth quarter reinforce FINTEPLA's potential to provide transformational and durable seizure reduction for many Dravet syndrome patients. We look forward to further increasing U.S. physician and patient adoption of FINTEPLA in the year ahead. Moreover, we are excited to launch FINTEPLA in the EU shortly, following recent receipt of marketing authorization."

    Preliminary, Unaudited Fourth Quarter FINTEPLA Net Product Sales

    Based on preliminary, unaudited financial information, the Company expects total FINTEPLA net product sales to be approximately $8.1 million for the fourth quarter of 2020. Unaudited cash, cash equivalents and marketable securities at December 31, 2020, were approximately $505.8 million.

    The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the Company's fourth quarter of 2020. Zogenix expects to report its complete financial results for the fourth quarter and full-year 2020 in February 2021.

    As of December 31, 2020, 492 healthcare providers had completed the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) certification process. In addition, as of December 31, 2020, more than 550 patients had been prescribed FINTEPLA and were enrolled in the REMS program, and a total of 416 patients were receiving reimbursed therapy, of which approximately 60% were new to FINTEPLA.

    Key 2021 Corporate Objectives

    FINTEPLA Commercialization:

    • Continue to drive adoption of FINTEPLA in the U.S. by building on the positive momentum with existing and new prescribing physicians
    • Continue to work in partnership with U.S. payors to provide optimal access to FINTEPLA for all appropriate patients
    • Launch FINTEPLA for the treatment of patients with Dravet syndrome in Europe, beginning with the planned launch in Germany in the first quarter of 2021
    • Secure positive pricing and reimbursement decisions in major European countries
    • Submit J-NDA in Japan for FINTEPLA for the treatment of patients with Dravet syndrome in collaboration with Zogenix's partner, Nippon Shinyaku
    • Significantly expand the eligible patient population for FINTEPLA by submitting an sNDA in the U.S. for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome

    Additional FINTEPLA Pipeline Programs:

    • Initiate a Phase 3 study of FINTEPLA for the treatment of CDKL5 Deficiency Disorder, an infantile-onset genetic seizure disorder
    • Continue to explore FINTEPLA as a potential treatment for additional severe, treatment-resistant rare epilepsies through the initiation of other company-sponsored clinical studies

    MT1621

    • Complete all clinical, non-clinical and CMC studies and assessments required to support planned 2022 U.S. NDA and EMA MAA submissions for MT1621, the Company's investigational treatment for patients with the mitochondrial disease, thymidine kinase 2 deficiency (TK2d)

    Early-Stage R&D Activities

    • Support research and drug discovery activities with Zogenix's partner, Tevard Biosciences, to advance novel gene therapy candidates for the treatment of Dravet syndrome and other serious, treatment-resistant genetic epilepsies

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with the rare epilepsy, Lennox-Gastaut syndrome, and one for MT1621, an investigational therapy for the treatment of a rare genetic disorder called TK2 deficiency (being developed through its subsidiary Modis Therapeutics). Zogenix is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for genetic rare epilepsies. Further information on FINTEPLA is available at www.FINTEPLA.com.

    Forward-Looking Statement

    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include Zogenix's preliminary, unaudited financial results for the fourth quarter 2020, expectations regarding U.S. FINTEPLA adoption growth; Zogenix's plans to commercialize FINTEPLA in Europe, including the timing of the launch; and Zogenix's 2021 corporate objectives. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: adjustments to the preliminary, unaudited financial results in connection with completion of financial closing procedures and an audit for the 2020 fiscal year; the timing of enrollment or results of Zogenix's clinical trials; the timing of planned regulatory submissions and Zogenix's dependence on its partner Nippon Shinyaku with respect to the J-NDA for FINTEPLA for the treatment of patients with Dravet syndrome; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to commercialize FINTEPLA in the U.S. and Europe; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could delay submission of new drug applications, limit commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 | 

    Investors

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 | 

    Media

    Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |



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    • Dravet syndrome is a rare, debilitating and difficult-to-treat lifelong epilepsy that begins in infancy

    • EC approval is based on Phase 3 study data demonstrating that FINTEPLA safely and significantly reduced convulsive seizure frequency for Dravet syndrome patients whose seizures were not adequately controlled on existing medications, including stiripentol
    • First EU market launch planned for Germany in Q1 2021

    EMERYVILLE, Calif., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, announced today that the European Commission (EC) has granted marketing authorization for FINTEPLA® (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome as…

    • Dravet syndrome is a rare, debilitating and difficult-to-treat lifelong epilepsy that begins in infancy



    • EC approval is based on Phase 3 study data demonstrating that FINTEPLA safely and significantly reduced convulsive seizure frequency for Dravet syndrome patients whose seizures were not adequately controlled on existing medications, including stiripentol
    • First EU market launch planned for Germany in Q1 2021

    EMERYVILLE, Calif., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, announced today that the European Commission (EC) has granted marketing authorization for FINTEPLA® (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. Dravet syndrome is a rare, lifelong epilepsy that begins in infancy and is marked by severe refractory seizures, frequent medical emergencies, significant cognitive and behavioral impairments, and an increased risk of sudden premature death (SUDEP).

    "We deeply appreciate the physicians and Dravet community whose support led to this important milestone," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "With the EC approval in place, we can now begin making FINTEPLA more widely available for the treatment of Dravet syndrome patients in Europe who seek new safe and effective treatment options."

    The EC's approval of FINTEPLA was based on positive safety and efficacy results from two randomized, international, multi-center, placebo-controlled Phase 3 trials (Study 1 and Study 2), as well as data from an interim analysis of a long-term, open-label extension study in 330 Dravet syndrome patients treated up to 3 years.

    "After a healthy start in life, children with Dravet syndrome suffer from frequent and prolonged epileptic seizures, which determine the future of the child and mean that parents are on constant alert. Current treatments for Dravet syndrome are unsatisfactory, resulting in the disease affecting motor and mental development," said Dr. Tilman Polster, a pediatric epilepsy specialist at the Mara Hospital of the Bethel Epilepsy Centre in Bielefeld, Germany, and primary investigator for fenfluramine oral solution in Dravet syndrome in Germany. "Experience from clinical studies has shown that FINTEPLA offers an impressive reduction in seizures, plus an improvement in quality of life. In conjunction with the ongoing data being collected on the safety profile of the therapy, FINTEPLA represents an effective new treatment option and an important hope for the families concerned."

    When added to other antiepileptic therapies, including stiripentol, FINTEPLA provided a highly statistically significant and clinically meaningful reduction in convulsive seizure frequency. The most commonly reported adverse events that occurred in patients treated with this included decreased appetite, diarrhea, pyrexia, fatigue, upper respiratory tract infection, lethargy, somnolence and bronchitis.

    With this approval, and subject to price and reimbursement being implemented according to national regulations, Zogenix will be able to market FINTEPLA in all European Union member countries, and in the United Kingdom, Norway, Iceland, and Liechtenstein.

    Controlled Access Program

    FINTEPLA will be available in Europe under a controlled access program requested by the European Medicines Agency to prevent off-label use for weight management and to confirm that prescribing physicians have been informed of the need for periodic cardiac monitoring in patients taking FINTEPLA.

    Zogenix will also conduct the FINTEPLA Registry, an observational registry to provide data on long-term safety of FINTEPLA and frequency of echocardiographic monitoring in routine practice.

    Earlier this year, FINTEPLA was approved by the U.S. Food & Drug Administration (FDA) for the treatment of seizures associated with Dravet syndrome in patients aged two years and older. In addition, Zogenix recently reported positive results of a third Phase 3 study of FINTEPLA in Dravet syndrome to support planned registration in Japan, which corroborated the highly statistically significant and clinically meaningful convulsive seizure reductions seen in earlier multinational Phase 3 studies. FINTEPLA is also being studied for the potential treatment of seizures associated with other rare epilepsies.

    About Dravet Syndrome

    Dravet syndrome is a rare, devastating and life-long form of epilepsy that generally begins in infancy and is marked by frequent, treatment-resistant seizures, significant developmental, motor, and behavioral impairments, and an increased risk of sudden unexpected death in epilepsy (SUDEP). Affecting one in 15,700 live births in the U.S. and approximately one in 20,000 to 40,000 live births in Europe, most patients follow a course of developmental delay with cognitive, motor and behavioral deficits that persist into adulthood. Dravet syndrome severely impacts quality of life for patients, families and caregivers due to the high physical, emotional, caregiving, and financial burden associated with the disease.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare epilepsy, and one for MT1621, an investigational therapy for the treatment of a rare genetic disorder called TK2 deficiency (being developed through its subsidiary Modis Therapeutics). Zogenix is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for genetic rare epilepsies.

    Forward-Looking Statement

    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the potential that fenfluramine oral solution will be an important new treatment option for Dravet syndrome patients; Zogenix's plans to commercialize fenfluramine in Europe, including the timing of the launch. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: Zogenix's ability to successfully launch FINTEPLA, including launching a controlled access program implemented due to risks related to valvular heart disease and pulmonary arterial hypertension, and the conduct of the FINTEPLA Registry, and the timing thereof; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to commercialize FINTEPLA in Europe and Zogenix's ability to generate product revenue in Europe; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA in Europe; unexpected adverse side effects or inadequate therapeutic efficacy of fenfluramine that could limit commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 | 

    Investors

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 | 

    Media

    In Europe: Kerry Lloyd-Jones, Account Director, Porter Novelli

    +44 (0) 7949 794 290 |

    In the US: Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |

     



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  6. CAMBRIDGE, Mass. and EMERYVILLE, Calif., Dec. 3, 2020 /PRNewswire/ -- Tevard Biosciences, a privately-held biotechnology company pioneering tRNA-based gene therapies, and Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that the companies have entered into a collaboration to identify and develop novel tRNA-based gene therapies for Dravet syndrome and other genetic epilepsies.

    Under the collaboration, Tevard will utilize its two unique tRNA-based discovery platforms focused on mRNA Stabilization and Nonsense Codon Suppression to discover and advance novel drug candidates for the treatment of Dravet syndrome and other genetic epilepsies. Zogenix will further develop the candidates through advanced preclinical studies and clinical development, and be responsible for worldwide commercialization.

    Zogenix is responsible for funding the collaboration and, under the terms of the agreement, Tevard will receive an initial collaboration payment of $10 million, of which approximately $5 million has previously been paid by Zogenix. Tevard will also receive $5 million in the form of a convertible note. Tevard is also eligible to receive additional development, regulatory and commercial-related milestone payments ranging from $70 million to $100 million for each program, as well as tiered royalties on future net global sales on any commercial products that result from the collaboration.

    Tevard's unique tRNA technology platforms are designed to address underlying genetic mutations in a precise and regulated manner through the correction of nonsense mutations and the enhanced production of functional proteins. Together, these approaches hold promise to treat genetic disorders that are not well-suited to conventional gene replacement approaches.

    "We are pleased to announce our collaboration with Zogenix, whose commitment to developing new treatments for Dravet syndrome and other genetic epilepsies is unparalleled," said Daniel E. Fischer, Co-founder, President, and Chief Executive Officer at Tevard Biosciences. "Tevard has assembled a team of leading experts focused on developing our breakthrough tRNA-based gene therapy platforms. Our collaboration with Zogenix will advance our mission to bring transformative gene therapy products to those living with Dravet and other rare and severe genetic disorders.

    "We are thrilled to be working with an innovative company like Tevard to develop promising next-generation therapies," said Stephen J. Farr, Ph.D., President and Chief Executive Officer of Zogenix. "Through this important new collaboration, we have reinforced our long-term commitment to transforming the lives of rare epilepsy patients and their families, and look forward to sharing updates as our work together progresses."

    About Dravet Syndrome

    Dravet syndrome is a rare childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of death (SUDEP). In addition to the catastrophic impact on the patient, the severity and unpredictability of the seizures, coupled with around-the-clock concern for the diagnosed child's safety and well-being, can present significant emotional and logistical challenges for parents and all members of the family.

    About Tevard Biosciences

    Tevard Biosciences is a privately held biotechnology company pioneering tRNA-based gene therapies to cure rare and severe genetic diseases with limited or no approved treatment options. Tevard was founded by MIT Professor and Whitehead Institute Founding Member Harvey Lodish, Ph.D., with life science entrepreneurs and executives Daniel Fischer and Warren Lammert, fathers of children with Dravet syndrome. The company is developing and applying two novel tRNA-based gene therapy platforms, co-invented by Professor Lodish with Johns Hopkins School of Medicine Professor Jeff Coller, Ph.D. and University of Iowa Professor Chris Ahern, Ph.D., for Dravet syndrome and other rare diseases caused by haploinsufficiency and/or nonsense mutations that are not amenable to traditional approaches to gene therapy. For more information, please visit www.tevard.com.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and received a positive CHMP opinion in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a different rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

    Forward Looking Statements

    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the potential that the use tRNA-based discovery platforms will result in the discovery and advancement novel drug candidates for the treatment of genetic epilepsies; and Zogenix's intention to develop any drug candidates discovered through tRNA-based discovery platforms. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, uncertainties related to pharmaceutical product development, including whether any drug candidate will be discovered; results from preclinical or clinical studies may not support the continued development or commercialization of any discovered drug candidate; delays or disruptions in Zogenix's or Tevard's business operations due to the COVID-19 pandemic and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Tevard Biosciences 

    Investors and Media 

    Karen L. Bergman for Tevard

    +1 (650) 575-1509

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578

    Media

    Stefanie Tuck

    Vice President, Porter Novelli

    +1 (978) 390-1394

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/tevard-biosciences-and-zogenix-announce-collaboration-to-advance-novel-gene-therapies-for-dravet-syndrome-and-other-genetic-epilepsies-301186221.html

    SOURCE Tevard Biosciences

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    • New long-term safety, efficacy, and durability data for FINTEPLA® (fenfluramine) oral solution in Dravet syndrome

    • Full results from Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome

    • New data from investigator-initiated study in CDKL5 Deficiency Disorder

    EMERYVILLE, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, announced that data from eleven poster presentations related to FINTEPLA® (fenfluramine) oral solution in Dravet syndrome, Lennox-Gastaut syndrome, and other rare epilepsies will be presented at the American Epilepsy Society (AES) Annual Meeting, being held virtually from December 4-8, 2020. Zogenix will also host a virtual scientific…

    • New long-term safety, efficacy, and durability data for FINTEPLA® (fenfluramine) oral solution in Dravet syndrome



    • Full results from Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome



    • New data from investigator-initiated study in CDKL5 Deficiency Disorder

    EMERYVILLE, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, announced that data from eleven poster presentations related to FINTEPLA® (fenfluramine) oral solution in Dravet syndrome, Lennox-Gastaut syndrome, and other rare epilepsies will be presented at the American Epilepsy Society (AES) Annual Meeting, being held virtually from December 4-8, 2020. Zogenix will also host a virtual scientific exhibition room and sponsor a continuing medical education (CME) symposium during AES 2020.

    "We are honored to collaborate with leading international epilepsy experts to broaden our understanding of how FINTEPLA, a drug recently approved by the FDA to treat seizures associated with Dravet syndrome, may improve the lives of epilepsy patients and their families," said Zogenix's Chief Medical Officer Bradley S. Galer, M.D. "With new long-term data in Dravet syndrome, full results from our Lennox-Gastaut syndrome Phase 3 trial, and data from investigator-initiated studies, we are eager to continue advancing FINTEPLA as a potential new treatment option for additional rare epilepsies."

    Main Conference

    Full data for the FINTEPLA posters presented in the main conference will be available on the AES 2020 conference site starting this Friday, December 4, at 9:00 a.m. Eastern Time and will be available after AES on the Zogenix Newsroom site. Authors will be available to discuss their data with attendees during the following times:

    • Efficacy and Tolerability of Adjunctive FINTEPLA (Fenfluramine Hydrochloride) in an Open-Label Extension Study of Dravet Syndrome Patients Treated for Up to 3 Years

      Scheffer, Devinsky, Perry et al

      Poster #978

      Authors available: Monday, December 7, 1:303:00 PM ET
    • Treatment with FINTEPLA (Fenfluramine) in Patients with Dravet Syndrome has no Long-Term Effect on Weight and Growth

      Gil-Nagel, Ceulemans, Wirrell et al

      Poster #977

      Authors available: Monday, December 7, 1:303:00 PM ET
    • Fenfluramine (FINTEPLA) Provides Comparable Clinical Benefit in Adults and Children with Dravet Syndrome: Real-World Experience from the US Early Access Program

      Perry, Knupp, Wirrell, et al

      Poster #1057

      Authors available: Monday, December 7, 1:303:00 PM ET
    • The Long-Term Effects of Fenfluramine on Patients with Dravet Syndrome and Their Families: A Qualitative Analysis

      Jensen, Salem, Gammaitoni et al

      Poster #418

      Authors available: Sunday, December 6, 12:00 – 1:30 PM ET
    • University of Washington Caregiver Stress Scale Translations

      Amtmann, Bamer, Salem et al

      Poster #287

      Authors available: Sunday, December 6, 12:00 – 1:30 PM ET
    • Fenfluramine (FINTEPLA) in Dravet Syndrome: Results of a Third Randomized, Placebo-Controlled Clinical Trial

      Sullivan, Lagae, Cross et al

      Poster #853

      Authors available: Monday, December 7, 9:00 – 10:30 AM ET
    • Efficacy and Tolerability with FINTEPLA (Fenfluramine) in Adult Patients with Dravet Syndrome: A Case Series of Patients Participating in Phase 3 Studies

      Miller, Devinsky, Auvin et al

      Poster #849

      Authors available: Monday, December 7, 9:00 – 10:30 AM ET
    • Fenfluramine for the Treatment of Patients with Lennox-Gastaut Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

      Knupp, Lagae, Arzimaniglou et al

      Poster #852

      Authors available: Monday, December 7, 9:00 – 10:30 AM ET
    • Fenfluramine to Treat Convulsive Seizures in Patients with CDKL5 Deficiency Disorder

      Devinsky, King, and Price

      Poster #1060

      Authors available: Monday, December 7, 1:303:00 PM ET

    Scientific Exhibit Room

    All posters from the main conference above, plus the two additional Scientific Exhibit Room posters, will be available in the Zogenix Scientific Exhibit Room. Questions regarding data in the Scientific Exhibition Room will be answered during a live discussion on Sunday, December 6, from 8:00 – 11:00 a.m. Eastern Time.

    • Impact of FINTEPLA (Fenfluramine) on the Incidence Rate of SUDEP in Patients with Dravet Syndrome

      Cross, Galer, Gil-Nagel et al
    • Fenfluramine Prevents Audiogenic Seizures in a 129/SvTer Mouse Model of Sudden Unexpected Death in Epilepsy (SUDEP)

      Martin, Biraben, Harnandez et al

    Satellite Symposium:

    Zogenix is proud to sponsor the Industry CME Satellite Symposium: An Update on Rare Childhood-Onset Epilepsies, which will be held on Sunday, December 6, from 6:00 – 7:30 p.m. Eastern Time with the following speakers and topics:

    • Epileptic Encephalopathies: Phenotypic Evolution

      Elaine Wirrell, M.D., FRCPC (Program Chair)
    • Mechanisms of Epileptogenesis in a Zebrafish Model of Dravet Syndrome

      Camila V. Esguerra, Ph.D.,
    • An Update on Sunflower Syndrome: Clinical Features and Treatment Challenges

      Elizabeth Thiele, M.D., Ph.D.
    • An Update on CDKL5 Deficiency Disorder: Clinical Presentations, Genetic Variation, and Approaches to Treatment

      Orrin Devinsky, M.D.

    About Dravet Syndrome

    Dravet syndrome is a rare and devastating infant-onset epilepsy highly correlated with a mutation in the SCN1A gene. The disease is marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death (SUDEP). In addition to its impact on the patient, the severity and unpredictability of the disease, coupled with around-the-clock concern for the diagnosed child's well-being, can present significant emotional and logistical challenges for all members of the family.

    About Lennox-Gastaut Syndrome

    Lennox-Gastaut Syndrome (LGS) is a rare and devastating lifelong childhood-onset epilepsy that can arise from multiple different causes. LGS is characterized by many different seizure types, including many that result in frequent falls and injuries and that often don't respond to currently available seizure medications The intellectual and behavioral problems associated with LGS, as well as around-the-clock care requirements, add to the complexity of life with this disease.

    About CDKL5 Deficiency Disorder

    CDKL5 deficiency disorder is a rare developmental epileptic encephalopathy caused by mutations in the CDKL5 gene. The hallmarks are early-onset, intractable epilepsy and neurodevelopmental delay impacting cognitive, motor, speech, and visual function. Although rare, it one of the most common forms of genetic epilepsy.

    About FINTEPLA® (fenfluramine) oral solution

    FINTEPLA (fenfluramine) oral solution is approved in the United States, has received a positive CHMP opinion in Europe, and is in development in Japan for the treatment of seizures associated with Dravet syndrome, and is being investigated as a potential treatment for Lennox-Gastaut syndrome (LGS) and other rare and severe childhood-onset epilepsy disorders.

    United States

    IMPORTANT SAFETY INFORMATION

    Boxed WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION

    • There is an association between serotonergic drugs with 5HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension.
    • Echocardiogram assessments are required before, during, and after treatment with FINTEPLA.
    • FINTEPLA is available only through a restricted program called the FINTEPLA REMS.

    Contraindications

    FINTEPLA is contraindicated in patients with hypersensitivity to fenfluramine or any of the excipients in FINTEPLA and with concomitant use of, or within 14 days of the administration of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome.

    WARNINGS AND PRECAUTIONS

    Valvular Heart Disease and Pulmonary Arterial Hypertension (see boxed Warning)

    Because of the association between serotonergic drugs with 5‑HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension, cardiac monitoring via echocardiogram is required prior to starting treatment, during treatment, and after treatment with FINTEPLA concludes. Cardiac monitoring via echocardiogram can aid in early detection of this condition. In clinical trials of up to 3 years in duration, no patient receiving FINTEPLA developed valvular heart disease or pulmonary arterial hypertension.

    Monitoring

    Prior to starting treatment, patients must undergo an echocardiogram to evaluate for valvular heart disease and pulmonary arterial hypertension. Echocardiograms should be repeated every 6 months, and once 3-6 months post-treatment with FINTEPLA.

    If valvular heart disease or pulmonary arterial hypertension is observed on an echocardiogram, the prescriber must consider the benefits versus the risks of initiating or continuing treatment with FINTEPLA.

    FINTEPLA REMS Program (see boxed Warning)

    In the United States, FINTEPLA is available only through a restricted distribution program called the FINTEPLA REMS program. Prescribers must be certified by enrolling in the FINTEPLA REMS program. Prescribers must Counsel patients receiving FINTEPLA about the risk of valvular heart disease and pulmonary arterial hypertension, how to recognize signs and symptoms of valvular heart disease and pulmonary arterial hypertension, the need for baseline (pretreatment) and periodic cardiac monitoring via echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment. Patients must enroll in the REMS program and comply with ongoing monitoring requirements. The pharmacy must be certified by enrolling in the REMS program and must only dispense to patients who are authorized to receive FINTEPLA. Wholesalers and distributors must only distribute to certified pharmacies. Further information is available at www.FinteplaREMS.com or by telephone at 1-877-964-3649.

    Decreased Appetite and Decreased Weight

    FINTEPLA can cause decreases in appetite and weight. Decreases in weight appear to be dose related. Most patients resumed the expected measured increases in weight by the end of the open-label extension study. Weight should be monitored regularly during treatment with FINTEPLA and dose modifications should be considered if a decrease in weight is observed.

    Somnolence, Sedation, and Lethargy

    FINTEPLA can cause somnolence, sedation, and lethargy. Other central nervous system (CNS) depressants, including alcohol, could potentiate these effects of FINTEPLA. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA to gauge whether it adversely affects their ability to drive or operate machinery.

    Suicidal Behavior and Ideation

    Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior.

    Anyone considering prescribing FINTEPLA or any other AED must balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

    Withdrawal of Antiepileptic Drugs

    As with most AEDs, FINTEPLA should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered.

    Serotonin Syndrome

    Serotonin syndrome, a potentially life-threatening condition, may occur with FINTEPLA, particularly with concomitant administration of FINTEPLA with other serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (eg, St. John's Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA, dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the emergence of signs and symptoms of serotonin syndrome, which include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started.

    Increase in Blood Pressure

    FINTEPLA can cause an increase in blood pressure. Significant elevation in blood pressure, including hypertensive crisis, has been reported rarely in adult patients treated with fenfluramine, including patients without a history of hypertension. Monitor blood pressure in patients treated with FINTEPLA. In clinical trials of up to 3 years in duration, no patient receiving FINTEPLA developed hypertensive crisis.

    Glaucoma

    Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Consider discontinuing treatment with FINTEPLA in patients with acute decreases in visual acuity or ocular pain.

    Adverse Reactions

    The most common adverse reactions (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus.

    Drug Interactions

    Strong CYP1A2 and CYP2B6 Inducers: Coadministration with rifampin or a strong CYP1A2 and CYP2B6 inducer will decrease fenfluramine plasma concentrations.

    Consider an increase in FINTEPLA dosage when coadministered with rifampin or a strong CYP1A2 and CYP2B6 inducer.

    Use in Specific Populations

    Administration to patients with moderate or severe renal impairment or to patients with hepatic impairment is not recommended.

    Please see full Prescribing Information, including Boxed Warning, for additional important information on FINTEPLA.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, C-IV is approved by the U.S. FDA, has received positive CHMP opinion in Europe, and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, devastating infant-onset epilepsy. FINTEPLA is also in development for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare and devastating childhood-onset epilepsy. Through its subsidiary Modis Therapeutics, Zogenix is developing MT1621, an investigational novel deoxynucleoside substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder.

    Forward Looking Statements

    Zogenix cautions you that statements included in this press release and the poster presentations that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include Zogenix's development plans for FINTEPLA in Lennox-Gastaut syndrome (LGS) and CDKL5 deficiency disorder and for MT1621, and the potential clinical value that FINTEPLA provides for Dravet syndrome, LGS and CDKL5 deficiency disorder patients and their families. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the timing of enrollment or results of Zogenix's clinical trials; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to complete the planned studies of MT1621; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA or MT1621 that could limit development or commercialization, or that could result in recalls or product liability claims; additional data from Zogenix's ongoing studies may contradict or undermine the data reported for Dravet syndrome or other indications; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578

    Media

    Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394



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  7. EMERYVILLE, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that Stephen J. Farr, Ph.D., President and CEO, and Michael P. Smith, Executive Vice President, CFO, and Treasurer, will participate in a fireside chat on Wednesday, November 18, 2020, at the Stifel 2020 Virtual Healthcare Conference.

    Zogenix Fireside Chat Details 
    Date: Wednesday, November 18, 2020
    Time: 10:00 AM Eastern Time

    The fireside chat will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing…

    EMERYVILLE, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that Stephen J. Farr, Ph.D., President and CEO, and Michael P. Smith, Executive Vice President, CFO, and Treasurer, will participate in a fireside chat on Wednesday, November 18, 2020, at the Stifel 2020 Virtual Healthcare Conference.

    Zogenix Fireside Chat Details 
    Date: Wednesday, November 18, 2020
    Time: 10:00 AM Eastern Time

    The fireside chat will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and received a positive CHMP opinion in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a different rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.  

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578

    Media

    Stefanie Tuck

    Vice President, Porter Novelli

    +1 (978) 390-1394

     

    Primary Logo

    View Full Article Hide Full Article
    • FINTEPLA® (fenfluramine) oral solution launched in the U.S. in late July for Dravet syndrome with high enrollment of physicians and patients into the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) program

    • More than 300 patients prescribed FINTEPLA and enrolled in the FINTEPLA REMS program in the third quarter; over half of the patients were new to FINTEPLA
       
    • Received a positive opinion from the Committee for Medicinal Products for Human Use for FINTEPLA in Dravet syndrome; European approval of the Marketing Authorization Application anticipated by the end of 2020

    • Announced highly positive top-line results from third Phase 3 trial of FINTEPLA in Dravet syndrome (Study 3) to support a planned submission of a Japan New Drug Application in
    • FINTEPLA® (fenfluramine) oral solution launched in the U.S. in late July for Dravet syndrome with high enrollment of physicians and patients into the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) program



    • More than 300 patients prescribed FINTEPLA and enrolled in the FINTEPLA REMS program in the third quarter; over half of the patients were new to FINTEPLA

       
    • Received a positive opinion from the Committee for Medicinal Products for Human Use for FINTEPLA in Dravet syndrome; European approval of the Marketing Authorization Application anticipated by the end of 2020



    • Announced highly positive top-line results from third Phase 3 trial of FINTEPLA in Dravet syndrome (Study 3) to support a planned submission of a Japan New Drug Application in the third quarter of 2021

       
    • Ended the third quarter with $525 million in cash, cash equivalents, and marketable securities

    EMERYVILLE, Calif. , Nov. 09, 2020 (GLOBE NEWSWIRE) --  Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced financial results for the three and nine months ended September 30, 2020 and provided a corporate update. The Company will host a conference call today, Monday, November 9, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

    "This continues to be a very positive and rewarding year for Zogenix as our deeply experienced international teams successfully advance key clinical, regulatory, and commercial programs," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "The strong physician and patient adoption of FINTEPLA® in this early stage of our U.S. launch and the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP) speak to FINTEPLA's effectiveness, safety, and potential to provide meaningful and lasting seizure control for more Dravet syndrome patients. This increases our excitement for our next set of major FINTEPLA milestones – anticipated approval for Dravet syndrome in Europe later this year, regulatory submission for Dravet syndrome in Japan next year, and regulatory submissions for Lennox-Gastaut syndrome (LGS) in the U.S. and Europe, also next year."

    "Equally important," said Dr. Farr, "following a productive meeting with the U.S. Food and Drug Administration (FDA), we believe we have a clearly defined development and regulatory path for MT1621, our late-stage investigational therapy for the treatment of the often-fatal mitochondrial disease thymidine kinase 2 deficiency (TK2d), for which no approved therapies currently exist. Our goal is to have all required data in hand by the end of 2021 to enable a planned New Drug Application (NDA) submission in 2022."

    Corporate Update

    • FINTEPLA for the treatment of seizures associated with Dravet syndrome:



      °  Received FDA approval on June 25, 2020 and initiated U.S. commercial launch on July 27, 2020



      °  More than 360 prescribers had successfully completed Risk Evaluation and Mitigation Strategy (REMS) certification process by the end of September



      °  During the third quarter, more than 300 patients were prescribed FINTEPLA and enrolled in the FINTEPLA REMS program to become eligible to receive therapy, with approximately 90% completing echocardiograms. More than half of these patients were new to FINTEPLA.



      °  Received positive CHMP opinion in October 2020 for FINTEPLA in Dravet syndrome; anticipate European Medicines Agency approval by the end of 2020, and have ramped up preparations for a potential commercial launch in Europe in the first quarter of 2021



      °  Announced positive top-line results from third multinational (including Japan) Phase 3 study in Dravet syndrome; results corroborate highly statistically significant reductions in convulsive seizure frequency seen in two earlier Phase 3 studies of FINTEPLA in Dravet. Anticipate submission of a Japan NDA to Japan's Pharmaceutical and Medical Devices Agency in the third quarter of 2021
    • FINTEPLA for the treatment of seizures associated with LGS:



      °  Anticipate submitting supplemental NDA in the second quarter of 2021 following a successful Type C meeting in September clarifying regulatory path



      °  Anticipate submitting MAA with EMA in the third quarter of 2021



    • MT1621 for the treatment of TK2d:



      °  Recently held positive FDA meetings to discuss development path and data required to support planned NDA submission



      °  Company expects availability of all required data by end of 2021, and anticipates the submission of an NDA in first half of 2022

    Third Quarter 2020 Financial Results

    • The Company recorded $2.9 million in revenue for the third quarter ended September 30, 2020. This included product sales of FINTEPLA in the U.S. of  $1.5 million, in addition to $1.4 million in revenue as a result of the March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded $0.6 million in revenue for the corresponding period of 2019.



    • Research and development expenses for the third quarter ended September 30, 2020, totaled $34.4 million, up from $28.4 million in the third quarter ended September 30, 2019, as the Company expanded clinical activities in LGS and MT1621, partially offset by decreased spending in Dravet syndrome.



    • Selling, general and administrative expenses for the third quarter ended September 30, 2020, totaled $24.6 million, compared with $15.8 million in the third quarter ended September 30, 2019, as the Company continued investment related to the launch of FINTEPLA for the treatment of Dravet syndrome in the U.S. and prepared for potential launch in Europe.



    • Net loss for the third quarter ended September 30, 2020, was $60.1 million, or a net loss of $1.08 per share, compared with a net loss of $290.5 million, or a net loss of $6.75 per share, in the third quarter ended September 30, 2019. Net loss for the three months ended September 30, 2019, included $249.4 million of acquired in-process research and development consisting of existing research and development projects at the time of the Modis acquisition.     

    Nine Months Ended September 30, 2020 Financial Results Compared to Nine Months Ended September 30, 2019

    • The Company recorded $5.1 million in revenue for the nine months ended September 30, 2020. This included product sales of FINTEPLA in the U.S. of $1.5 million, in addition to $3.6 million in revenue as a result of the March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded $1.7 million in revenue for the corresponding period of 2019.



    • Research and development expenses for the nine months ended September 30, 2020, totaled $102.0 million, up from $79.8 million in the nine months ended September 30, 2019, as the Company expanded clinical activities in LGS and MT1621, partially offset by decreased spending in Dravet syndrome.



    • Selling, general and administrative expenses for the nine months ended September 30, 2020, totaled $70.3 million, up from $42.1 million in the nine months ended September 30, 2019, as the Company continued investment related to the launch of FINTEPLA for the treatment of Dravet syndrome in the U.S. and prepared for prospective launch in Europe.



    • Net loss for the nine months ended September 30, 2020, was $139.2 million, or a net loss of $2.62 per share, compared with a net loss of $363.4 million, or a net loss of $8.54 per share, in the nine months ended September 30, 2019.



    • As of September 30, 2020, the Company had $525.2 million in cash, cash equivalents, and marketable securities, reflecting the issuance of a $200 million convertible bond on September 28, 2020, compared to $251.2 million at December 31, 2019.

    Conference Call

    Monday, November 9 at 4:30 PM Easter Time / 1:30 PM Pacific Time

    Toll Free:                     877-407-9716
    International:               201-493-6779
    Conference ID:           13711927
    Webcast:                     http://public.viavid.com/index.php?id=141969

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and received a positive CHMP opinion in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a different rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company. 

    Forward Looking Statements

    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the potential that FINTEPLA, if approved by the EC, will be an important new treatment option for Dravet syndrome patients; and the timing and results of any decision regarding the MAA for FINTEPLA for the treatment of seizures associated with Dravet syndrome. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the EC may not agree with the Company's interpretation of the clinical data submitted in the MAA; the EC may not affirm the CHMP opinion and grant a centralized marketing authorization; additional data from Zogenix's ongoing studies may contradict or undermine the data submitted in the Dravet syndrome MAA for FINTEPLA or reported for LGS; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578

    Media

    Stefanie Tuck

    Vice President, Porter Novelli

    +1 (978) 390-1394

    Zogenix, Inc.

    Condensed Consolidated Balance Sheets (Unaudited)

    (in thousands)

     September 30, 2020 December 31, 2019
    Assets:   
    Current assets:   
    Cash and cash equivalents$297,460  $62,070 
    Marketable securities227,707  189,085 
    Accounts receivable, net1,309   
    Inventory1,010   
    Prepaid expenses and other current assets12,905  11,084 
    Acquisition holdback placed in escrow25,000  25,000 
    Total current assets565,391  287,239 
    Property and equipment, net9,050  9,424 
    Operating lease right-of-use assets8,002  7,774 
    Intangible asset, net100,529  102,500 
    Goodwill6,234  6,234 
    Other noncurrent assets2,840  1,079 
    Total assets$692,046  $414,250 
    Liabilities and stockholders' equity:   
    Current liabilities:   
    Accounts payable$7,223  $7,979 
    Accrued and other current liabilities31,882  30,117 
    Acquisition holdback liability24,444  24,444 
    Deferred revenue, current4,900  5,927 
    Current portion of operating lease liabilities1,654  1,322 
    Current portion of contingent consideration22,200  25,600 
    Total current liabilities92,303  95,389 
    Deferred revenue, noncurrent6,331  7,425 
    Operating lease liabilities, net of current portion10,660  10,752 
    Contingent consideration, net of current portion32,700  38,200 
    Convertible senior notes127,960   
    Deferred tax liability  17,425 
    Total liabilities269,954  169,191 
    Commitments and contingencies   
    Stockholders' equity:   
    Common stock56  45 
    Additional paid-in capital1,676,408  1,360,092 
    Accumulated deficit(1,254,670) (1,115,457)
    Accumulated other comprehensive income298  379 
    Total stockholders' equity422,092  245,059 
    Total liabilities and stockholders' equity$692,046  $414,250 

    Zogenix, Inc.

    Condensed Consolidated Statements of Operations (Unaudited)

    (in thousands, except per share amounts)

     Three Months Ended September 30, Nine Months Ended September 30,
     2020 2019 2020 2019
    Revenues:       
    Net product sales$1,520  $  $1,520  $ 
    Collaboration revenue1,340  630  3,621  1,699 
    Total revenues2,860  630  5,141  1,699 
    Costs and expenses:       
    Cost of product sales (excluding amortization of intangible asset)140    140   
    Research and development34,425  28,372  102,038  79,820 
    Selling, general and administrative24,583  15,762  70,332  42,139 
    Amortization of intangible asset1,971    1,971   
    Acquired in-process research and development and acquisition-related costs1,500  249,437  4,500  249,437 
    Change in fair value of contingent consideration1,800  400  6,100  2,700 
    Total costs and expenses64,419  293,971  185,081  374,096 
    Loss from operations(61,559) (293,341) (179,940) (372,397)
    Other income, net934  481  20,798  433 
    Interest income, net536  2,382  2,504  8,521 
    Loss before income taxes(60,089) (290,478) (156,638) (363,443)
    Income tax benefit    (17,425)  
    Net loss$(60,089) $(290,478) $(139,213) $(363,443)
            
    Net loss per share, basic and diluted$(1.08) $(6.75) $(2.62) $(8.54)
            
    Weighted average number of shares used in the calculation of basic and diluted net loss per common share55,548  43,029  53,039  42,577 

     

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  8. EMERYVILLE, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that it has changed the date of its previously announced earnings release and earnings call. The Company will now report its financial results for the three and nine months ended September 30, 2020 and host a corporate update conference call and webcast after the market close on Monday, November 9, 2020, at 4:30 PM Eastern Time.

    Conference Call Details
    Monday, November 9, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
    Toll Free:877-407-9716
    International:201-493-6779
    Conference ID:13711927
    Webcast:

    http://public.viavid.com/index.php?id=141969

    About Zogenix
    Zogenix is a global biopharmaceutical…

    EMERYVILLE, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that it has changed the date of its previously announced earnings release and earnings call. The Company will now report its financial results for the three and nine months ended September 30, 2020 and host a corporate update conference call and webcast after the market close on Monday, November 9, 2020, at 4:30 PM Eastern Time.

    Conference Call Details

    Monday, November 9, at 4:30 PM Eastern Time / 1:30 PM Pacific Time

    Toll Free:877-407-9716
    International:201-493-6779
    Conference ID:13711927
    Webcast:



    http://public.viavid.com/index.php?id=141969



    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and received a positive CHMP opinion in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a different rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

    Zogenix 

    Melinda Baker 

    Senior Director, Corporate Communications 

    +1 (510) 788-8732 |  

    Investors 

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC 

    +1 (212) 915-2578 |  

    Media 

    In Europe: Kerry Lloyd-Jones, Account Director, Porter Novelli

    +44 (0) 7949 794 290 |

    In the US: Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |

    Primary Logo

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  9. EMERYVILLE, Calif., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that it will report its financial results for the three and nine months ended September 30, 2020 and host a corporate update conference call and webcast after the market close on Tuesday, November 10, 2020, at 4:30 PM Eastern Time.

    Conference Call Details
    Tuesday, November 10, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
    Toll Free:877-407-9716
    International:201-493-6779
    Conference ID:13711927
    Webcast:                
    http://public.viavid.com/index.php?id=141969

    About Zogenix
    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the…

    EMERYVILLE, Calif., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that it will report its financial results for the three and nine months ended September 30, 2020 and host a corporate update conference call and webcast after the market close on Tuesday, November 10, 2020, at 4:30 PM Eastern Time.

    Conference Call Details

    Tuesday, November 10, at 4:30 PM Eastern Time / 1:30 PM Pacific Time

    Toll Free:877-407-9716
    International:201-493-6779
    Conference ID:13711927
    Webcast:                

    http://public.viavid.com/index.php?id=141969

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and received a positive CHMP opinion in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a different rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

    Zogenix 

    Melinda Baker 

    Senior Director, Corporate Communications 

    +1 (510) 788-8732 |  

    Investors 

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC 

    +1 (212) 915-2578 |  

    Media 

    In Europe: Kerry Lloyd-Jones, Account Director, Porter Novelli

    +44 (0) 7949 794 290 |

    In the US: Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |

     

    Primary Logo

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    • Dravet syndrome is a rare, life-long, infant- and childhood-onset epilepsy associated with severe, treatment-resistant seizures

    • CHMP positive opinion based on Phase 3 study data that demonstrated FINTEPLA® significantly reduced convulsive seizure frequency in patients whose seizures were not adequately controlled on other medications, including stiripentol

    • Final decision on Marketing Authorization Application expected by year-end 2020

    EMERYVILLE, Calif., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that the Committee for Medicinal Products for Human Use (CHMP), a part of the European Medicines Agency (EMA), has adopted a positive opinion recommending…

    • Dravet syndrome is a rare, life-long, infant- and childhood-onset epilepsy associated with severe, treatment-resistant seizures



    • CHMP positive opinion based on Phase 3 study data that demonstrated FINTEPLA® significantly reduced convulsive seizure frequency in patients whose seizures were not adequately controlled on other medications, including stiripentol



    • Final decision on Marketing Authorization Application expected by year-end 2020

    EMERYVILLE, Calif., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that the Committee for Medicinal Products for Human Use (CHMP), a part of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization of FINTEPLA® (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome, a rare and devastating infant- and childhood onset epilepsy, as an add-on therapy to other antiepileptic medicines for patients two years of age and older. The European Commission (EC) is expected to make a final decision on the company's Marketing Authorization Application (MAA) by the end of the year.

    "We are pleased that the CHMP's regulatory review of FINTEPLA for quality, safety, and efficacy has resulted in their positive opinion," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "We began our rigorous global development program for FINTEPLA nearly six years ago after researchers in Belgium recognized the potential of fenfluramine, a drug with distinct pharmacology from all other anticonvulsant agents, to treat intractable seizures in Dravet syndrome. Many Dravet syndrome patients continue to experience frequent severe seizures even while taking one or more currently available anti-seizure medications. For this reason, we are excited to be another step closer to potentially introducing FINTEPLA as an important new treatment option for these patients and their families in Europe."

    "Reducing seizure frequency is the first and most important step in treating all Dravet syndrome children, regardless of age," said Lieven Lagae, M.D, Ph.D., Full Professor and Head of Pediatric Neurology Department at the University Hospitals of Leuven in Belgium. "I am thrilled that all Phase 3 studies with fenfluramine demonstrated a clinically meaningful, highly statistically significant decrease of seizure frequency in Dravet syndrome patients."

    The MAA for FINTEPLA included positive results from two randomized, controlled Phase 3 trials (Study 1 and Study 2), together with an interim analysis of an ongoing long-term, open-label extension study involving a total of 330 Dravet syndrome patients. These studies demonstrated that adjunctive fenfluramine treatment provided a highly statistically significant and clinically meaningful reduction in convulsive seizure frequency compared to placebo and was generally well-tolerated. In one of the trials, Study 2, all subjects were treated with a background regimen that included stiripentol, with significant improvement observed for FINTEPLA over placebo. The long-term, open-label extension study demonstrated durable efficacy, with patients in that study treated for up to three years with FINTEPLA. The most commonly reported adverse events experienced during these studies were decreased appetite, diarrhea, pyrexia, fatigue, upper respiratory tract infection, lethargy, somnolence and bronchitis.1,2,3 No patient developed any cardiovascular adverse events, including valvular heart disease or pulmonary arterial hypertension.

    If authorized by the EC, FINTEPLA will be approved for use by patients with Dravet syndrome aged two years and older in all European Union member states, as well as the United Kingdom, Iceland, Liechtenstein and Norway. The product is expected to be made available under a controlled access program to ensure regular cardiac monitoring and to mitigate potential off-label use for weight management.

    Earlier this year, FINTEPLA was approved by the U.S. Food & Drug Administration (FDA) for the treatment of seizures associated with Dravet syndrome in patients aged two years and older. A third positive Phase 3 clinical trial (Study 3) was recently reported to support registration of FINTEPLA in Japan.

    About Dravet Syndrome 

    Dravet syndrome is a rare, devastating and life-long form of epilepsy that begins in infancy and is marked by frequent, treatment-resistant seizures, significant developmental, motor, and behavioral impairments, and an increased risk of sudden unexpected death in epilepsy. Affecting one in 15,700 individuals in the U.S. and approximately one in 20,000 to 40,000 in Europe, most patients follow a course of developmental delay with cognitive, motor and behavioral deficits that persist into adulthood. Dravet syndrome severely impacts quality of life for patients, families and caregivers due to the high physical, emotional, and financial burden associated with the disease.4,5,6,7

      

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and has received a positive CHMP opinion in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy in patients aged two and older. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a different rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

    Forward-Looking Statement        

    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the potential that FINTEPLA, if approved by the EC, will be an important new treatment option for Dravet syndrome patients; and the timing and results of any decision regarding the MAA for FINTEPLA for the treatment of seizures associated with Dravet syndrome. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the EC may not agree with the Company's interpretation of the clinical data submitted in the MAA; the EC may not affirm the CHMP opinion and grant a centralized marketing authorization; additional data from Zogenix's ongoing studies may contradict or undermine the data submitted in the Dravet syndrome MAA for FINTEPLA or reported for LGS; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS: 

    Zogenix 

    Melinda Baker 

    Senior Director, Corporate Communications 

    +1 (510) 788-8732 |  

    Investors 

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC 

    +1 (212) 915-2578 |  

    Media 

    In Europe: Kerry Lloyd-Jones, Account Director, Porter Novelli

    +44 (0) 7949 794 290 |

    In the US: Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |

    1 Lagae L, Sullivan J, Knupp K, et al. Fenfluramine hydrochloride for the treatment of seizures in Dravet syndrome: a randomised, double-blind, placebo-controlled trial. Lancet. 2020;394:2243-2254.

    2 Nabbout R, Mistry A, Zuberi S, et al. Fenfluramine for treatment-resistant seizures in patients with Dravet syndrome receiving stiripentol-inclusive regimens. JAMA Neurol. 2020;77:300-308.

    3 Sullivan J, Auvin S, Pringsheim M, et al. Long-term (2-year) safety and efficacy of adjunctive ZX008 (fenfluramine hydrochloride oral solution) for Dravet syndrome: Interim results of an ongoing open-label extension study. Originally scheduled for presentation at the cancelled American Academy of Neurology 2020 Annual Meeting. Program number S31.007. 

    4 Aras LM, Isla J, Mingorance-Le Meur A. The European patient with Dravet syndrome: results from a parent-reported survey on antiepileptic drug use in the European population with Dravet syndrome. Epilepsy Behav. 2015;44:104-9.

    5 Lagae L, Brambilla I, Mingorance A, et al. Quality of life and comorbidities associated with Dravet syndrome severity: a multinational cohort survey. Dev Med Child Neurol. 2018;60:63-72.

    6 Sullivan J, Knupp K, Wirrel E. Rare disease database: Dravet syndrome. National Organization of Rare Diseases. Available at: https://rarediseases.org/rare-diseases/dravet-syndrome-spectrum/. Last updated: 2018. Last accessed: September 2020.

    7 Villas N, Meskis MA, Goodliffe S. Dravet syndrome: characteristics, comorbidities, and caregiver concerns. Epilepsy Behav. 2017;74:81-86.

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    • Interim data from open-label extension trial showed substantial seizure reductions were maintained in patients treated with FINTEPLA® for up to two years
    • Post-hoc analysis demonstrated NNTs (Number Needed to Treat) to achieve a clinically meaningful response compared favorably to similar studies of other Dravet syndrome therapies

    EMERYVILLE, Calif., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, shared new data analyses for FINTEPLA® (fenfluramine) oral solution in Dravet syndrome at the Child Neurology Society and International Child Neurology Congress (CNS/ICNA) 2020. Dravet syndrome is a rare, highly refractory form of infant- and childhood-onset epilepsy…

    • Interim data from open-label extension trial showed substantial seizure reductions were maintained in patients treated with FINTEPLA® for up to two years
    • Post-hoc analysis demonstrated NNTs (Number Needed to Treat) to achieve a clinically meaningful response compared favorably to similar studies of other Dravet syndrome therapies

    EMERYVILLE, Calif., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, shared new data analyses for FINTEPLA® (fenfluramine) oral solution in Dravet syndrome at the Child Neurology Society and International Child Neurology Congress (CNS/ICNA) 2020. Dravet syndrome is a rare, highly refractory form of infant- and childhood-onset epilepsy marked by frequent and often prolonged seizures that are difficult to control with existing medications, significant cognitive and motor impairments, and a higher risk of sudden death.

    "In addition to the significant convulsive seizure reductions seen in all three multi-national Phase 3 studies of FINTEPLA in Dravet syndrome, we are proud to collaborate with expert clinician investigators to show the durability of the clinically meaningful seizure reduction that FINTEPLA provided for patients treated for up to two years," said Bradley S. Galer, M.D., Executive Vice President and Chief Medical Officer at Zogenix. "Furthermore, new post-hoc data analysis from our studies demonstrated that for every two to three patients treated with FINTEPLA, one patient achieved ≥75% (profound) convulsive seizure reduction compared with placebo. We believe these new data analyses further showcase the clinical value that FINTEPLA provides for many Dravet syndrome patients and their families."

    The company's CNS 2020 posters are now available in the Zogenix Newsroom and include:

    • Long-Term (2-Year) Safety and Efficacy of Adjunctive ZX008 (Fenfluramine HCl) for Dravet Syndrome: Interim Results of an Ongoing Open-Label Extension Study

      (Sullivan, Auvin, Pringsheim et al)



    • Number Needed to Treat (NNT) with Fenfluramine to Achieve a Clinically Meaningful Reduction in Convulsive Seizure Frequency in Patients with Dravet Syndrome

      (Sullivan, Dlugos, Nabbout et al)



    • Quantifying "Clinically Meaningful Changes" in Seizure Frequency—Data From 3 Phase 3 Studies of ZX008 (Fenfluramine Hydrochloride Oral Solution) in Dravet Syndrome: Do Expectations and Views Change Over Time?

      (Gammaitoni, Sullivan, Dlugos et al)

    About Dravet Syndrome

    Dravet syndrome is a rare childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death. Despite existing therapies, there remains a great unmet need in Dravet syndrome to reduce convulsive seizures that can lead to medical emergencies, hospitalizations, and SUDEP (sudden unexpected death in epilepsy). The severity and unpredictability of the disease, coupled with around-the-clock concern for the diagnosed child's well-being, can present significant emotional and logistical challenges for all members of the family.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, C-IV has been approved by the U.S. FDA, is under review in Europe, and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. FINTEPLA is also in development for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare childhood-onset epilepsy. Through its subsidiary Modis Therapeutics, Zogenix is also developing MT1621, an investigational novel deoxynucleoside substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder.

    Forward Looking Statements

    Zogenix cautions you that statements included in this press release and the poster presentations that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include Zogenix's development plans for FINTEPLA in Lennox-Gastaut syndrome and for MT1621, and the potential clinical value that FINTEPLA provides for Dravet syndrome patients and their families. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the timing of enrollment or results of Zogenix's clinical trials; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to complete the planned studies of MT1621; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA or MT1621 that could limit development or commercialization, or that could result in recalls or product liability claims; additional data from Zogenix's ongoing studies may contradict or undermine the data reported for Dravet syndrome; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578

    Media

    Stefanie Tuck

    Vice President, Porter Novelli

    +1 (978) 390-1394

    Primary Logo

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  10. EMERYVILLE, Calif., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that the initial purchasers of the previously announced offering of its 2.75% convertible senior notes due 2027 in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended, elected to exercise in full their 13-day option to purchase an additional $30,000,000 aggregate principal amount of the notes (the "additional notes"). The sale of the additional notes closed today.

    The additional notes have identical terms to the 2.75% convertible senior notes due 2027 sold on September 28, 2020 (the "original notes" and, together…

    EMERYVILLE, Calif., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that the initial purchasers of the previously announced offering of its 2.75% convertible senior notes due 2027 in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended, elected to exercise in full their 13-day option to purchase an additional $30,000,000 aggregate principal amount of the notes (the "additional notes"). The sale of the additional notes closed today.

    The additional notes have identical terms to the 2.75% convertible senior notes due 2027 sold on September 28, 2020 (the "original notes" and, together with the additional notes, the "notes") and, following today's closing, there is a total of $230,000,000 aggregate principal amount of notes outstanding. The aggregate net proceeds from the offering of the notes was approximately $222.7 million after deducting the initial purchasers' discounts and commissions and estimated expenses payable by Zogenix. Zogenix intends to use the net proceeds from the offering to fund development and commercialization of Fintepla in Dravet syndrome, Lennox-Gastaut syndrome, and other potential indications, to fund the development of MT1621 in TK2 deficiency and other general corporate purposes, such as working capital and general and administrative expenses.

    The offer and sale of the notes and any shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and any such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes or any shares of common stock issuable upon conversion of the notes, nor will there be any sale of the notes or any such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, C-IV has been approved by the U.S. FDA and is under review in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. In addition, the company has two late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the anticipated use of proceeds from the offering. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties inherent in Zogenix's business, including those described in the company's periodic filings with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Zogenix can be found under the heading "Risk Factors" in Zogenix's periodic reports, including its annual report on Form 10-K for the year ended December 31, 2019 and its quarterly report on form 10-Q for the quarterly period ended June 30, 2020, each of which are available on the SEC's web site at www.sec.gov. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    Contact Information

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 |  

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 |  

    Primary Logo

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  11. EMERYVILLE, Calif., Oct. 02, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, and its subsidiary Modis Therapeutics, shared new data and information about MT1621, the company's investigational therapy for Thymidine kinase 2 deficiency (TK2d), at this week's International Congress of the World Muscle Society (WMS 2020). TK2d is an inherited mitochondrial DNA depletion syndrome that primarily affects infants and children and is often fatal.

    "These new analyses highlight the unmet need in TK2 deficiency and underscore the important progress we are making in our MT1621 development program," said Joanne Quan, M.D., Chief Medical Officer for Modis Therapeutics…

    EMERYVILLE, Calif., Oct. 02, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, and its subsidiary Modis Therapeutics, shared new data and information about MT1621, the company's investigational therapy for Thymidine kinase 2 deficiency (TK2d), at this week's International Congress of the World Muscle Society (WMS 2020). TK2d is an inherited mitochondrial DNA depletion syndrome that primarily affects infants and children and is often fatal.

    "These new analyses highlight the unmet need in TK2 deficiency and underscore the important progress we are making in our MT1621 development program," said Joanne Quan, M.D., Chief Medical Officer for Modis Therapeutics. "We are excited to be collaborating with researchers and clinicians internationally to understand and develop a treatment for this devastating disease."

    The company's WMS 2020 posters, now available on the Zogenix Newsroom, include:

    1. MOA: MT1621 for Thymidine kinase 2 deficiency (TK2d) Mechanism of Action is via Mitochondrial DNA Incorporation

      (Seves, Kenny, Blazquez Bermejo et al)



    2. Modis Untreated Dataset: Analysis of Morbidity and Mortality in Untreated Patients with Thymidine Kinase 2 Deficiency

      (Domínguez-González, Garone, D'Souza et al)



    3. Collaborative Model for Diagnosis and Treatment of Very Rare Diseases: Experience in Spain with Thymidine Kinase 2 Deficiency

      (Paradas, Domínguez-González, Madruga-Garrido et al)



    4. Study 104 Protocol: Design of a Prospective Clinical Study for the Treatment of Thymidine Kinase 2 Deficiency (TK2d)

      (Hirano; Ali, Dominguez-Gonzalez, et al)

    About TK2 Deficiency

    Thymidine kinase 2 deficiency (TK2d) is a genetic disorder that primarily affects infants and young children and results in mitochondrial dysfunction, leading to inadequate energy production in cells. The disease presents as progressive and severe muscle weakness that profoundly impairs movement, breathing, eating, and other normal functions, and is often fatal. There are currently no approved therapies for this disease. To learn more, please visit www.tk2d.com.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, C-IV has been approved by the U.S. FDA, is under review in Europe, and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. FINTEPLA is also in development for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare childhood-onset epilepsy.

    Through its subsidiary Modis Therapeutics, Zogenix is also developing MT1621, an investigational novel deoxynucleoside substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. Deoxynucleoside combination therapy has been shown to improve cell function and prolong life in preclinical models of TK2d. Data from initial clinical studies suggest that this therapy may meaningfully alter the course of disease in patients with TK2d. The company plans to conduct a Phase 1 pharmacokinetic study in renal impairment and is compiling additional data required to submit a new drug application (NDA) for MT1621, which is expected to be submitted in the first half of 2022.

    Forward Looking Statements

    Zogenix cautions you that statements included in this press release and the poster presentations that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include Zogenix's development plan for MT1621, including the timing of the submission of an NDA to the U.S. FDA. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the timing of enrollment or results of Study 104 or the planned Phase 1 pharmacokinetic study in renal impairment may be delayed; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to complete the planned studies of MT1621; unexpected adverse side effects or inadequate therapeutic efficacy of MT1621 that could limit development or commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578

    Media

    Stefanie Tuck

    Vice President, Porter Novelli

    +1 (978) 390-1394

     

    Primary Logo

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  12. EMERYVILLE, Calif., Sept. 23, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX) today announced the pricing of its offering of $200,000,000 aggregate principal amount of 2.75% convertible senior notes due 2027 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The issuance and sale of the notes are scheduled to settle on September 28, 2020, subject to customary closing conditions. Zogenix also granted the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date notes are first issued, up to an additional $30,000,000 principal amount of notes.

    The notes will…

    EMERYVILLE, Calif., Sept. 23, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX) today announced the pricing of its offering of $200,000,000 aggregate principal amount of 2.75% convertible senior notes due 2027 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The issuance and sale of the notes are scheduled to settle on September 28, 2020, subject to customary closing conditions. Zogenix also granted the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date notes are first issued, up to an additional $30,000,000 principal amount of notes.

    The notes will be senior, unsecured obligations of Zogenix and will accrue interest at a rate of 2.75% per annum, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2021. The notes will mature on October 1, 2027, unless earlier repurchased, redeemed or converted. Before July 1, 2027, noteholders will have the right to convert their notes only upon the occurrence of certain events. From and after July 1, 2027, noteholders may convert their notes at any time at their election until the close of business on the second scheduled trading day immediately before the maturity date. Zogenix will settle conversions by paying or delivering, as applicable, cash, shares of its common stock or a combination of cash and shares of its common stock, at Zogenix's election. The initial conversion rate is 41.1794 shares of common stock per $1,000 principal amount of notes, which represents an initial conversion price of approximately $24.28 per share of common stock. The initial conversion price represents a premium of approximately 30% over the last reported sale of $18.68 per share of Zogenix's common stock on September 23, 2020. The conversion rate and conversion price will be subject to adjustment upon the occurrence of certain events.

    The notes will be redeemable, in whole or in part, for cash at Zogenix's option at any time, and from time to time, on or after October 7, 2024 and on or before the 40th scheduled trading day immediately before the maturity date, but only if the last reported sale price per share of Zogenix's common stock exceeds 130% of the conversion price for a specified period of time. The redemption price will be equal to the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date. If Zogenix elects to redeem less than all of the notes, at least $50.0 million aggregate principal amount of notes must be outstanding and not subject to redemption as of the relevant redemption notice date.

    If a "fundamental change" (as defined in the indenture for the notes) occurs, then, subject to a limited exception, noteholders may require Zogenix to repurchase their notes for cash. The repurchase price will be equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date.

    Zogenix estimates that the net proceeds from the offering will be approximately $193.6 million (or approximately $222.7 million if the initial purchasers fully exercise their option to purchase additional notes), after deducting the initial purchasers' discounts and commissions and estimated offering expenses. Zogenix intends to use the net proceeds from the offering to fund development and commercialization of Fintepla in Dravet syndrome, Lennox-Gastaut syndrome, and other potential indications, to fund the development of MT1621 in TK2 deficiency and other general corporate purposes, such as working capital and general and administrative expenses.

    The offer and sale of the notes and any shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and any such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes or any shares of common stock issuable upon conversion of the notes, nor will there be any sale of the notes or any such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, C-IV has been approved by the U.S. FDA and is under review in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. In addition, the company has two late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding Zogenix's expectations of the completion and timing of the offering and the anticipated use of proceeds therefrom. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the offering, as well as risks and uncertainties inherent in Zogenix's business, including those described in the company's periodic filings with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Zogenix can be found under the heading "Risk Factors" in Zogenix's periodic reports, including its annual report on Form 10-K for the year ended December 31, 2019 and its quarterly report on form 10-Q for the quarterly period ended June 30, 2020, each of which are available on the SEC's web site at www.sec.gov. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    Contact Information

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 |

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 |

    Primary Logo

    View Full Article Hide Full Article
  13. EMERYVILLE, Calif., Sept. 22, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX) today announced its intention to offer, subject to market and other conditions, $200,000,000 aggregate principal amount of convertible senior notes due 2027 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). Zogenix also expects to grant the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date notes are first issued, up to an additional $30,000,000 principal amount of notes.

    The notes will be senior, unsecured obligations of Zogenix, will accrue interest payable semi-annually…

    EMERYVILLE, Calif., Sept. 22, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX) today announced its intention to offer, subject to market and other conditions, $200,000,000 aggregate principal amount of convertible senior notes due 2027 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). Zogenix also expects to grant the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date notes are first issued, up to an additional $30,000,000 principal amount of notes.

    The notes will be senior, unsecured obligations of Zogenix, will accrue interest payable semi-annually in arrears and will mature on October 1, 2027, unless earlier repurchased, redeemed or converted. Noteholders will have the right to convert their notes in certain circumstances and during specified periods. Zogenix will settle conversions by paying or delivering, as applicable, cash, shares of its common stock or a combination of cash and shares of its common stock, at Zogenix's election. The notes will be redeemable, in whole or in part, for cash at Zogenix's option at any time, and from time to time, on or after October 7, 2024 and on or before the 40th scheduled trading day immediately before the maturity date, but only if the last reported sale price per share of Zogenix's common stock exceeds 130% of the conversion price for a specified period of time. The redemption price will be equal to the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date. The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.

    Zogenix intends to use the net proceeds from the offering to fund development and commercialization of Fintepla in Dravet syndrome, Lennox-Gastaut syndrome, and other potential indications, to fund the development of MT1621 in TK2 deficiency and other general corporate purposes, such as working capital and general and administrative expenses.

    The offer and sale of the notes and any shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and any such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes or any shares of common stock issuable upon conversion of the notes, nor will there be any sale of the notes or any such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, C-IV has been approved by the U.S. FDA and is under review in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. In addition, the company has two late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding Zogenix's expectations of the completion, timing and size of the proposed offering and the anticipated use of proceeds therefrom. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering, as well as risks and uncertainties inherent in Zogenix's business, including those described in the company's periodic filings with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Zogenix can be found under the heading "Risk Factors" in Zogenix's periodic reports, including its annual report on Form 10-K for the year ended December 31, 2019 and its quarterly report on form 10-Q for the quarterly period ended June 30, 2020, each of which are available on the SEC's web site at www.sec.gov. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    Contact Information

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 |

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 |

    Primary Logo

    View Full Article Hide Full Article
  14. Correction: In this updated news release issued September 21, 2020 by Zogenix, Inc, the name of the organization, WorldWideWomen, has been corrected. The full corrected press release follows.

    EMERYVILLE, Calif., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced the appointments of Caroline M. Loewy, Mary E. Stutts and Denelle J. Waynick to newly created seats on its Board of Directors, effective immediately. Zogenix's Board now includes 10 members, nine of whom are independent.

    "We are delighted to welcome Ms. Loewy, Ms. Stutts and Ms. Waynick to our Board of Directors," said Cam L. Garner, Chairman of the Board. "Their combined…

    Correction: In this updated news release issued September 21, 2020 by Zogenix, Inc, the name of the organization, WorldWideWomen, has been corrected. The full corrected press release follows.

    EMERYVILLE, Calif., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced the appointments of Caroline M. Loewy, Mary E. Stutts and Denelle J. Waynick to newly created seats on its Board of Directors, effective immediately. Zogenix's Board now includes 10 members, nine of whom are independent.

    "We are delighted to welcome Ms. Loewy, Ms. Stutts and Ms. Waynick to our Board of Directors," said Cam L. Garner, Chairman of the Board. "Their combined decades of experience in the biopharmaceutical industry and extensive knowledge in the areas of patient and rare disease advocacy, investor relations, corporate communications, public affairs, international operations, and legal affairs will prove invaluable to our team as Zogenix continues to evolve as a commercial-stage rare disease company. We look forward to their strategic insights and contributions to our long-term growth initiatives."

    Caroline M. Loewy

    Ms. Loewy has more than 25 years of experience in the biopharmaceutical industry and currently serves as a strategic business and financial advisor to life science companies. She has held numerous executive roles throughout her career, most recently as co-founder, Chief Financial Officer and Chief Business Officer of Achieve Life Sciences, Inc. Prior to Achieve Life Sciences, Ms. Loewy served as Chief Financial Officer of Tobira Therapeutics, Corcept Therapeutics and Poniard Pharmaceuticals. Earlier in her career, Ms. Loewy was Executive Director of Biotechnology Equity Research at Morgan Stanley and served as Managing Director of Biotechnology Equity Research at Prudential Securities. She began her career as a financial analyst at BankAmerica Corporation.

    Ms. Loewy serves on the Boards of Directors of PhaseBio Pharmaceuticals, Aptose Biosciences and CymaBay Therapeutics. She is a founding board member of the Global Genes Project, a leading rare disease patient advocacy organization, a member of the Steering Committee of the Forum for Collaborative Research in Rare Diseases, and a co-founder of KCNQ2 Cure Alliance, a non-profit advancing research for the rare disease KCNQ2 epileptic encephalopathy. Ms. Loewy holds an M.B.A. and M.S. from Carnegie Mellon University, and a B.A. from the University of California, Berkeley.

    Mary E. Stutts

    Ms. Stutts is a seasoned healthcare and brand management executive with over 25 years of experience. She currently serves as the Senior Vice President of Corporate Relations at Sumitovant Biopharma, a global biopharmaceutical company, where she is responsible for leading the strategic integration of corporate branding, digital innovation, communications, patient advocacy and inclusive diversity. Prior to Sumitovant, Ms. Stutts served as Chief Inclusion, Diversity & Health Equity Officer at Stanford Health Care. Prior to that role, she served as Vice President, External Affairs, at Comcast NBCUniversal from, and has provided global corporate relations leadership in roles in the biotechnology, pharmaceutical, healthcare and media industries, at companies including Bristol-Myers Squibb, Elan, UnitedHealth Group Genentech, Bayer Corporation, and Kaiser Permanente.

    Ms. Stutts serves as Board Chair for Zelot, a startup digital entertainment company, and serves on the Advisory Boards of private companies, Wellist, Slone Partners and WorldWideWomen. She earned a master's degree in Health Administration at the University of Southern California, a bachelor's degree from the University of Louisiana, and is also a graduate of the Executive Program on Strategy and Organization at the Stanford University Graduate School of Business.

    Denelle J. Waynick

    Ms. Waynick has more than 25 years of experience as a legal and strategic advisor across multiple sectors, including the biopharmaceutical industry. She currently serves as General Counsel and Corporate Secretary of MyoKardia. Previously, she served as Vice President, Legal Affairs (U.S.), U.S. General Counsel & Head of Global Enterprise Risk Management at UCB. During her tenure at UCB, Ms. Waynick relocated to UCB's headquarters in Belgium for a year where she provided counsel to the global business units, including commercial operations, R&D, and the regulatory team. Prior to UCB, Ms. Waynick oversaw legal operations as Vice President, Legal Affairs, Global Brands at Actavis, Inc. (now AbbVie) and as Legal Director at Schering-Plough (now Merck). In addition to her roles as in-house counsel, Ms. Waynick was Chief of Staff for the Office of the New Jersey Attorney General.

    Ms. Waynick serves on the Board of the Atlanta Volunteer Lawyers Foundation. She holds a Juris Doctor degree from Howard University School of Law and received her bachelor's degree in Accounting from Rutgers, The State University of New Jersey-Newark.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution,

    C-IV has been approved by the U.S. FDA, is under review in Europe, and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. FINTEPLA is also in development for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare childhood-onset epilepsy. Through its subsidiary Modis Therapeutics, Zogenix is also developing MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578

    Media

    Stefanie Tuck

    Vice President, Porter Novelli

    +1 (978) 390-1394

     

    Primary Logo

    View Full Article Hide Full Article
  15. EMERYVILLE, Calif., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced the appointments of Caroline M. Loewy, Mary E. Stutts and Denelle J. Waynick to newly created seats on its Board of Directors, effective immediately. Zogenix's Board now includes 10 members, nine of whom are independent.

    "We are delighted to welcome Ms. Loewy, Ms. Stutts and Ms. Waynick to our Board of Directors," said Cam L. Garner, Chairman of the Board. "Their combined decades of experience in the biopharmaceutical industry and extensive knowledge in the areas of patient and rare disease advocacy, investor relations, corporate communications, public affairs…

    EMERYVILLE, Calif., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced the appointments of Caroline M. Loewy, Mary E. Stutts and Denelle J. Waynick to newly created seats on its Board of Directors, effective immediately. Zogenix's Board now includes 10 members, nine of whom are independent.

    "We are delighted to welcome Ms. Loewy, Ms. Stutts and Ms. Waynick to our Board of Directors," said Cam L. Garner, Chairman of the Board. "Their combined decades of experience in the biopharmaceutical industry and extensive knowledge in the areas of patient and rare disease advocacy, investor relations, corporate communications, public affairs, international operations, and legal affairs will prove invaluable to our team as Zogenix continues to evolve as a commercial-stage rare disease company. We look forward to their strategic insights and contributions to our long-term growth initiatives."

    Caroline M. Loewy

    Ms. Loewy has more than 25 years of experience in the biopharmaceutical industry and currently serves as a strategic business and financial advisor to life science companies. She has held numerous executive roles throughout her career, most recently as co-founder, Chief Financial Officer and Chief Business Officer of Achieve Life Sciences, Inc. Prior to Achieve Life Sciences, Ms. Loewy served as Chief Financial Officer of Tobira Therapeutics, Corcept Therapeutics and Poniard Pharmaceuticals. Earlier in her career, Ms. Loewy was Executive Director of Biotechnology Equity Research at Morgan Stanley and served as Managing Director of Biotechnology Equity Research at Prudential Securities. She began her career as a financial analyst at BankAmerica Corporation.

    Ms. Loewy serves on the Boards of Directors of PhaseBio Pharmaceuticals, Aptose Biosciences and CymaBay Therapeutics. She is a founding board member of the Global Genes Project, a leading rare disease patient advocacy organization, a member of the Steering Committee of the Forum for Collaborative Research in Rare Diseases, and a co-founder of KCNQ2 Cure Alliance, a non-profit advancing research for the rare disease KCNQ2 epileptic encephalopathy. Ms. Loewy holds an M.B.A. and M.S. from Carnegie Mellon University, and a B.A. from the University of California, Berkeley.

    Mary E. Stutts

    Ms. Stutts is a seasoned healthcare and brand management executive with over 25 years of experience. She currently serves as the Senior Vice President of Corporate Relations at Sumitovant Biopharma, a global biopharmaceutical company, where she is responsible for leading the strategic integration of corporate branding, digital innovation, communications, patient advocacy and inclusive diversity. Prior to Sumitovant, Ms. Stutts served as Chief Inclusion, Diversity & Health Equity Officer at Stanford Health Care. Prior to that role, she served as Vice President, External Affairs, at Comcast NBCUniversal from, and has provided global corporate relations leadership in roles in the biotechnology, pharmaceutical, healthcare and media industries, at companies including Bristol-Myers Squibb, Elan, UnitedHealth Group Genentech, Bayer Corporation, and Kaiser Permanente.

    Ms. Stutts serves as Board Chair for Zelot, a startup digital entertainment company, and serves on the Advisory Boards of private companies, Wellist, Slone Partners and WorldWideWomen.com. She earned a master's degree in Health Administration at the University of Southern California, a bachelor's degree from the University of Louisiana, and is also a graduate of the Executive Program on Strategy and Organization at the Stanford University Graduate School of Business.

    Denelle J. Waynick

    Ms. Waynick has more than 25 years of experience as a legal and strategic advisor across multiple sectors, including the biopharmaceutical industry. She currently serves as General Counsel and Corporate Secretary of MyoKardia. Previously, she served as Vice President, Legal Affairs (U.S.), U.S. General Counsel & Head of Global Enterprise Risk Management at UCB. During her tenure at UCB, Ms. Waynick relocated to UCB's headquarters in Belgium for a year where she provided counsel to the global business units, including commercial operations, R&D, and the regulatory team. Prior to UCB, Ms. Waynick oversaw legal operations as Vice President, Legal Affairs, Global Brands at Actavis, Inc. (now AbbVie) and as Legal Director at Schering-Plough (now Merck). In addition to her roles as in-house counsel, Ms. Waynick was Chief of Staff for the Office of the New Jersey Attorney General.

    Ms. Waynick serves on the Board of the Atlanta Volunteer Lawyers Foundation. She holds a Juris Doctor degree from Howard University School of Law and received her bachelor's degree in Accounting from Rutgers, The State University of New Jersey-Newark.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, C-IV has been approved by the U.S. FDA, is under review in Europe, and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. FINTEPLA is also in development for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare childhood-onset epilepsy. Through its subsidiary Modis Therapeutics, Zogenix is also developing MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578

    Media

    Stefanie Tuck

    Vice President, Porter Novelli

    +1 (978) 390-1394

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    • Results corroborate highly statistically significant convulsive seizure reductions seen in earlier multinational Phase 3 studies of FINTEPLA in Dravet syndrome
    • Positive study will support Japanese new drug application (J-NDA) submission, planned for 2021

    EMERYVILLE, Calif., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today reported positive top-line results from its third…

    • Results corroborate highly statistically significant convulsive seizure reductions seen in earlier multinational Phase 3 studies of FINTEPLA in Dravet syndrome
    • FINTEPLA at 0.7 mg/kg/day achieved a 64.8% greater reduction in mean monthly convulsive seizures compared to placebo (p<0.0001) and FINTEPLA at a lower dose of 0.2 mg/kg/day achieved a 49.9% greater reduction in mean monthly convulsive seizures compared to placebo (p<0.0001)
    • Positive study will support Japanese new drug application (J-NDA) submission, planned for 2021

    EMERYVILLE, Calif., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today reported positive top-line results from its third Phase 3 study (Study 3) of FINTEPLA® (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome. The study corroborates the substantial impact of FINTEPLA on convulsive seizure reduction previously demonstrated in two earlier Phase 3 trials (Studies 1 and 2) in patients with this severe, rare and often debilitating form of infant-onset epilepsy. It also expands the countries where FINTEPLA has been evaluated to include Japan and Study 3 will be the pivotal study included in the Company's planned submission of a new drug application (J-NDA) in that country, expected to occur in 2021.

    "There remains a substantial unmet need in the Dravet treatment landscape globally and these compelling results corroborate the substantial levels of seizure control provided by FINTEPLA in Dravet syndrome that was also demonstrated in Studies 1 and 2," said Stephen J. Farr, Ph.D., President & CEO of Zogenix. "Importantly, Study 3 included subjects from Japan and, based on our prior discussions with Japan's Pharmaceuticals and Medical Devices Agency (PMDA), should meet the requirements to serve as the pivotal study for a J-NDA submission. We are excited to work with our commercialization partner in Japan, Nippon Shinyaku, to leverage their expertise and commitment to rare diseases to provide FINTEPLA, if approved, as a potential new treatment option for patients and their families. On behalf of everyone at Zogenix, I would like to extend sincere gratitude to the patients, families and investigators involved in this study. With FINTEPLA now commercially available in the U.S. and under regulatory review in Europe, we are excited to continue our work to bring FINTEPLA to patients in additional countries over time."

    Study 3 was a multi-national, randomized, double-blind, placebo-controlled, Phase 3 study enrolling 143 children and young adults with Dravet syndrome, whose seizures were not adequately controlled by existing anti-epileptic drugs. The median age of patients was 9 years (range, 2-18 years) and the average baseline convulsive seizure frequency across the study groups was approximately 63 seizures per month.

    Following a six-week baseline observation period, patients were randomized to one of three treatment groups: FINTEPLA 0.7 mg/kg/day (26 mg maximum daily dose; n=49), FINTEPLA 0.2 mg/kg/day (n=46) or placebo (n=48), in which FINTEPLA or placebo was added to each patient's current treatment regimen of anti-epileptic drugs. Patients were titrated to their target dose of FINTEPLA over two weeks and then remained at that fixed dose for 12 weeks.

    The study met its primary objective in demonstrating that patients in the FINTEPLA 0.7 mg/kg/day group achieved a 64.8% greater reduction in mean monthly convulsive seizures compared to the placebo group (p<0.0001). The median percent reduction in monthly convulsive seizure frequency was 73.7% among FINTEPLA 0.7 mg/kg/day patients compared to 7.6% in placebo patients.

    The same analyses comparing FINTEPLA at a lower dose of 0.2 mg/kg/day versus placebo was a key secondary objective and demonstrated that patients in the lower dose group achieved a 49.9% greater reduction in mean monthly convulsive seizures compared to placebo (p<0.0001). Collectively, these top-line data are highly consistent with the results of Study 1 in demonstrating a dose-response relationship for FINTEPLA in the treatment of convulsive seizures in Dravet syndrome.

    "Dravet syndrome is a rare, highly refractory form of childhood onset epilepsy marked by frequent and often prolonged seizures that are difficult to control with existing medications," said Joseph Sullivan, M.D., Professor of Neurology & Pediatrics and Director of the Pediatric Epilepsy Center of Excellence at the UCSF Benioff Children's Hospitals, and the Principal Investigator for FINTEPLA in Dravet syndrome. "Given the profound reductions in convulsive seizure frequency seen across clinical studies, combined with the ongoing, robust safety monitoring that will be part of this medicine's use, I continue to believe that it will offer an extremely important treatment option for Dravet syndrome patients, and bring new hope to families around the world living with the severe effects of this disease."

    Additional key secondary objectives of the study were to compare FINTEPLA 0.7 mg/kg/day and 0.2 mg/kg/day (independently) with placebo in terms of (1) the proportion of patients who achieved ≥50% reductions in monthly convulsive seizures and (2) the median of the longest convulsive seizure-free interval. These results are shown in the following table. The proportion of patients who achieved ≥75% seizure reductions, a secondary efficacy measure, is also presented.

     FINTEPLA 0.7

    mg/kg/day

    (N=48)
    FINTEPLA 0.2

    mg/kg/day

    (N=46)
    Placebo

    (N=48)
    Patients with ≥50%

    reduction in monthly

    convulsive seizures
    72.9%

    (p<0.0001)
    45.7%

    (p<0.0010)
    6.3%
    Patients with ≥75%

    reduction in monthly

    convulsive seizures
    47.9%

    (p=0.0001)
    28.3%

    (p=0.0047)
    4.2%
    Longest seizure-free

    interval (median)
    43 days

    (p<0.0001)
    24 days

    (p<0.0010)
    13.3 days

    FINTEPLA was generally well-tolerated in this study, with adverse events consistent with those observed in Study 1 and Study 2 and with the known safety profile of fenfluramine. The incidence of treatment-emergent adverse events was higher in the treatment groups as compared to the placebo group, with 91.7% (n=44) of patients in the 0.7 mg/kg/day group and 91.3% (n=42) of patients in the 0.2 mg/kg/day group experiencing at least one treatment-emergent adverse event compared to 83.3% (n=40) of patients in the placebo group. The incidence of serious adverse events was similar in all three groups with 6.3% (n=3) of patients in the 0.7 mg/kg/day group and 6.5% (n=3) of patients in the 0.2 mg/kg/day group experiencing at least one treatment-emergent serious adverse event compared to 4.2% (n=2) of patients in the placebo group, including one placebo patient who died due to SUDEP (sudden unexpected death in epilepsy). Prospective cardiac safety monitoring throughout the study showed that no study patients developed valvular heart disease or pulmonary arterial hypertension.

    FINTEPLA was approved by the U.S. Food and Drug Administration (FDA) in June 2020 for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older and a Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA). In March 2019, Zogenix entered into an exclusive distribution agreement with Nippon Shinyaku, Co., Ltd. for the commercialization of FINTEPLA in Japan. Zogenix will supply product to Nippon Shinyaku and retains responsibility for completing its global clinical development programs for FINTEPLA, including those underway to support Zogenix's planned submissions of new drug applications in Japan for Dravet syndrome and Lennox-Gastaut syndrome.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, C-IV has been approved by the U.S. FDA, is under review in Europe, and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. FINTEPLA is also in development for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare childhood-onset epilepsy. Through its subsidiary Modis Therapeutics, Zogenix is also developing MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder.

    Forward Looking Statements

    Zogenix cautions you that statements included in this press release and the conference call that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include: FINTEPLA providing an important treatment option for patients with Dravet syndrome; Zogenix's plans to submit the J-NDA supported by the Study 3 trial results and the timing thereof; Zogenix's belief that results from Study 3 corroborate the results from Study 1 and Study 2; and Zogenix's plans to bring FINTEPLA to patients in additional countries over time. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: top-line data Zogenix reports is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of a clinical trial, and the Japanese regulatory authority may not agree with the Zogenix's interpretation of such results; the Japanese regulatory authority may disagree that results of Study 3 may serve as a pivotal trial to support the J-NDA or that the existing safety and efficacy data, or Zogenix's analysis of such data, is sufficient to support marketing approval in Japan; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to commercialize FINTEPLA and Zogenix's ability to generate product revenue; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit commercialization, or that could result in recalls or product liability claims; additional data from Zogenix's ongoing studies may contradict or undermine the data reported for Dravet syndrome; Zogenix's dependence on third parties for the manufacture of FINTEPLA;; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578

    Media

    Stefanie Tuck

    Vice President, Porter Novelli

    +1 (978) 390-1394

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    • FINTEPLA® (fenfluramine) in Dravet syndrome is now FDA approved and commercially launched in the U.S.

    • More than 230 prescribers have already completed FINTEPLA REMS enrollment and certification

    • FDA meeting scheduled in September to discuss planned sNDA for FINTEPLA in Lennox-Gastaut syndrome

    • Held productive meetings with FDA to discuss MT1621 development program

    EMERYVILLE, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced financial results for the three and six months ended June 30, 2020, and provided a corporate update. The Company will host a conference call today, Wednesday, August 5, at 4:30 PM Eastern Time/1:30…

    • FINTEPLA® (fenfluramine) in Dravet syndrome is now FDA approved and commercially launched in the U.S.



    • More than 230 prescribers have already completed FINTEPLA REMS enrollment and certification



    • FDA meeting scheduled in September to discuss planned sNDA for FINTEPLA in Lennox-Gastaut syndrome



    • Held productive meetings with FDA to discuss MT1621 development program

    EMERYVILLE, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced financial results for the three and six months ended June 30, 2020, and provided a corporate update. The Company will host a conference call today, Wednesday, August 5, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

    "In June, we were thrilled to receive U.S. Food and Drug Administration (FDA) approval for FINTEPLA® for the treatment of seizures associated with Dravet syndrome," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "This was a significant milestone for Zogenix and those in the Dravet community seeking effective new treatment options. Last week, we commenced the commercial launch of FINTEPLA in the United States and are very pleased with our early progress. More than 230 U.S. healthcare providers have successfully completed the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) certification required to begin prescribing of FINTEPLA."

    "Despite the global pandemic, we have been able to continue advancing projects that will further support our growth as a commercial-stage rare disease company," continued Dr. Farr. "We recently held positive meetings with the FDA to discuss the remaining development path to support a planned New Drug Application (NDA) submission for MT1621 for the treatment of thymidine kinase 2 deficiency. In addition, a meeting with the FDA has been scheduled in September to discuss next steps for our supplemental NDA (sNDA) for FINTEPLA in Lennox-Gastaut syndrome (LGS), another difficult-to-treat childhood onset epilepsy."

    Corporate Update

    • FINTEPLA for the treatment of seizures associated with Dravet syndrome:



      - Received FDA approval on June 25, 2020 and executed initial commercial launch on July 27, 2020



      - Over 230 prescribers have successfully completed REMS certification process to date



      - FINTEPLA Marketing Authorization Application (MAA) is under active review by the European Medicines Agency (EMA) and commercial launch preparations are ongoing in Europe



      - Last patient enrolled in pivotal Phase 3 study in Japan, with top-line data expected in the fourth quarter of this year; anticipate submission of a J-NDA to Japan's Pharmaceutical and Medical Devices Agency in the first half of 2021



      - Eight U.S. patents (expiring between 2033-2039) added to the Orange Book listing for FINTEPLA
    • FINTEPLA for the treatment of seizures associated with LGS:



      - Primary endpoint achieved in Study 1601; patients taking FINTEPLA 0.7 mg/kg/day demonstrated a statistically significant greater reduction in monthly drop seizure frequency compared to placebo (p=0.0012). FINTEPLA was generally well-tolerated; the most common adverse events were decreased appetite, somnolence, fatigue, vomiting, diarrhea, and pyrexia. No cases of valvular heart disease or pulmonary arterial hypertension were observed.



      - Advancing non-clinical carcinogenicity and clinical Phase 1 pharmacokinetic (PK) studies in hepatic and renal impairment to support sNDA submission



      - FDA meeting scheduled in September 2020 to discuss requirements for sNDA submission
    • MT1621 for the treatment of thymidine kinase 2 (TK2) deficiency:



      - Recently held positive FDA meetings to discuss development path and required data to support planned NDA submission



      - Company expects availability of all required data by end of 2021, and anticipates the submission of an NDA in first half of 2022

    Second Quarter 2020 Financial Results

    • The Company recorded $1.0 million in revenue for the second quarter ended June 30, 2020, as a result of its March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded $1.1 million in revenue for the corresponding period of 2019.
    • Research and development expenses for the second quarter ended June 30, 2020, totaled $34.4 million, up from $27.1 million in the second quarter ended June 30, 2019, as the Company decreased spending in Dravet syndrome and expanded clinical activities in LGS and MT1621.
    • Selling, general and administrative expenses for the second quarter ended June 30, 2020, totaled $24.4 million, compared with $15.5 million in the second quarter ended June 30, 2019, as the Company continued investment related to the launch of FINTEPLA for the treatment of Dravet syndrome in the U.S. and prepared for prospective launch in Europe.
    • Net loss for the second quarter ended June 30, 2020, was $53.3 million, or a net loss of $0.96 per share, reflective of two offsetting non-cash items related to the approval of FINTEPLA, involving contingent consideration and the deferred tax liability, compared with a net loss of $37.8 million, or a net loss of $0.89 per share, in the second quarter ended June 30, 2019.

    Six Months Ended June 30, 2020 Financial Results Compared to Six Months Ended June 30, 2019

    • The Company recorded $2.3 million in revenue for the six months ended June 30, 2020, as a result of its March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded $1.1 million in revenue for the corresponding period of 2019.
    • Research and development expenses for the six months ended June 30, 2020, totaled $67.6 million, up from $51.4 million in the six months ended June 30, 2019, as the Company decreased spending in Dravet syndrome and expanded clinical activities in LGS and MT1621.
    • Selling, general and administrative expenses for the six months ended June 30, 2020, totaled $45.7 million, up from $26.4 million in the six months ended June 30, 2019, as the Company continued investment related to the launch of FINTEPLA for the treatment of Dravet syndrome in the U.S. and prepared for prospective launch in Europe.
    • Net loss for the six months ended June 30, 2020, was $79.1 million, or a net loss of $1.53 per share, compared with a net loss of $73.0 million, or a net loss of $1.72 per share, in the six months ended June 30, 2019.
    • As of June 30, 2020, the Company had $390.2 million in cash, cash equivalents, and marketable securities, compared to $251.2 million at December 31, 2019.

    Conference Call

    Wednesday, August 5, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
    Toll Free: 866-269-4260
    International: 323-347-3612
    Conference ID: 8881331
    Webcast:http://public.viavid.com/index.php?id=141049



    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, C-IV has been approved by the U.S. FDA and is under review in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. In addition, the company has two late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

    Forward Looking Statements

    Zogenix cautions you that statements included in this press release and the conference call that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include: FINTEPLA providing a treatment option for patients with Dravet syndrome; Zogenix's plans to commercialize FINTEPLA; the timing of review by EMA with respect to the MAA for FINTEPLA for the treatment of patients with Dravet syndrome; Zogenix's plans to finalize the studies and data required to support an sNDA for FINTEPLA in LGS; and the timing of regulatory submissions and meetings or other interactions with regulatory agencies related to FINTEPLA and MT1621. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: Zogenix's ability to successfully launch FINTEPLA in the U.S.; EMA may disagree that existing safety and efficacy data, or Zogenix's analysis of such data, is sufficient to support marketing approval in Europe; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to commercialize FINTEPLA and Zogenix's ability to generate product revenue; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit commercialization, or that could result in recalls or product liability claims; additional data from Zogenix's ongoing studies may contradict or undermine the data reported for LGS; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA; Zogenix's dependence on third parties for the manufacture of FINTEPLA; Zogenix's ability to achieve and maintain adequate levels of coverage and reimbursement for FINTEPLA; the scope and validity of patent protection or regulatory exclusivity protection for FINTEPLA and Zogenix's ability to commercialize FINTEPLA without infringing the patent rights of others; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578

    Media

    Stefanie Tuck

    Vice President, Porter Novelli

    +1 (978) 390-1394

    Zogenix, Inc.

    Condensed Consolidated Balance Sheets (Unaudited)

    (in thousands)

     June 30, 2020 December 31, 2019
    Assets:   
    Current assets:   
    Cash and cash equivalents$136,871   $62,070  
    Marketable securities253,378   189,085  
    Inventory, net475     
    Prepaid expenses and other current assets10,833   11,084  
    Acquisition holdback placed in escrow25,000   25,000  
    Total current assets426,557   287,239  
    Property and equipment, net9,300   9,424  
    Operating lease right-of-use assets8,266   7,774  
    Intangible asset102,500   102,500  
    Goodwill6,234   6,234  
    Other noncurrent assets2,250   1,079  
    Total assets$555,107   $414,250  
    Liabilities and stockholders' equity:   
    Current liabilities:   
    Accounts payable$8,518   $7,979  
    Accrued and other current liabilities40,176   30,117  
    Acquisition holdback liability24,444   24,444  
    Deferred revenue, current5,303   5,927  
    Current portion of operating lease liabilities1,633   1,322  
    Current portion of contingent consideration13,000   25,600  
    Total current liabilities93,074   95,389  
    Deferred revenue, noncurrent5,768   7,425  
    Operating lease liabilities, net of current portion11,022   10,752  
    Contingent consideration, net of current portion40,100   38,200  
    Deferred tax liability   17,425  
    Total liabilities149,964   169,191  
    Commitments and contingencies   
    Stockholders' equity:   
    Common stock55   45  
    Additional paid-in capital1,599,047   1,360,092  
    Accumulated deficit(1,194,581)  (1,115,457) 
    Accumulated other comprehensive income622   379  
    Total stockholders' equity405,143   245,059  
    Total liabilities and stockholders' equity$555,107   $414,250  

    Zogenix, Inc.

    Condensed Consolidated Statements of Operations (Unaudited)

    (in thousands, except per share amounts)

     Three Months Ended June 30, Six Months Ended June 30,
     2020 2019 2020 2019
    Collaboration revenue$1,032   $1,069   $2,281   $1,069  
    Operating expenses:       
    Research and development34,373   27,096   67,613   51,448  
    Selling, general and administrative24,431   15,459   45,749   26,377  
    Acquired in-process research and development expense1,500      3,000     
    Change in fair value of contingent consideration12,200   (700)  4,300   2,300  
    Total operating expenses72,504   41,855   120,662   80,125  
    Loss from operations(71,472)  (40,786)  (118,381)  (79,056) 
    Other (expense) income, net(157)  40   19,864   (48) 
    Interest income880   2,983   1,968   6,139  
    Loss before income taxes(70,749)  (37,763)  (96,549)  (72,965) 
    Income tax benefit(17,425)     (17,425)    
    Net loss$(53,324)  $(37,763)  $(79,124)  $(72,965) 
            
    Net loss per share, basic and diluted$(0.96)  $(0.89)  $(1.53)  $(1.72) 
            
    Weighted average number of shares used in the calculation of basic and diluted net loss per common share55,355   42,458   51,770   42,348  

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  16. EMERYVILLE, Calif., July 29, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it will report its financial results for the three and six months ended June 30, 2020, after the market close, and will host a corporate update conference call and webcast on Wednesday, August 5, 2020, at 4:30 PM Eastern Time.

    Conference Call Details
    Wednesday, August 5, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
    Toll Free:866-269-4260 
    International:323-347-3612 
    Conference ID:8881331
    Webcast:http://public.viavid.com/index.php?id=141049 

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform…

    EMERYVILLE, Calif., July 29, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it will report its financial results for the three and six months ended June 30, 2020, after the market close, and will host a corporate update conference call and webcast on Wednesday, August 5, 2020, at 4:30 PM Eastern Time.

    Conference Call Details

    Wednesday, August 5, at 4:30 PM Eastern Time / 1:30 PM Pacific Time

    Toll Free:866-269-4260 
    International:323-347-3612 
    Conference ID:8881331
    Webcast:http://public.viavid.com/index.php?id=141049 

    About Zogenix

    Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, C-IV has been approved by the U.S. FDA and is under review in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. In addition, the company has two late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a rare childhood-onset epilepsy and one for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732  | 

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 |

    Primary Logo

    View Full Article Hide Full Article
  17. EMERYVILLE, Calif., June 25, 2020 /PRNewswire/ -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved FINTEPLA® (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older. FINTEPLA will be launched through a restricted distribution program, called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program, and is expected to be available through Zogenix's specialty pharmacy partner by the end of July.

    Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8722951-zogenix-fda-approval-dravet-syndrome/

    EMERYVILLE, Calif., June 25, 2020 /PRNewswire/ -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved FINTEPLA® (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older. FINTEPLA will be launched through a restricted distribution program, called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program, and is expected to be available through Zogenix's specialty pharmacy partner by the end of July.

    Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8722951-zogenix-fda-approval-dravet-syndrome/

    "The approval of FINTEPLA by the FDA is a significant milestone we are proud to celebrate with the patients and families living with Dravet syndrome," said Stephen J. Farr, Ph.D., President and Chief Executive Officer of Zogenix. "We began this global development program nearly six years ago after researchers in Belgium recognized the potential of fenfluramine, a drug with distinct pharmacology from all other anticonvulsant agents, to treat intractable seizures in Dravet syndrome. Our heartfelt gratitude goes to the patients, families, and everyone who supported the rigorous development program that led to FINTEPLA's approval."

    Dravet syndrome is a rare childhood-onset epilepsy marked by frequent and severe treatment-resistant seizures, associated hospitalizations and medical emergencies, significant developmental and motor impairments, and an increased risk of sudden unexpected death (SUDEP).

    "There remains a huge unmet need for the many Dravet syndrome patients who continue to experience frequent severe seizures even while taking one or more of the currently available anti-seizure medications," said Joseph Sullivan, M.D., Director of the Pediatric Epilepsy Center of Excellence at the UCSF Benioff Children's Hospitals and the Principal Investigator for FINTEPLA in Dravet syndrome. "Given the profound reductions in convulsive seizure frequency seen in the FINTEPLA clinical trials, combined with the ongoing, robust safety monitoring that will be part of its use, I feel FINTEPLA will offer an extremely important treatment option for Dravet syndrome patients."

    The FDA's approval of FINTEPLA in Dravet syndrome was based on data from two randomized, double-blinded, placebo-controlled Phase 3 clinical trials, published in The Lancet1 and JAMA Neurology2, and safety data from an open-label extension trial in which many patients received FINTEPLA for up to three years. When added to existing treatment regimens, FINTEPLA significantly reduced the monthly convulsive seizure frequency compared to placebo in study patients whose seizures were not adequately controlled on one or more antiepileptic drugs. In addition, most study patients responded to treatment with FINTEPLA within three to four weeks and effects remained consistent over the treatment period.

    The most common adverse reactions (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus.

    FINTEPLA will be available to certified prescribers in the U.S. in July. Zogenix is launching Zogenix Central™, a comprehensive support service that will provide ongoing product assistance to patients, caregivers, and their medical teams. Further information is available at www.FINTEPLA.com to assist patients and their families.

    "Having a new FDA-approved treatment option is so important because it improves our ability to optimize each patient's treatment," said Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation. "Moreover, because families living with Dravet syndrome never know when the next seizure is going to occur, whether they will end up in the E.R., or what the consequences might be following the seizure, having a strong support program like Zogenix Central to reduce the strain on families is very welcome. This will allow family members to remain focused on providing the best care of their loved one with Dravet."

    Conference Call

    Friday, June 26, at 8:30 AM Eastern Time / 5:30 AM Pacific Time

    Toll Free:                     877-407-9716

    International:               201-493-6779

    Conference ID:           13706215

    Webcast:                     http://public.viavid.com/index.php?id=140519

     

    About Dravet Syndrome

    Dravet syndrome is a rare childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death. Despite existing therapies, there remains a great unmet need in Dravet syndrome to reduce convulsive seizures that can lead to medical emergencies, hospitalizations, and SUDEP (sudden unexpected death in epilepsy). The severity and unpredictability of the disease, coupled with around-the-clock concern for the diagnosed child's well-being, can present significant emotional and logistical challenges for all members of the family. 

    About FINTEPLA® (fenfluramine) oral solution, CIV

    FINTEPLA is an approved treatment, in the U.S., for seizures associated with Dravet syndrome in patients 2 years of age and older. Across multiple clinical studies, FINTEPLA demonstrated significant and sustained reduction of convulsive seizures associated with Dravet syndrome. In two pivotal Phase 3 trials, the reduction in convulsive seizure frequency per 28 days was statistically significantly greater for all dose groups of FINTEPLA compared to placebo.

    IMPORTANT SAFETY INFORMATION

    Boxed WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION

    • There is an association between serotonergic drugs with 5–HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension.
    • Echocardiogram assessments are required before, during, and after treatment with FINTEPLA.
    • FINTEPLA is available only through a restricted program called the FINTEPLA REMS.

    Contraindications

    FINTEPLA is contraindicated in patients with Hypersensitivity to fenfluramine or any of the excipients in FINTEPLA and with concomitant use of, or within 14 days of the administration of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome.

    WARNINGS AND PRECAUTIONS

    Valvular Heart Disease and Pulmonary Arterial Hypertension (see boxed Warning)

    Because of the association between serotonergic drugs with 5–HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension, cardiac monitoring via echocardiogram is required prior to starting treatment, during treatment, and after treatment with FINTEPLA concludes. Cardiac monitoring via echocardiogram can aid in early detection of this condition. In clinical trials of up to 3 years in duration, no patient receiving FINTEPLA developed valvular heart disease or pulmonary arterial hypertension.

    Monitoring

    Prior to starting treatment, patients must undergo an echocardiogram to evaluate for valvular heart disease and pulmonary arterial hypertension. Echocardiograms should be repeated every 6 months, and once 3-6 months post-treatment with FINTEPLA.

    If valvular heart disease or pulmonary arterial hypertension is observed on an echocardiogram, the prescriber must consider the benefits versus the risks of initiating or continuing treatment with FINTEPLA.

    FINTEPLA REMS Program (see boxed Warning)

    FINTEPLA is available only through a restricted distribution program called the FINTEPLA REMS program.  Prescribers must be certified by enrolling in the FINTEPLA REMS program.   Prescribers must Counsel patients receiving FINTEPLA about the risk of valvular heart disease and pulmonary arterial hypertension, how to recognize signs and symptoms of valvular heart disease and pulmonary arterial hypertension, the need for baseline (pretreatment) and periodic cardiac monitoring via echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment.  Patients must enroll in the REMS program and comply with ongoing monitoring requirements.  The pharmacy must be certified by enrolling in the REMS program and must only dispense to patients who are authorized to receive FINTEPLA.  Wholesalers and distributers must only distribute to certified pharmacies.  Further information is available at www.FinteplaREMS.com or by telephone at 1-877-964-3649.

    Decreased Appetite and Decreased Weight

    FINTEPLA can cause decreases in appetite and weight. Decreases in weight appear to be dose related. Most patients resumed the expected measured increases in weight by the end of the open-label extension study. Weight should be monitored regularly during treatment with FINTEPLA and dose modifications should be considered if a decrease in weight is observed.

    Somnolence, Sedation, and Lethargy

    FINTEPLA can cause somnolence, sedation, and lethargy. Other central nervous system (CNS) depressants, including alcohol, could potentiate these effects of FINTEPLA. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA to gauge whether it adversely affects their ability to drive or operate machinery.

    Suicidal Behavior and Ideation

    Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior.

    Anyone considering prescribing FINTEPLA or any other AED must balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

    Withdrawal of Antiepileptic Drugs 

    As with most AEDs, FINTEPLA should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered.

    Serotonin Syndrome

    Serotonin syndrome, a potentially life-threatening condition, may occur with FINTEPLA, particularly with concomitant administration of FINTEPLA with other serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (eg, St. John's Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA, dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the emergence of signs and symptoms of serotonin syndrome, which include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started.

    Increase in Blood Pressure

    FINTEPLA can cause an increase in blood pressure.  Significant elevation in blood pressure, including hypertensive crisis, has been reported rarely in adult patients treated with fenfluramine, including patients without a history of hypertension. Monitor blood pressure in patients treated with FINTEPLA. In clinical trials of up to 3 years in duration, no patient receiving FINTEPLA developed hypertensive crisis.

    Glaucoma

    Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Consider discontinuing treatment with FINTEPLA in patients with acute decreases in visual acuity or ocular pain.

    Adverse Reactions

    The most common adverse reactions (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus.

    Drug Interactions

    Strong CYP1A2 and CYP2B6 Inducers: Coadministration with rifampin or a strong CYP1A2 and CYP2B6 inducer will decrease fenfluramine plasma concentrations.

    Consider an increase in FINTEPLA dosage when coadministered with rifampin or a strong CYP1A2 and CYP2B6 inducer.

    Use in Specific Populations

    Administration to patients with moderate or severe renal impairment or to patients with hepatic impairment is not recommended.

    About Zogenix

    Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, C-IV has been approved by the U.S. FDA and is under review in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. In addition, the company has two late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a rare childhood-onset epilepsy and one for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

    Forward Looking Statements

    Zogenix cautions you that statements included in this press release and the conference call that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include: FINTEPLA providing a treatment option for patients with Dravet syndrome; and Zogenix's plans to commercialize FINTEPLA, including the timing of the launch of the restricted distribution program, FINTEPLA REMS Program, and the launch of Zogenix Central and the availability of product assistance to patients, caregivers, and their medical teams. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: Zogenix's ability to successfully launch FINTEPLA, including establishing the restricted distribution program, FINTEPLA REMS Program, and Zogenix Central, and the timing thereof; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to commercialize FINTEPLA and Zogenix's ability to generate product revenue; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit commercialization, or that could result in recalls or product liability claims; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA; Zogenix's dependence on third parties for the manufacture of FINTEPLA; Zogenix's ability to achieve and maintain adequate levels of coverage and reimbursement for FINTEPLA; the scope and validity of patent protection or regulatory exclusivity protection for FINTEPLA and Zogenix's ability to commercialize FINTEPLA without infringing the patent rights of others; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 |

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578

    Media

    Stefanie Tuck

    +1 (978) 390-1394 |

    ¹ The Lancet, Volume 394, Issue 10216, P2243-2254, December 21, 2019

    ² JAMA Neurol. 2020 Mar; 77(3): 300–308.

    Cision View original content:http://www.prnewswire.com/news-releases/fda-approves-fintepla--fenfluramine-for-the-treatment-of-seizures-associated-with-dravet-syndrome-301084208.html

    SOURCE Zogenix, Inc.

    View Full Article Hide Full Article
    • FINTEPLA® significantly and substantially reduced convulsive seizure frequency in patients whose seizures were not adequately controlled on other medications, as observed in two phase 3 placebo-controlled clinical trials
    • Commercial launch planned for July 2020
    • Zogenix to host an investor call tomorrow, June 26, at 8:30 AM ET / 5:30 AM PT

    EMERYVILLE, Calif., June 25, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved FINTEPLA® (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older. FINTEPLA will be launched through a restricted…

    • FINTEPLA® significantly and substantially reduced convulsive seizure frequency in patients whose seizures were not adequately controlled on other medications, as observed in two phase 3 placebo-controlled clinical trials

    • Commercial launch planned for July 2020
    • Zogenix to host an investor call tomorrow, June 26, at 8:30 AM ET / 5:30 AM PT

    EMERYVILLE, Calif., June 25, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved FINTEPLA® (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older. FINTEPLA will be launched through a restricted distribution program, called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program, and is expected to be available through Zogenix's specialty pharmacy partner by the end of July.

    "The approval of FINTEPLA by the FDA is a significant milestone we are proud to celebrate with the patients and families living with Dravet syndrome," said Stephen J. Farr, Ph.D., President and Chief Executive Officer of Zogenix. "We began this global development program nearly six years ago after researchers in Belgium recognized the potential of fenfluramine, a drug with distinct pharmacology from all other anticonvulsant agents, to treat intractable seizures in Dravet syndrome. Our heartfelt gratitude goes to the patients, families, and everyone who supported the rigorous development program that led to FINTEPLA's approval."

    Dravet syndrome is a rare childhood-onset epilepsy marked by frequent and severe treatment-resistant seizures, associated hospitalizations and medical emergencies, significant developmental and motor impairments, and an increased risk of sudden unexpected death (SUDEP).

    "There remains a huge unmet need for the many Dravet syndrome patients who continue to experience frequent severe seizures even while taking one or more of the currently available anti-seizure medications," said Joseph Sullivan, M.D., Director of the Pediatric Epilepsy Center of Excellence at the UCSF Benioff Children's Hospitals and the Principal Investigator for FINTEPLA in Dravet syndrome. "Given the profound reductions in convulsive seizure frequency seen in the FINTEPLA clinical trials, combined with the ongoing, robust safety monitoring that will be part of its use, I feel FINTEPLA will offer an extremely important treatment option for Dravet syndrome patients."

    The FDA's approval of FINTEPLA in Dravet syndrome was based on data from two randomized, double-blinded, placebo-controlled Phase 3 clinical trials, published in The Lancet1 and JAMA Neurology2, and safety data from an open-label extension trial in which many patients received FINTEPLA for  up to three years. When added to existing treatment regimens, FINTEPLA significantly reduced the monthly convulsive seizure frequency compared to placebo in study patients whose seizures were not adequately controlled on one or more antiepileptic drugs. In addition, most study patients responded to treatment with FINTEPLA within three to four weeks and effects remained consistent over the treatment period.

    The most common adverse reactions (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus.

    FINTEPLA will be available to certified prescribers in the U.S. in July. Zogenix is launching Zogenix Central™, a comprehensive support service that will provide ongoing product assistance to patients, caregivers, and their medical teams. Further information is available at www.FINTEPLA.com to assist patients and their families.

    "Having a new FDA-approved treatment option is so important because it improves our ability to optimize each patient's treatment," said Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation. "Moreover, because families living with Dravet syndrome never know when the next seizure is going to occur, whether they will end up in the E.R., or what the consequences might be following the seizure, having a strong support program like Zogenix Central to reduce the strain on families is very welcome. This will allow family members to remain focused on providing the best care of their loved one with Dravet."

    Conference Call

    Friday, June 26, at 8:30 AM Eastern Time / 5:30 AM Pacific Time
    Toll Free:  877-407-9716
    International:  201-493-6779
    Conference ID: 13706215
    Webcast:  http://public.viavid.com/index.php?id=140519

    Multimedia components are available with this press release here: https://www.multivu.com/players/English/8722951-zogenix-fda-approval-dravet-syndrome/.   

    About Dravet Syndrome

    Dravet syndrome is a rare childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death. Despite existing therapies, there remains a great unmet need in Dravet syndrome to reduce convulsive seizures that can lead to medical emergencies, hospitalizations, and SUDEP (sudden unexpected death in epilepsy). The severity and unpredictability of the disease, coupled with around-the-clock concern for the diagnosed child's well-being, can present significant emotional and logistical challenges for all members of the family.

    About FINTEPLA® (fenfluramine) oral solution, CIV

    FINTEPLA is an approved treatment, in the U.S., for seizures associated with Dravet syndrome in patients 2 years of age and older. Across multiple clinical studies, FINTEPLA demonstrated significant and sustained reduction of convulsive seizures associated with Dravet syndrome. In two pivotal Phase 3 trials, the reduction in convulsive seizure frequency per 28 days was statistically significantly greater for all dose groups of FINTEPLA compared to placebo.

    IMPORTANT SAFETY INFORMATION

    Boxed WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION

    • There is an association between serotonergic drugs with 5‑HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension.
    • Echocardiogram assessments are required before, during, and after treatment with FINTEPLA.
    • FINTEPLA is available only through a restricted program called the FINTEPLA REMS.

    Contraindications

    FINTEPLA is contraindicated in patients with Hypersensitivity to fenfluramine or any of the excipients in FINTEPLA and with concomitant use of, or within 14 days of the administration of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome.

    WARNINGS AND PRECAUTIONS

    Valvular Heart Disease and Pulmonary Arterial Hypertension (see boxed Warning)

    Because of the association between serotonergic drugs with 5‑HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension, cardiac monitoring via echocardiogram is required prior to starting treatment, during treatment, and after treatment with FINTEPLA concludes. Cardiac monitoring via echocardiogram can aid in early detection of this condition. In clinical trials of up to 3 years in duration, no patient receiving FINTEPLA developed valvular heart disease or pulmonary arterial hypertension.

    Monitoring

    Prior to starting treatment, patients must undergo an echocardiogram to evaluate for valvular heart disease and pulmonary arterial hypertension. Echocardiograms should be repeated every 6 months, and once 3-6 months post-treatment with FINTEPLA.

    If valvular heart disease or pulmonary arterial hypertension is observed on an echocardiogram, the prescriber must consider the benefits versus the risks of initiating or continuing treatment with FINTEPLA.

    FINTEPLA REMS Program (see boxed Warning)

    FINTEPLA is available only through a restricted distribution program called the FINTEPLA REMS program.  Prescribers must be certified by enrolling in the FINTEPLA REMS program.   Prescribers must Counsel patients receiving FINTEPLA about the risk of valvular heart disease and pulmonary arterial hypertension, how to recognize signs and symptoms of valvular heart disease and pulmonary arterial hypertension, the need for baseline (pretreatment) and periodic cardiac monitoring via echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment.  Patients must enroll in the REMS program and comply with ongoing monitoring requirements.  The pharmacy must be certified by enrolling in the REMS program and must only dispense to patients who are authorized to receive FINTEPLA.  Wholesalers and distributors must only distribute to certified pharmacies.  Further information is available at www.FinteplaREMS.com or by telephone at 1-877-964-3649.

    Decreased Appetite and Decreased Weight

    FINTEPLA can cause decreases in appetite and weight. Decreases in weight appear to be dose related. Most patients resumed the expected measured increases in weight by the end of the open-label extension study. Weight should be monitored regularly during treatment with FINTEPLA and dose modifications should be considered if a decrease in weight is observed.

    Somnolence, Sedation, and Lethargy

    FINTEPLA can cause somnolence, sedation, and lethargy. Other central nervous system (CNS) depressants, including alcohol, could potentiate these effects of FINTEPLA. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA to gauge whether it adversely affects their ability to drive or operate machinery.

    Suicidal Behavior and Ideation

    Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior.

    Anyone considering prescribing FINTEPLA or any other AED must balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

    Withdrawal of Antiepileptic Drugs

    As with most AEDs, FINTEPLA should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered.

    Serotonin Syndrome

    Serotonin syndrome, a potentially life-threatening condition, may occur with FINTEPLA, particularly with concomitant administration of FINTEPLA with other serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (eg, St. John's Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA, dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the emergence of signs and symptoms of serotonin syndrome, which include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started.

    Increase in Blood Pressure

    FINTEPLA can cause an increase in blood pressure.  Significant elevation in blood pressure, including hypertensive crisis, has been reported rarely in adult patients treated with fenfluramine, including patients without a history of hypertension. Monitor blood pressure in patients treated with FINTEPLA. In clinical trials of up to 3 years in duration, no patient receiving FINTEPLA developed hypertensive crisis.

    Glaucoma

    Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Consider discontinuing treatment with FINTEPLA in patients with acute decreases in visual acuity or ocular pain.

    Adverse Reactions

    The most common adverse reactions (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus.

    Drug Interactions

    Strong CYP1A2 and CYP2B6 Inducers: Coadministration with rifampin or a strong CYP1A2 and CYP2B6 inducer will decrease fenfluramine plasma concentrations.

    Consider an increase in FINTEPLA dosage when coadministered with rifampin or a strong CYP1A2 and CYP2B6 inducer.

    Use in Specific Populations

    Administration to patients with moderate or severe renal impairment or to patients with hepatic impairment is not recommended.

    About Zogenix

    Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, C-IV has been approved by the U.S. FDA and is under review in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. In addition, the company has two late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a rare childhood-onset epilepsy and one for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

    Forward Looking Statements

    Zogenix cautions you that statements included in this press release and the conference call that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include: FINTEPLA providing a treatment option for patients with Dravet syndrome; and Zogenix's plans to commercialize FINTEPLA, including the timing of the launch of the restricted distribution program, FINTEPLA REMS Program, and the launch of Zogenix Central and the availability of product assistance to patients, caregivers, and their medical teams. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: Zogenix's ability to successfully launch FINTEPLA, including establishing the restricted distribution program, FINTEPLA REMS Program, and Zogenix Central, and the timing thereof; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to commercialize FINTEPLA and Zogenix's ability to generate product revenue; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit commercialization, or that could result in recalls or product liability claims; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA; Zogenix's dependence on third parties for the manufacture of FINTEPLA; Zogenix's ability to achieve and maintain adequate levels of coverage and reimbursement for FINTEPLA; the scope and validity of patent protection or regulatory exclusivity protection for FINTEPLA and Zogenix's ability to commercialize FINTEPLA without infringing the patent rights of others; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:



    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 |

    Investors

    Brian Ritchie

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578



    Media

    Stefanie Tuck

    +1 (978) 390-1394 |

    ¹ The Lancet, Volume 394, Issue 10216, P2243-2254, December 21, 2019

    ² JAMA Neurol. 2020 Mar; 77(3): 300–308.

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  18. EMERYVILLE, Calif., June 12, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced the introduction in the U.S. of a new suite of materials to better support and celebrate siblings of those living with Dravet syndrome. Dravet syndrome is a rare, severe childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death.

    The severity and unpredictability of Dravet syndrome, coupled with around-the-clock concern for the family member with Dravet syndrome, can cause significant challenges for all members of the family and increase a sibling's risk for anxiety and depression. These…

    EMERYVILLE, Calif., June 12, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced the introduction in the U.S. of a new suite of materials to better support and celebrate siblings of those living with Dravet syndrome. Dravet syndrome is a rare, severe childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death.

    The severity and unpredictability of Dravet syndrome, coupled with around-the-clock concern for the family member with Dravet syndrome, can cause significant challenges for all members of the family and increase a sibling's risk for anxiety and depression. These new materials, created in collaboration with the Dravet Syndrome Foundation, other epilepsy experts, and mental health professionals, include printed brochures to help parents and caregivers recognize when their child, teen, or young adult may need more support. The materials also include a boxed VIP kit and other resources to help siblings work through complex emotions they may be experiencing and remind them how important they are.

    "The extra care that a family member with Dravet syndrome needs can have a huge impact on a family's quality of life, compounded these days by the uncertainties of navigating a global pandemic," said Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation. "We are very pleased to partner with Zogenix to address the lack of resources in this area and put sibling care in the spotlight."

    The Parent & Caregiver Resources include:

    • Guides on how to recognize signs that their children with a Dravet syndrome sibling may need extra support, ideas for staying connected, and suggestions on when and how to ask for help.
    • Customizable information sheets that families can share with a sibling's teachers and others to help them understand what Dravet syndrome is, how it might affect a sibling, and what to do when the family must attend to the child with Dravet syndrome when affected by seizures and medical emergencies.
    • A pad of love notes parents can put in lunch boxes and back packs for siblings who could benefit from a reminder of how important they are.

    The VIP Sibling Kits for children ages 4-18 contain:

    • Journals with prompts for self-expression
    • Positive affirmation coloring books
    • VIP "Rockin' It / Rough Day" wrist bands to help them show their mood
    • VIP stress putty
    • Kits for younger siblings (ages 4-10) also include a plush star and the Dravet Syndrome Foundation's book My Sibling Is Special
    • Kits for older siblings (ages 11-18) include a reversable "I need space / Come on in" door hanger and a VIP smart phone pop socket

    The materials were presented to the U.S.-based Dravet syndrome community this week in a special Dravet Syndrome Foundation webinar and will be available through the Dravet Syndrome Foundation starting August 1, 2020.

    "My colleague on this project, Laurie Bailey, and I have learned a lot – and shed a few tears – as we heard from so many siblings how Dravet syndrome affects their lives," said Carla Schad, M.D., M.S., Senior Director of Medical Science Liaisons at Zogenix. "These siblings are brilliant, feisty, witty, devoted, and compassionate. They love their families and want to help care for and protect their sibling living with Dravet. We are so proud to help ensure they feel equally supported, loved, and cared for."

    About the Zogenix Sibling Voices Initiative

    Zogenix has worked with the Dravet Syndrome Foundation, the broader Dravet community, and a variety of other Dravet syndrome and mental health experts to better understand and address the impact of rare epilepsies on caregivers, families, and siblings. Other materials in the resulting Sibling Voices library include infographics summarizing research findings, infographics for siblings to let them know they are not alone, sibling workshops and events, and presentations of data to clinicians, parents, and advocacy groups around the world. In addition, Zogenix recently launched the Shine Forward with Dravet website and Facebook page in the United States, which offers tips and tools to inspire and uplift Dravet syndrome parents and caregivers and help them stay connected to all members of the family.

    About Zogenix

    Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    Zogenix

    +1 (510) 788-8732 |

    Media

    Stefanie Tuck

    +1 (978) 390-1394 |

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  19. EMERYVILLE, Calif., May 15, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced the U.S. launch of Shine Forward with Dravet, a unique set of online tips, tools, and advice from Dravet families designed to inspire deeper connections between parents and siblings of children diagnosed with Dravet syndrome.

    Dravet syndrome is a rare childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death. The severity and unpredictability of the disease, coupled with around-the-clock concern for the diagnosed child's well-being, can present significant emotional and logistical challenges…

    EMERYVILLE, Calif., May 15, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced the U.S. launch of Shine Forward with Dravet, a unique set of online tips, tools, and advice from Dravet families designed to inspire deeper connections between parents and siblings of children diagnosed with Dravet syndrome.

    Dravet syndrome is a rare childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death. The severity and unpredictability of the disease, coupled with around-the-clock concern for the diagnosed child's well-being, can present significant emotional and logistical challenges for all members of the family.

    "Families managing life with Dravet are incredibly strong and resilient," said Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation. "As the disease progresses, however, and care requirements intensify, parents and siblings alike may have days when they feel alone, misunderstood, or overwhelmed. Zogenix's Shine Forward with Dravet offers support with uplifting insights and approaches from families who understand and share their journey."

    Shine Forward with Dravet includes a website (www.shineforwardwithdravet.com) and Facebook page (https://www.facebook.com/ShineForward/) with information for parents, tips for day-to-day coping, and approaches for effectively listening to and appropriately involving their children of different ages. The sites also feature a growing collection of activities parents can do at home with their children. For times when deeper expertise is needed, the sites include links to Dravet Syndrome Foundation resources (www.dravetfoundation.org).

    "We collaborated with the Dravet community to conduct pioneering research into the impact of Dravet syndrome on siblings," said Ashish Sagrolikar, Chief Commercial Officer at Zogenix. "Now, we're honored to partner again to develop Shine Forward with Dravet, a resource that, we hope, will help make life a little easier for every member of the family."

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder.

    CONTACT:
    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732 |

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  20. EMERYVILLE, Calif., May 06, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that Stephen J. Farr, Ph.D., will participate in a fireside chat on Wednesday, May 13, 2020, at the BofA Securities 2020 Virtual Healthcare Conference.

    Zogenix Fireside Chat Details
    Date: Wednesday, May 13, 2020
    Time: 3:00 PM Eastern Time
    Webcast: https://www.veracast.com/webcasts/bofa/healthcare2020/id67211238289.cfm

    The fireside chat will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com.

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential…

    EMERYVILLE, Calif., May 06, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that Stephen J. Farr, Ph.D., will participate in a fireside chat on Wednesday, May 13, 2020, at the BofA Securities 2020 Virtual Healthcare Conference.

    Zogenix Fireside Chat Details
    Date: Wednesday, May 13, 2020
    Time: 3:00 PM Eastern Time
    Webcast: https://www.veracast.com/webcasts/bofa/healthcare2020/id67211238289.cfm

    The fireside chat will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com.

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.

    CONTACTS:
    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732 |

    Investors
    Brian Ritchie
    Managing Director, LifeSci Advisors LLC
    +1 (212) 915-2578 |

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    • FDA PDUFA target action date of June 25, 2020, for FINTEPLA® NDA in Dravet syndrome
    • Plan to meet with FDA in second half of 2020 to discuss planned FINTEPLA Lennox-Gastaut syndrome sNDA
    • Closed public offering of common stock for net proceeds of $221.7 million; approximately $420 million in cash and marketable securities at March 31, 2020

    EMERYVILLE, Calif., May 05, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced financial results for the three months ended March 31, 2020, and provided a corporate update. The Company will host a conference call today, Tuesday, May 5, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

    "We continue to make progress on several…

    • FDA PDUFA target action date of June 25, 2020, for FINTEPLA® NDA in Dravet syndrome
    • Plan to meet with FDA in second half of 2020 to discuss planned FINTEPLA Lennox-Gastaut syndrome sNDA
    • Closed public offering of common stock for net proceeds of $221.7 million; approximately $420 million in cash and marketable securities at March 31, 2020

    EMERYVILLE, Calif., May 05, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced financial results for the three months ended March 31, 2020, and provided a corporate update. The Company will host a conference call today, Tuesday, May 5, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

    "We continue to make progress on several key initiatives to support Zogenix's growth and transition to a commercial-stage company," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "During the pandemic, our priority has been to ensure that the approximately 530 Dravet syndrome patients currently taking FINTEPLA® in our clinical studies and expanded access program continue to receive this investigational product. As we approach the June 25th PDUFA date for FINTEPLA in Dravet syndrome, we continue to support the FDA's review of our application and advance our commercial preparations in parallel. Our plans now also address potential ongoing pandemic-related circumstances that could impact how we launch FINTEPLA, if approved, in the third quarter.

    "Recently, we were very pleased to share additional compelling clinical efficacy and safety data from an interim analysis of our ongoing open-label extension (OLE) study in Dravet syndrome," continued Dr. Farr. "These data demonstrated significant, lasting and clinically meaningful reductions in convulsive seizure frequency in patients after up to two years of treatment with FINTEPLA."

    "Following positive top-line results from our global pivotal Phase 3 trial (Study 1601) of FINTEPLA in Lennox-Gastaut syndrome (LGS), a notoriously difficult to treat rare epilepsy, we are now focused on finalizing the studies and data required to support a supplemental NDA (sNDA) and intend to meet with the FDA later this year to discuss our planned submission," concluded Dr. Farr.

    Corporate Update

    • FINTEPLA for the treatment of seizures associated with Dravet syndrome:
      — FDA has established a PDUFA target action date of June 25, 2020
      — FINTEPLA Marketing Authorization Application (MAA) under active review by the European Medicines Agency (EMA)
      — Commercial readiness activities ongoing in the U.S. and Europe
      — An interim analysis of the OLE study with a cutoff date of February 15, 2019, which includes results for a total of 330 patients and a median treatment duration of 445 days (range 7-899 days), was presented and showed continued clinically meaningful reductions in convulsive seizure frequency after up to two years of treatment. The most common adverse events (AEs) were pyrexia, nasopharyngitis, decreased appetite, and diarrhea. There were no cases of valvular heart disease or pulmonary arterial hypertension.
    • FINTEPLA for the treatment of seizures associated with LGS:
      — Primary endpoint achieved in Study 1601; patients taking FINTEPLA 0.7 mg/kg/day demonstrated a statistically significant median reduction of 26.5% in monthly drop seizure frequency (p=0.0012). FINTEPLA was generally well-tolerated; the most common AEs were decreased appetite, somnolence, fatigue, vomiting, diarrhea, and pyrexia. No cases of valvular heart disease or pulmonary arterial hypertension were observed.
      — Intend to meet with the FDA second half of 2020 to confirm plan for sNDA submission
    • FINTEPLA for the treatment of other rare epilepsy disorders:
      — Start-up activities for our planned Phase 2 basket study (Study 1901) temporarily paused due to COVID-19; will resume when COVID-19 measures are eased, and healthcare systems return to more normal operations
      — Positive interim data from an investigator-initiated study were presented in Sunflower syndrome, a rare, drug-resistant epileptic disorder with photo-induced seizures characterized by episodes of hand-waving while looking towards bright light
    • MT1621 for the treatment of TK2 deficiency:
      — Held constructive End of Phase 2 meeting with FDA regarding MT1621 clinical and non-clinical programs; awaiting official minutes from the FDA
      — Additional FDA meeting scheduled in June to focus on CMC matters
    • Financing
      — Successfully closed an underwritten public offering of 9,798,000 shares of common stock for net proceeds of approximately $221.7 million
    • Executive Team
      — Appointed Shawnte M. Mitchell to the role of Executive Vice President, General Counsel and Secretary, to lead the Company's Legal and Compliance functions, manage corporate affairs and serve as a member of the Zogenix Executive Team

    First Quarter 2020 Financial Results

    • The Company recorded $1.2 million in revenue for the first quarter ended March 31, 2020, as a result of its March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded no revenue for the corresponding period of 2019.
    • Research and development expenses for the first quarter ended March 31, 2020, totaled $33.2 million, up from $24.4 million in the first quarter ended March 31, 2019.
    • Selling, general and administrative expenses for the first quarter ended March 31, 2020, totaled $21.3 million, compared with $10.9 million in the first quarter ended March 31, 2019.
    • Net loss for the first quarter ended March 31, 2020, was $25.8 million, or a net loss of $0.54 per share, reflective of a net operating loss of $46.9 million, partially offset by $19.7 million in non-operating income recognized related to rebate claims submitted under the United Kingdom's small and medium-sized enterprise research and development tax relief program, compared with a net loss of $35.2 million, or a net loss of $0.83 per share, in the first quarter ended March 31, 2019.
    • As of March 31, 2020, the Company had $420.2 million in cash, cash equivalents, and marketable securities, compared to $251.2 million at December 31, 2019.

    Conference Call

    Tuesday, May 5, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
    Toll Free: 888-254-3590
    International: 323-994-2093
    Conference ID: 3810961
    Webcast: http://public.viavid.com/index.php?id=139572

    About Zogenix

    Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.

    Forward Looking Statements

    Zogenix cautions you that statements included in this press release and the webcast that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include: the timing of the FDA's PDUFA target action date and the timing of review by the EMA with respect to the NDA and MAA, respectively, for FINTEPLA for the treatment of patients with Dravet syndrome; the potential that FINTEPLA, if approved, will provide treatment options for patients with Dravet syndrome and LGS; Zogenix's plans to commercialize FINTEPLA, if approved; Zogenix's plans to finalize the studies and data required to support an sNDA for FINTEPLA in LGS; and the timing of regulatory submissions and meetings or other interactions with regulatory agencies. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the potential for the FDA to delay the PDUFA target goal date due to FDA's internal resource constraints or other reasons, including delays related to the COVID-19 pandemic; the FDA and EMA may disagree that the existing safety and efficacy data, or Zogenix's analysis of such data, is sufficient to support marketing approval; interim results do not necessarily predict final results and one or more of the clinical outcomes may materially change as the trial continues, following more comprehensive reviews of the data, and as more patient data become available; additional data from Zogenix's ongoing studies may contradict or undermine the data submitted in the Dravet syndrome NDA for FINTEPLA or reported for LGS; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA, if approved; Zogenix may encounter further delays or difficulties in enrolling patients in its clinical trials as a result of the COVID-19 pandemic; the COVID-19 pandemic may disrupt Zogenix's business operations, increasing its costs or impairing its ability to prepare for potential commercialization of FINTEPLA and its ability to generate any product revenue, if approved; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732

    Investors
    Brian Ritchie
    Managing Director, LifeSci Advisors LLC
    +1 (212) 915-2578


    Zogenix, Inc.

    Condensed Consolidated Balance Sheets (Unaudited)
    (in thousands)

        March 31, 2020   December 31, 2019
    Assets:        
    Current assets:        
    Cash and cash equivalents   $ 269,975     $ 62,070  
    Marketable securities   150,218     189,085  
    Other receivable   19,741      
    Prepaid expenses and other current assets   13,647     11,084  
    Acquisition holdback placed in escrow   25,000     25,000  
    Total current assets   478,581     287,239  
    Property and equipment, net   9,560     9,424  
    Operating lease right-of-use assets   8,546     7,774  
    Indefinite-lived intangible assets   102,500     102,500  
    Goodwill   6,234     6,234  
    Other noncurrent assets   1,485     1,079  
    Total assets   $ 606,906     $ 414,250  
    Liabilities and stockholders' equity:        
    Current liabilities:        
    Accounts payable   $ 7,887     $ 7,979  
    Accrued and other current liabilities   25,803     30,117  
    Acquisition holdback liability   24,444     24,444  
    Deferred revenue, current   5,696     5,927  
    Current portion of operating lease liabilities   1,383     1,322  
    Current portion of contingent consideration   23,600     25,600  
    Total current liabilities   88,813     95,389  
    Deferred revenue, noncurrent   6,407     7,425  
    Operating lease liabilities, net of current portion   11,454     10,752  
    Contingent consideration, net of current portion   32,300     38,200  
    Deferred income taxes   17,425     17,425  
    Total liabilities   156,399     169,191  
    Commitments and contingencies        
    Stockholders' equity:        
    Common stock   55     45  
    Additional paid-in capital   1,591,497     1,360,092  
    Accumulated deficit   (1,141,257 )   (1,115,457 )
    Accumulated other comprehensive income   212     379  
    Total stockholders' equity   450,507     245,059  
    Total liabilities and stockholders' equity   $ 606,906     $ 414,250  


    Zogenix, Inc.

    Condensed Consolidated Statements of Operations (Unaudited)
    (in thousands, except per share amounts)

        Three Months Ended March 31,
        2020   2019
    Collaboration revenue   $ 1,249     $  
    Operating expenses:        
    Research and development   33,240     24,352  
    Selling, general and administrative   21,318     10,918  
    Acquired in-process research and development expense   1,500      
    Change in fair value of contingent consideration   (7,900 )   3,000  
    Total operating expenses   48,158     38,270  
    Loss from operations   (46,909 )   (38,270 )
    Other income (expense):        
    Interest income   1,088     3,156  
    Other income (expense), net   20,021     (88 )
    Total other income   21,109     3,068  
    Net loss   $ (25,800 )   $ (35,202 )
             
    Net loss per share, basic and diluted   $ (0.54 )   $ (0.83 )
             
    Weighted average number of shares used in the calculation of basic and diluted net loss per common share   48,185     42,236  


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  21. EMERYVILLE, Calif., April 28, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it will report its financial results for the first quarter ended March 31, 2020, after the market close, and will host a corporate update conference call and webcast on Tuesday, May 5, 2020, at 4:30 PM Eastern Time.

    Conference Call Details  
    Tuesday, May 5, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
    Toll Free: 888-254-3590
    International: 323-994-2093
    Conference ID: 3810961
    Webcast: http://public.viavid.com/index.php?id=139572

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the…

    EMERYVILLE, Calif., April 28, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it will report its financial results for the first quarter ended March 31, 2020, after the market close, and will host a corporate update conference call and webcast on Tuesday, May 5, 2020, at 4:30 PM Eastern Time.

    Conference Call Details  
    Tuesday, May 5, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
    Toll Free: 888-254-3590
    International: 323-994-2093
    Conference ID: 3810961
    Webcast: http://public.viavid.com/index.php?id=139572

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.

    CONTACTS:
    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732 |

    Investors
    Brian Ritchie
    Managing Director, LifeSci Advisors LLC
    +1 (212) 915-2578 |

     

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  22. EMERYVILLE, Calif., April 20, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced it has appointed Shawnte M. Mitchell to the role of Executive Vice President, General Counsel and Secretary. In this role, Ms. Mitchell will lead the company's Legal team, manage certain corporate affairs, and serve as a member of the Zogenix Executive Team.

    "I am very pleased to welcome Shawnte to Zogenix," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "Her expertise as a trusted and strategic legal advisor, especially in the area of corporate governance, will further strengthen our current in-house capabilities, supporting our goals for growth as a commercial-stage…

    EMERYVILLE, Calif., April 20, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced it has appointed Shawnte M. Mitchell to the role of Executive Vice President, General Counsel and Secretary. In this role, Ms. Mitchell will lead the company's Legal team, manage certain corporate affairs, and serve as a member of the Zogenix Executive Team.

    "I am very pleased to welcome Shawnte to Zogenix," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "Her expertise as a trusted and strategic legal advisor, especially in the area of corporate governance, will further strengthen our current in-house capabilities, supporting our goals for growth as a commercial-stage company."

    An accomplished attorney, Ms. Mitchell has more than 15 years of experience advising publicly traded and privately held companies. She joins Zogenix from Aptevo Therapeutics, where she was most recently Senior Vice President, General Counsel and Corporate Affairs, contributing to the development and execution of the company's strategic and operational plans and overseeing compliance, governance, SEC, intellectual property, data privacy, and contractual matters. Prior to Aptevo, Ms. Mitchell was Vice President, Associate General Counsel and Assistant Secretary at the specialty biopharmaceutical company Emergent BioSolutions. Earlier, as an Associate at Ropes & Gray, she advised health care, life sciences, and technology clients in mergers and acquisitions, venture capital investment, and other matters. Ms. Mitchell received a B.S. in Biological Sciences from Stanford University and a J.D. from The George Washington University Law School.

    "I'm excited to join Zogenix," said Ms. Mitchell. "The company's commitment to providing new therapies for patients with rare diseases is inspiring, and I'm thrilled to join an executive team deeply committed both to this mission and to the company's continued success."

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.

    CONTACTS:

    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732 |

    Investors
    Brian Ritchie
    Managing Director, LifeSci Advisors LLC
    +1 (212) 915-2578 |

    Primary Logo

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  23. EMERYVILLE, Calif., March 06, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, announced today that it has closed its previously announced underwritten public offering of 9,798,000 shares of its common stock, including 1,278,000 shares sold pursuant to the underwriters' full exercise of their option to purchase additional shares, at a price to the public of $23.50 per share. The gross proceeds to Zogenix from the offering, before underwriting discounts and commissions and offering costs, were approximately $230.3 million. 

    Zogenix intends to use the net proceeds from the proposed offering to support its activities related to the potential commercialization of FINTEPLA®…

    EMERYVILLE, Calif., March 06, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, announced today that it has closed its previously announced underwritten public offering of 9,798,000 shares of its common stock, including 1,278,000 shares sold pursuant to the underwriters' full exercise of their option to purchase additional shares, at a price to the public of $23.50 per share. The gross proceeds to Zogenix from the offering, before underwriting discounts and commissions and offering costs, were approximately $230.3 million. 

    Zogenix intends to use the net proceeds from the proposed offering to support its activities related to the potential commercialization of FINTEPLA® for the treatment of Dravet syndrome, submission of regulatory applications in the United States and the European Union for FINTEPLA for the treatment of Lennox-Gastaut syndrome, funding of future clinical trials of FINTEPLA for other indications, continuing development and activities related to the potential commercialization of MT1621 for the treatment of thymidine kinase 2 deficiency, and for working capital and general corporate purposes. 

    SVB Leerink and Stifel acted as joint book-running managers for the offering.

    The securities described above were offered by Zogenix pursuant to a shelf registration statement filed by Zogenix with the Securities and Exchange Commission (SEC) that became automatically effective on October 2, 2017. A final prospectus supplement relating to this offering has been filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 800-808-7525, ext. 6218 or by email at ; or from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at . Electronic copies of the final prospectus supplement and accompanying prospectus are also available on the website of the SEC at http://www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    About Zogenix

    Zogenix, Inc. is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding anticipated use of proceeds from the public offering. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including risks and uncertainties inherent in Zogenix's business, including those described in the company's periodic filings with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Zogenix can be found under the heading "Risk Factors" in Zogenix's periodic reports, including its annual report on Form 10-K for the year ended December 31, 2019, and in the final prospectus supplement related to the proposed offering filed with the SEC on March 4, 2020, each available on the SEC's web site at www.sec.gov. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    CONTACTS:

    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732 |

    Investors
    Brian Ritchie
    Managing Director, LifeSci Advisors LLC
    +1 (212) 915-2578 |

    Primary Logo

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  24. EMERYVILLE, Calif., March 03, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, announced today that it has priced an underwritten public offering of 8,520,000 shares of its common stock at a price to the public of $23.50 per share. The gross proceeds to Zogenix from the offering, before underwriting discounts and commissions and offering costs, are expected to be approximately $200.2 million.  Zogenix has granted the underwriters a 30-day option to purchase up to an additional 1,278,000 shares of common stock. All of the shares to be sold in the offering are being sold by Zogenix. The offering is expected to close on or about March 6, 2020, subject to satisfaction of customary…

    EMERYVILLE, Calif., March 03, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, announced today that it has priced an underwritten public offering of 8,520,000 shares of its common stock at a price to the public of $23.50 per share. The gross proceeds to Zogenix from the offering, before underwriting discounts and commissions and offering costs, are expected to be approximately $200.2 million.  Zogenix has granted the underwriters a 30-day option to purchase up to an additional 1,278,000 shares of common stock. All of the shares to be sold in the offering are being sold by Zogenix. The offering is expected to close on or about March 6, 2020, subject to satisfaction of customary closing conditions.  

    Zogenix intends to use the net proceeds from the proposed offering to support its activities related to the potential commercialization of FINTEPLA® for the treatment of Dravet syndrome, submission of regulatory applications in the United States and the European Union for FINTEPLA for the treatment of Lennox-Gastaut syndrome, funding of future clinical trials of FINTEPLA for other indications, continuing development and activities related to the potential commercialization of MT1621 for the treatment of thymidine kinase 2 deficiency, and for working capital and general corporate purposes. 

    SVB Leerink and Stifel are acting as joint book-running managers for the offering.

    The securities described above are being offered by Zogenix pursuant to a shelf registration statement filed by Zogenix with the Securities and Exchange Commission (SEC) that became automatically effective on October 2, 2017. A preliminary prospectus supplement relating to this offering has been filed with the SEC and a final prospectus supplement relating to this offering will be filed with the SEC. The offering may be made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 800-808-7525, ext. 6218 or by email at ; or from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at . Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the website of the SEC at http://www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    About Zogenix

    Zogenix, Inc. is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding Zogenix's expectations of market conditions and the satisfaction of customary closing conditions related to the public offering and the anticipated use of proceeds therefrom. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the public offering, as well as risks and uncertainties inherent in Zogenix's business, including those described in the company's periodic filings with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Zogenix can be found under the heading "Risk Factors" in Zogenix's periodic reports, including its annual report on Form 10-K for the year ended December 31, 2019, and in the preliminary prospectus supplement related to the proposed offering filed with the SEC on March 3, 2020, each available on the SEC's web site at www.sec.gov. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    CONTACTS:

    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732 |

    Investors
    Brian Ritchie
    Managing Director, LifeSci Advisors LLC
    +1 (212) 915-2578 |

     

    Primary Logo

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  25. EMERYVILLE, Calif., March 03, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, announced today that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. Zogenix also expects to grant to the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares to be sold in the offering are to be sold by Zogenix.

    Zogenix intends to use the net proceeds from the proposed offering to support its activities related to the potential commercialization of FINTEPLA® for the treatment of Dravet syndrome, submission of regulatory…

    EMERYVILLE, Calif., March 03, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, announced today that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. Zogenix also expects to grant to the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares to be sold in the offering are to be sold by Zogenix.

    Zogenix intends to use the net proceeds from the proposed offering to support its activities related to the potential commercialization of FINTEPLA® for the treatment of Dravet syndrome, submission of regulatory applications in the United States and the European Union for FINTEPLA for the treatment of Lennox-Gastaut syndrome, funding of future clinical trials of FINTEPLA for other indications, continuing development and activities related to the potential commercialization of MT1621 for the treatment of thymidine kinase 2 deficiency, and for working capital and general corporate purposes.

    SVB Leerink and Stifel are acting as joint book-running managers for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    The securities described above are being offered by Zogenix pursuant to a shelf registration statement filed by Zogenix with the Securities and Exchange Commission (SEC) that became automatically effective on October 2, 2017. A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 800-808-7525, ext. 6218 or by email at ; or from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at . Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at http://www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    About Zogenix

    Zogenix, Inc. is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding Zogenix's expectations of the completion, timing and size of the proposed public offering and the anticipated use of proceeds therefrom. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed public offering, as well as risks and uncertainties inherent in Zogenix's business, including those described in the company's periodic filings with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Zogenix can be found under the heading "Risk Factors" in Zogenix's periodic reports, including its annual report on Form 10-K for the year ended December 31, 2019, and in the preliminary prospectus supplement related to the proposed offering to be filed with the SEC on or about the date hereof, each available on the SEC's web site at www.sec.gov. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    CONTACTS:

    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732 |

    Investors
    Brian Ritchie
    Managing Director, LifeSci Advisors LLC
    +1 (212) 915-2578 |

    Primary Logo

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    • NDA for FINTEPLA® in Dravet syndrome accepted for review by FDA; new PDUFA target acion date of June 25, 2020
    • Two-year interim analysis of FINTEPLA open-label extension study in Dravet syndrome patients demonstrated a 77% and 83% reduction in median convulsive seizure frequency at one and two years, respectively
    • Global Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome achieved primary drop seizure reduction endpoint with high statistical significance

    EMERYVILLE, Calif., March 02, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today provided a corporate update and announced financial results for the quarter and full-year ended December 31, 2019. The Company will host…

    • NDA for FINTEPLA® in Dravet syndrome accepted for review by FDA; new PDUFA target acion date of June 25, 2020
    • Two-year interim analysis of FINTEPLA open-label extension study in Dravet syndrome patients demonstrated a 77% and 83% reduction in median convulsive seizure frequency at one and two years, respectively
    • Global Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome achieved primary drop seizure reduction endpoint with high statistical significance

    EMERYVILLE, Calif., March 02, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today provided a corporate update and announced financial results for the quarter and full-year ended December 31, 2019. The Company will host a conference call today, Monday, March 2, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

    "The last six months have been especially active as we continued to advance our lead programs through the development and regulatory review processes. In the fourth quarter, the U.S. Food and Drug Administration (FDA) accepted our New Drug Application (NDA) filing for FINTEPLA® in Dravet syndrome with Priority Review," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "While our Prescription Drug User Fee Act (PDUFA) target action date was recently extended by three months to June 25, 2020, in response to an information request from the FDA, we remain very confident in the data supporting our NDA submission, and continue to actively prepare for the potential commercial launch of FINTEPLA."

    "Additionally, we are pleased to announce that the results from an interim analysis of our ongoing open-label extension (OLE) study in Dravet syndrome continues to show clinically meaningful reductions in convulsive seizure frequency for up to two years of treatment, further highlighting that FINTEPLA may be an important new treatment option for patients with Dravet syndrome," continued Dr. Farr.

    "In a different rare epilepsy, Lennox-Gastaut syndrome (LGS), we were very pleased with the recently announced positive top-line results from Study 1601, our global, pivotal Phase 3 trial in LGS, which highlight FINTEPLA's potential to also be an important new treatment option for LGS, one of the most difficult to treat rare epilepsies," concluded Dr. Farr.

    Corporate Update

    • FINTEPLA for the treatment of seizures associated with Dravet syndrome:
      • FDA accepted NDA submission with Priority Review in November 2019
      • FDA recently extended their review period for the NDA by three months, with a new PDUFA target action date of June 25, 2020, to allow FDA additional time to review additional data and conduct additional efficacy analyses from Zogenix's two successfully completed pivotal Phase 3 studies (Study 1 and Study 1504)
      • FINTEPLA Marketing Authorization Application (MAA) under active review by the European Medicines Agency (EMA)
      • Commercial readiness activities ongoing in the U.S. and Europe
      • An interim analysis of the OLE study with a cutoff date in the first quarter of 2019 includes results for a total of 330 patients, with a median treatment duration of 445 days (range 7-899 days).  In patients treated up to one year (n=222), there was a 77% decrease (p<0.001; IQR -42, -95) in median convulsive seizure frequency when comparing treatment effect at months 10 - 12 to baseline; and for those treated up to two years (n=52), the median decrease in convulsive seizure frequency was 83% (p<0.001; IQR -58, -100) at months 22 - 24 compared to baseline. Data to be presented at American Academy of Neurology Annual Meeting in Toronto, April 25-May 1, 2020
      • Results from the Company's two pivotal Phase 3 studies of FINTEPLA in Dravet syndrome were published in JAMA Neurology (Study 1504) and The Lancet (Study 1)
      • Presented eight abstracts, including three-late breaker presentations with new data analyses from the Dravet syndrome clinical program, at the annual American Epilepsy Society meeting in December 2019
    • FINTEPLA for the treatment of seizures associated with LGS:
      • Primary endpoint achieved in Study 1601; patients taking FINTEPLA 0.7 mg/kg/day demonstrated a statistically significant median reduction of 26.5% in monthly drop seizure frequency (p=0.0012)
      • No cases of valvular heart disease or pulmonary hypertension observed in Study 1601
    • MT1621 for the treatment of TK2 deficiency:
      • Announced results of the Phase 2 RETRO study in October 2019
      • FDA meeting scheduled in early second quarter to discuss next steps for MT1621 program
      • Enrollment complete in Study 102, a prospective, open-label, continuation study of MT1621 in patients with TK2 deficiency

    Fourth Quarter 2019 Financial Results

    • The Company recorded $1.9 million in revenue for the fourth quarter ended December 31, 2019, as a result of its March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded no revenue for the corresponding period of 2018.
    • Research and development expenses for the fourth quarter ended December 31, 2019, totaled $35.8 million, up from $23.6 million in the fourth quarter ended December 31, 2018, as the Company concluded Phase 3 clinical trials in Dravet syndrome and expanded clinical trial activities related to its ongoing Phase 3 development program of FINTEPLA in LGS.
    • Selling, general and administrative expenses for the fourth quarter ended December 31, 2019, totaled $18.7 million, compared with $11.3 million in the fourth quarter ended December 31, 2018. The increase was driven by commercial launch preparations.
    • Net loss for the fourth quarter ended December 31, 2019, was $56.1 million, or a net loss of $1.26 per share, compared with a net loss of $22.4 million, or a net loss of $0.53 per share, in the fourth quarter ended December 31, 2018.

    Year Ended December 31, 2019 Financial Results Compared to Year Ended December 31, 2018

    • The Company recorded $3.6 million in revenue for the year ended December 31, 2019, as a result of its March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded no revenue for the corresponding period of 2018.
    • Research and development expenses for the year ended December 31, 2019, totaled $115.6 million, up from $100.9 million in the year ended December 31, 2018, as the Company concluded Phase 3 clinical trials in Dravet syndrome and expanded clinical trial activities related to its ongoing Phase 3 development program of FINTEPLA in LGS.
    • Selling, general and administrative expenses for the year ended December 31, 2019, totaled $60.8 million, up from $39.0 million in the year ended December 31, 2018. The increase was driven by commercial launch preparations.
    • Net loss for the year ended December 31, 2019, was $419.5 million, or a net loss of $9.74 per share, compared with a net loss of $123.9 million, or a net loss of $3.27 per share, in the year ended December 31, 2018.  The increase in net loss was primarily attributable to $251.4 million of acquired in-process research and development consisting of existing research and development projects at the time of the Modis acquisition.
    • As of December 31, 2019, the Company had $251.2 million in cash, cash equivalents, and marketable securities, compared to $514.2 million at December 31, 2018.  The decrease in cash was primarily attributable to the $175.5 million used for the Modis acquisition on September 6, 2019.

    Conference Call Details
    Monday, March 2 at 4:30 PM Eastern Time / 1:30 PM Pacific Time                     

    Toll Free:  877-407-9716
    International: 201-493-6779
    Conference ID: 13699528
    Webcast: http://public.viavid.com/index.php?id=138178

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.

    Forward-Looking Statements
    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the timing of the FDA's PDUFA target action date and the timing of review by the EMA with respect to the NDA and MAA, respectively, for FINTEPLA for the treatment of patients with Dravet syndrome; the potential that FINTEPLA, if approved, will be provide treatment options for patients with Dravet syndrome and LGS; our plans to commercialize FINTEPLA, if approved; the timing of regulatory submissions and meetings or other interactions with regulatory agencies; and the potential for MT1621 to significantly improve outcomes in patients with TK2 deficiency. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the FDA and EMA may disagree that the existing safety and efficacy data, or Zogenix's analysis of such data, is sufficient to support marketing approval; top-line data the Company reports is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of a clinical trial; later developments with the FDA that may be inconsistent with feedback received at prior meetings with the FDA; additional data from Zogenix's ongoing studies may contradict or undermine the data submitted in the Dravet syndrome NDA for FINTEPLA or reported for LGS; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; Zogenix may not be successful in executing our sales and marketing strategy for the commercialization of FINTEPLA, if approved; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732 |

    Investors
    Brian Ritchie
    Managing Director, LifeSci Advisors LLC
    +1 (212) 915-2578 |


    Zogenix, Inc.
    Condensed Consolidated Balance Sheets (Unaudited)
    (in thousands)

      December 31,
      2019   2018
    Assets:      
    Current assets:      
    Cash and cash equivalents $ 62,070       $ 68,454    
    Marketable securities 189,085       445,733    
    Prepaid expenses 8,593       6,718    
    Acquisition holdback amount placed in escrow 25,000          
    Other current assets 2,491       11,825    
    Total current assets 287,239       532,730    
    Property and equipment, net 9,424       2,870    
    Operating lease right-of-use assets 7,774          
    Indefinite-lived intangible asset 102,500       102,500    
    Goodwill 6,234       6,234    
    Other noncurrent assets 1,079       3,997    
    Total assets $ 414,250       $ 648,331    
    Liabilities and stockholders' equity:      
    Current liabilities:      
    Accounts payable $ 7,979       $ 7,989    
    Accrued clinical trial expenses 18,666       10,621    
    Other current liabilities 11,451       7,465    
    Acquisition holdback liability 24,444          
    Deferred revenue, current 5,927          
    Current portion of operating lease liabilities 1,322          
    Current portion of contingent consideration 25,600       32,300    
    Total current liabilities 95,389       58,375    
    Deferred revenue, noncurrent 7,425          
    Operating lease liabilities, net of current portion 10,752          
    Contingent consideration, net of current portion 38,200       45,900    
    Deferred tax liability 17,425       17,425    
    Deferred rent and lease incentive obligation       3,830    
    Total liabilities 169,191       125,530    
    Commitments and contingencies      
    Stockholders' equity:      
    Common stock 45       42    
    Additional paid-in capital 1,360,092       1,218,710    
    Accumulated other comprehensive income 379       3    
    Accumulated deficit (1,115,457 )     (695,954 )  
    Total stockholders' equity 245,059       522,801    
    Total liabilities and stockholders' equity                            $ 414,250       $ 648,331    


    Zogenix, Inc.

    Condensed Consolidated Statements of Operations (Unaudited)
    (in thousands, except per share amounts)

      Three Months Ended
     December 31,
      Twelve Months Ended
     December 31,
      2019   2018   2019   2018
    Collaboration revenue $ 1,949       $       $ 3,648       $    
    Operating expenses:              
    Research and development 35,820       23,596       115,639       100,925    
    Selling, general and administrative 18,653       11,287       60,792       38,950    
    Acquired IPR&D and related costs 2,000             251,438          
    Change in fair value of contingent consideration 2,900       (1,900 )     5,600       1,300    
    Total operating expenses 59,373       32,983       433,469       141,175    
    Loss from operations (57,424 )     (32,983 )     (429,821 )     (141,175 )  
    Other income (expense):              
    Interest income 1,283       3,175       9,802       7,164    
    Other income (expense) 81       7,375       516       10,295    
    Total other income 1,364       10,550       10,318       17,459    
    Net loss from continuing operations (56,060 )     (22,433 )     (419,503 )     (123,716 )  
    Loss from discontinued operations                   (198 )  
    Net loss $ (56,060 )     $ (22,433 )     $ (419,503 )     $ (123,914 )  
                   
    Net loss per share, basic and diluted $ (1.26 )     $ (0.53 )     $ (9.74 )     $ (3.27 )  

     

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  26. EMERYVILLE, Calif., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for FINTEPLA® for the treatment of seizures associated with Dravet syndrome. The new Prescription Drug User Fee Act (PDUFA) target action date has been extended by three months to June 25, 2020.

    The extension allows the FDA time to review additional data submitted by Zogenix in response to a recent information request from the FDA. The FDA determined that the submission of this information constituted a major amendment to the NDA, resulting in this extension of the…

    EMERYVILLE, Calif., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for FINTEPLA® for the treatment of seizures associated with Dravet syndrome. The new Prescription Drug User Fee Act (PDUFA) target action date has been extended by three months to June 25, 2020.

    The extension allows the FDA time to review additional data submitted by Zogenix in response to a recent information request from the FDA. The FDA determined that the submission of this information constituted a major amendment to the NDA, resulting in this extension of the PDUFA goal date by three months.

    "We remain very confident in the data supporting our NDA submission, and look forward to continuing discussions with the FDA during the review process," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "We are committed to bringing this investigational therapy forward to help meet the needs of patients and families with Dravet syndrome."

    The NDA for FINTEPLA was originally accepted for filing in November 2019 under the FDA's Priority Review program with a six-month review period, and is based on data from two positive pivotal Phase 3 trials in Dravet syndrome and an interim analysis from an ongoing open-label extension study, which included 232 patients treated for up to 21 months.

    Zogenix will be hosting its previously announced corporate update conference call and webcast on Monday, March 2, 2020, at 4:30 PM Eastern Time.

    About Zogenix
    Zogenix, Inc. is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.

    Forward-Looking Statement
    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the timing and results of any decision regarding the NDA from FDA. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the FDA may not agree with the Company's interpretation of results from its clinical trials; the FDA may request additional data in connection with its review of the NDA; the potential for the FDA to further delay the PDUFA target action date related to the Dravet syndrome NDA due to the FDA's internal resource constraints or other reasons; additional data from Zogenix's ongoing studies may contradict or undermine the data submitted in the Dravet syndrome NDA for FINTEPLA or reported for LGS; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732 |

    Investors
    Brian Ritchie
    Managing Director, LifeSci Advisors LLC
    +1 (212) 915-2578 |  

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  27. EMERYVILLE, Calif., Feb. 24, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it will report its financial results for the fourth quarter and full year ended December 31, 2019, after the market close, and will host a corporate update conference call and webcast on Monday, March 2, 2020, at 4:30 PM Eastern Time.

    Conference Call Details
    Monday, March 2nd @ 4:30pm Eastern Time / 1:30pm Pacific Time
    Toll Free:  877-407-9716
    International:  201-493-6779
    Conference ID:  13699528
    Webcast:  http://public.viavid.com/index.php?id=138178

    About Zogenix
    Zogenix, Inc. is a global pharmaceutical company committed to developing and commercializing therapies with the…

    EMERYVILLE, Calif., Feb. 24, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it will report its financial results for the fourth quarter and full year ended December 31, 2019, after the market close, and will host a corporate update conference call and webcast on Monday, March 2, 2020, at 4:30 PM Eastern Time.

    Conference Call Details
    Monday, March 2nd @ 4:30pm Eastern Time / 1:30pm Pacific Time
    Toll Free:  877-407-9716
    International:  201-493-6779
    Conference ID:  13699528
    Webcast:  http://public.viavid.com/index.php?id=138178

    About Zogenix
    Zogenix, Inc. is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.

    CONTACTS:
    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732  | 

    Investors
    Brian Ritchie
    Managing Director, LifeSci Advisors LLC
    +1 (212) 915-2578 |

    Primary Logo

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    • Primary Endpoint Achieved - Statistically Significant Reduction in Drop Seizures for FINTEPLA 0.7 mg/kg/day versus Placebo
       
    • FINTEPLA Also Demonstrated Statistically Significant Improvement on Multiple Secondary Endpoints
       
    • Zogenix to Host Conference Call and Live Webcast Today at 4:30 PM Eastern Time/1:30 PM Pacific Time

    EMERYVILLE, Calif., Feb. 06, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today reported positive top-line results from its global Phase 3 clinical trial (Study 1601) of its lead investigational therapy, FINTEPLA® (ZX008, fenfluramine oral solution) in Lennox-Gastaut Syndrome (LGS), a severe and treatment-resistant childhood-onset epilepsy.  The trial…

    • Primary Endpoint Achieved - Statistically Significant Reduction in Drop Seizures for FINTEPLA 0.7 mg/kg/day versus Placebo
       
    • FINTEPLA Also Demonstrated Statistically Significant Improvement on Multiple Secondary Endpoints
       
    • Zogenix to Host Conference Call and Live Webcast Today at 4:30 PM Eastern Time/1:30 PM Pacific Time

    EMERYVILLE, Calif., Feb. 06, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today reported positive top-line results from its global Phase 3 clinical trial (Study 1601) of its lead investigational therapy, FINTEPLA® (ZX008, fenfluramine oral solution) in Lennox-Gastaut Syndrome (LGS), a severe and treatment-resistant childhood-onset epilepsy.  The trial met its primary objective of demonstrating that FINTEPLA at a dose of 0.7 mg/kg/day was superior to placebo in reducing the frequency of drop seizures, based on the change between baseline and the titration and maintenance treatment period (p=0.0012). The same dose of FINTEPLA (0.7 mg/kg/day) also demonstrated statistically significant improvements versus placebo in key secondary efficacy measures, including the proportion of patients with a clinically meaningful reduction (≥50%) in drop seizure frequency. A decrease in the frequency of drop seizures between baseline and the treatment period was observed for a lower dose of FINTEPLA (0.2 mg/kg/day) compared to placebo, but this change did not reach statistical significance (p=0.0915).  FINTEPLA was generally well-tolerated, with the adverse events consistent with those observed in the Company's two prior Phase 3 studies in Dravet syndrome.

    "LGS is a rare and severe form of epilepsy where nearly all patients have highly treatment resistant and lifelong seizures. As a result, the frequent falls and injuries, and also the cognitive impairment, limit the quality of life for patients and caregivers, even with current treatment options," said Associate Professor Kelly Knupp, M.D., MSCS, FAES of Children's Hospital Colorado, Principal Investigator for Study 1601. "The results observed in this placebo-controlled study are indicative of the potential of fenfluramine to treat patients with refractory LGS. If approved, FINTEPLA could represent an important new treatment option for these patients and their families in need."

    Study Design
    The Phase 3 multicenter, global LGS trial has two parts: Part 1 was a double-blind, placebo-controlled study to assess the safety, tolerability and efficacy of FINTEPLA when added to a patient's current anti-epileptic regimen. The study included a total of 263 patients between the ages of 2 and 35 years whose seizures were currently uncontrolled while on one or more anti-epileptic drugs (AEDs), randomized into three treatment groups: FINTEPLA 0.7 mg/kg/day (26 mg maximum daily dose; n=87), FINTEPLA 0.2 mg/kg/day (n=89), and placebo (n=87). The median age of patients was 13 years, with 29% being 18 years or older. Patients entering the study were taking between one and four AEDs and previously had tried and discontinued an average of seven other AEDs. The median baseline drop seizure frequency across the study groups was 77 seizures per month. After establishing baseline seizure frequency for 4 weeks, randomized patients were titrated to their dose over a 2-week titration period, followed by a 12-week fixed dose maintenance period. Patients who completed Part 1 were eligible to enter Part 2 of the clinical trial, an ongoing 12-month open-label extension study to evaluate the long-term safety, tolerability and effectiveness of FINTEPLA.

    Results
    Study 1601 met its primary endpoint of showing a highly statistically significant reduction from baseline compared to placebo in the median percent change in monthly drop seizure frequency. Patients taking FINTEPLA 0.7 mg/kg/day achieved a median reduction of 26.5% compared to a median reduction of 7.8% in patients taking placebo (p=0.0012). Using a parametric analysis, patients taking FINTEPLA 0.7 mg/kg/day demonstrated a 26.5% greater reduction in mean monthly drop seizure frequency compared to placebo (p=0.0034). The median percent reduction in monthly drop seizures between baseline and the treatment period for the lower study dose of FINTEPLA (0.2 mg/kg/day), a secondary endpoint, was 13.2% and did not reach statistical significance compared to placebo (p=0.0915).

    Additional secondary endpoints of the study were to compare the proportion of study patients treated with FINTEPLA 0.7 mg/kg/day who achieved a ≥50% reduction in monthly drop seizures versus placebo and to compare Clinical Global Impression of Improvement ratings (CGI-I, a measure of improvement of worsening relative to baseline) as assessed by the investigator. Results are shown in the following table:

        FINTEPLA 0.7
    mg/kg/day

    (N=87)
    Placebo
    (N=87)
     
      Patients with ≥50%
    reduction in monthly
    drop seizures
    (T+M Period)
    25.3%
    (p=0.0165)¹
    10.3%  
      CGI-I (Proportion of
    Patients Improved)
     

    48.8%
    (p=0.0567)¹

     
    33.8%  
      CGI-I (Proportion of
    Patients Much
    Improved or Very Much
    Improved)
    26.3%
    (p=0.0007)¹
    6.3%  
      ¹P-values versus Placebo      
             

    FINTEPLA was generally well-tolerated in this study, with the adverse events consistent with those observed in the Company's two prior Phase 3 studies in Dravet syndrome. The incidence of patients who experienced at least one adverse event was 89.7% of patients in the FINTEPLA 0.7 mg/kg/day group, 76.4% in the FINTEPLA 0.2 mg/kg/day group and 79.3% in the placebo group. The most common adverse events (≥10%) in the FINTEPLA-treated groups were decreased appetite, somnolence, fatigue, vomiting, diarrhea, and pyrexia. The incidence of serious adverse events was 11.5% (n=10) in the 0.7 mg/kg/day group, 4.5% (n=4) in the 0.2 mg/kg/day group, and 4.6% (n=4) in the placebo group. Six patients in the 0.7 mg/kg/day group had an adverse event leading to study discontinuation compared to four subjects in the 0.2 mg/kg/day group and one patient in the placebo group; the majority of these were considered treatment-related. There was one death during the trial (0.7 mg/kg/day group) caused by SUDEP (sudden unexpected death in epilepsy), which was assessed by the investigator to be unrelated to the study drug.

    No cases of valvular heart disease or pulmonary hypertension have been observed in Study 1601, including both Part 1 and Part 2. A total of 247 (93.9%) patients entered the open-label extension phase.

    "On behalf of everyone at Zogenix, I would like to thank the patients, families and investigators who gave their time and effort to participate in this study," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "We are pleased with the top-line efficacy and safety results from Study 1601, which highlight FINTEPLA's potential to be an important new treatment option for one of the most difficult to treat rare epilepsies. We look forward to working with regulatory agencies to potentially bring FINTEPLA to the LGS patient community." 

    FINTEPLA for the treatment of LGS has previously been designated as an orphan drug by both the U.S. Food and Drug Administration (FDA) and the European Commission. 

    The Company's New Drug Application (NDA) for FINTEPLA for the treatment of seizures associated with Dravet syndrome is under Priority Review by the FDA, with a PDUFA (Prescription Drug User Fee Act) target action date of March 25, 2020. In addition, a Marketing Authorization Application (MAA) for FINTEPLA in Dravet syndrome is under review by the European Medicines Agency. The NDA and MAA are based on data from two pivotal Phase 3 trials (Studies 1 and 1504) of FINTEPLA in Dravet syndrome and an interim analysis from an ongoing open-label extension study, which included 232 patients treated for up to 21 months.  FINTEPLA is also under development in Japan.

    Conference Call
    Zogenix will host a conference call and webcast to discuss the results from Study 1601 today, February 6, 2020, at 4:30 PM Eastern Time. Details to participate in the call are below.

    Conference Call Details
    4:30 PM Eastern Time / 1:30 PM Pacific Time
    Toll Free: 1-877-407-9716
    International: 1-201-493-6779
    Conference ID: 13698945
    Webcast (with slides): http://public.viavid.com/index.php?id=138046

    About Lennox-Gastaut Syndrome
    Lennox-Gastaut Syndrome (LGS) is a rare and devastating form of childhood-onset epilepsy characterized by many different seizure types, which often don't respond to currently available seizure medications (also known as anti-epileptic drugs, or AEDs). According to the Epilepsy Foundation, LGS accounts for only 2-5% of childhood epilepsies, yet LGS patients are well known to both pediatric and adult neurologists because their seizures are hard to control, and they need life-long treatment. The intellectual and behavioral problems associated with LGS, as well as around-the-clock care requirements, add to the complexity of life with this disease.

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.

    Forward-Looking Statement
    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the potential that FINTEPLA, if approved, will be an important new treatment option for LGS patients;; and the timing and results of any decision regarding the NDA or MAA for FINTEPLA for the treatment of seizures associated with Dravet syndrome. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: top-line data the Company reports is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of a clinical trial, and the FDA may not agree with the Company's interpretation of such results; later developments with the FDA that may be inconsistent with feedback received at prior meetings with the FDA; the potential for the FDA to delay the PDUFA target action date related to the Dravet syndrome NDA due to the FDA's internal resource constraints or other reasons; additional data from Zogenix's ongoing studies may contradict or undermine the data submitted in the Dravet syndrome NDA for FINTEPLA or reported for LGS; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732 |

    Investors
    Brian Ritchie
    Managing Director, LifeSci Advisors LLC
    +1 (212) 915-2578 |

    Primary Logo

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  28. FINTEPLA as adjunctive therapy showed a significant, dose-dependent reduction in convulsive seizure frequency in Dravet syndrome patients versus placebo

    EMERYVILLE, Calif., Dec. 17, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that The Lancet has published the results of its Phase 3 clinical trial, Study 1, of the Company's investigational drug, FINTEPLA® (ZX008, fenfluramine oral solution), in children and young adults with Dravet syndrome, a rare, severe infantile-onset epilepsy characterized by frequent, disabling seizures that are very difficult to treat with existing anti-epileptic drugs. The study showed that both doses of FINTEPLA, when  added…

    FINTEPLA as adjunctive therapy showed a significant, dose-dependent reduction in convulsive seizure frequency in Dravet syndrome patients versus placebo

    EMERYVILLE, Calif., Dec. 17, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that The Lancet has published the results of its Phase 3 clinical trial, Study 1, of the Company's investigational drug, FINTEPLA® (ZX008, fenfluramine oral solution), in children and young adults with Dravet syndrome, a rare, severe infantile-onset epilepsy characterized by frequent, disabling seizures that are very difficult to treat with existing anti-epileptic drugs. The study showed that both doses of FINTEPLA, when  added to the patients' existing treatment regimens, provided a significant reduction in convulsive seizure frequency compared to placebo.

    "The results from this study are tremendously encouraging in reducing the magnitude and duration of seizures in our patients with Dravet syndrome," said Joseph Sullivan, M.D., Director of the Pediatric Epilepsy Center of Excellence at the UCSF Benioff Children's Hospitals, co-lead author of the manuscript, and Principal Investigator for Study 1. "If future outcomes are as positive, it could help clinicians set new standards of care for a treatment-resistant disease like Dravet syndrome, in which frequent debilitating seizures and significant cognitive and functional impairments are the norm."

    Study 1 was an international, double blind, placebo-controlled Phase 3 study of 119 Dravet syndrome patients ages 2-18 years (mean age 9 years) treated at sites in the U.S., Canada, Europe and Australia. Patients were randomized to one of three treatment groups: FINTEPLA at 0.7 mg/kg/day with a 26 mg maximum daily dose* (n=40), FINTEPLA at 0.2 mg/kg/day (n=39), or placebo (n=40), which were added to the patient's current antiepileptic drug regimen that excluded use of stiripentol. Following a 6-week baseline observation period, patients were titrated to their target dose over two weeks and remained at that dose for 12 weeks. The mean baseline convulsive seizure frequency across the study groups was approximately 40 seizures per month.

    The primary endpoint was the change in mean monthly frequency of convulsive seizures during the treatment period compared with baseline in the 0.7 mg/kg/day group versus placebo. Results showed that patients taking FINTEPLA at 0.7 mg/kg/day achieved a 62.3% greater reduction in mean monthly convulsive seizure frequency compared to placebo (95% CI -47.7 to -72.8, p<0.0001). The same analysis for the group treated at 0.2 mg/kg/day versus placebo was a key secondary endpoint, with results showing a 32.4% greater reduction in mean monthly convulsive seizure frequency compared to placebo (95% CI -6.2 to -51.3, p=0.0209).  

    During the treatment period, the median reduction in seizure frequency was 74.9% in the 0.7 mg/kg/day group (from median 20.7 per 28 days to 4.7 per 28 days), 42.3% in the 0.2 mg/kg/day group (from median 17.5 per 28 days to 12.6 per 28 days), and 19.2% in the placebo group (from median 27.3 per 28 days to 22.0 per 28 days).

    In addition to the seizure frequency data described above, more patients treated with FINTEPLA during the study  achieved a clinically meaningful (≥ 50%) reduction in convulsive seizure frequency compared to placebo: 27 (68%) of 40 patients in the 0.7 mg/kg/day group (p<0.0001) and 15 (38%) of 39 patients in the 0.2 mg/kg/day group (p=0.0091), compared with five (12%) of 40 patients in the placebo group. FINTEPLA also provided significantly longer periods of seizure freedom to patients in the study: the median longest seizure-free intervals were 25 days in the 0.7 mg/kg/day group (p=0.0001) and 15 days in the 0.2 mg/kg/day group (p=0.0352), compared to 9.5 days in the placebo group.

    The most common adverse events (occurring in at least 10% of patients, and more frequently in the FINTEPLA groups), were decreased appetite, diarrhea, fatigue, lethargy, somnolence and decreased weight. Echocardiographic examinations revealed normal valve function and morphology in all patients during the trial and no signs of pulmonary arterial hypertension.

    "We are proud that the prestigious journal, The Lancet, has published these important results for the international medical community and very much appreciate the investigators, patients and families who made this study possible," said Stephen J. Farr, Ph.D., President and Chief Executive Officer at Zogenix. "In addition, we are excited to see the continued signs of safety and efficacy of our investigational drug, FINTEPLA, used in Dravet syndrome patients over time in our ongoing open-label extension study and look forward to continuing to work with regulators to advance FINTEPLA as a potential new treatment option for patients suffering from Dravet syndrome."

    *Study 1 data results were previously presented by Zogenix at the December 2017 71st American Epilepsy Society (AES) Annual Meeting. In that and other presentations, Zogenix expressed doses of FINTEPLA (ZX008, fenfluramine) as doses of the HCl salt, with an upper limit of 0.8 mg/kg/day and 30 mg maximum daily dose. Due to current regulatory guidelines, Zogenix has chosen to express study doses as the fenfluramine base-equivalent, with an upper limit dosing of 0.7 mg/kg/day and 26 mg maximum daily dose.

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency. Applications for Zogenix's investigational drug, FINTEPLA, for Dravet syndrome are under review by the U.S. Food & Drug Administration and the European Medicines Agency. Zogenix expects top-line data from its Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome in the first quarter of 2020. FINTEPLA is also in development in Japan.

    Forward-Looking Statement
    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the potential benefits FINTEPLA may have, if approved; the impacts that Dravet syndrome has on patients; and the potential timing of top-line data for Zogenix's Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome (Study 1601). These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the FDA may disagree that the existing safety and efficacy data is sufficient to approve the NDA of FINTEPLA for the treatment of Dravet syndrome; the FDA may require Zogenix to conduct the additional chronic toxicity studies noted in the Refusal to File letter, dated April 3, 2019, or other studies or information in connection with its review of the NDA; the timing of the data from Study 1601 of FINTEPLA in patients suffering from LGS could be delayed; the results of Study 1601 may differ from the results of prior clinical studies in LGS or may demonstrate adverse safety data compared to the prior Phase 3 clinical trials of FINTEPLA; top-line data the Company reports is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of a clinical trial, and the FDA may not agree with the Company's interpretation of such results; later developments with the FDA that may be inconsistent with feedback received at prior meetings with the FDA; additional data from Zogenix's ongoing studies may contradict or undermine the data submitted in the NDA for FINTEPLA; the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA and MT1621; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; risks associated with the acquisition of Modis and integration of Modis' operations into Zogenix's business, including an increase in near and long-term expenditures, exposure to unknown liabilities and diversion of Zogenix's management's time and attention; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732 |

    Investors
    Andrew McDonald
    Founding Partner, LifeSci Advisors LLC
    +1 (646) 597-6987 |

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  29. EMERYVILLE, Calif., Dec. 05, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it will host an Investor Update Lunch on its investigational drug, FINTEPLA® (ZX008, fenfluramine oral solution), on Monday, December 9, 2019, from 12:00 PM to 2:00 PM ET, at the American Epilepsy Society (AES) 2019 Annual Meeting in Baltimore.

    The event will include a discussion of new data presented at the AES conference and a Key Opinion Leader will review the evidence of long-term neurocognitive improvements associated with seizure reduction demonstrated in the FINTEPLA® clinical studies. 

    Zogenix management team will provide updates on the ongoing expanded access program…

    EMERYVILLE, Calif., Dec. 05, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it will host an Investor Update Lunch on its investigational drug, FINTEPLA® (ZX008, fenfluramine oral solution), on Monday, December 9, 2019, from 12:00 PM to 2:00 PM ET, at the American Epilepsy Society (AES) 2019 Annual Meeting in Baltimore.

    The event will include a discussion of new data presented at the AES conference and a Key Opinion Leader will review the evidence of long-term neurocognitive improvements associated with seizure reduction demonstrated in the FINTEPLA® clinical studies. 

    Zogenix management team will provide updates on the ongoing expanded access program and open-label extension study with FINTEPLA and U.S. pre-launch preparation activities in anticipation of the potential approval of FINTEPLA in Dravet syndrome. In addition, management will present plans for exploring new potential indications for FINTEPLA.

    This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited.  For those who are unable to attend in person, a live webcast and replay of the presentations will be accessible here.

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: investigational drug FINTEPLA® (ZX008, fenfluramine oral solution), for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder.  Zogenix's New Drug Application for FINTEPLA for Dravet syndrome has been accepted for review by the U.S. Food & Drug Administration; its application for FINTEPLA for Dravet syndrome is under review by the European Medicines Agency. Zogenix expects top-line data from its Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome in the first quarter of 2020. FINTEPLA is also in development in Japan.

    Forward-Looking Statement
    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the potential timing of top-line data for Zogenix's Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome (Study 1601). These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the timing of the data from Study 1601 of FINTEPLA in patients suffering from LGS could be delayed; the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:
    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732  | 

    Investors
    Andrew McDonald
    Founding Partner, LifeSci Advisors LLC
    +1 (646) 597-6987 |

    Primary Logo

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    • Addition of FINTEPLA to stiripentol-inclusive regimens provided a 54% greater reduction in study patients' mean monthly convulsive seizure frequency compared to placebo

    • A significantly greater proportion of study patients taking FINTEPLA compared to placebo experienced clinically meaningful (50%) or profound (75%) seizure reduction

    • Patients in the FINTEPLA treatment group also experienced significantly longer periods of seizure freedom

    EMERYVILLE, Calif., Dec. 02, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, announced today that JAMA Neurology has published the results of Zogenix's Phase 3 study (Study 1504) of the investigational drug, FINTEPLA® (ZX008, fenfluramine…

    • Addition of FINTEPLA to stiripentol-inclusive regimens provided a 54% greater reduction in study patients' mean monthly convulsive seizure frequency compared to placebo

    • A significantly greater proportion of study patients taking FINTEPLA compared to placebo experienced clinically meaningful (50%) or profound (75%) seizure reduction

    • Patients in the FINTEPLA treatment group also experienced significantly longer periods of seizure freedom

    EMERYVILLE, Calif., Dec. 02, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, announced today that JAMA Neurology has published the results of Zogenix's Phase 3 study (Study 1504) of the investigational drug, FINTEPLA® (ZX008, fenfluramine oral solution), in Dravet syndrome patients whose antiepileptic drug treatment regimens included stiripentol but who were still experiencing a high number of convulsive seizures. Dravet syndrome is a rare, severe, and very difficult to treat infantile-onset epilepsy characterized by frequent, disabling seizures. The study demonstrated that adding FINTEPLA to these patients' treatment regimens led to a significant and clinically meaningful (> 50%) reduction in monthly convulsive seizure frequency (MCSF).

    "Because it is common for physicians to use stiripentol for their Dravet syndrome patients, it was important to evaluate the benefit and tolerability of adding FINTEPLA to a stiripentol-inclusive treatment regimen in those patients who were still experiencing frequent convulsive seizures," said study author, Professor Rima Nabbout, M.D., Ph.D., Department of Pediatric Neurology, Reference Center for Rare Epilepsies, Necker Enfants Malades Hospital, Paris, France, and Principal Investigator of Study 1504. "We found that adding FINTEPLA to a regimen containing stiripentol resulted in a significant and clinically meaningful reduction in monthly convulsive seizure frequency early and for the duration of the study period. Patients in the FINTEPLA arm also experienced longer seizure-free intervals, which is important as many were previously experiencing multiple seizures per week."

    Study 1504 was an international, double-blind, placebo-controlled Phase 3 study of 87 Dravet syndrome patients age 2-19 taking background anti-epileptic drug regimens that included stiripentol, randomized to placebo (n=44) or FINTEPLA 0.4 mg/kg/day (n=43)*. The study was conducted at 28 centers in Canada, France, Germany, the Netherlands, Spain, the United Kingdom and the United States. Eligible patients in the trial were experiencing seizures that were poorly controlled with their current anti-seizure medications consisting of stiripentol plus clobazam and/or valproic acid. After a 6-week period to establish baseline seizure frequency, patients were randomized to receive FINETPLA starting at a dose of 0.2 mg/kg/day, twice-daily with gradual blinded titration over a 3 week period to 0.4 mg/kg/d (maximum of 17 mg per day)* over 3 weeks. Patients maintained their regimen for an additional 12 weeks at a stable dose, then either continued treatment in an open-label extension study or discontinued treatment.

    The study met its primary efficacy endpoint and all key secondary endpoints. Patients treated with FINTEPLA achieved a 54% greater reduction in mean MCSF than those receiving the placebo (95% CI, 35.6%-67.2%; p<0.001). Additionally, 54% of patients treated with FINTEPLA experienced a clinically meaningful (>50%) reduction in MCSF versus 5% with placebo (p<0.001). Profound seizure reduction (>75% reduction in MCSF) was experienced by 35% of FINTEPLA-treated patients compared to 2% with placebo (p=0.003). The median longest seizure-free interval was 22 days (3.0-105.0) with FINTEPLA and 13 days (1.0-40.0) with placebo (p=0.004).

    In the study, FINTEPLA was generally well-tolerated and demonstrated a safety profile consistent with the findings of Zogenix's first Phase 3 study of FINTEPLA in Dravet syndrome, called Study 1, as well as with findings from an analysis of the company's ongoing open-label extension study (Study 1503). The most common adverse events in Study 1504 were decreased appetite (19 patients taking fenfluramine [44%] vs 5 taking placebo [11%]), fatigue (11 [26%] vs 2 [5%]), diarrhea (10 [23%] vs 3 [7%]), and pyrexia (11 [26%] vs 4 [9%]). Across all three studies, no patient exhibited clinical or echocardiographic evidence of valvular heart disease or pulmonary arterial hypertension.

    "Given the devastating and lifelong impacts associated with the frequent convulsive seizures experienced by Dravet syndrome patients, we are very much encouraged by the results of this study in patients still having many seizures on a stiripentol-containing medication regimen and by its publication in JAMA Neurology," said Bradley S. Galer, M.D., Executive Vice President and Chief Medical Officer at Zogenix. "We hope that this and our other clinical study data will help clinicians better understand the potential that FINTEPLA, if approved, could have for patients needing additional novel treatment options."

    * Note: Zogenix originally presented Study 1504 data results in December 2018 at the 72nd American Epilepsy Society (AES) Annual Meeting.  In that and other presentations, Zogenix expressed doses of FINTEPLA (ZX008, fenfluramine oral solution) as doses of the HCl salt, with an upper limit of 0.5 mg/kg/day and 20 mg maximum daily dose. Due to current regulatory guidelines, Zogenix has chosen to express study doses as the fenfluramine base-equivalent, with an upper limit dosing of 0.4 mg/kg/day and 17 mg maximum daily dose.

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.  The company's New Drug Application for FINTEPLA for Dravet syndrome has been accepted for review by the U.S. Food & Drug Administration; its application for FINTEPLA for Dravet syndrome is under review by the European Medicines Agency. Zogenix expects top-line data from its Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome (LGS) in the first quarter of 2020. FINTEPLA is also in development in Japan.

    Forward-Looking Statement
    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the potential benefits FINTEPLA may have, if approved; the impacts that Dravet syndrome has on patients; and the potential timing of top-line data for Study 1601. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the FDA may disagree that the existing safety and efficacy data is sufficient to approve the NDA of FINTEPLA for the treatment of Dravet syndrome; the FDA may require Zogenix to conduct the additional chronic toxicity studies noted in the Refusal to File letter, dated April 3, 2019, or other studies or information in connection with its review of the NDA; the timing of the data from Study 1601 of FINTEPLA in patients suffering from LGS could be delayed; the results of Study 1601 may differ from the results of prior clinical studies in LGS or may demonstrate adverse safety data compared to the prior Phase 3 clinical trials of FINTEPLA; top-line data the Company reports is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of a clinical trial, and the FDA may not agree with the Company's interpretation of such results; later developments with the FDA that may be inconsistent with feedback received at prior meetings with the FDA; additional data from Zogenix's ongoing studies may contradict or undermine the data submitted in the NDA for FINTEPLA; the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA and MT1621; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; risks associated with the acquisition of Modis and integration of Modis' operations into Zogenix's business, including an increase in near and long-term expenditures, exposure to unknown liabilities and diversion of Zogenix's management's time and attention; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732 |

    Investors
    Andrew McDonald
    Founding Partner, LifeSci Advisors LLC
    +1 (646) 597-6987 |

    Primary Logo

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  30. EMERYVILLE, Calif., Dec. 02, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, announced that data from eight abstracts related to its investigational therapy, FINTEPLA® (ZX008, fenfluramine oral solution), for the treatment of seizures associated with Dravet syndrome will be presented at the American Epilepsy Society (AES) Annual Meeting being held in Baltimore, MD, from December 6-10, 2019. Below are the titles of the eight posters that will be presented at the 2019 AES Annual Meeting. Authors will be available to answer questions on their posters at the times specified below.

    In addition to the posters, Zogenix will host a Scientific Exhibit Room on Sunday, December…

    EMERYVILLE, Calif., Dec. 02, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, announced that data from eight abstracts related to its investigational therapy, FINTEPLA® (ZX008, fenfluramine oral solution), for the treatment of seizures associated with Dravet syndrome will be presented at the American Epilepsy Society (AES) Annual Meeting being held in Baltimore, MD, from December 6-10, 2019. Below are the titles of the eight posters that will be presented at the 2019 AES Annual Meeting. Authors will be available to answer questions on their posters at the times specified below.

    In addition to the posters, Zogenix will host a Scientific Exhibit Room on Sunday, December 8, from 8:00 – 11:00 am Eastern Time (ET).

    Saturday, December 7
    General Poster Session 1, 12:00 - 6:00 pm ET, Level 100, Hall E/F

    1. FINTEPLA® (ZX008, Fenfluramine Hydrochloride Oral Solution) in Dravet Syndrome: Comparison of Study 1 Results Using 4-Week Versus 6-Week Baseline Seizure Collection (J. Sullivan, G. Morrison, M. Lock, G. Farfel) – Poster #217
       
    2. Caregiver Benefit and Caring for a Child with an Epileptic Encephalopathy (D. Amtmann, A. Bamer, A. Gammaitoni, et al) – Poster #419

    Sunday, December 8
    General Poster Session 2, 10:00 am - 4:00 pm ET, Level 100, Hall E/F

    1. Evaluation of the Acute Anticonvulsant Efficacy of Fenfluramine in Mouse Models of Acute and Chronic Seizures (P. Martin, S. White, M. Barker-Haliski) – Poster #203
       
    2. Fenfluramine in Dravet Syndrome: Re-analysis of Study 1 Using Time-to-Event to Measure Treatment Effect (D. Dlugos, J. French, M. Lock, et al) – Poster #224
       
    3. Profound Reduction in Seizure Frequency (≥75%) Leads to Improved Everyday Executive Function: Analysis From a Phase 3 Study of ZX008 (Fenfluramine HCl) in Children/Young Adults With Dravet Syndrome (K. Bishop, P. Isquith, G. Gioia, et al) – Late Breaker Poster #438

    Monday, December 9
    General Poster Session 3, 8:00 am - 2:00 pm ET, Level 100, Hall E/F

    1. The Action of Fenfluramine to Prevent Seizure-Induced Death in the DBA/1 Mouse SUDEP Model is Selectively Blocked by an Antagonist or Enhanced by an Agonist for the Serotonin 5-HT4 Receptor (C. Faingold, S. Tupal) – Poster #292
       
    2. ZX008 (Fenfluramine Hydrochloride) Provides Clinically Meaningful Reduction in Seizure Frequency Irrespective of Concomitant AEDs Commonly Used in Dravet Syndrome: Pooled Analysis of 2 Phase 3 Trials (K. Knupp, L. Lagae, E. Thiele, et al)
      – Late Breaker Poster #430
       
    3. Fenfluramine Reduces Seizure Burden by Significantly Increasing Number of Seizure-Free Days and Time Between Seizures in Patients with Dravet Syndrome (J. Sullivan, O. Devinsky, B. Galer, et al) – Late Breaker Poster #431

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.  Zogenix's New Drug Application for FINTEPLA for Dravet syndrome has been accepted for review by the U.S. Food & Drug Administration; its application for FINTEPLA for Dravet syndrome is under review by the European Medicines Agency. Zogenix expects top-line data from its Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome in the first quarter of 2020. FINTEPLA is also in development in Japan.

    Forward-Looking Statement
    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the potential timing of top-line data for Zogenix's Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome (Study 1601). These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the timing of the data from Study 1601 of FINTEPLA in patients suffering from LGS could be delayed; the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732 |

    Investors
    Andrew McDonald
    Founding Partner, LifeSci Advisors LLC
    +1 (646) 597-6987 |

    Primary Logo

    View Full Article Hide Full Article
  31. EMERYVILLE, Calif., Nov. 27, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that Stephen J. Farr, Ph.D., will participate in a fireside chat on Thursday, December 5, 2019, at the 31st Annual Piper Jaffray Healthcare Conference, taking place December 3-5, 2019, in New York City.

    Zogenix Fireside Chat Details
    Date:   Thursday, December 5, 2019
    Location:   Lotte New York Palace Hotel
    Time:   10:00 AM Eastern Time
    Webcast:   The fireside chat will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing…

    EMERYVILLE, Calif., Nov. 27, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that Stephen J. Farr, Ph.D., will participate in a fireside chat on Thursday, December 5, 2019, at the 31st Annual Piper Jaffray Healthcare Conference, taking place December 3-5, 2019, in New York City.

    Zogenix Fireside Chat Details
    Date:   Thursday, December 5, 2019
    Location:   Lotte New York Palace Hotel
    Time:   10:00 AM Eastern Time
    Webcast:   The fireside chat will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. The Company has two late-stage development programs underway: FINTEPLA® (fenfluramine) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies. Additionally, Zogenix is in clinical development with MT1621, a novel, investigational substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency. The U.S. Food & Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for FINTEPLA for the treatment of seizures associated with Dravet syndrome. The FDA granted Priority Review for the NDA for FINTEPLA. The marketing authorization application for FINTEPLA for Dravet syndrome is under review by the European Medicines Agency. Zogenix expects top-line data results from its Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome in the first quarter of 2020. FINTEPLA is also in development in Japan for Dravet and Lennox-Gastaut syndromes.

    CONTACTS:
    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732  | 

    Investors
    Andrew McDonald
    Founding Partner, LifeSci Advisors LLC
    +1 (646) 597-6987 |

    Primary Logo

    View Full Article Hide Full Article
  32. EMERYVILLE, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet syndrome. The FDA granted Priority Review for the NDA for FINTEPLA, which provides for a six-month review from the date of receipt, and assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2020.

    "The FDA's acceptance for filing of the NDA under Priority Review for our investigational product, FINTEPLA, represents a significant milestone…

    EMERYVILLE, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet syndrome. The FDA granted Priority Review for the NDA for FINTEPLA, which provides for a six-month review from the date of receipt, and assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2020.

    "The FDA's acceptance for filing of the NDA under Priority Review for our investigational product, FINTEPLA, represents a significant milestone in its development," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "We are excited to continue working with the FDA with the goal of bringing FINTEPLA to Dravet syndrome patients and their families in need as quickly as possible."

    Priority review is granted for investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.

    In its NDA filing acceptance letter, the FDA also stated that it is not currently planning to hold an advisory committee meeting to discuss the application for FINTEPLA.

    The NDA is based on data from two positive pivotal Phase 3 trials in Dravet syndrome and an interim analysis from an ongoing open-label extension study, which included 232 patients treated for up to 21 months. Zogenix is also investigating FINTEPLA in Lennox-Gastaut syndrome, another rare, severe childhood-onset epileptic syndrome, for which a Phase 3 trial is ongoing, with top-line data results anticipated in the first quarter of 2020.

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. The Company has two late-stage development programs underway: FINTEPLA® (fenfluramine) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies. Additionally, Zogenix is in clinical development with MT1621, a novel, investigational substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency. The U.S. Food & Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for FINTEPLA for the treatment of seizures associated with Dravet syndrome. The FDA granted Priority Review for the NDA for FINTEPLA. The marketing authorization application for FINTEPLA for Dravet syndrome is under review by the European Medicines Agency. Zogenix expects top-line data results from its Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome in the first quarter of 2020. FINTEPLA is also in development in Japan for Dravet and Lennox-Gastaut syndromes.

    Forward-Looking Statement
    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the timing and results of any decision regarding the NDA from the FDA; and the potential timing of top-line data for the Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome (Study 1601). These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the potential for the FDA to delay the PDUFA target action date due to the FDA's internal resource constraints or other reasons; the FDA may later determine to hold an advisory committee meeting and risks associated therewith; the FDA may disagree that the existing safety and efficacy data is sufficient to approve the NDA; the FDA may require Zogenix to conduct the additional chronic toxicity studies noted in the Refusal to File letter, dated April 3, 2019, or other studies or information in connection with its review of the NDA; the timing of the data from Study 1601 of FINTEPLA in patients suffering from Lennox-Gastaut syndrome could be delayed; additional data from Zogenix's ongoing studies may contradict or undermine the data submitted in the NDA for FINTEPLA; the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA and MT1621; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:
    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732  | 

    Investors
    Andrew McDonald
    Founding Partner, LifeSci Advisors LLC
    +1 (646) 597-6987 |

    Primary Logo

    View Full Article Hide Full Article
  33. EMERYVILLE, Calif., Nov. 12, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that Stephen J. Farr, Ph.D., President and CEO, and Michael P. Smith, Executive Vice President, CFO, Treasurer and Secretary, will participate in two investor conferences in November: Guggenheim Healthcare Talks Idea Forum Neuro/Immunology Day and Stifel 2019 Healthcare Conference. 

    Guggenheim Healthcare Talks Idea Forum Neuro/Immunology Day
    Date: Monday, November 18, 2019
    Location: St. Regis Hotel, New York
    Participant: Michael P. Smith, CFO
    Time: 2:30 PM Eastern Time
       
    Stifel 2019 Healthcare Conference  
    Date: Tuesday, November 19, 2019
    Location: Lotte New York Palace Hotel,

    EMERYVILLE, Calif., Nov. 12, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that Stephen J. Farr, Ph.D., President and CEO, and Michael P. Smith, Executive Vice President, CFO, Treasurer and Secretary, will participate in two investor conferences in November: Guggenheim Healthcare Talks Idea Forum Neuro/Immunology Day and Stifel 2019 Healthcare Conference. 

    Guggenheim Healthcare Talks Idea Forum Neuro/Immunology Day
    Date: Monday, November 18, 2019
    Location: St. Regis Hotel, New York
    Participant: Michael P. Smith, CFO
    Time: 2:30 PM Eastern Time
       
    Stifel 2019 Healthcare Conference  
    Date: Tuesday, November 19, 2019
    Location: Lotte New York Palace Hotel, New York
    Participant: Stephen J. Farr, President and CEO, and Michael P. Smith, CFO
    Time: 4:45 PM Eastern Time
    Webcast: The presentation will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com 

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.  Zogenix recently resubmitted its New Drug Application for FINTEPLA for Dravet syndrome to the U.S. Food & Drug Administration; its application for FINTEPLA for Dravet syndrome is under review by the European Medicines Agency. Zogenix expects top-line data from its Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome in the first quarter of 2020. FINTEPLA is also in development in Japan.

    CONTACTS:
    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732  | 

    Investors
    Andrew McDonald
    Founding Partner, LifeSci Advisors LLC
    +1 (646) 597-6987 |

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    • Resubmitted NDA for FINTEPLA® for the treatment of Dravet syndrome

    • Enrollment completed for FINTEPLA global Phase 3 trial in Lennox Gastaut syndrome; top-line data anticipated in Q1 2020

    • Acquired Modis Therapeutics, Inc.; adding MT1621, a proprietary, late-stage investigational therapy for Thymidine Kinase 2 deficiency (TK2d) that has received FDA Breakthrough Therapy and EMA PRIME designations

    • Presented positive pivotal Phase 2 study results for MT1621 in TK2d

    EMERYVILLE, Calif., Nov. 07, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced financial results for the three and nine months ended September 30, 2019, and provided a corporate update. The Company…

    • Resubmitted NDA for FINTEPLA® for the treatment of Dravet syndrome

    • Enrollment completed for FINTEPLA global Phase 3 trial in Lennox Gastaut syndrome; top-line data anticipated in Q1 2020

    • Acquired Modis Therapeutics, Inc.; adding MT1621, a proprietary, late-stage investigational therapy for Thymidine Kinase 2 deficiency (TK2d) that has received FDA Breakthrough Therapy and EMA PRIME designations

    • Presented positive pivotal Phase 2 study results for MT1621 in TK2d

    EMERYVILLE, Calif., Nov. 07, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global pharmaceutical company developing rare disease therapies, today announced financial results for the three and nine months ended September 30, 2019, and provided a corporate update. The Company will host a conference call today, Thursday, November 7, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

    "We were pleased to resubmit the New Drug Application (NDA) for FINTEPLA® for the treatment of seizures associated with Dravet syndrome to the U.S. Food and Drug Administration (FDA) in late September, and we expect to hear from the FDA regarding the filing status of our NDA submission shortly," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "Following completion of enrollment in our program for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in July, we remain on track to announce top-line safety and efficacy results in the first quarter of 2020."

    "In addition, we were very excited to announce the acquisition of Modis Therapeutics and add a novel, late-stage clinical candidate, MT1621, for the treatment of patients with Thymidine Kinase 2 deficiency (TK2d), to our rare disease pipeline," continued Dr. Farr. "Last month, safety and positive efficacy data from a global, retrospective Phase 2 study supporting the potential of MT1621 to significantly alter the course of TK2d, an often-fatal mitochondrial DNA depletion disorder, were presented."

    Corporate Update

    • FINTEPLA for the treatment of seizures associated with Dravet syndrome
      • Resubmitted FINTEPLA NDA; expect response from FDA on status of NDA submission in early to mid-December
      • FINTEPLA Marketing Authorization Application under active review by the European Medicines Agency in Europe
      • Commercial readiness activities ongoing in the U.S. and Europe
      • Presented new positive data for FINTEPLA in Dravet syndrome at Childhood Neurology Society Annual Meeting.  Data included:
        • Long-term, clinically meaningful reduction in convulsive seizure frequency in Dravet syndrome patients under 6 years of age participating in ongoing open-label extension (Study 1503)
        • Clinically meaningful and profound reduction in the frequency of generalized tonic-clonic seizures in Dravet syndrome patients in a pooled analysis of two previously completed Phase 3 trials (Study 1 & Study 1504)
        • Results of a Phase 1 study to assess the potential drug-drug interaction of fenfluramine and cannabidiol (CBD) which showed that the effects of CBD on fenfluramine are unlikely to require dose adjustments when the drugs are co-administered
    • FINTEPLA for the treatment of seizures associated with LGS
      • Completed enrollment for, and randomized the last patient (n=263) into, the treatment period of Study 1601, Zogenix's Phase 3 trial of FINTEPLA in LGS
      • Top-line safety and efficacy data anticipated in first quarter of 2020
         
    • Acquired Modis Therapeutics, Inc. and MT1621
      • Advanced strategy of providing transformative therapies to patients and families living with serious rare diseases
      • Presented positive clinical study results for TK2d from a global, retrospective pivotal Phase 2 study (RETRO)
        • Highly significant impact on survival probability (p<0.0006) for treated patients compared to untreated natural history control subjects, all treated patients remain alive
        • Most (~95%) treated patients experienced improvement (68%) or disease stabilization (26%), using a responder analysis
        • Among clinical responders, profound responses, such as re-acquiring previously lost motor milestones, were observed in some patients
      • Expect to conduct a meeting with the FDA in the first half of 2020 to discuss next steps for MT1621 program

    Third quarter 2019 Financial Results

    • The Company recorded $0.6 million in revenue for the third quarter ended September 30, 2019, as a result of its March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded no revenue for the corresponding period of 2018.
       
    • Research and development expenses for the third quarter ended September 30, 2019, totaled $28.4 million, up from $27.6 million in the third quarter ended September 30, 2018, as the Company concluded Phase 3 clinical trials in Dravet syndrome and expanded clinical trial activities related to its ongoing Phase 3 development program of FINTEPLA in LGS.
       
    • Selling, general and administrative expenses for the third quarter ended September 30, 2019, totaled $15.8 million, compared with $11.0 million in the third quarter ended September 30, 2018.
       
    • Net loss for the third quarter ended September 30, 2019, was $290.5 million, or a net loss of $6.75 per share, compared with a net loss of $42.3 million, or a net loss of $1.08 per share, in the third quarter ended September 30, 2018. The increase in net loss was primarily attributable to $249.4 million of acquired in-process research and development consisting of existing research and development projects at the time of the Modis acquisition.

    Nine months Ended September 30, 2019 Financial Results Compared to Nine months Ended September 30, 2018

    • The Company recorded $1.7 million in revenue for the nine months ended September 30, 2019, as a result of its March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded no revenue for the corresponding period of 2018.
       
    • Research and development expenses for the nine months ended September 30, 2019, totaled $79.8 million, up from $77.3 million in the nine months ended September 30, 2018, as the Company concluded Phase 3 clinical trials in Dravet syndrome and expanded clinical trial activities related to its ongoing Phase 3 development program of FINTEPLA in LGS.
       
    • Selling, general and administrative expenses for the nine months ended September 30, 2019, totaled $42.1 million, up from $27.7 million in the nine months ended September 30, 2018.
       
    • Net loss for the nine months ended September 30, 2019, was $363.4 million, or a net loss of $8.54 per share, compared with a net loss of $101.5 million, or a net loss of $2.78 per share, in the nine months ended September 30, 2018.  The increase in net loss was primarily attributable to $249.4 million of acquired in-process research and development consisting of existing research and development projects at the time of the Modis acquisition.
       
    • As of September 30, 2019, the Company had $255.0 million in cash, cash equivalents, and marketable securities, compared to $514.2 million at December 31, 2018.  The decrease in cash was primarily attributable to the $175.5 million used for the Modis acquisition on September 6, 2019.

    Conference Call

    Thursday, November 7 at 4:30 PM Eastern Time/1:30 PM Pacific Time 
    Toll Free:   877-407-9716
    International:   201-493-6779
    Conference ID:   13695588
    Webcast:   http://public.viavid.com/index.php?id=136560

    About Zogenix
    Zogenix is a global pharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a combination deoxynucleoside substrate enhancement therapy for the treatment of TK2 deficiency, a rare, debilitating, and often fatal genetic disorder that primarily affects infants and children and for which there are currently no approved therapies.  Zogenix recently resubmitted its New Drug Application for FINTEPLA for Dravet syndrome to the U.S. Food & Drug Administration; its application for FINTEPLA for Dravet syndrome is under review by the European Medicines Agency. Zogenix expects top-line data from its Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome in the first quarter of 2020. FINTEPLA is also in development in Japan. Zogenix acquired Modis Therapeutics and the MT1621 program in September 2019.

    Forward-Looking Statement
    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the potential acceptance by the FDA of Zogenix's resubmission of the NDA for FINTEPLA in patients with Dravet syndrome; the timing and results of any decision regarding the NDA from the FDA or the MAA from the EMA; the potential timing of top-line data for Study 1601; the expected strengthening in Zogenix's intellectual property position based on newly issued U.S. patents and the notice of allowance for a U.S. patent application; FINTEPLA's potential as a promising drug candidate and important new treatment option for the control of seizures in patients suffering from LGS; the potential for MT1621 to significantly improve outcomes in patients with TK2d; and Zogenix's timing expectations for discussing next steps with regulatory authorities for MT1621 program. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the FDA may refuse to accept the re-submitted NDA; the FDA may disagree that the existing safety and efficacy data is sufficient to approve the NDA; the FDA may require Zogenix to conduct the additional chronic toxicity studies noted in the Refusal to File letter, dated April 3, 2019, or other studies or information in connection with its review of the NDA; the timing of the data from Study 1601 of FINTEPLA in patients suffering from LGS could be delayed; the results of Study 1601 may differ from the results of prior clinical studies in LGS or may demonstrate adverse safety data compared to the prior Phase 3 clinical trials of FINTEPLA; top-line data the Company reports is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of a clinical trial, and the FDA may not agree with the Company's interpretation of such results; later developments with the FDA that may be inconsistent with feedback received at prior meetings with the FDA; additional data from Zogenix's ongoing studies may contradict or undermine the data submitted in the NDA for FINTEPLA; the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA and MT1621; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; risks associated with the acquisition of Modis and integration of Modis' operations into Zogenix's business, including an increase in near and long-term expenditures, exposure to unknown liabilities and diversion of Zogenix's management's time and attention; the inherent risks of clinical development of MT1621; risks associated with relying on a retrospective analysis for pivotal efficacy and safety data for MT1621; risks associated with relying on a retrospective analysis for pivotal efficacy and safety data for MT1621; FDA Breakthrough Therapy and EMA PRIME designations do not guarantee that the FDA or EMA will approve MT1621 or expedite its review of MT1621; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix
    Melinda Baker
    Senior Director, Corporate Communications
    +1 (510) 788-8732 |

    Investors
    Andrew McDonald
    Founding Partner, LifeSci Advisors LLC
    +1 (646) 597-6987 |


    Zogenix, Inc.
    Condensed Consolidated Balance Sheets (Unaudited)
    (in thousands)

      September 30, 2019   December 31, 2018
    Assets:      
    Current assets:      
    Cash and cash equivalents $ 33,099     $ 68,454  
    Marketable securities 221,865     445,733  
    Prepaid expenses 9,108     6,718  
    Acquisition holdback amount placed in escrow 25,000      
    Other current assets 3,202     11,825  
    Total current assets 292,274     532,730  
    Property and equipment, net 9,782     2,870  
    Operating lease right-of-use assets 8,134      
    Intangible assets 102,500     102,500  
    Goodwill 6,234     6,234  
    Other noncurrent assets 1,442     3,997  
    Total assets $ 420,366     $ 648,331  
    Liabilities and stockholders' equity:      
    Current liabilities:      
    Accounts payable $ 7,553     $ 7,989  
    Accrued and other current liabilities 23,125     18,086  
    Acquisition holdback liability 24,444      
    Deferred revenue, current 5,688      
    Current portion of operating lease liabilities 1,431      
    Current portion of contingent consideration 35,200     32,300  
    Total current liabilities 97,441     58,375  
    Deferred revenue, noncurrent 8,113      
    Operating lease liabilities, net of current portion 11,095      
    Contingent consideration, net of current portion 35,700     45,900  
    Deferred income taxes 17,425     17,425  
    Other long-ter