ZGNX Zogenix Inc.

20.43
-0.52  -2%
Previous Close 20.95
Open 20.95
52 Week Low 16.65
52 Week High 32.42
Market Cap $1,137,402,066
Shares 55,673,131
Float 55,386,789
Enterprise Value $822,598,094
Volume 519,612
Av. Daily Volume 993,093
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Upcoming Catalysts

Drug Stage Catalyst Date
Fintepla
Lennox-Gastaut syndrome
sNDA Filing
sNDA Filing
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MT1621
Thymidine kinase 2 deficiency
NDA Filing
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Drug Pipeline

Drug Stage Notes
FINTEPLA
CDKL5 Deficiency Disorder
Phase 3
Phase 3
Phase 3 trial to be initiated in 2021.
FINTEPLA (ZX008)
Dravet syndrom
Approved
Approved
FDA approval announced June 25, 2020.
Abuse deterrent formulations of Zohydro ER
Moderate to severe pain
Approved
Approved
Approved January 30, 2015.
Zohydro ER
Moderate to severe pain
Approved
Approved
Approved October 25, 2013.
Sumavel
Migraine
Approved
Approved
Approved July 16, 2009.

Latest News

  1. 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 |



    Primary Logo

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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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  2. 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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  3. 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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