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1. 10 September 2020 Zogenix Announces Positive Top-Line Results from its Third Pivotal Phase 3 Clinical Trial (Study 3) of FINTEPLA® in Dravet Syndrome

   • 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
   
   britc

   Media
   
   Stefanie Tuck
   
   Vice President, Porter Novelli
   
   +1 (978) 390-1394
   
   

   

   

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2. 05 August 2020 Zogenix Provides Corporate Update and Reports Second Quarter 2020 Financial Results

   • 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 securities	253,378					189,085
   Inventory, net	475					—
   Prepaid expenses and other current assets	10,833					11,084
   Acquisition holdback placed in escrow	25,000					25,000
   Total current assets	426,557					287,239
   Property and equipment, net	9,300					9,424
   Operating lease right-of-use assets	8,266					7,774
   Intangible asset	102,500					102,500
   Goodwill	6,234					6,234
   Other noncurrent assets	2,250					1,079
   Total assets	$	555,107				$	414,250
   Liabilities and stockholders' equity:
   Current liabilities:
   Accounts payable	$	8,518				$	7,979
   Accrued and other current liabilities	40,176					30,117
   Acquisition holdback liability	24,444					24,444
   Deferred revenue, current	5,303					5,927
   Current portion of operating lease liabilities	1,633					1,322
   Current portion of contingent consideration	13,000					25,600
   Total current liabilities	93,074					95,389
   Deferred revenue, noncurrent	5,768					7,425
   Operating lease liabilities, net of current portion	11,022					10,752
   Contingent consideration, net of current portion	40,100					38,200
   Deferred tax liability	—					17,425
   Total liabilities	149,964					169,191
   Commitments and contingencies
   Stockholders' equity:
   Common stock	55					45
   Additional paid-in capital	1,599,047					1,360,092
   Accumulated deficit	(1,194,581		)			(1,115,457		)
   Accumulated other comprehensive income	622					379
   Total stockholders' equity	405,143					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 development	34,373					27,096					67,613					51,448
   Selling, general and administrative	24,431					15,459					45,749					26,377
   Acquired in-process research and development expense	1,500					—					3,000					—
   Change in fair value of contingent consideration	12,200					(700		)			4,300					2,300
   Total operating expenses	72,504					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 income	880					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 share	55,355					42,458					51,770					42,348

   

   

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3. 29 July 2020 Zogenix to Release Second Quarter 2020 Financial Results and Host Conference Call and Webcast on August 5

   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 |
   
   

   

   

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4. 25 June 2020 FDA Approves FINTEPLA® (fenfluramine) for the Treatment of Seizures Associated with 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/…

   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.

   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.

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5. 25 June 2020 FDA Approves FINTEPLA® (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome

   • 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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