Item 8.01. Other Events.
On December 18, 2020, Zogenix, Inc. (“Zogenix”) announced that the European Commission (“EC”) has granted marketing authorization for FINTEPLA® (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome as an add-on therapy to other anti-epileptic medicines for patients two years of age and older.
The EC’s approval of FINTEPLA was based on positive safety and efficacy results from two randomized, international, multi-center, placebo-controlled Phase 3 trials (Study 1 and Study 2), as well as data from an interim analysis of a long-term, open-label extension study in 330 Dravet syndrome patients treated up to 3 years.
When added to other antiepileptic therapies, including stiripentol, FINTEPLA provided a highly statistically significant and clinically meaningful reduction in convulsive seizure frequency. The most commonly reported adverse events that occurred in patients treated with this included decreased appetite, diarrhea, pyrexia, fatigue, upper respiratory tract infection, lethargy, somnolence and bronchitis.
With this approval, and subject to price and reimbursement being implemented according to national regulations, Zogenix will be able to market FINTEPLA in all European Union member countries, and in the United Kingdom, Norway, Iceland, and Liechtenstein. Zogenix expects its first European Union market launch to occur in Germany in the first quarter of 2021.
FINTEPLA will be available in Europe under a controlled access program requested by the European Medicines Agency to prevent off-label use for weight management and to confirm that prescribing physicians have been informed of the need for periodic cardiac monitoring in patients taking FINTEPLA.
Zogenix will also conduct the FINTEPLA Registry, an observational registry to provide data on long-term safety of FINTEPLA and frequency of echocardiographic monitoring in routine practice.
Earlier this year, FINTEPLA was approved by the U.S. Food & Drug Administration (“FDA”) for the treatment of seizures associated with Dravet syndrome in patients aged two years and older. In addition, Zogenix recently reported positive results of a third Phase 3 study of FINTEPLA in Dravet syndrome to support planned registration in Japan, which corroborated the highly statistically significant and clinically meaningful convulsive seizure reductions seen in earlier multinational Phase 3 studies. FINTEPLA is also being studied for the potential treatment of seizures associated with other rare epilepsies.
Forward-Looking Statements
Zogenix cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed,” and similar expressions are intended to identify forward-looking statements. These statements include the potential that fenfluramine oral solution will be an important new treatment option for Dravet syndrome patients; Zogenix’s plans to commercialize fenfluramine in Europe, including the timing of the launch. These statements are based on Zogenix’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: Zogenix’s ability to successfully launch FINTEPLA, including launching a controlled access program implemented due to risks related to valvular heart disease and pulmonary arterial hypertension, and the conduct of the FINTEPLA Registry, and the timing thereof; the COVID-19 pandemic may disrupt Zogenix’s business operations, impairing the ability to commercialize FINTEPLA in Europe and Zogenix’s ability to generate product revenue in Europe; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA in Europe; unexpected adverse side effects or inadequate therapeutic efficacy of fenfluramine that could limit commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix’s 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 report to reflect events or circumstances after the date hereof, unless required by law. 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.