UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01. | Other Events. |
On November 30, 2021, Zogenix, Inc. (the “Company”) announced the U.S. Food and Drug Administration (the “FDA”) has accepted for filing and granted Priority Review to the Company’s supplemental New Drug Application (“sNDA”) for the use of FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome (“LGS”). The FDA granted Priority Review, which means that the FDA has a goal to complete its review within six months from the date of receipt, with a Prescription Drug User Fee Act (“PDUFA”) target action date of March 25, 2022. FDA Priority Review is granted for investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.
The sNDA submission is based on a positive global randomized, placebo-controlled Phase 3 clinical trial, Study 1601, in 263 patients (age 2-35 years) that demonstrated FINTEPLA at a dose of 0.7/mg/kg/day was superior to placebo in reducing the frequency of drop seizures (p=0.0012), as well as long-term safety and effectiveness data from the Companys ongoing open-label extension trials.
In June 2020, FINTEPLA was approved by the FDA for the treatment of seizures associated with Dravet syndrome in patients two years of age and older.
Forward Looking Statements
The Company 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 timing of review by the FDA of the sNDA for the use of FINTEPLA for the treatment of seizures associated with LGS; plans to submit a J-NDA for FINTEPLA in Japan and the estimated timing for that submission; the potential for our product candidates to provide new treatment options; and the Company’s plans with respect to its development programs. These statements are based on the Company’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by the Company 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 the Company’s business, including, without limitation: the potential for the FDA to delay the PDUFA target action date related to the LGS sNDA due to the FDA’s internal resource constraints or other reasons; the FDA may disagree that the existing safety and efficacy data is sufficient to approve the sNDA; FINTEPLA may not achieve broad market acceptance as a treatment option of seizures associated with LGS or Dravet syndrome, which would limit the Company’s ability to generate revenues; the COVID-19 pandemic may continue to disrupt the Company’s business operations, impairing the ability to commercialize FINTEPLA in Europe and the Company’s ability to generate product revenue in Europe and conduct its development programs; unexpected adverse side effects or inadequate therapeutic efficacy of fenfluramine that could limit regulatory approval or commercialization, or that could result in recalls or product liability claims; later developments with FDA that may be inconsistent with the already completed meetings; additional data from the Company’s ongoing studies may contradict or undermine the data previously reported; and other risks described in the Company’s prior 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 the Company undertakes no obligation to revise or update this report 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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ZOGENIX, INC. | ||||||
| Date: December 1, 2021 | By: | /s/ Shawnte M. Mitchell | ||||
| Name: | Shawnte M. Mitchell | |||||
| Title: | Executive Vice President, General Counsel and Corporate Secretary | |||||