CELEBRATION, Fla., March 30, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics (NasdaqGS: ZVRA) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease therapeutics company, today announced that it has appointed Wendy L. Dixon, Ph.D., to the Company’s Board of Directors (the “Board”), effective immediately following the conclusion of the 2023 Annual Meeting of Stockholders (“2023 Annual Meeting”), to fill the vacancy resulting from Dr. Travis Mickle’s resignation from the Board effective as of the day of the 2023 Annual Meeting to be held on April 25, 2023. Dr. Dixon is a seasoned biopharma executive with more than 40 years in senior leadership roles, including serving as Chief Marketing Officer and President of Global Marketing at Bristol Myers Squibb.
Dr. Dixon also held senior roles at Merck, West Pharmaceuticals, Osteotech, Centocor and GlaxoSmithKline. She brings to the Zevra Board significant experience as a public company director, having served as a Board Chair and a member of Nominating and Governance, Compensation and Audit committees, as well as special committees for Commercial Planning and R&D strategy.
Matthew R. Plooster, Chairman of the Zevra Board, said, “Wendy Dixon’s appointment demonstrates Zevra’s ongoing commitment to strong corporate governance, deep industry experience and diverse, independent thought. We began a search for new directors in 2022 as part of our strategic shift toward rare diseases, and since then have added two highly qualified directors in Chris Posner and Wendy Dixon. We believe that Wendy’s experience launching and growing more than 20 major pharmaceutical products, including successful global brands, is an important addition to the Board as Zevra advances its late-stage clinical pipeline. As we continue our efforts to bring much-needed therapies to patients with rare diseases, we are confident the entire Board and management team will benefit from her experience and insights."
Dr. Dixon said, “Zevra has a promising portfolio and has made significant progress to advance much-needed solutions for patients with rare diseases and their families. I am excited to leverage my experience and to work collaboratively with my fellow Board members as we support management in guiding Zevra on its transformational path to change lives and create value for shareholders.”
As announced earlier this year, Travis C. Mickle, Ph.D., Zevra’s co-founder and President, has resigned from his executive role and as a Director on the Zevra Board effective as of the day of the 2023 Annual Meeting. Dr. Mickle will continue to support Zevra’s drug development and regulatory approval activities as a scientific advisor.
About Wendy Dixon, Ph.D.:
Wendy Dixon has more than 40 years of biopharmaceutical industry experience in drug development with leadership roles in regulatory affairs and commercial capabilities. She currently serves on the Board of Directors of Arivinas, Inc., Black Diamond Therapeutics, Inc., and Iovance Biotherapeutics, Inc. Previously, Dr. Dixon has served on the Boards of Directors of Alkermes plc, Ardea Biosciences, Inc., bluebird bio, Inc., Dentsply International, Furiex Pharmaceuticals, Incyte, Orexigen Therapeutics, Sesen Bio, Inc. (formerly Eleven Biotherapeutics, Inc.), and Voyager Therapeutics, Inc.
Dr. Dixon was Chief Marketing Officer and President of Global Marketing at Bristol Myers Squibb for eight years and served as a Senior Vice President of Marketing at Merck for five years. Earlier in her career, she held executive management positions at West Pharmaceuticals, Osteotech and Centocor, as well as roles at SmithKline and French (now GlaxoSmithKline) in marketing, regulatory affairs, project management and as a biochemist. Dr. Dixon holds a Ph.D. in biochemistry and an M.Sc. and B.Sc. in Natural Science from the University of Cambridge.
Zevra Therapeutics is a rare disease company melding science, data, and patient need to create transformational therapies for diseases with limited or no treatment options. With unique, data-driven clinical, regulatory, and commercialization strategies, the Company is overcoming complex drug development challenges to bring much-needed therapies to patients.
Arimoclomol, Zevra’s orally delivered, first-in-class investigational product candidate for the treatment of Niemann-Pick disease type C (“NPC”), has been granted orphan drug designation, Fast Track designation, Breakthrough Therapy designation and rare pediatric disease designation for the treatment of NPC by the U.S. Food and Drug Administration (“FDA”), and orphan medicinal product designation for the treatment of NPC by the European Medicines Agency (“EMA”).
KP1077 is Zevra’s lead clinical candidate being developed to treat idiopathic hypersomnia (“IH”) and narcolepsy. KP1077 is comprised solely of serdexmethylphenidate (“SDX”), Zevra’s proprietary prodrug of d-methylphenidate (“d-MPH”). The FDA has granted KP1077 orphan drug designation for the treatment of IH, and the U.S. Drug Enforcement Agency (“DEA”) has classified SDX as a Schedule IV controlled substance based on evidence suggesting SDX has a lower potential for abuse when compared to d-MPH, a Schedule II controlled substance.
Early access programs are made available by Zevra Therapeutics, Inc. and its affiliates and are subject to the Company's Early Access Program (“EAP”) policy as published on its website at zevra.com. Participation in these programs is subject to the laws and regulations of each jurisdiction under which each respective program is operated. Eligibility for participation in any such program is at the treating physician's discretion.
Caution Concerning Forward-Looking Statements:
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, and which can be identified by the use of words such as "may," "will," "expect," "project," "estimate," "anticipate," "plan," "believe," "potential," "should," "continue," "could," "intend," "target," "predict," or the negative versions of those words or other comparable words or expressions, although not all forward-looking statements contain these identifying words or expressions. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements include without limitation statements regarding executive and director transitions, including the timing thereof. These forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the "Risk Factors" section of Zevra’s (formerly KemPharm) Annual Report on Form 10-K for the year ended December 31, 2022, and Zevra’s (formerly KemPharm) other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.
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