BURLINGTON, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced today that it has made two key appointments to its leadership team: Carolyn Beaty Scimemi, Esq., an experienced compliance and legal professional, as Chief Compliance Officer, and Adam Muzikant, Ph.D., a veteran biotechnology deal negotiator and strategist, as Vice President, Business Development.
Ms. Scimemi and Dr. Muzikant join the Flexion leadership team as the company prepares to submit a planned new drug application (NDA) in the fourth quarter of 2016 to the U.S. Food and Drug Administration (FDA) for its drug candidate Zilretta™ (also known as FX006), a potential treatment for patients with moderate to severe knee osteoarthritis (OA) pain.
Michael Clayman, MD, President and Chief Executive Officer of Flexion, stated, “We are delighted to add Carolyn and Adam to our leadership roster based upon their depth of experience and backgrounds in their respective fields. Carolyn will play a critical role as we work through the legal and compliance areas crucial to the approval and launch of Zilretta, and as we create a robust culture of compliance. In addition, we will benefit greatly from Adam’s leadership as we forge partnerships and continue to build our pipeline.”
Ms. Scimemi has more than a decade of experience working with legal and contractual matters for publicly traded biopharmaceutical companies in both pre-approval and in commercial stages of product development. She joined Dyax in 2009 and most recently served as Vice President, Associate General Counsel & Chief Compliance Officer. Previously, she was Associate Director of Legal Affairs and Compliance for Oscient Pharmaceuticals in Waltham, MA, an associate attorney at Palmer and Dodge LLP in Boston, and a contracts administrator at the Massachusetts Institute of Technology. She earned her JD and Bachelor’s of Science degrees from Suffolk Law School in Boston.
Dr. Muzikant joins Flexion with 18 years of hands-on leadership experience in biotechnology and specialty pharmaceuticals companies, and consulting firms. Most recently, he was Vice President, Business Development at Synta Pharmaceuticals in Lexington, Mass., where he led the strategic transaction process culminating in a merger with Madrigal Pharmaceuticals. Prior to Synta, Dr. Muzikant held business development leadership positions at AMAG Pharmaceuticals, Inotek Pharmaceuticals, EPIX Pharmaceuticals, and Predix Pharmaceuticals, and also performed transaction/strategic advisory work for biotechnology and pharmaceutical clients with Locust Walk Partners. Prior to moving into business development, Dr. Muzikant led an anti-arrhythmia drug discovery program at Predix targeting ion channels. He received his Ph.D. in biomedical engineering from Duke University, and a Bachelor’s degree in bioengineering from the University of California, San Diego.
About Flexion Therapeutics
Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company's lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive IA injections for knee OA annually.
Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; our plans for, and the expected timing of, our Zilretta NDA submission with the FDA; our plans to commercialize Zilretta; and the potential therapeutic and other benefits of Zilretta, are forward-looking statements. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; our reliance on third parties to manufacture and conduct clinical trials of Zilretta, which could delay or limit its future development or regulatory approval; our ability to meet anticipated regulatory filing dates for Zilretta; the fact that we will require additional capital, including prior to commercializing Zilretta or any other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to us; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta; the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.GlobeNewswire
Last updated on: 13/09/2016
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