BURLINGTON, Mass., Sept. 14, 2016 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced today the appointment of Mark Stejbach, Senior Vice President and Chief Commercial Officer at Alkermes plc, to its Board of Directors as the company prepares for commercialization of its drug candidate Zilretta™ (also known as FX006), a potential treatment for patients with moderate to severe knee osteoarthritis (OA) pain. Flexion plans to submit a new drug application (NDA) in the fourth quarter of 2016 to the U.S. Food and Drug Administration (FDA).
Michael Clayman, MD, President and Chief Executive Officer of Flexion, stated, “We are delighted to be bringing Mark’s considerable commercial experience and know-how to our Board of Directors. We are confident that his strategic expertise and his deep and current knowledge of sales and marketing will complement the backgrounds of the existing Board members and will contribute insight and perspective to our recently expanded internal commercial capabilities. All of this is vitally important as we prepare Zilretta for potential approval and commercial launch, which we anticipate to happen in 2017.”
Mr. Stejbach has more than 25 years of leadership experience in biotech and commercial marketing, sales, managed care, and finance. As Chief Commercial Officer at Alkermes, Mr. Stejbach is responsible for marketing, sales, managed care and trade channels, commercial analytics, patient services, new product planning and commercial strategy. Previously, he served at Tengion, Inc. from 2008 to 2012, most recently as Chief Commercial Officer. He previously held senior positions at Merck & Co. and Biogen Idec. Mr. Stejbach received his MBA from the University of Pennsylvania and a Bachelor of Science in mathematics from Virginia Tech.
“I’m honored to join the Flexion Therapeutics Board of Directors as the company prepares to submit an NDA for its drug candidate, Zilretta, to the FDA,” said Mr. Stejbach. “If approved for commercialization, Zilretta would be an important drug in the armamentarium of physicians who treat patients with pain associated with knee OA.”
About Zilretta
Zilretta is being investigated as the first intra-articular sustained-release, non-opioid treatment for patients with moderate to severe knee OA pain. Zilretta employs proprietary microsphere technology combining TCA — a commonly administered, short-acting corticosteroid — with a polymer (PLGA) intended to provide persistent concentrations of drug locally to both amplify the magnitude and prolong the duration of pain relief.
To date, more than 600 patients have been treated with Zilretta in clinical trials. No drug-related serious adverse events have been observed in these trials and adverse events have typically been localized, mild and comparable to those observed with immediate-release TCA and placebo. The data from these trials are consistent with Zilretta providing meaningful and durable pain relief.
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.
Forward-Looking Statements
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, including the expected timing for approval and commercial launch 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, approval, and commercial launch 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.