– USA, MA – 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.”
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.
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