FLXN Flexion Therapeutics Inc

Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that William T. Andrews, M.D., F.A.C.P., will join the company as Chief Medical Officer (CMO), effective July 1, 2021.

"Will brings an impressive combination of medical, clinical, regulatory and corporate development skills, complemented by deep commercial experience he gained launching seven products throughout his career,” said Michael Clayman, MD, President and Chief Executive Officer of Flexion Therapeutics. “He will play an integral role in building and strengthening our organization, and we could not be more excited to welcome him to our senior management team.”

"I have been tremendously impressed by the caliber of the people and the programs at Flexion, and I am delighted to join the company at this exciting time in its growth and evolution,” said Dr. Andrews. “I look forward to working closely with the team as we prepare to investigate ZILRETTA® for the treatment of shoulder osteoarthritis and as we advance our pipeline of potentially transformative investigational drug candidates.”

Dr. Andrews has more than 20 years of experience in the biopharmaceutical industry, most recently serving as CMO at Akcea Therapeutics (acquired by Ionis Pharmaceuticals). Prior to Akcea, Dr. Andrews served as CMO for Acer Therapeutics, a biopharmaceutical company focused on the development of therapies for rare and severe diseases. He previously held senior leadership positions and roles of increasing responsibility at Aegerion Pharmaceuticals, Santhera Pharmaceuticals, Sepracor, and ClinQuest.

Dr. Andrews earned his B.A. in Biology from Harvard University and his M.D. from Yale University School of Medicine. Before joining industry, he practiced medicine in the Boston area for seven years as a board-certified internist and an attending physician at Brigham and Women’s Hospital and was on the clinical faculty at Harvard Medical School.

Indication and Select Important Safety Information for ZILRETTA (triamcinolone acetonide extended-release injectable suspension)

Indication: ZILRETTA is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee.

Limitation of Use: The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated.

Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.

Warnings and Precautions:

• Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration.
• Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use.
• Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs.
• Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and if confirmed, institute appropriate antimicrobial treatment.

Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions.

Please see ZilrettaLabel.com for full Prescribing Information.

About ZILRETTAOn October 6, 2017, ZILRETTA was approved by the U.S. FDA as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide — a commonly administered, short-acting corticosteroid — with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase 3 trial on which the approval of ZILRETTA was based showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through Week 16. Learn more at www.zilretta.com.

About Flexion TherapeuticsFlexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of people with musculoskeletal conditions, beginning with osteoarthritis, the most common form of arthritis. The Company's core values are focus, ingenuity, tenacity, transparency and fun. Please visit flexiontherapeutics.com.

Forward-Looking Statements This press release contains forward-looking statements that are based on the current expectations and beliefs of Flexion. Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; future contributions of Dr. Andrews; and plans with respect to clinical trials and development of Flexion’s pipeline, 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 related to clinical trials, including potential delays, safety issues, or negative results; the fact that future results may not be consistent with preliminary results or results from prior studies or trials; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 10, 2021, 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.

Contact:

Scott YoungVice President, Corporate Communications & Investor RelationsT: 781-305-7194syoung@flexiontherapeutics.com

Julie DownsAssociate Director, Corporate Communications & Investor RelationsT: 781-305-7137jdowns@flexiontherapeutics.com