Flexion Therapeutics Names Melissa Layman Chief Commercial Officer

BURLINGTON, Mass., March 11, 2020 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that Melissa Layman has been named Chief Commercial Officer (CCO). Ms. Layman joins Flexion with more than 25 years of commercial experience within the life science industry. Over the course of her career she has held positions of increasing responsibility across all areas of commercial operations including sales, marketing, market access and analytics.

“I am genuinely delighted to welcome Melissa to Flexion during one of the most exciting periods in Flexion’s history,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “She combines deep and broad commercial expertise with important leadership experience and a strong track record of success. I am confident that she will make a very real difference for us and for patients on the journey to realizing the potential of ZILRETTA®.”

"Flexion is an extraordinary company, and I am so proud and excited to assume one of the premier executive opportunities in the biotech space," said Ms. Layman. "ZILRETTA is a phenomenal product that has the potential to help so many patients, and I look forward to helping it become the leading intra-articular treatment for OA knee pain. I am also tremendously enthusiastic about the transformative potential of both FX201 and FX301."

Before joining Flexion, Ms. Layman served as Vice President, Global Sales and Marketing at Lantheus Medical Imaging where she was a member of the executive leadership team. During her nearly 10-year tenure, she was responsible for global sales, marketing, communications, health policy, pricing and reimbursement, commercial development and international operations. Prior to Lantheus, she served as Executive Marketing Director at Forest Laboratories (now Allergan), where she led the cardiovascular franchise through the successful launch of its lead product, Bystolic. Ms. Layman also held senior marketing positions at Altus Pharmaceuticals (now Vertex) and Sepracor (now Sunovion), where she launched Xopenex MDI and Lunesta, building and integrating the market access function across the business. She began her career with TAP Pharmaceuticals (now Takeda Oncology) where her positions ranged from sales representative to National Marketing Director, Gastroenterology and Oncology.

Ms. Layman holds a B.A. from Ithaca College and an executive M.B.A. from the Kellogg School of Management at Northwestern University.

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  for full Prescribing Information.

About ZILRETTA

On 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 knee pain for 12 weeks, with some people experiencing pain relief through Week 16.

About Osteoarthritis (OA) of the Knee

OA, also known as degenerative joint disease, affects more than 30 million adults living in the U.S. and accounts for more than $185 billion in annual expenditures. In 2016, more than 15 million Americans were diagnosed with OA of the knee and the average age of physician-diagnosed knee OA has fallen by 16 years, from 72 in the 1990s to 56 in the 2010s. The prevalence of OA is expected to continue to increase as a result of aging, obesity and sports injuries. Each year, approximately five million OA patients receive either an immediate-release corticosteroid or hyaluronic acid intra-articular injection to manage their knee pain.

About Flexion Therapeutics

Flexion 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. Flexion is building a portfolio of non-opioid therapeutics, with the goal of making a meaningful difference in the lives of patients. The Company's core values are focus, ingenuity, tenacity, transparency and fun. Visit .

Forward-Looking Statements

This 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, the expected benefits of Flexion's appointment of Ms. Layman as CCO, the potential of ZILRETTA and Flexion’s product pipeline, and expected increases in the prevalence of OA 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, whether we are able to retain key employees including Ms. Layman; the risk that we may not be able to successfully maintain an effective sales force to commercialize ZILRETTA; competition from alternative therapies; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to ZILRETTA; the risk that ZILRETTA may not be successfully commercialized or adopted; risks regarding our ability to obtain adequate reimbursement from payers for ZILRETTA; risks related to the manufacture and distribution of ZILRETTA, including our reliance on sole sources of supply and distribution; risks inherent in developing novel product candidates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 filed with the SEC on November 7, 2019 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.

Contacts:

Scott Young

Vice President, Corporate Communications & Investor Relations

Flexion Therapeutics, Inc.

T: 781-305-7194

Julie Downs

Associate Director, Corporate Communications & Investor Relations

Flexion Therapeutics, Inc.

T: 781-305-7137

A photo accompanying this announcement is available at