U.S. Patent No. 10,301,645 was awarded to Baylor College of Medicine in Houston, Texas. In December of 2017, Flexion acquired the global rights to FX201 from GeneQuine Biotherapeutics GmbH, and as part of that agreement, Flexion obtained an exclusive license to the underlying intellectual property rights from Baylor for human applications.
"OA is a serious disease that is progressive and incurable, and we believe that by persistently controlling inflammation in the joint, FX201 may hold the potential to both provide lasting pain relief and modify the underlying disease," said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. "While still early days for the program, the issuance of this patent represents one important step in our journey to bring FX201 to the market."
FX201 is a locally administered gene therapy product candidate designed to stimulate the production of an anti-inflammatory protein, interleukin-1 receptor antagonist (IL-1Ra), whenever inflammation is present within the joint. Inflammation is a known cause of pain, and chronic inflammation is thought to play a major role in the progression of OA. By persistently suppressing inflammation, Flexion believes FX201 holds the potential to both reduce OA pain and modify the disease.
Flexion is currently completing Good Laboratory Practice (GLP) toxicology studies and has successfully transferred the manufacturing process for FX201 to a U.S. based contract manufacturing organization. The company expects to file an Investigational New Drug application and initiate clinical trials in the second half of 2019.
About Osteoarthritis (OA) of the Knee
OA, also known as degenerative joint disease, affects more than 30 million Americans 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, more than 15 million Americans are treated for OA-related knee pain, and 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 patients with musculoskeletal conditions, beginning with osteoarthritis, a type of degenerative arthritis. The company's core values are focus, ingenuity, tenacity, transparency and fun. For the past two years, Flexion has been named one of the Best Places to Work by the Boston Business Journal, and a Top Place to Work in Massachusetts by The Boston Globe.
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 to develop and commercialize FX201, including the expected timing of clinical and regulatory events; expected increases in the rate of individuals with OA of the knee; and the potential therapeutic and other benefits of FX201, 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 developing FX201; the fact that the results of prior preclinical studies may not predict results of subsequent preclinical or clinical studies; the risk that we may incur unexpected expenses or cash requirements; our reliance on third parties to manufacture FX201; the risk that we may not be able to maintain and enforce our intellectual property, including licensed intellectual property related to FX201; the risk the license agreement with Baylor could be terminated early if we do not comply with our obligations; competition from alternative therapies; regulatory developments and safety issues, including difficulties in obtaining and maintaining regulatory approvals to conduct clinical trials and market FX201; 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2019. 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.
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