- Adding Patheon as a contract manufacturer, in addition to Evonik Corporation, bolsters manufacturing capacity for planned commercialization of company's lead program
BURLINGTON, Mass. -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced it has entered into a strategic manufacturing and supply agreement with Patheon, a leading global provider of high-quality drug development and delivery solutions to the pharmaceutical and biopharmaceutical industries, for the manufacture of FX006, Flexion's lead program. This agreement will complement Flexion's existing manufacturing relationship with Evonik Corporation and create redundant supply for FX006, which is an intra-articular (IA) sustained-release steroid for the treatment of osteoarthritis (OA). Patheon and Flexion will establish a dedicated manufacturing suite at Patheon's specialty sterile manufacturing facility in Swindon, England, to allow Flexion greater control of unit production and provide added scale to meet long-term product demand.
Flexion expects to report topline data from a pivotal Phase 2b clinical trial of FX006 in September 2015 and has recently completed enrollment of patients in a Phase 3 clinical trial, each of which is exploring FX006 as a treatment for pain associated with OA of the knee.
"With data from our second FX006 pivotal trial expected during the first quarter of 2016, entering into a complementary manufacturing agreement with Patheon, a world-class CMO, is important at this time as we prepare for the potential submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration for FX006 in 2016," stated Michael Clayman, M.D., Flexion Therapeutics' President and Chief Executive Officer. "We believe having two leading manufacturers to the global biopharmaceutical industry as our partners will help ensure that we have appropriate supply capacity and redundancy in manufacturing capabilities for the future commercialization of FX006."
Under the agreements with Patheon, Patheon will be responsible for the construction of the dedicated manufacturing suites, installation and validation of the manufacturing equipment and the potential commercial manufacture of FX006. Flexion will oversee the purchase and design of the dedicated manufacturing equipment to be installed in the facility and will have personnel on-site to ensure the optimization of Flexion's proprietary manufacturing process.
"This agreement with Flexion is testament to our company's mission to be a critical partner to our customers who rely on our customized formulation, development and manufacturing expertise to address their growing needs," said Antonio Magnelli, Senior Vice President, European Commercial Operations, Patheon. "We are pleased to have been selected by Flexion to support the manufacturing needs for FX006."
FX006 is a first-in-class injectable, sustained-release, IA steroid treatment for patients with moderate to severe OA pain. FX006 was specifically designed to address the limitations of current IA therapies by providing long-lasting, local analgesia while avoiding systemic side effects. To date, approximately 600 patients have been treated with FX006. In a completed Phase 2b dose-ranging clinical trial, FX006 has demonstrated clinically meaningful and significantly better pain relief compared to the current injectable standard of care, triamcinolone acetonide. In two Phase 2a synovial fluid pharmacokinetic studies, a single IA injection of FX006 demonstrated therapeutic concentrations of drug in joint fluid for at least 12 weeks. FX006 is currently being studied in pivotal Phase 2b and Phase 3 clinical trials, which are designed to provide the required data for FX006 to be submitted for regulatory approval by the U.S. Food and Drug Administration.
About Flexion Therapeutics
Flexion is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel pain therapies. The company is currently advancing a portfolio of local, injectable drug candidates that have the potential to provide better and more persistent analgesia compared with existing therapy. The company's lead program, FX006, is an intra-articular sustained-release steroid in development for patients with moderate to severe OA pain. The company also has two additional product candidates, FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage OA patients.
About Evonik Corporation
Evonik, the creative industrial group from Germany, is one of the world leaders in specialty chemicals. Profitable growth and a sustained increase in the value of the company form the heart of Evonik's corporate strategy. Its activities focus on the key megatrends health, nutrition, resource efficiency and globalization. Evonik benefits specifically from its innovative prowess and integrated technology platforms.
Evonik is active in over 100 countries around the world. In fiscal 2014 more than 33,000 employees generated sales of around €12.9 billion and an operating profit (adjusted EBITDA) of about €1.9 billion.
Patheon is a leading global provider of outsourced pharmaceutical development and manufacturing services. With approximately 8,700 employees worldwide, Patheon provides a comprehensive, integrated and highly customizable set of solutions to help customers of all sizes satisfy complex development and manufacturing needs at any stage of the pharmaceutical development cycle. The company is owned by JLL Partners and Royal DSM.
Statements in this press release regarding matters that are not historical facts, including statements relating to the future of Flexion, its ongoing development and manufacture of its product candidates (including FX006), the potential for Patheon to help ensure Flexion's supply capacity and manufacturing redundancy, anticipated activities under the manufacturing and supply agreement, expected timelines related to clinical trials and regulatory filings and potential commercial launch, benefits of FX006 and the nature and benefit of the services offered by Evonik and Patheon. 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 and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics, the fact that past clinical trial results may not be predictive of results in future trials, whether Flexion and Patheon will comply with their obligations under the manufacturing and supply agreement, the fact that Flexion relies on third parties to manufacture and conduct the clinical trials of its product candidates, which could delay or limit their future development or regulatory approval, the fact that Flexion will require additional capital, including prior to commercializing FX006 or any of its other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to it, and other risks and uncertainties described in Flexion's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Flexion's Annual Report on Form 10-K for the year ended December 31, 2014 and subsequent filings with the SEC. You are encouraged to read Flexion's filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this press release, and Flexion undertakes no obligation to update or revise any of the statements.
CONTACT: Media Contact Jamie Lacey-Moreira PressComm PR, LLC T: 410-299-3310 [email protected] Corporate Contact Lisa Davidson, MBA Vice President, Finance and Administration Flexion Therapeutics, Inc. T: 781-305-7765 [email protected]