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."