Patheon and Flexion will establish a dedicated manufacturing suite at Patheon's specialty sterile manufacturing facility in Swindon, England, allowing for greater control of unit production and additional scale to meet long-term product demand. Patheon will be responsible for construction of the dedicated manufacturing suites, installation and validation of the manufacturing equipment, and commercial manufacture of FX006. Flexion will oversee the purchase and design of the manufacturing equipment and will have personnel on-site to ensure the optimization of Flexion's manufacturing process.
"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 NDA to the FDA for FX006 in 2016," said 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."
"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."