Flexion, Patheon Plan Dedicated Mfg Suite
Flexion Therapeutics, Inc., a clinical-stage specialty pharmaceutical company, has entered into a strategic manufacturing and supply agreement with Patheon, 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.
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.
Flexion expects to report topline data from a Phase IIb clinical trial of FX006 in September 2015 and has recently completed enrollment of patients in a Phase III clinical trial, each of which is exploring FX006 as a treatment for pain associated with OA of the knee.
FX006 is an 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.