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Apr 18, 2013

Data Presented at OARSI’s 2013 World Congress on Osteoarthritis Show
Flexion’s FX006 Has Prolonged Therapeutic Concentration in Knee Joint

Data Presented at OARSI’s 2013 World Congress on Osteoarthritis Show Flexion’s FX006 Has Prolonged Therapeutic Concentration in Knee Joint

Data Presented at OARSI’s 2013 World Congress on Osteoarthritis Show Flexion’s FX006 Has Prolonged Therapeutic Concentration in Knee Joint

WOBURN, Mass., April 18, 2013 -  Flexion Therapeutics, Inc. announced today the presentation of a poster titled "FX006 prolongs the residency of triamcinolone acetonide in the synovial tissues of patients with knee osteoarthritis" at Osteoarthritis Research Society International's (OARSI) 2013 World Congress on Osteoarthritis in Philadelphia. Flexion co-founder and chief medical officer, Neil Bodick, M.D., Ph.D., will discuss the findings during the poster session from 3:30 p.m. to 5:00 p.m. on Friday, April 19 and Saturday, April 20.

As previously announced, FX006, Flexion's novel intra-articular, sustained release steroid, maintained therapeutic concentrations in the knee joint significantly longer than the most commonly prescribed immediate release (IR) steroid, triamcinolone acetonide (TCA) in a Phase 2 pharmacokinetic study. At six weeks, FX006, a sustained release formulation of TCA, remained in the joint at clinically active concentrations while the IR steroid was no longer detectable. Patients treated with FX006 also showed a significantly reduced systemic exposure to the parent steroid compared to the IR formulation. FX006 was well tolerated at all doses throughout the study.

"These data validate our sustained release, intra-articular approach and their presentation at OARSI is an important event for Flexion," said Michael Clayman, M.D., co-founder and chief executive officer of Flexion. "We expect that the combination of persistent therapeutic concentrations of FX006 in the knee and very low systemic exposures will result in more effective and safer therapy for patients suffering the debilitating pain of osteoarthritis."

About FX006

FX006 is Flexion's novel, proprietary, sustained-release, intra-articular formulation of triamcinolone acetonide for the treatment of Osteoarthritis (OA) of the knee. It is designed to provide prolonged pain relief while avoiding untoward systemic effects associated with steroids as front-line therapy. In preclinical models of OA, FX006 demonstrates both superior efficacy and beneficial effects on structural progression compared with immediate release steroids. A Phase 2b dose-ranging study evaluating safety and efficacy has completed enrollment in the U.S., Canada and Australia and data are expected in the middle of 2013.

About Flexion Therapeutics
Flexion is a clinical-stage specialty pharmaceutical company developing innovative therapeutics for musculoskeletal disorders. In our efforts to provide products with superior efficacy and safety, we are merging novel pharmacology with local, sustained delivery of drug to the site of disease - an approach that aims to ensure lasting therapeutic effect and systemic safety. We are currently advancing a portfolio of best-in-class drug candidates that have the potential to treat mild, moderate and severe forms of osteoarthritis. Top-line data for FX005, an intra-articular sustained release p38 MAP kinase inhibitor and our lead compound, showed prolonged improvement in joint pain and function throughout the 12-week duration of the Phase 2 study. FX006, an intra-articular sustained release steroid, is currently being evaluated in a Phase 2b dose-ranging study with data expected in the middle of 2013. FX007, an intra-articular sustained release TrkA inhibitor, is being developed to safely address the intractable pain associated with end-stage osteoarthritis.

For more information please visit www.flexiontherapeutics.com.


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