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Flexion CEO Makes The Case For Zilretta

Executive Summary

Flexion CEO Mike Clayman shares expectations for Zilretta for knee osteoarthritis and discusses plans for commercialization in an interview at the Biotech Showcase in January.

Flexion Therapeutics Inc. has been planning the commercial, and pricing, strategy for its long-acting corticosteroid Zilretta for a long time, and has the market research to support it, CEO Mike Clayman explained in an interview with Scrip’s Emily Hayes.

Following submission of a new drug application for Zilretta (FX006) for knee osteoarthritis in mid-December 2016, Clayman is hoping for priority review with the US FDA and market entry by the end of the year.

Zilretta is an extended release formulation of the steroid triamcinolone acetonide. Steroid injection is a common treatment upon diagnosis, but pain relief wanes after two to four weeks. Flexion is positioning Zilretta as a longer-acting corticosteroid – the candidate is formulated to stay in the knee joint for three months – and a more potent pain relief option for patients with knee osteoarthritis.

Competing against generic steroids, which cost only $10 to $20 per dose, presents a big commercial challenge, however. In an interview at the Biotech Showcase, which was held in parallel with the J.P. Morgan Healthcare Conference, Clayman explains the rationale for pricing a long-acting steroid at $500 per dose and the company's commercial strategy, including plans to launch shortly after approval. (Also see "Flexion's OA Knee Injection On Track For H2 Filing" - Scrip, 17 Feb, 2016.)

Source: EBD Group & Scrip

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