Creating a Product Portfolio from the Ground Up

Mike Clayman, CEO of Flexion Therapeutics, talks about his company's strategy to focus on a single therapeutic area.
Jun 01, 2012
By BioPharm International Editors
Volume 25, Issue 6

Mike Clayman is CEO of Flexion Therapeutics, Woburn, MA.
Flexion Therapeutics was founded in late 2007 with the idea of rapidly progressing compounds in the clinic to meaningful proof of concept. Today, the company, based in Woburn, Massachusetts, has a full range of therapies for osteoarthritis and, in particular, therapies that are injected within the joint (i.e., intra-articular treatments). Here, CEO Mike Clayman talks about Flexion's business model and how focusing on one therapeutic class is making the biotech company a leader in its class.

BioPharm: How did Flexion decide on osteoarthritis as a therapeutic target?

Clayman: Osteoarthritis affects over 100 million people worldwide in terms of symptomatic disease, 27 million of which are in the US. Flexion's goal is to treat patients with osteoarthritis of the knee, which is the most commonly injected joint (over 10 million patients have knee osteoarthritis in the US). The prevalence of knee osteoarthritis is actually growing in light of an aging population and an increasingly obese population; it is also driven by sports injuries. If you tear your anterior cruciate ligament as a young athlete, you have a 60% chance of developing osteoarthritis within 10 to 15 years.

What drew us to this field was the recognition that the current osteoarthritis treatments are inadequate. Oral therapies provide limited pain relief and are associated with serious organ toxicities. Current intra-articular therapies (e.g., steroids and hyaluronic acids), either provide pain relief of inadequate duration or inadequate magnitude. Yet, intra-articular therapies generate well over $1.5 billion per year worldwide in sales. And in the US, successful commercialization of these therapies entail sales forces of fewer than 100. When we put this scenario together, we said to ourselves, 'This is a space that is ripe for innovation with a substantial and growing unmet medical need. Flexion could make a real difference by advancing to launch and commercialization—at least in the US—important new medicines.' We came to believe that our sustained-release intra-articular approach had the potential to provide real and meaningful benefits for patients with limited options.

BioPharm: Flexion has been successful by focusing not only on the intra-articular treatment for osteoarthritis but also by targeting a full range of treatments for the condition. Can you talk about why the company took that particular approach and how it's been working to date?

Clayman: If we were going to be in this space, we needed to have a critical mass of product opportunities. We in-licensed a sustained release p38 inhibitor from AstraZeneca as one of our initial products and that became our nucleating asset, if you will, for a portfolio that now includes a sustained-release steroid, triamcinolone acetonide, and a sustained-release TrkA antagonist (TrkA is the receptor for nerve growth factor).

What we like about this portfolio is that, assuming we generate the data that we hope to in terms of efficacy and safety, it can address a range of patient needs. The sustained-release steroid is naturally positioned as a near frontline therapy—while the sustained-release p38 inhibitor is intended for patients who progress to needing something beyond steroids, and the sustained-released TrkA antagonist is focused on patients with end-stage disease who have pain refractory to any other analgesic approaches. So our portfolio has the potential to address the spectrum of disease on osteoarthritis in terms of pain relief. We also plan to pursue the potential for these therapies to be disease modifying, which is an enormous unmet medical need in osteoarthritis because the natural history of this disease is for many patients to require joint replacement.

BioPharm: What key challenges has Flexion faced while developing a pipeline of drugs for the full-range treatment of this disease?

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