Clayman: We did have to make a transition in our strategy. The original idea for Flexion was to in-license attractive assets from
large pharmaceutical companies that were not being adequately progressed by the sponsors and to progress them ourselves to
meaningful proof of concept. We would then partner or sell those assets and repeat the process of bringing in other assets
to do the same thing.
But we began to wonder about the validity of a strategy that aimed to monetize assets at proof of concept. We had become increasingly
aware that large pharma was engaging in more option-based deals with modest upfront payments and a lot of downstream milestones
and royalties. Alternatively, a large pharma might come to us and say, 'Very interesting proof of concept data. Why don't
you generate the Phase IIb dose ranging study data and get back to us.' These are not great scenarios for a small venture-backed
company like Flexion. So we took a step back and decided that we needed a compelling strategy that would reduce our dependence
on large pharma. We had already in-licensed five assets by this point and one was the p38 inhibitor for osteoarthritis. We
saw the potential to go it alone in the intra-articular-for-osteoarthritis space using the p38 inhibitor as our initial asset.
Essentially, we shifted to a focus on osteoarthritis and, particularly, intra-articular therapies for osteoarthritis.
Once we made that switch, we had a clear direction and were fortunate enough to originate the sustained-release steroid ourselves
and build strong IP around that. Then we were able to in-license the TrkA antagonist from AstraZeneca. It's important to point
out that both of the in-license assets from AstraZeneca are Flexion's to commercialize without restriction. So now, we have
a critical mass of high quality assets in the portfolio.
BioPharm: Other small companies may be trying to take a similar strategic approach within a different therapeutic area. Can you offer
any best practices for companies starting down that path?
Clayman: I don't know about being able to offer best practices, but I can say that I'm glad we re-evaluted our original strategy,
and that we've refined it to focus on intra-articular therapies for osteoarthritis. I feel very good about where we are headed.
BioPharm: You definitely have a very specific approach, and I imagine, at least on the management side, that being open and flexible
Clayman: Absolutely. And I think it's also true that we're pretty good at knowing what we don't know. We're open to learning and accessing the best expertise in the world to help us be as effective as we need to be.
Having said that, we have purposefully kept ourselves small. We've hired what I think is an outstanding development team at
Flexion. The entire employee base is 10, and we will grow judiciously in the face of positive data.
BioPharm: In what direction is Flexion now headed in terms of strategy?
Clayman: Our strategy is to go it alone to commercialization at least in the US, and to consider partnering elsewher. We'll have definparing
clinical data for our p38 inhibitor soon, and shortly thereafter, our sustained-release steroid will be entering the clinic.
So we're moving things along and confident that we're designing the right clinical trials that will generate the data that
will clearly define the opportunity for these assets.
We are in active discussions with partners around the world regarding specific assets and the portfolio. The coming months
have the potential to create a number of partnerships. We are currently well financed, and we will pursue additional financing
as appropriate and necessary to allow us to continue to implement the strategy.
Listen to the full interview with Flexion Therapeutic's Mike Clayman online, at http://biopharminternational.com/ and click on "Basic Training."