Locally acting therapies are like a religion to Flexion Therapeutics (NSDQ:FLXN) co-founder & CEO Dr. Mike Clayman, who spent decades at Eli Lilly (NYSE:LLY) with the company’s co-founder, Dr. Neil Bodick, watching promising compounds fail in late-stage trials on the heels of unanticipated safety results.
“That’s part of the reason, not the whole reason but part of the reason, why the industry only has a 60% success rate in Phase III, because you can’t predict what safety’s going to look like if you’re giving a systemically-administered product that has the potential for off-target effects,” Clayman told Drug Delivery Business News.
After testing and evaluating a number of in-licensed products, Flexion began with a promising candidate that they developed internally – an extended-release formulation of triamcinolone acetonide designed to help patients with osteoarthritis manage pain.
“We recognized an imminent need in the steroid space, where immediate-release steroids are injected in over 4 million patients each year. None are formulated for sustained release so, after injection, they flood out of the joint. The pain relief that a patient gets, which is usually pretty good, wanes after two to four weeks. And by convention, steroids aren’t injected anymore often than every three months, so there is an unmet medical need,” Clayman explained.
Zilretta, as the product came to be called, won FDA approval in October this year and officially launched at the end of November. Getting the product from a concept to an approved pain-relief therapy wasn’t easy. Flexion tested and scrutinized 50 different formulations of the drug before landing on its final version.
“It is not a common story in our space to go from ground-level zero, to go from concept-on-napkin to commercialized product. Yeah, we did a lot of right things but anyone who claims that there wasn’t a bit of luck along the way in any venture that gets a product to the market is just deluding themselves,” he told us.
Of course, it was more than luck – it necessitated perseverance as Clayman persuaded board members of the product’s potential. It also required plenty of clinical evaluation, something that Clayman is particularly fond of.
“I love the kind of the intellectual puzzle of creating a protocol that will reveal truth about a molecule for a given indication,” he said. “‘In God we trust – all others, bring data.'”
Flexion touts Zilretta as the first intra-articular extended-release therapy for patients with pain associated with osteoarthritis of the knee. The product incorporates triamcinolone acetonide into a polymer, which is then formulated into microspheres that are injected into the joint to provide pain relief for up to 12 weeks.
As Flexion moves forward with the product’s commercial launch, Clayman and his team are optimistic about Zilretta’s potential, but the chief executive is quick to note that they have done their homework.
“We are super sensitive to the fact that many small companies launching their first product have faltered, at least faltered in terms of disappointing The Street, and so much so that it becomes topic of regular discussion with investors and you’re put in the position of proving the negative: ‘Tell us why you’re not gonna disappoint us,’ which you can’t do until you have the data and sales numbers,” he said.
“But what we did do is we went back over the last decade of launches by small companies, 56 companies worth of data, to look at companies that got it right and companies that did not to tease out the themes, to pressure-test whether we had adequately addressed the issues that had befallen our predecessors,” Clayman explained.
The company is well-positioned financially to support a strong commercial launch and they have recently hired 103 sales representatives to get Zilretta into the offices of orthopedic surgeons, he added.
Flexion has also hired Dan Deardorf to lead Zilretta’s launch. Deardorf was VP of marketing for Genzyme franchise Synvisc, helping to lead the launch of Synvisc-One, which eventually became one of the most successful products in the intra-articular injection space.
“I don’t sit here saying we have it all right, but I think that we’ve gone to extraordinary lengths to understand the history of other companies that have gone before us and to aggressively support Dan in his efforts to ensure that we will be successful commercially,” Clayman said.
Looking ahead, the company hopes to expand Zilretta’s label to include pain relief in the hip and shoulder. It’s also conducting clinical studies to see if the product could be used on both knees simultaneously.
Beyond Zilretta, Clayman noted that Flexion is in talks to in-license other locally-acting therapies, in line with the company’s mantra of avoiding the sometimes toxic side effects of systemic medications.
“We’re in advanced discussions on an in-licensing candidate,” he said. “Our goal is to build a pipeline of at least three compelling shots on goal, where each one has the potential to be a transformative medicine as a local therapy for musculoskeletal disease.
“Our commitment is to continue to build what we believe is a company that has the potential to become great. Great for us is distinctive results, sustainable performance, and a compelling culture. We are heads-down, implementing a plan that will continue to move us in the direction of great. And you know, that journey’s never done.”
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