June 12, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Burlington, Mass. – Flexion Therapeutics announced it will provide full analysis of a Phase II trial with its Zilretta (FX006) at the American Diabetes Association’s 77th Scientific Sessions on June 11.
On Feb. 7, Flexion indicated the U.S. Food and Drug Administration (FDA) had accepted its New Drug Application (NDA) for Zilretta as a new treatment for patients with osteoarthritis (OA) of the knee. The PDUFA date is October 6, 2017. The new study is being used to underline a potential advantage of Zilretta—it doesn’t appear to cause spikes in blood glucose levels in diabetes that are often associated with steroid injections for OA.
About 4 million people with OA received steroid shots, and about 20 percent of them have diabetes, or 800,000 patients. Steroid shots are known to increase A1C levels, often briefly, but nonetheless can be a hazard for diabetes patients with OA.
Zilretta is a sustained-release corticosteroid. Analysts have projected, if Zilretta is approved, that it could hit $500 to $600 million in peak sales. If it is approved for other joint indications, it could hit the $1 billion blockbuster target.
The new study of 33 patients found that Zilretta had less impact on blood glucose levels compared to steroids. Blood glucose levels were monitored for one week before the injection and two weeks after. The primary endpoint was change in average blood glucose concentration from the 3-day pre-treatment baseline period to the 3-day post-treatment period for Zilretta versus triamcinolone acetonide in crystalline suspension (TAcs).
Blood glucose concentration after Zilretta was 14.7 mg/dL compared to 33.9 mg/dL with TAcs.
“You don’t have to be a scientist to see there is a difference,” Michael Clayman, Flexion’s chief executive officer, said at the ADA meeting this weekend, showing a chart. “The full study report was filed with the NDA. We propose reference to these data in Zilretta not being associated with a spike in glucose.”
John Carroll, writing for Endpoints News, says, “Flexion has been focused more and more on their October PDUFA date for Zilretta. The biotech’s been steadily building out a commercial operation, Clayman tells me, lining up job offers for 80 to 100 sales reps as they keep their fingers crossed that the FDA will come through with an approval.”
Back in late March, there were reports that Paris-based Sanofi was in talks with Flexion to acquire the company. According to at least one report, Flexion’s board had already voted to accept the non-binding offer with a price in the mid-30s. At that point, Flexion stock was trading at $19.68. It spiked at those rumors, hitting $29.26 on March 27, but is for $17.07.
In March, Carroll wrote, “A deal for Flexion would amount to a relatively small but reliable bolt-on buyout for Sanofi, which needs to prove that it can close on a negotiation. It would also mark a big payout to investors who have backed this company through the development phase.”
Carroll asked Clayman about a potential Sanofi deal, but just indicated the company doesn’t comment on market rumors.
Of today’s study, Clayman said in a statement, “Treating OA-related knee pain in patients with Type 2 diabetes can be complicated by the hyperglycemia which commonly occurs following the use of immediate-release corticosteroids. The findings from this study suggest that Zilretta may significantly reduce those blood glucose spikes by delivering a slower and extended release of corticosteroid in the knee joint and minimizing systemic exposure. We believe that Zilretta, if approved, has the potential to provide extended pain relief while supporting these patients in their efforts to maintain consistent blood glucose levels.”
