September 15, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WOBURN, Mass. – Flexion Therapeutics scrapped an eight-year-old agreement with pharma giant AstraZeneca to develop an end-stage osteoarthritis treatment.
The Massachusetts-based company notified AstraZeneca on Sept. 8. The company later later disclosed its decision in a filing with the U.S. Securities and Exchange Commission. Flexion did not provide a reason it was terminating the license for a sustained-release kinase inhibitor. Flexion did say it has discontinued internal development of the program.
The two companies initially struck the agreement in June of 2009, Flexion said. The developmental agreement focused on Flexion’s sustained-release p38 MAP, or mitogen-activated protein, kinase inhibitor development known as FX005. The experimental therapy was being developed for end-stage osteoarthritis.
Flexion did not indicate its reasons for terminating the license for that product in its brief notice to the SEC. Flexion said the rights to FX005 will revert to AstraZeneca. The company added its milestone, royalty and patent maintenance obligations under the agreement will cease.
The program with AstraZeneca is expected to formally end in December, three months after Flexion notified AstraZeneca of the ending of the license agreement.
Flexion is currently waiting for the U.S. Food and Drug Administration to make a decision regarding Zilretta (FX006), a treatment for osteoarthritis of the knee. The company submitted its NDA in December. Zilretta received Fast Track designation from the FDA and anticipates a decision on Oct. 6. FX006 is an intra-articular sustained release steroid.
Phase III data shows that Zilretta was able to demonstrate a “highly significant” reduction in average daily pain versus placebo in patients with moderate to severe OA-associated knee pain. Zilretta also reduced the amount of analgesic rescue medications during recovery, the company said earlier this month.
“In clinical trials, Zilretta has demonstrated clinically meaningful pain relief for patients with OA of the knee for at least 12 weeks, and the reduced utilization of rescue medicines observed in this analysis serves as another important indicator of the robustness of Zilretta’s analgesic profile,” Flexion Chief Executive Officer Michael Clayman said in a statement earlier this month.
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.
According to Flexion, about 30 million Americans are affected with osteoarthritis. That number could grow as more and more Americans become heavier, Flexion said on its website. Approximately 35 percent of U.S. adults are obese, which increases the risk of developing OA, the company said.
Earlier this year Flexion was rumored to be the target of a buyout by Paris-based Sanofi.
