October 11, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WOBURN, Mass. – With regulatory approval of its new osteoarthritis of the knee pain drug Zilretta, Flexion Therapeutics is ramping up hiring for about 100 sales positions to support the launch of the therapy.
The U.S. Food and Drug Administration approved Zilretta, an extended-release, intra-articular injection, on Oct. 6. The company said that it intended to have supplies available for commercialization by late October following the completion of its manufacturing process validation. In an interview with the Boston Business Journal, Flexion Chief Executive Officer Mike Clayman said the company sees Zilretta as “the first step in what will be a long and fruitful journey.” The Journal first reported the ramping up of sales staff to drive the newly approved Flexion revenue stream. The company’s online jobs portal does not yet show 100 sales positions, but does list a number of open jobs, including a commercial operations analyst and a commercial training manager.
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 is not an opioid-based therapy and the company believes that will give the drug a leg up when it comes to sales. When the FDA announced its approval of Zilretta, Clayman said the regulatory nod comes at a time when “our society is in urgent need of non-addictive therapies” to manage pain. 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.
Analysts have pegged Zilretta to generate between $500 and $600 million in sales. If the drug is approved by the FDA for other indications, then analysts have suggested it could become a blockbuster drug, hitting $1 billion in sales.
It’s that kind of revenue stream the company is hoping for in order to support additional research and development. Clayman told the Journal that the company is working on another “longer-acting osteoarthritis drug” that is still in preclinical development.
Last month, Flexion scrapped an eight-year-old agreement with pharma giant AstraZeneca to develop an end-stage osteoarthritis treatment. In its filing, Flexion did not provide a reason it was terminating the license for p38 MAP, a mitogen-activated protein, kinase inhibitor.
Shares of Flexion spiked following the FDA approval of Zilretta, jumping from $25.39 to $30.40. The stock though has dropped back a bit. Shares dropped in aftermarket trading on Tuesday to $26.45 after a closing price of $27.17.
