Catalyst Pharmaceutical, that ardent admirer of Turing Pharmaceuticals’ M.O., was dealt a bit of a regulatory blow this week. That is, the FDA just sent a “refusal to file” letter to the Florida company for its late-stage drug that’s already been in use for decades.
Catalyst is sending a long-used drug through clinical trials and – post-approval – has aims to raise its price considerably. But the FDA said the company’s new drug application was not complete and needs more time for review, New York Times reports.
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The drug in question treats a disease called Lambert-Eaton Myasthenic Syndrome, or LEMS. It’s been given away by a New Jersey drugmaker called Jacobus Pharmaceutical Company. But in recent years, Catalyst has jumped on the LEMS bandwagon and, renaming the generic drug Firdapse, told investors it’d make millions of dollars on the drug.
A similar approach was taken, of course, by Martin Shkreli at Turing Pharmaceuticals – in which it acquired a little-used, low-cost drug and increased the price per pill from $13.50 to $750.
“We expect to work closely with the FDA over the coming weeks in an effort to resolve the open issues and to define a path forward for a successful resubmission of our application at the earliest point in time,” Catalyst CEO Patrick J. McEnany said in a statement. “We remain focused on delivering on our promise to transform the way people living with LEMS and CMS are provided access to a safe and effective, FDA approved therapy. Additionally, our Expanded Access Program continues to enroll new patients and provide Firdapse at no cost to patients who meet the enrollment criteria.”
