Update on Catalyst Pharmaceuticals (CPRX)
Earlier today Catalyst Pharmaceuticals (CPRX) disclosed that Teva (TEVA) filed an abbreviated new drug application seeking authorization from the FDA to make and sell a generic version of FIRDAPSE into the U.S. market.
FIRDAPSE is a formulation of amifampridine for the treatment of adults with Lambert-Eaton myasthenic syndrome (LEMS). Catalyst received FDA approval to treat U.S. adults with FIRDAPSE in 2018 and for pediatric patients (over six years old) in Q3 2022. FIRDAPSE is also sold in Japan and Canada.
In 2019 the FDA approved Jacobus Pharmaceutical’s formulation of amifampridine, called Ruzurgi (for pediatric patients).
Catalyst sued the FDA, arguing the approval violated its statutory rights to exclusivity under the Orphan Drug Act. Fast forward to early 2022 and the FDA told Jacobus that approval of Ruzurgi was on hold until the seven-year orphan drug exclusivity of FIRDAPSE expired.
Catalyst also sued Jacobus. That suit was resolved when Catalyst acquired the rights to Ruzurgi last summer (July 2022).
In short, Catalyst successfully protected its FIRDAPSE franchise. But it didn’t happen overnight.
In previous SEC filings, Catalyst has disclosed that “… third parties may seek to market generic versions of FIRDAPSE® by filing an ANDA filing with the FDA in which they claim that the patents protecting FIRDAPSE® owned or licensed by us and listed with the FDA in ‘the Orange Book’ are invalid, unenforceable and/or not infringed, a so-called Paragraph IV filing.”
If this happens Catalyst “… will need to defend and/or assert our patents, including by filing lawsuits against the Paragraph IV filer alleging patent infringement.”
This is basically what Teva has done. And Catalyst needs to do what it did with the FDA and Jacobus. In short, go to battle to protect its FIRDAPSE franchise.
This is creating uncertainty around the stock, which is why it is trading down today. This is incredibly frustrating as CPRX has been doing so well. There could be an extended legal battle. Or this may be a hostile attempt by Teva to weaken Catalyst and launch a takeover. Or some other scenario may unfold.
Right now, the stock is digesting this development. I’ve been working to dig up info today and will continue tomorrow. Until we know a little more, Catalyst Pharmaceuticals is a hold. HOLD
