Catalyst Pharma Profiteering Assailed by LEMS Patients, Doctors

BOSTON ( TheStreet) -- Fred Kellerman's normal, active life will end if Catalyst Pharmaceuticals ( CPRX) succeeds in charging patients with a rare neuromuscular disease a sky-high price for access to an old drug they now get for free.

"I will become a vegetable," says Kellerman, a 74-year-old retiree living in Las Vegas with Lambert-Eaton Myasthenic Syndrome (LEMS).

Right now, Kellerman walks and swims daily because severe muscle weakness -- the hallmark symptom of LEMS -- is kept in check with 3,4-Dap, a drug he gets free of charge from Jacobus Pharmaceuticals, a small, private New Jersey drug maker.

Catalyst Pharmaceuticals is developing its own version of the LEMS drug known as Firdapse. 3,4-Dap and Firdapse are equally helpful for LEMS patients, but Catalyst is likely to charge $60,000 or more if it receives FDA approval, which would also block Jacobus from being able to supply 3,4-Dap for free.

"I live on Social Security and there is no way I could afford the co-pay if Catalyst gets Firdapse approved," says Kellerman. "Without 3,4-Dap, I will not be able to walk. I will go back to being bed ridden. I'll be a vegetable. Catalyst is not interested in helping LEMS patients at all, They're only interested in getting their stock price higher."

Kellerman and others accuse Catalyst of profiteering off LEMS patients because the company did not invent Firdapse. Instead, Catalyst is exploiting a loophole in U.S. law which allows companies to seek FDA approval for older drugs, which for a variety of reasons were never formally reviewed by regulators.

3,4-Dap is one of these "non-marketed" drugs. For more than 20 years, Jacobus has been making and supplying 3,4-Dap to LEMS patients under free, compassionate use programs supervised by doctors across the country. As I reported last week, Jacobus is also seeking FDA approval for 3,4-Dap because the company's founders want to prevent Catalyst from using orphan drug laws to rip off LEMS patients with high-priced Firdapse.

"David and Laura Jacobus are the most magnificent people in the world," says Kellerman, referring to the father-daughter team who run Jacobus Pharmaceuticals. "They're caring people who want to make a living but are not out to screw anybody."

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