Catalyst Pharmaceuticals Announces Issuance of U.S. Patent for Firdapse®
"We are pleased that our patent for Firdapse® (amifampridine) has issued and believe that it will create significant barriers to therapeutically equivalent generic competition from entering the market for approximately nine years beyond orphan drug exclusivity," said
“This patent is directed to innovative methods of administering amifampridine to slow metabolizers of amifampridine,” commented
Amifampridine is extensively metabolized by N-Acetyl Transferase, type 2 (or NAT2) and the rate of this metabolism can be quite variable in patients. The patent is directed to the use of suitable doses of amifampridine to treat patients, regardless of the therapeutic indication, that are slow metabolizers of amifampridine. Any drug product containing amifampridine with a label that states the patented dosing regimens and doses in the Dosing and Administration section prior to
Firdapse® (amifampridine) 10 mg tablets is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization. This action results in the opening of slow voltage-dependent calcium (Ca2+) channels, allowing for a subsequent influx of Ca2+. In turn, it induces the exocytosis of synaptic vesicles containing Acetylcholine (ACh) to release more ACh into the synaptic cleft, enhancing neuromuscular transmission, and providing for improved muscle function.
Firdapse is currently being evaluated in clinical trials for the treatment of MuSK-MG and SMA Type 3 and has received Orphan Drug Designation from the FDA for myasthenia gravis.
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) the scope of protection from competition provided by the patent, and (ii) those factors described in Catalyst's Annual Report on Form 10-K for fiscal year 2019 and its other filings with the
Brian KorbSolebury Trout (646) 378-2923 email@example.com Company Contact Patrick J. McEnany Catalyst PharmaceuticalsChief Executive Officer (305) 420-3200 firstname.lastname@example.org Media Contact David Schull Russo Partners(212) 845-4271 email@example.com
Source: Catalyst Pharmaceuticals, Inc.