Catalyst Pharmaceuticals Announces Issuance of U.S. Patent 11,060,128 a Method of Use Patent with Claims Covering Firdapse®
- New patent bolsters intellectual property protection for Firdapse®
- First in a family of four pending patents for Firdapse® to issue
"We are pleased that this second patent for Firdapse® has been issued and believe that it further enhances our intellectual property protection for Firdapse®”, said
“This patent is directed to innovative methods of administering amifampridine to slow metabolizers of amifampridine for the treatment of LEMS,” 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 suffering with Lambert-Eaton myasthenic syndrome (LEMS), that are slow metabolizers of amifampridine. Any drug product containing amifampridine with a label for the treatment of LEMS, that states the patented dosing regimens and doses in the Dosing and Administration section of a product label could possibly infringe this patent.
Firdapse® (amifampridine) Tablets 10 mg 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.
About Catalyst Pharmaceuticals
Firdapse® is currently being evaluated in clinical trials for the treatment of MuSK-MG 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 this patent, (ii) whether any of Catalyst's other pending patents for Firdapse® will be issued, and (iii) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2020 and Catalyst's other filings with the
David Schull Russo Partners(212) 845-4271 firstname.lastname@example.org Company Contact Patrick J. McEnany Catalyst PharmaceuticalsChief Executive Officer (305) 420-3200 email@example.com
Source: Catalyst Pharmaceuticals, Inc.