Catalyst Pharmaceuticals, Inc. a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, announced that the United States Patent and Trademark Office (USPTO) has issued a new U.S. patent to Catalyst Pharmaceuticals for Firdapse® (amifampridine), U.S. Patent No. 10,793,893, Methods of Administering 3,4-Diaminopyridine, expiring April 7, 2034.
"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 Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst. Mr. McEnany added, "We remain committed to serving the neuromuscular community by continuing to investigate Firdapse® for other rare neurodegenerative diseases. We also look forward to results from various investigator-sponsored trials that, if positive, will strengthen the value proposition for the use of Firdapse®.”
“This patent is directed to innovative methods of administering amifampridine to slow metabolizers of amifampridine,” commented Steven Miller, Ph.D., Chief Operating Officer and Chief Scientific Officer of Catalyst. Dr. Miller added, “Within the next few days, we intend to submit a request to the FDA that this patent be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the FDA’s Orange Book), which is published by the United States Food and Drug Administration.”
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 4/7/2034 could possibly infringe this patent. Generic drug product labels would necessarily have to do this, and Catalyst would take appropriate action to protect its intellectual property.
Zydus Cadila, a global innovation driven healthcare company, announced that it is launching Forglyn pMDI, India’s first pressurized Metered Dose Inhaler (pMDI) with a combination of Long Acting Muscarinic Antagonist (LAMA) and Long Acting Beta Agonist (LABA) for patients suffering from Chronic Obstructive Pulmonary Disease (COPD) in India. Forglyn pMDI is priced at Rs. 495 per pack and has been developed in-house using Zydus’ innovations in formulation technology. The administration of the two drugs Formoterol fumarate (LABA) + Glycopyrrolate (LAMA) in a single inhalation will improve outcomes due to the desired synergistic effect of the two drugs and a better adherence to the treatment.
COPD is a common respiratory disorder characterized by progressive airflow obstruction due to alveolar and bronchial abnormalities and inflammation caused by exposure to noxious substances. A highly debilitating disease, COPD impacts the normal daily activities and limits the quality of life. The disease is progressive in nature and can sometimes worsen due to sudden exacerbations, leading to significant disability and death. COPD is the third leading cause of death worldwide and in India an estimated 55.3 million patients suffer from COPD.
Speaking on the development, Managing Director, Cadila Healthcare Ltd., Dr. Sharvil Patel said, “Our focus has always been on helping people lead a better quality of life and making therapies accessible and affordable to people. Our innovations have brought in next-generation therapies in respiratory, women’s healthcare, cardio-metabolic disorders, gastrointestinal and pain management segments. With this new technology, we hope to bring much relief to patients suffering from COPD and help them improve their health and quality of life.”
The novel process for Forglyn pMDI developed at the group’s Pharmaceutical Technology Center, ensures that delivery of the two drugs administered simultaneously through the inhaler are consistent and uniform which is critical for inhalation products. The process technology employed for the manufacturing of this product is simple, affordable and scalable. The Company has also filed a patent application for the novel process of this product.
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