Florida based biopharma firm Catalyst Pharmaceuticals Inc. has recently announced that it has signed a definitive agreement with Endo Ventures Limited, a subsidiary of Endo International plc (ENDP). Apparently, this move is focused on further developing and commercializing generic Sabril (vigabatrin) tablets through the U.S. Generic Pharmaceuticals segment of Endo.
According to a press release by Catalyst Pharmaceuticals, it would be receiving an up-front payment as well as milestone payments depending on the achievement of regulatory approvals, as per the agreement, along with a sharing of defined net profits upon commercialization.
Catalyst Pharmaceuticals’ Chairman and Chief Executive Officer, Patrick J. McEnany, was quoted saying that by working with Endo, the company would be bringing generic Sabril® tablets to the market. He stated that in the generic vigabatrin marketplace, Endo is an established leader.
McEnany further mentioned that the company’s search for an appropriate partner to develop this product was long but rewarding with this deal. Catalyst Pharmaceuticals looks forward to bringing this important medication to the market for improving the lives of patients, he added.
Brandon Rockwell, Endo’s Senior Vice President, Business Development and Strategy, said in a statement that the current powder vigabatrin offering of the company would be complemented with the generic vigabatrin tablets. This would further expand the number of patients that would be benefitted from having access to a high-quality, generic vigabatrin option.
For the record, Catalysts Pharmaceuticals is focused on the development and commercialization of innovative therapies for patients with rare debilitating, chronic neurological and neuromuscular diseases. These include spinal muscular atrophy (SMA) type 3, MuSK antibody positive myasthenia gravis (MuSK-MG), congenital myasthenic syndromes (CMS) and Lambert-Eaton Myasthenic Syndrome (LEMS).
The new drug application for Firdapse (amifampridine) 10 mg tablets from Catalyst for treating adults with LEMS was purportedly approved by the U.S. Food & Drug Administration (FDA) recently, and Firdapse is predicted to be available in the U.S. for commercial use by first quarter of 2019.