The U.S.-based privately held clinical-stage specialty pharmaceutical firm, Banner Life Sciences LLC, reportedly declared that its New Drug Application (NDA 505(b)(2)) for BAFIERTAM™ has been tentatively approved by the United States FDA. As per trusted sources, BAFIERTAM™ is known to be a unique fumarate bioequivalent substitute to Tecfidera® (dimethyl fumarate) of Biogen, Inc., and can be effectively utilized to treat patients with relapsing forms of multiple sclerosis.
The Chief Executive Officer of Banner Life Sciences LLC, Franck Rousseau, M.D., was reportedly quoted stating that the company is delighted to receive tentative approval of FDA and it’s a significant milestone which brings Banner Life Sciences closer to providing another treatment option to patients suffering from relapsing-remitting multiple sclerosis. Rousseau further added that Banner Life Sciences will create a commercial vehicle as it anticipates final approval and would continue to refine its strategic positioning for BAFIERTAM and develop the clinical profile of the drug.
Sources with the knowledge of the matter claim that full FDA approval is anticipated to be received following the expiration of U.S. Patent Number 7,619,001 (‘001) in June 2020. BAFIERTAM meets the required quality, efficacy, safety, and bioequivalence standards for approval. Reportedly, the approval is expected ahead of generic erosion and is likely to be fast-tracked based on the result of a pending lawsuit with Biogen pertaining to the patent.
For the record, Biogen Inc., dismissed its litigation against Banner in September 2018. Biogen had apparently claimed in the lawsuit that BAFIERTAM would infringe on Tecfidera patents 8,399,514 and 7,320,999, essentially granting Banner freedom to operate following the expiration of the ‘001 patent.
According to a report published by MPR, Tecfidera of Biogen is presently approved to treat patients with relapsing forms of multiple sclerosis. The drug has been made available in 120mg and 240mg delayed-release capsules.