Banner Life Sciences LLC (the Company or Banner), a privately held specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted tentative approval on November 16, 2018 of the Company’s New Drug Application (NDA 505(b)(2)) for BAFIERTAM™, a novel fumarate bioequivalent alternative to a prodrug of BAFIERTAM, Tecfidera® (dimethyl fumarate) of Biogen, Inc., as a treatment for patients with relapsing forms of multiple sclerosis (see also Banner Life Sciences LLC).
According to the letter, BAFIERTAM meets the required bioequivalence, safety, efficacy and quality standards for approval. At present, full FDA approval is expected following the expiration of U.S. Patent Number 7,619,001 (‘001) on June 20, 2020 and anticipated ahead of generic erosion. Approval may be accelerated based on the outcome of pending litigation with Biogen regarding this patent.
In September of 2018, Biogen Inc., dismissed its lawsuit against Banner in which Biogen had claimed BAFIERTAM would infringe on Tecfidera patents 7,320,999 and 8,399,514, thus granting Banner freedom to operate after the expiration of the ‘001 patent.
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