Banner Receives FDA Tentative Approval for BAFIERTAM for the Treatment of Relapsing Forms of Multiple Sclerosis

HIGH POINT, N.C.--(BUSINESS WIRE)-- Banner Life Sciences LLC (the Company or Banner), a privately held specialty pharmaceutical company, announced today 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.

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.

“We are very pleased with the FDA’s tentative approval and this important milestone brings us one step closer to providing another treatment option to patients living with relapsing-remitting multiple sclerosis,” said Franck Rousseau, M.D., Chief Executive Officer of Banner Life Sciences LLC. “In anticipation of final approval, we will establish our commercial vehicle, continue developing the clinical profile of BAFIERTAM and refine our strategic positioning for this important drug.”

About Relapsing-Remitting Multiple Sclerosis
Relapsing-remitting multiple sclerosis (RRMS), the most common form of MS, is a debilitating autoimmune disease characterized by inflammatory attacks to the central nervous system followed by periods of remission. RRMS affects approximately 85 per cent of patients diagnosed with MS, or an estimated 2 million people worldwide.¹ There is no cure for MS and disease progression and degree of impairment vary widely by patient depending on the location and extent of nerve damage. Treatment regimens for RRMS focus on symptom management, slowing disease progression and reducing relapses.

About BAFIERTAM™
BAFIERTAM, a novel fumarate, is indicated for the treatment of patients with relapsing forms of multiple sclerosis. While BAFIERTAM has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, the precise mechanism of action has not been fully elucidated. The prodrug of BAFIERTAM was shown in two separate studies to reduce the risk of relapse by 49% and 34%, and to reduce the number of relapses by 53% and 44%, compared to placebo. ²

About Banner Life Sciences LLC
Banner Life Sciences LLC, a privately held clinical-stage pharmaceutical company, combines a proven history of formulation expertise with proprietary technologies to create specialty pharmaceuticals that solve real unmet clinical needs.

^{______________________________________
1} National Multiple Sclerosis Society
² https://www.tecfidera.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20190102005088/en/