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.
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1
National Multiple Sclerosis Society
2 https://www.tecfidera.com
