Banner Life Sciences LLC , a privately held specialty pharmaceutical company, revealed on Wednesday that it has received tentative approval from the US Food and Drug Administration (FDA) for its 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.

BAFIERTAM is intended for the treatment of patients with relapsing forms of multiple sclerosis (RRMS) and according to the the FDA notification, granted on 16 November 2018, BAFIERTAM meets the required bioequivalence, safety, efficacy and quality standards for approval.

The company said it currently expects full FDA approval on 20 June 2020, following the expiration of US Patent Number 7,619,001 ('001). It added that 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.

According to Banner, relapsing-remitting multiple sclerosis (RRMS), the most common form of MS, is a debilitating autoimmune disease characterised by inflammatory attacks to the central nervous system followed by periods of remission. RRMS affects around 85% of patients diagnosed with MS, or an estimated two million people worldwide. Currently, 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.