HIGH POINT, N.C.--(BUSINESS WIRE)--Banner Life Sciences LLC (Banner), a privately held specialty pharmaceutical company, announced today that the U.S. District Court for the District of Delaware has ruled in favor of Banner’s motion for judgment on the pleadings against Biogen, Inc. The District Court’s decision held that Banner’s BAFIERTAMTM product does not infringe U.S. Patent Number 7,619,001 (“the ‘001 patent”) which protects Biogen’s product Tecfidera®.1
In January 2019, Banner announced that the U.S. Food and Drug Administration (FDA) had granted tentative approval of BAFIERTAM, a monomethyl fumarate (MMF)-containing product to be indicated for the treatment of patients with relapsing forms of multiple sclerosis. At that time, Banner indicated that final FDA approval was expected following the expiration of the ‘001 patent in June of 2020, but Banner also noted that BAFIERTAM might receive final approval earlier based on the outcome of pending litigation with Biogen, Inc. regarding the ‘001 patent. The Court’s decision permits Banner to seek final FDA approval.
“We are pleased by the Court’s decision,” said Franck Rousseau, M.D., Chief Executive Officer of Banner. “This ruling allows us to move forward with our goal to commercialize BAFIERTAM and bring a new treatment option to patients suffering with multiple sclerosis.”
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 percent of patients diagnosed with MS, or an estimated 2 million people worldwide.2 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.
BAFIERTAM (monomethyl fumarate) will be 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.
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 Tecfidera is a registered trademark of Biogen
2 National Multiple Sclerosis Society
SOURCE: Banner Life Sciences LLC