HIGH POINT, N.C.–(BUSINESS WIRE)–Banner Life Sciences LLC (Banner), a privately held specialty pharmaceutical company, announced today that the United States Court of Appeals for the Federal Circuit has upheld the United States District Court for the District of Delaware’s decision that Banner’s BAFIERTAM™ product does not infringe the extended portion (under the Hatch-Waxman Act) of U.S. Patent Number 7,619,001 (the “‘001 patent”) which protects Biogen’s product Tecfidera®.1
BAFIERTAM™ (monomethyl fumarate), a bioequivalent alternative to prodrug Tecfidera (dimethyl fumarate), was tentatively approved, subject to the District of Delaware’s earlier decision, by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsing forms of multiple sclerosis (MS).
“We are pleased with the Federal Circuit’s decision,” said Franck Rousseau, M.D., Chief Executive Officer of Banner. “This ruling clears the way for us to proceed with our commercial strategy and move closer to making this important medicine available to physicians and patients in the U.S.”
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) is an oral 95 mg delayed-release capsule 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