HIGH POINT, N.C.–(BUSINESS WIRE)–Banner Life Sciences LLC (Banner), a privately held specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) granted final approval of BAFIERTAM™ (monomethyl fumarate) delayed-release capsules for the treatment of relapsing forms of multiple sclerosis (MS).

“The FDA’s final approval marks an important milestone for Banner and for patients living with relapsing-remitting multiple sclerosis,” said Franck Rousseau, M.D., Chief Executive Officer of Banner. “We are working diligently and are eager to bring this alternative treatment to physicians and patients as soon as possible.”

“As a practicing neurologist treating patients with MS, I’m encouraged that a lower dose of BAFIERTAM is equivalent to Tecfidera and may possibly lead to improved gastrointestinal tolerability for patients, especially early in the treatment regimen,” said Daniel Wynn, M.D. FACNS FAASM, Director, Clinical Research, Director Consultants in Neurology Multiple Sclerosis Comprehensive Care Center, Chicago, Illinois.

The FDA granted tentative approval of BAFIERTAM on November 16, 2018 under a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway. BAFIERTAM, a novel fumarate bioequivalent alternative to a prodrug of BAFIERTAM, Tecfidera®1 (dimethyl fumarate) of Biogen Inc, met the required bioequivalence, safety, efficacy and quality standards for tentative approval. Final approval was pending the expiration of U.S. Patent Number 7,619,001 (“the ‘001 patent”) on June 20, 2020 protecting Biogen’s Tecfidera, or the outcome of pending litigation between Banner and Biogen regarding the patent.

In January 2019, Banner announced that the U.S. District Court for the District of Delaware had ruled in favor of Banner’s motion for judgment on the pleadings against Biogen, Inc. deciding BAFIERTAM does not infringe the ‘001 patent, thus permitting Banner to seek final FDA approval. On April 21, 2020, Banner announced that the United States Court of Appeals for the Federal Circuit had upheld the earlier Court’s decision.

About BAFIERTAM™ (monomethyl fumarate)

BAFIERTAM is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

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.

SELECTED SAFETY INFORMATION

CONTRAINDICATIONS

BAFIERTAM is contraindicated in patients with known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of BAFIERTAM.

WARNINGS AND PRECAUTIONS

Anaphylaxis and Angioedema – BAFIERTAM can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in patients taking dimethyl fumarate (the prodrug of BAFIERTAM) have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue BAFIERTAM and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema.

Progressive Multifocal Leukoencephalopathy – Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with dimethyl fumarate (the prodrug of BAFIERTAM).