HIGH POINT, N.C.--(BUSINESS WIRE)--Banner Life Sciences LLC (Banner), a privately held specialty pharmaceutical company, today announced that BAFIERTAM™ (monomethyl fumarate), a novel fumarate for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, has commercially launched and is now available in the U.S.
“The launch of BAFIERTAM is a significant milestone for Banner, but more importantly it allows us to bring a new, safe and effective medicine to patients living with relapsing MS,” said Franck Rousseau, M.D., Chief Executive Officer of Banner. “We stand ready to assist both newly diagnosed MS patients as well as those who may be considering switching from their existing therapy. Our support teams are in place to provide education and to help patients and healthcare providers navigate access and reimbursement.”
BAFIERTAM will be available through a network of specialty pharmacies. Information about BAFIERTAM for healthcare professionals, people with MS and their caregivers can be found at www.BAFIERTAM.com. Through this site, physicians can access the Patient Enrollment Form and other important resources. In addition, Banner’s Patient Support Services center is available to address questions from physicians and patients from 8:30 a.m. ET to 8:00 p.m. ET Monday thru Friday at 1-855-3BANNER (1-855-322-6637).
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.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™ (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. It is not known if BAFIERTAM is safe and effective in children.
BAFIERTAM is contraindicated in patients with a known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of BAFIERTAM. Serious side effects include anaphylaxis and angioedema, and cases of progressive multifocal leukoencephalopathy, a rare opportunistic viral infection of the brain which has been associated with death or severe disability, have been seen with dimethyl fumarate (the prodrug of BAFIERTAM) patients in the setting of prolonged lymphopenia although the role of lymphopenia in these cases is uncertain. Other serious side effects include a decrease in mean lymphocyte counts during the first year of treatment, liver injury and flushing. In clinical trials, the most common adverse events associated with dimethyl fumarate were flushing, abdominal pain, diarrhea and nausea.
Please click here for Important Safety Information and full Prescribing Information, including Patient Information for BAFIERTAM.
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.
1National Multiple Sclerosis Society