Relapsing-Remitting Multiple Sclerosis

DGAP-News: Immunic, Inc. Publishes Full Unblinded Clinical Data From Phase 2 EMPhASIS Trial of IMU-838 in Patients With Relapsing-Remitting Multiple Sclerosis and Announces Poster Presentation at the MSVirtual2020

Retrieved on: 
Friday, September 11, 2020
Fox Broadcasting Company, Metromedia, Relapsing-Remitting Multiple Sclerosis, IMU-838, Immunic, Inc.

Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurologic Institute, Cleveland Clinic, Cleveland, Ohio.

Key Points: 
  • Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurologic Institute, Cleveland Clinic, Cleveland, Ohio.
  • The poster presentation, including Dr. Fox's audio track, will be published today at 8:00 am ET in the MSVirtual2020 E-Poster Hall.
  • Dr. Fox receives compensation as a chair of the steering committee for the EMPhASIS trial.
  • As previously announced, the phase 2 EMPhASIS trial achieved all primary and key secondary endpoints.

Banner Life Sciences Announces BAFIERTAM, a Novel Oral Fumarate Treatment for Relapsing Forms of Multiple Sclerosis, is Now Available in the U.S.

Retrieved on: 
Thursday, September 3, 2020
Biotechnology, Pharmaceutical, Health, Other Health, Multiple sclerosis, Dimethyl fumarate, Fumarates, Fungicides, Monomethyl fumarate, Relapsing-Remitting Multiple Sclerosis, BAFIERTAM™ (monomethyl fumarate), Banner Life Sciences LLC

We stand ready to assist both newly diagnosed MS patients as well as those who may be considering switching from their existing therapy.

Key Points: 
  • 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.
  • In addition, Banners Patient Support Services center is available to address questions from physicians and patients from 8:30 a.m.
  • BAFIERTAM is contraindicated in patients with a known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of BAFIERTAM.

DGAP-News: Immunic, Inc. Reports Positive Top-line Data from Phase 2 EMPhASIS Trial of IMU-838 in Patients with Relapsing-Remitting Multiple Sclerosis

Retrieved on: 
Sunday, August 2, 2020
Health, Clinical research, Design of experiments, Medical research, Clinical trials, Placebo-controlled study, Tcelna, Draft:Remune™, Relapsing-Remitting Multiple Sclerosis, IMU-838, Immunic, Inc.

"Patients in the EMPhASIS trial exhibited robust responses across all study endpoints included in the top-line analysis.

Key Points: 
  • "Patients in the EMPhASIS trial exhibited robust responses across all study endpoints included in the top-line analysis.
  • The phase 2 EMPhASIS trial was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group study, designed to assess the efficacy and safety of IMU-838 in patients with RRMS.
  • All enrolled patients were required to have shown disease activity based on clinical evidence of relapse and additional MRI criteria.
  • - June 2020: Dosed the first patients in CALVID-1 clinical trial, a prospective, multicenter, randomized, placebo-controlled, double-blind phase 2 trial of IMU-838 in patients with moderate COVID-19.

Banner Life Sciences Announces Commercial Launch of BAFIERTAM, a Novel Oral Fumarate Treatment for Relapsing Forms of Multiple Sclerosis

Retrieved on: 
Thursday, July 16, 2020
Biotechnology, Pharmaceutical, Health, Other Health, Medical specialties, Immunology, Medicine, Medical emergencies, Dimethyl fumarate, Fumarates, Fungicides, Multiple sclerosis, Anaphylaxis, Angioedema, Relapsing-Remitting Multiple Sclerosis, BAFIERTAM™ (monomethyl fumarate), Banner Life Sciences LLC

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.

Key Points: 
  • 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.
  • BAFIERTAM is contraindicated in patients with known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of BAFIERTAM.
  • Anaphylaxis and Angioedema - BAFIERTAM can cause anaphylaxis and angioedema after the first dose or at any time during treatment.
  • Concomitant Dimethyl Fumarate or Diroximel Fumarate - Both dimethyl fumarate and diroximel fumarate are metabolized to monomethyl fumarate.

Banner Life Sciences Announces Final FDA Approval of BAFIERTAM for Multiple Sclerosis

Retrieved on: 
Thursday, April 30, 2020
Biotechnology, General Health, FDA, Health, Pharmaceutical, Dimethyl fumarate, Fumarates, Fungicides, Multiple sclerosis, Medical specialties, Chemistry, Monoclonal antibodies, Biology, Immunosuppressants, BAFIERTAM™ (monomethyl fumarate), Relapsing-Remitting Multiple Sclerosis, Banner Life Sciences LLC

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).

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

Banner Life Sciences Receives Favorable Appellate Court Decision in Biogen Patent Infringement Dispute

Retrieved on: 
Tuesday, April 21, 2020
Health, FDA, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Nuclear factor erythroid 2-related factor 2, Dimethyl fumarate, Relapsing-Remitting Multiple Sclerosis, BAFIERTAM™, Banner Life Sciences LLC

We are pleased with the Federal Circuits decision, said Franck Rousseau, M.D., Chief Executive Officer of Banner.

Key Points: 
  • We are pleased with the Federal Circuits decision, said Franck Rousseau, M.D., Chief Executive Officer of Banner.
  • 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.
  • 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.