Biogen and Alkermes Announce FDA Approval of Vumerity (diroximel fumarate) for Relapsing Forms of Multiple Sclerosis

On November 11, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that biotechnology companies Biogen and Alkermes announced that Vumerity, a novel oral fumarate medication jointly developed by the two parties, had received FDA approval for the treatment of patients with relapsing forms of multiple sclerosis (MS).

Alkermes primarily led the development of Vumerity, while Biogen holds the exclusive global commercialization license for the drug and plans to launch it in the U.S. market shortly. As part of their collaboration agreement, Biogen will pay Alkermes $150 million. Additionally, Alkermes will receive royalties on global sales of Vumerity.

Vumerity is an immunosuppressant administered orally twice daily. It is a controlled-release prodrug of monomethyl fumarate (MMF) that is rapidly converted to MMF upon entering the body. MMF exhibits immunomodulatory, antioxidant, and neuroprotective effects, helping to protect myelin and insulate nerve fibers.

Specifically, MMF can activate the Nrf2 signaling pathway, participate in cellular oxidative stress responses, and reduce oxidative stress-induced cellular damage, thereby achieving the goal of protecting neuronal cells. Studies have found that the immunomodulatory effects of MMF may be related to the nuclear factor-kappa B (NF-κB)-mediated pathway, with NF-κB playing a key role in the immune system.

Multiple sclerosis (MS) is a common demyelinating disease of the central nervous system (CNS) and a chronic condition affecting the human CNS. During acute active phases, multiple inflammatory demyelinating plaques form in the white matter of the CNS, while older lesions develop into calcified plaques due to glial fiber proliferation. The disease is characterized by multifocal lesions, chronic neurodegeneration, and a tendency for relapse, with a predilection for the optic nerves, spinal cord, and brainstem. Relapsing-remitting MS (RRMS) is the most common subtype of MS, characterized by periodic relapses and remissions. Approximately 85% of patients are diagnosed with RRMS.

According to a report by the Institute for Clinical and Economic Review cited by The Boston Globe, Biogen has not yet disclosed the price of Vumerity, but the annual net revenue for its other multiple sclerosis (MS) treatment, Tecfidera, was $79,500 in 2018. The approval of Vumerity may provide a new treatment option for patients with relapsing forms of MS. It is believed that with the continuous advancement of medical technology, this therapy will benefit more patients.

Biogen, founded in 1978 and headquartered in Massachusetts, USA, is a biotechnology and healthcare company. The company focuses on therapeutic areas including neurological diseases, autoimmune disorders, oncology, and rare diseases, with its primary business being the development, manufacturing, and sales of biopharmaceutical products for neurological conditions. Biogen went public on the NASDAQ Stock Exchange in 1991 under the ticker symbol BIIB.

Alkermes, founded in 2011 and headquartered in Indiana, USA, is a biotechnology and pharmaceutical company. The company is dedicated to the development, manufacturing, and marketing of therapeutic drugs for chronic diseases, such as central nervous system (CNS) disorders, diabetes, and autoimmune diseases.

(Compiled by Xu Xiaoxue)