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New MS drug from Biogen and Alkermes wins approval

Biogen’s headquarters in Cambridge.
Biogen’s headquarters in Cambridge. John Tlumacki/Globe Staff/file

A new multiple sclerosis drug developed by Biogen and Alkermes was approved Wednesday as the companies, among the biggest biopharma employers in Massachusetts, face significant challenges.

The Food and Drug Administration approved the oral drug Vumerity to treat relapsing forms of multiple sclerosis, a serious chronic disease that affects the central nervous system. The disorder stems from overactive immune cells that cause inflammation and can result in debilitating symptoms, including difficulty walking and seeing.

Cambridge-based Biogen already markets four drugs for multiple sclerosis, including Tecfidera, which generated more than $4 billion in sales last year. But Vumerity caused fewer gastrointestinal problems than Tecfidera in clinical trials while providing comparable benefits, according to both companies.

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“It’s important for people with MS to have treatments that are both efficacious and tolerable to help manage their disease,” said Bruce Bebo, executive vice president of research for the nonprofit National Multiple Sclerosis Society.

Biogen declined to disclose a price tag for Vumerity. But if the biotech’s list prices for other multiple sclerosis drugs are any indication, Vumerity won’t be cheap.

Tecfidera’s annual net price at the end of 2018, after rebates and discounts, was $79,500, according to a Boston drug-pricing watchdog group, the Institute for Clinical and Economic Review, or ICER.

The price for a single 240-milligram pill rose by about 10 percent in 2017 and 2018, increasing to $109 from $99 and raising overall health care costs by $313 million, according to a recent report by the watchdog group. ICER said Tecfidera’s benefits to patients didn’t warrant the price increase.

Brian Skorney, an analyst with Baird in New York, said Biogen’s multiple sclerosis franchises are the mainstay of its business. The biotech, he said, was largely motivated to get Vumerity approved because Tecfidera is scheduled to lose patent protection by 2028 and go generic — and potentially years before that if competing drug makers win patent challenges.

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Skorney said Vumerity is similar to Tecfidera and that Biogen hopes to shift patients to the newer drug by underscoring that it causes fewer gastrointestinal problems.

“The verdict is really out on whether they will be able to convert patients from Tecfidera to Vumerity,” he said.

Biogen holds the exclusive worldwide license to market Vumerity and plans to make it available in the United States soon. Under the terms of the license and collaboration agreement between Biogen and Alkermes, Biogen will pay Alkermes $150 million in connection with Wednesday’s approval. Alkermes is also entitled to receive a royalty on global sales.

Biogen, which ranked as the third-biggest biopharma employer in Massachusetts in a report by the Massachusetts Biotechnology Council in August, with 2,400 employees, suffered a devastating setback this year in its effort to treat another neurological disorder: Alzheimer’s disease.

In March, Biogen announced that it was abandoning tests on a closely watched Alzheimer’s drug, aducanumab, based on the recommendations of an independent monitoring board entrusted to protect patients in the study. Biogen and its Japanese partner Eisai said the compound was unlikely to help patients.

Biogen’s stock plunged, and the company lost a staggering $18 billion the day of the announcement.

Then last week, Biogen stunned the drug industry when it said it would revive the Alzheimer’s medicine and seek FDA approval based on a new analysis of data results. Several stock analysts were deeply skeptical, with Skorney e-mailing investors a report headlined “If You Torture the Data Long Enough, It Will Confess to Anything.”

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Alkermes, which is headquartered in Dublin but has research and development operations in Waltham, has also had setbacks lately.

In February, the FDA declined to approve Alkermes’s opioid-based depression drug, citing a need for additional data to prove it was effective. Last week, Richard Pops, the longtime chief executive of Alkermes, said the company was undertaking a restructuring to save about $150 million and planned to cut 160 jobs, mostly in Waltham, where it had more than 800 employees.

Alkermes employs about 2,400 people worldwide, a spokesman said, and was ranked the 13th-biggest biopharma employer in Massachusetts this year by MassBio.


Jonathan Saltzman can be reached at jsaltzman@globe.com.