New Data Presented at ECTRIMS Reinforce Long-term Benefits of TECFIDERA® (dimethyl fumarate) Over 10 Years

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CAMBRIDGE, Mass., Sept. 11, 2019 (GLOBE NEWSWIRE) --  (Nasdaq: BIIB) announced new data to support the consistent, long-term benefits of treatment with TECFIDERA (dimethyl fumarate) over 10 years, as well as additional diroximel fumarate data that further characterize the tolerability profile of this investigational oral fumarate for relapsing multiple sclerosis (MS). These findings are being presented at the 35 Congress of the European Committee for Treatment and Research in MS (ECTRIMS) and 24 Annual Conference of Rehabilitation in MS in Stockholm (September 11-13).

“Biogen’s new data underscore TECFIDERA’s role as a meaningful long-term therapy option for relapsing MS, with many patients in the study experiencing no relapses or progression in their disability over a 10-year period,” said Alfred Sandrock, Jr., M.D., Ph.D., executive vice president and chief medical officer at Biogen. “We are proud of the strong legacy TECFIDERA has achieved over the years and are excited to continue building our franchise of fumarate products with the potential addition of diroximel fumarate. As a next-generation fumarate, diroximel fumarate offers a differentiated gastrointestinal tolerability profile and, if approved, will be a strong choice for physicians and patients with relapsing MS to consider.”

Separately, a meta-analysis of real-world evidence to compare the effectiveness of TECFIDERA versus other disease-modifying therapies for relapsing MS is also being presented. The meta-analysis analyzed data from 18 databases of large real-world studies and found that TECFIDERA was significantly more effective than interferon beta, glatiramer acetate and teriflunomide in reducing annualized relapse rate and delaying time to first relapse. TECFIDERA demonstrated comparable effectiveness to fingolimod and was less effective than natalizumab and alemtuzumab. These results are consistent with previously reported comparative effectiveness data and reinforce the strong efficacy of TECFIDERA over platform treatments across multiple data sets.

In the study, most adverse events were mild to moderate in nature. The overall rate of treatment discontinuation due to adverse events was low (7.1 percent), with less than 1 percent of patients discontinuing diroximel fumarate treatment due to gastrointestinal (GI) side effects. These data are further supportive of recently reported topline results from the elective Phase 3 EVOLVE-MS-2 study, in which diroximel fumarate demonstrated statistically superior GI tolerability compared to TECFIDERA on the study’s primary endpoint assessing self-reported GI events.

Exploratory efficacy results from EVOLVE-MS-1 suggest diroximel fumarate significantly reduced annualized relapse rate by 79.4 percent and the mean number of gadolinium-enhancing lesions by 64.3 percent from baseline to 24 months, with similar results observed in newly diagnosed patients.

TECFIDERA is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. Rare 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 TECFIDERA 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, which then plateaued, and liver function abnormalities, which resolved upon treatment discontinuation. In clinical trials, the most common adverse events associated with TECFIDERA were flushing and gastrointestinal (GI) events.

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These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation the occurrence of adverse safety events and/or unexpected concerns that may arise from additional data or analysis; risks of unexpected costs or delays; regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates, including diroximel fumarate; actual timing and content of submissions to and decisions made by the regulatory authorities regarding our drug candidates, including diroximel fumarate; regulatory submissions may take longer or be more difficult to complete than expected; the risk that we may not fully enroll our clinical trials or enrollment will take longer than expected; unexpected concerns may arise from additional data, analysis or results obtained during our clinical trials; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; uncertainty of success in the development and potential commercialization of VUMERITY; risks relating to the potential launch of VUMERITY, including preparedness of healthcare providers to treat patients, the ability to obtain and maintain adequate reimbursement for VUMERITY and other unexpected difficulties or hurdles; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this news release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

_________________________ Combined post-marketing data based on prescriptions and clinical trials exposure to TECFIDERA as of June 30, 2019.

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Globe Newswire: 10:00 GMT Wednesday 11th September 2019

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