Biogen Completes Acquisition of Reata Pharmaceuticals

• Reata acquisition bolsters Biogen's rare disease portfolio with the addition of SKYCLARYS^® (omaveloxolone), the first and only FDA approved treatment for Friedreich's ataxia in the U.S.
  
  

CAMBRIDGE, Mass., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) – has completed the acquisition of Reata Pharmaceuticals, Inc. (NASDAQ:RETA), a company focused on developing therapeutics that regulate cellular metabolism and inflammation in serious neurologic diseases. As a result of the transaction, Biogen has now acquired SKYCLARYS^® (omaveloxolone), as well as other clinical and preclinical pipeline programs.

SKYCLARYS^®, Reata Pharmaceuticals' lead asset, was approved for the treatment of Friedreich's ataxia (FA), a rare neuromuscular disorder, in the United States earlier this year. FA is genetic, progressive, life-shortening, debilitating, and degenerative, affecting an estimated 5,000 diagnosed patients within the United States¹. The commercial launch of SKYCLARYS^® is underway in the United States and European regulatory review is ongoing. As of the closing date, over 1,000 patient start forms for SKYCLARYS^® have been submitted in the United States.

"By adding a highly complementary product in an area of significant unmet medical need to our portfolio, we believe the acquisition of Reata aligns with our strategy to serve patients, drive sustainable growth and create significant shareholder value," said Christopher A. Viehbacher, President and Chief Executive Officer at Biogen. "With the transaction now complete, we look forward to leveraging Biogen's rare disease expertise and capabilities to work together with our Reata colleagues as one team to bring SKYCLARYS^® to patients living with this devastating disease."

Biogen anticipates significant synergies with its existing rare disease portfolio and plans to update its Full Year 2023 Financial Guidance in conjunction with its third quarter 2023 earnings release. The acquisition of Reata is expected to be slightly dilutive to Biogen's Non-GAAP diluted Earnings Per Share (EPS) in 2023, roughly neutral in 2024, and significantly accretive beginning in 2025, inclusive of associated transaction costs. As a result of the transaction closing, Reata's Class A common stock will no longer be listed for trading on the Nasdaq Global Market.

About SKYCLARYS^® (omaveloxolone)

SKYCLARYS^® (omaveloxolone) is an oral, 150 mg once-daily medication indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older in the United States. Additionally, the company's Marketing Authorization Application for omaveloxolone is under review in Europe by the European Medicines Agency (EMA). The European Commission has granted Orphan Drug designation in Europe to omaveloxolone for the treatment of Friedreich's ataxia.

About Biogen

Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer's disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.

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This press release contains forward-looking statements, relating to: the anticipated benefits of the Reata Pharmaceuticals acquisition, our strategy and our future financial and operating results. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "potential," "possible," "prospect," "will," "would," and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements.

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These statements speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.

References:

1. Lynch DR, et al., Safety and Efficacy of Omaveloxolone in Friedreich Ataxia (MOXIe Study). Ann Neurol. 2021 Feb;89(2):212-225. doi: 10.1002/ana.25934