Organon acquires US rights to arthritis biosimilar TOFIDENCE

Published 01/04/2025, 12:40
Organon acquires US rights to arthritis biosimilar TOFIDENCE

JERSEY CITY, N.J. - Organon (NYSE: OGN), a global healthcare company, has acquired the U.S. regulatory and commercial rights for TOFIDENCE™, a biosimilar to ACTEMRA®, from Biogen Inc. (NASDAQ: BIIB), a prominent $20 billion market cap biotechnology company currently trading near its 52-week low. According to InvestingPro analysis, Biogen appears undervalued based on its Fair Value metrics. TOFIDENCE™ is the first approved tocilizumab biosimilar in the U.S. and is designed for intravenous infusion to treat various forms of arthritis and COVID-19.

Launched in May 2024, TOFIDENCE™ is indicated for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19 in certain patients. Kevin Ali, CEO of Organon, expressed the company’s belief in the growth potential of TOFIDENCE™, citing Organon’s commercial expertise and market access capabilities.

The terms of the acquisition include an upfront payment to Biogen, with Organon taking on the responsibility to pay tiered royalty payments based on net sales and tiered annual net sales milestone payments that Biogen owed to Bio-Thera Solutions Ltd., the developer of TOFIDENCE™. Bio-Thera Solutions Ltd. will retain manufacturing rights for the product in the U.S. market. Biogen, which generated $9.7 billion in revenue over the last twelve months with a healthy 76% gross margin, maintains strong financial health according to InvestingPro metrics.

TOFIDENCE™ comes with a boxed WARNING for the risk of serious infections, which may lead to hospitalization or death, and is contraindicated in patients with known hypersensitivity to tocilizumab products. The prescribing information advises caution for patients with a history of chronic or recurrent infection and recommends monitoring for signs and symptoms of infection during and after treatment.

Organon, headquartered in Jersey City, New Jersey, has a diverse portfolio of over 70 medicines and products across women’s health, biosimilars, and established medicines. The company, which employs approximately 10,000 people, is focused on investing in innovative solutions and research to drive future growth in these areas. For detailed analysis of both companies’ financial health, growth prospects, and Fair Value estimates, investors can access comprehensive Pro Research Reports through InvestingPro, which covers over 1,400 US stocks with expert insights and actionable intelligence.

This news article is based on a press release statement and does not include any endorsements of claims or marketing promotions.

In other recent news, Biogen Inc. has announced a strategic collaboration with Stoke Therapeutics to develop and commercialize zorevunersen, a potential treatment for Dravet syndrome, outside of North America. This partnership includes a Phase 3 study scheduled to begin in 2025, with Biogen holding exclusive commercialization rights outside the U.S., Canada, and Mexico. Additionally, Biogen has signed a 15-year lease for a new global headquarters in Cambridge, Massachusetts, expected to open in 2028. This new facility aims to centralize its operations and foster innovation in life sciences.

Analyst activity has seen mixed responses to Biogen’s developments. Oppenheimer has maintained an Outperform rating with a $255 price target, citing the Stoke partnership as a strategic fit for Biogen’s focus on rare diseases. Conversely, Piper Sandler has reduced Biogen’s price target to $135, maintaining a Neutral rating due to concerns over declining revenue forecasts and competitive pressures. Bernstein SocGen also adjusted its price target to $159, reflecting a cautious outlook on Biogen’s multiple sclerosis treatments.

Biogen’s recent earnings report has influenced these analyst revisions, with attention on its financial projections and strategic initiatives. The company’s ongoing efforts to expand its pipeline and real estate footprint indicate a focus on long-term growth and innovation. Investors are closely monitoring these developments as Biogen navigates the competitive biotech landscape.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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