Baxter International and Coherus Biosciences said today they will develop and commercialize a biosimilar to etanercept for Europe, Canada, Brazil, and other (unspecified) markets. Baxter expects the exclusive collaboration—projected by the companies to generate up to $246 million—will speed up its expansion into the biosimilars market.
Under the agreement, Baxter will pay Coherus $30 million up front, and up to $216 million in payments tied to development and regulatory milestones, in return for Coherus carrying out development of the biosimilar. The agreement also allows the companies to develop and commercialize an alternative biosimilar to etanercept, pending the outcome of clinical data.
''The collaboration allows us to partner with a company that brings demonstrated capabilities with potential to support accelerated entry into the biosimilar market for Baxter,” Ludwig Hantson, Ph.D., president of Baxter's BioScience business, said in a statement. ''As an established biologics leader, we're looking forward to entering the market with biosimilar treatments that will broaden patient access to care.''
Etanercept, marketed as Enbrel, is a tumor necrosis factor (TNF) blocker indicated for rheumatoid arthritis, as well as for polyarticular juvenile idiopathic arthritis in patients aged 2 years or older; psoriatic arthritis; ankylosing spondylitis; and plaque psoriasis. Patents are set to expire in the European Union in 2015 and in the United States in 2019, 2023, 2028, and 2029.
Etanercept is marketed by Amgen in the United States and Canada under an agreement with Pfizer set to expire Oct. 31. Last year the drug racked up $7.963 billion in sales, including $4.236 billion by Amgen and $3.737 billion by Pfizer.
Dr. Hantson added that the Coherus collaboration, together with Baxter's ongoing relationship with Momenta Pharmaceuticals, will expand his company’s pipeline, which now includes several biosimilars in the areas of immunology and oncology.
In announcing second-quarter results on Aug. 1, Momenta said it had three biosimilars under development with Baxter—M923 and M834 (two products targeting autoimmune and inflammatory indications) and M511 (a monoclonal antibody for oncology). Momenta said it is working to achieve technical development criteria and submit an IND for M923 next year, as well as achieve development criteria that will trigger a license payment and a milestone payment for M511 and M834.
“If all these milestones are achieved, the Company would be eligible to receive an aggregate of $26 million,” Momenta stated in a 10-Q filing with the U.S. Securities and Exchange Commission dated Aug. 6.
Baxter has the right until February 2015 to select up to three additional biosimilars to be included in the collaboration.
Baxter agreed in December 2011 to pay Momenta $33 million up front toward development of up to six biosimilars, with additional payments toward development of the compounds tied to technical, development and regulatory milestones.