Redwood City, CA (GLOBE NEWSWIRE) - Coherus BioSciences, Inc. (Nasdaq:CHRS), today announced that it has filed a petition for Inter Partes Review (“IPR”) in the United States Patent and Trademark Office seeking invalidation of U.S. Patent 8,163,522 (“ ‘522 patent”). The ‘522 patent, controlled by Amgen, is generally directed to a method for making etanercept, the pharmaceutically active component of ENBREL®. Coherus also announced its intention to file an IPR in the near future seeking invalidation of related U.S. Patent 8,063,182 (“ ‘182 patent”), also controlled by Amgen and generally directed to the etanercept protein.
Dennis M. Lanfear, President and CEO of Coherus noted, “The ‘182 and ‘522 patents do not expire until 2028 and 2029. This could result in over 30 years of patent coverage for Enbrel.” Mr. Lanfear added, “We believe this is an anti-competitive and unjustified distortion in our patent system that threatens to inflict another dozen years of massive costs on the healthcare system given Amgen’s history of substantial price increases for this drug which already total over 400% since launch.” Mr. Lanfear further added, “Fortunately, there are compelling grounds why these patents should never have issued, and we are advancing these arguments in both the ‘522 IPR, filed today, and the ‘182 IPR which will follow shortly. Biosimilars are an essential drug cost control mechanism for the healthcare system, and challenging these patents in IPR aligns with our decision to refocus the priorities of our etanercept biosimilar program, CHS-0214, on the potential U.S. opportunity, delivering much needed savings.”
About Coherus BioSciences, Inc.
Coherus is a leading pure-play, global biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales & marketing and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis. For additional information, please visit www.coherus.com.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Coherus’ plans, potential opportunities including market opportunities, goals, objectives, strategies, product pipelineare forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including Coherus’ ability to invalidate the ‘522 or the ‘182 patents as a result of its IPR petitions. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of our regulatory filings and other matters that could affect the availability or commercial potential of our biosimilar drug candidates, as well as possible patent litigation. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, filed with the Securities and Exchange Commission on August 7, 2017 and its future periodic reports to be filed with the Securities and Exchange Commission.
ENBREL® is a registered trademark of Immunex Corporation.
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SOURCE: Coherus BioSciences, Inc.