Coherus BioSciences Completes Patent Dance Exchange with Amgen for Neulasta Biosimilar
April 25 2017 - 08:30AM
Coherus BioSciences, Inc. (Nasdaq:CHRS), announced today that it
completed the initial phases of the Biologics Price Competition and
Innovation Act (BPCIA) patent exchange procedure with Amgen for
Coherus’ Neulasta (pegfilgrastim) biosimilar candidate,
CHS-1701. Of the two patents originally listed by Amgen in
the process, the parties have reached agreement on a single patent
for potential litigation, U.S. patent 8,273,707 (the ‘707 patent),
directed to a method for purifying the product.
Under the provisions of the BPCIA patent dance,
Amgen is subject to a 30-day deadline, expiring on May 11, 2017, to
file a patent infringement suit against Coherus under the ‘707
patent. Failure to do so will result in Amgen’s loss of
injunctive rights under the patent, limiting any potential recovery
to monetary damages. Litigation has not yet been initiated.
“We are confident a court will conclude that our
CHS-1701 manufacturing process does not infringe the ‘707 patent,”
stated Denny Lanfear, President and CEO of Coherus, further adding
“aside from its lack of any relevance to our process, there are
also serious questions regarding the validity of this patent. We
are well prepared for the possibility that Amgen may decide to
assert the ‘707 patent against us and will defend any such suit
vigorously.”
Mr. Lanfear continued, “Coherus remains
committed to its mission of bringing the highest quality biosimilar
drugs to the marketplace. We are confident that we will prevail and
achieve our goals of increasing patient access and introducing
competition by offering biosimilar products at prices competitive
with and lower than those maintained by originator companies,
thereby delivering savings that are much-needed for new
therapies.”
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.
Forward-Looking StatementsExcept for the
historical information contained herein, the matters set forth in
this press release, including statements regarding Coherus’ plans,
potential opportunities, expectations, projections, goals,
objectives, milestones, strategies, product pipeline, clinical
studies, product development, release of data and the potential
benefits of its products under development are forward-looking
statements within the meaning of the "safe harbor" provisions of
the Private Securities Litigation Reform Act of 1995, including
Coherus’ ability to prevail against Amgen’s allegations and to
commercialize CHS-1701. 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 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-K for the year ended December 31, 2016, filed
with the Securities and Exchange Commission on March 13, 2017 and
its future periodic reports to be filed with the Securities and
Exchange Commission.
Neulasta® is a registered trademark of Amgen Inc.
CONTACT:
Patrick O’Brien
Senior Vice President, Investor Relations
Coherus BioSciences, Inc.
pobrien@coherus.com
+1 (650) 649-3527
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