Coherus BioSciences Regains Development and Commercial Rights to CHS-0214 From Shire
September 27 2016 - 8:00AM
Coherus BioSciences, Inc. (Nasdaq:CHRS) today announced that it has
regained from Shire plc all development and commercial rights
previously licensed for CHS-0214 etanercept, a biosimilar candidate
to Enbrel®, for Europe, Canada, Brazil, the Middle East and other
territories. Reconveyance of CHS-0214 rights to Coherus
results from Shire’s strategic portfolio review, following its June
2016 acquisition of Baxalta Incorporated, and includes no present
or future payments from Coherus.
“Good companies properly exercise discipline around their chosen
strategic focus, and we are very grateful to our colleagues at
Baxalta and Shire for their assistance in advancing the CHS-0214
Enbrel biosimilar program,” said Denny Lanfear, President and CEO
of Coherus BioSciences. “These reacquired geographical rights fit
well with our existing U.S. CHS-0214 rights, and we now have the
opportunity to license throughout Europe, U.S. and other key
commercial geographies two complimentary Anti-TNF assets— CHS-0214,
an Enbrel® biosimilar candidate and CHS-1420, a Humira® biosimilar
candidate. We remain on track for submission of a CHS-0214
Marketing Authorization Application (MAA) to the European Medicines
Agency in the fourth quarter of 2016.”
As of June 30, 2016, Coherus’ condensed consolidated balance
sheet reflected deferred revenue of $85.8 million and $76.8 million
for a contingent payment in the event Coherus commercially launched
CHS-0214 in the United States under the Shire collaboration.
As a result of the termination agreement with Shire, Coherus
expects to recognize the $162.6 million as collaboration and
license revenues in 2016.
About CHS-0214 CHS-0214 has successfully
completed two Phase 3 studies, one in chronic plaque psoriasis,
data released in November 2015, and one in rheumatoid arthritis,
data released in January 2016. Data from these Phase 3
studies as well as two pivotal clinical pharmacokinetic studies
will support the MAA. Coherus has partnered with Daiichi
Sankyo for the development and commercialization of CHS-0214 in
Japan.
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 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 including market opportunities,
expectations, goals, objectives, strategies, product pipeline,
clinical studies, product development, 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 license its Anti-TNF assets, CHS-1420 and CHS-0214. 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, 2016, filed with
the Securities and Exchange Commission on August 9, 2016 and its
future periodic reports to be filed with the Securities and
Exchange Commission.
Enbrel® is a registered trademark of Amgen, Inc.
Humira® is a registered trademark of AbbVie, Inc.
Contact:
Patrick O’Brien
Senior Vice President, Investor Relations
Coherus BioSciences, Inc.
pobrien@coherus.com
+1 (650) 649-3527
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