Pfizer Reaches a Global Agreement with AbbVie
30 Novembre 2018 - 4:00PM
Business Wire
All Intellectual Property Matters for Pfizer’s
Proposed Adalimumab Biosimilar Resolved
Pfizer Inc. (NYSE:PFE) today announced that it has signed
licensing agreements with AbbVie, resolving all global intellectual
property matters for Pfizer’s proposed adalimumab biosimilar. Under
the terms of the agreements, AbbVie grants Pfizer a non-exclusive
patent license for the use and sale of Pfizer’s proposed adalimumab
biosimilar for many countries around the world.
Pfizer may launch its adalimumab biosimilar upon approval by the
European Medicines Agency in Europe. In the United States, the
license period will begin on November 20, 2023.
“This settlement will facilitate patient access to Pfizer’s
proposed adalimumab biosimilar which we expect to be an
important addition to our broad portfolio of biosimilar medicines,”
said Richard Blackburn, Global President, Inflammation and
Immunology at Pfizer.
All litigation pending between the parties will be withdrawn.
The financial details of the agreements are confidential.
Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
important to investors on our website at www.pfizer.com. In
addition, to learn more, please visit us on www.pfizer.com and
follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube
and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is
as of November 30, 2018. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments.
This release contains forward-looking information about Pfizer’s
proposed adalimumab biosimilar, including its potential benefits,
that involves substantial risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statements. Risks and uncertainties include, among other
things, the uncertainties inherent in research and development,
including the ability to meet anticipated clinical trial
commencement and completion dates and regulatory submission dates,
as well as the possibility of unfavorable clinical trial results,
including unfavorable new clinical data and additional analyses of
existing clinical data; the risk that clinical trial data are
subject to differing interpretations, and, even when we view data
as sufficient to support the safety and/or effectiveness of a
product candidate, regulatory authorities may not share our views
and may require additional data or may deny approval altogether;
whether regulatory authorities will be satisfied with the design of
and results from our clinical studies; whether and when drug
applications may be filed in any other jurisdictions for Pfizer’s
proposed adalimumab biosimilar; whether and when any such
applications may be approved by regulatory authorities, which will
depend on the assessment by such regulatory authorities of the
benefit-risk profile suggested by the totality the efficacy and
safety information submitted, and, if approved, whether Pfizer’s
proposed adalimumab biosimilar will be commercially successful;
decisions by regulatory authorities regarding labeling and other
matters that could affect the availability or commercial potential
of Pfizer’s proposed adalimumab biosimilar; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2017 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the
U.S. Securities and Exchange Commission and available at
www.sec.gov and www.pfizer.com.
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Media Contact:Thomas
Biegi212-733-2204Thomas.Biegi@pfizer.comorInvestor Contact:Ryan
Crowe212-733-8160Ryan.Crowe@pfizer.com
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