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News breaking: 2018-01-08

Teva Announces Global License Agreement with Alder BioPharmaceutical..

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Teva Announces Global License Agreement with Alder BioPharmaceuticals® in the Field of Anti-CGRP-Based Therapy
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced that its subsidiary, Teva Pharmaceuticals International GmbH.,
has signed a global license agreement with Alder BioPharmaceuticals. The
agreement validates Teva’s IP and resolves Alder’s opposition to Teva’s
European Patent No. 1957106 B1, with respect to anti-calcitonin
gene-related peptide (CGRP) antibodies and methods for their use. It
also provides Alder with clarity for its ongoing plans in the field.
Under the terms of the agreement, Alder has received a non-exclusive
license to Teva’s anti-CGRP antibodies patent portfolio to develop,
manufacture and commercialize eptinezumab in the U.S. and worldwide,
excluding Japan and Korea. In exchange, Alder has agreed to:
Withdraw its appeal before the European Patent Office;
Make an immediate one-time payment of $25 million to Teva;
Make a second one-time payment of $25 million upon the approval of a
biologics license application (BLA) for Alder’s eptinezumab with the
U.S. Food and Drug Administration or of an earlier equivalent filing
with a regulatory authority elsewhere in the license territory in
which any Teva licensed patents exist;
Following commercial launch of eptinezumab, pay $75 million at each of
two sales-related milestones (at $1 billion and $2 billion in sales
achieved in a calendar year) and provide certain royalty payments on
net sales at rates from 5% to 7%.
“This agreement reinforces the broad coverage provided by Teva’s IP in
the field of anti-CGRP antibodies therapy. At the same time, it also
helps facilitate the ongoing development of additional potential
therapies in this exciting field – this can only be good for our
increased understanding of the area and ultimately improved patient
wellbeing”, said Marcelo Bigal, M.D., Ph.D., Chief Scientific Officer
and Head of Specialty R&D at Teva.
About TevaTeva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a leading global pharmaceutical company that delivers
high-quality, patient-centric healthcare solutions used by approximately
200 million patients in 100 markets every day. Headquartered in Israel,
Teva is the world’s largest generic medicines producer, leveraging its
portfolio of more than 1,800 molecules to produce a wide range of
generic products in nearly every therapeutic area. In specialty
medicines, Teva has the world-leading innovative treatment for multiple
sclerosis as well as late-stage development programs for other disorders
of the central nervous system, including movement disorders, migraine,
pain and neurodegenerative conditions, as well as a broad portfolio of
respiratory products. Teva is leveraging its generics and specialty
capabilities in order to seek new ways of addressing unmet patient needs
by combining drug development with devices, services and technologies.
Teva's net revenues in 2016 were $21.9 billion. For more information,
visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 which
are based on management’s current beliefs and expectations and are
subject to substantial risks and uncertainties, both known and unknown,
that could cause our future results, performance or achievements to
differ significantly from that expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to:
Our ability to defend our intellectual property rights, including
our CGRP antibodies patent portfolio;
our specialty medicines business, including: competition for our
specialty products, especially Copaxone®, our
leading medicine, which faces competition from existing and potential
additional generic versions and orally-administered alternatives; our
ability to achieve expected results from investments in our product
pipeline; competition from companies with greater resources and
capabilities; and the effectiveness of our patents, and other measures
to protect our intellectual property rights.
our business and operations in general, including: uncertainties
relating to the potential success and our ability to effectively
execute a restructuring plan; uncertainties relating to the potential
benefits and success of our new organizational structure and recent
senior management changes; our ability to develop and commercialize
additional pharmaceutical products; manufacturing or quality control
problems, which may damage our reputation for quality production and
require costly remediation; interruptions in our supply chain;
disruptions of our or third party information technology systems or
breaches of our data security; the restructuring of our manufacturing
network, including potential related labor unrest; the impact of
continuing consolidation of our distributors and customers; and
variations in patent laws that may adversely affect our ability to
manufacture our products;
compliance, regulatory and litigation matters, including: costs and
delays resulting from the extensive governmental regulation to which
we are subject; the effects of reforms in healthcare regulation and
reductions in pharmaceutical pricing, reimbursement and coverage;
potential additional adverse consequences following our resolution
with the U.S. government of our FCPA investigation; governmental
investigations into sales and marketing practices; potential liability
for sales of generic products prior to a final resolution of
outstanding patent litigation; product liability claims; increased
government scrutiny of our patent settlement agreements; failure to
comply with complex Medicare and Medicaid reporting and payment
obligations; and environmental risks;
and other factors discussed in our Annual Report on Form 20-F for the
year ended December 31, 2016 (“Annual Report”), including in the section
captioned “Risk Factors,” and in our other filings with the U.S.
Securities and Exchange Commission, which are available at www.sec.gov
and www.tevapharm.com.
Forward-looking statements speak only as of the date on which they are
made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise. You
are cautioned not to put undue reliance on these forward-looking
View source version on businesswire.com: http://www.businesswire.com/news/home/20180108005842/en/
Source: Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd.IR:United States:Kevin
C. Mannix, 215-591-8912orRan Meir, 215-591-3033orIsrael:Tomer
Amitai, 972 (3) 926-7656orPR:Israel:Iris
Beck Codner, 972 (3) 926-7208orUnited States:Kaelan
Hollon, 202-412-7076
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