Teva Announces Global License Agreement with Alder BioPharmaceuticals® in the Field of Anti-CGRP-Based Therapy
08 Janvier 2018 - 2:00PM
Business Wire
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 statements.
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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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