JERUSALEM--(BUSINESS WIRE)--Mar. 31, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced
that the U.S. Supreme Court has granted the Company’s COPAXONE®
certiorari petition and will hear its appeal of a decision from
the United States Court of Appeals for the Federal Circuit that
invalidated the claim of U.S. Patent 5,800,808 (the “’808 patent”). The
808 patent expires on September 1, 2015 and claims a process for
manufacturing the active ingredient of Teva’s relapsing-remitting
multiple sclerosis (RRMS) product, COPAXONE® (glatiramer acetate
injection) 20mg/mL. Teva is pleased that the Court has agreed to hear
its appeal and Teva remains committed to pursuing all options to protect
its intellectual property for COPAXONE®.
Teva previously prevailed in the District Court regarding nine COPAXONE®
patents, including the ‘808 patent. A ruling last year by the U.S. Court
of Appeals for the Federal Circuit upheld some of the COPAXONE®
patents that expire in May 2014, while invalidating the ‘808 patent that
is the subject of Teva’s now-granted certiorari petition.
Any purported generic version of COPAXONE® would be required
to obtain the Food and Drug Administration’s (FDA’s) approval prior to
being made available to the public. The inability to fully characterize
the active ingredients of the product leads many experts to believe that
the only way to ensure the safety, efficacy and immunogenicity of any
purported generic version of COPAXONE® would be through
full-scale, placebo-controlled clinical trials with measured clinical
endpoints (such as relapse rate) in RRMS patients.
The Company is confident COPAXONE® will remain a proprietary,
global market leading product for the reduction in the frequency of
relapses in RRMS patients over the product’s lifecycle, given the
strength of its intellectual property (IP) rights.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in approximately 60 countries.
Teva's branded businesses focus on CNS, oncology, pain, respiratory and
women's health therapeutic areas as well as biologics. Teva currently
employs approximately 45,000 people around the world and reached $20.3
billion in net revenues in 2013.
Safe Harbor Statement under the U.S. Private Securities Litigation
Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements 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
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially COPAXONE®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents); the possibility of
material fines, penalties and other sanctions and other adverse
consequences arising out of our ongoing FCPA investigations and related
matters; our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent and
during the timeframe intended by our cost reduction program; our ability
to identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; increased government scrutiny in both the U.S. and Europe
of our patent settlement agreements; our exposure to currency
fluctuations and restrictions as well as credit risks; the effectiveness
of our patents, confidentiality agreements and other measures to protect
the intellectual property rights of our specialty medicines; the
effects of reforms in healthcare regulation and pharmaceutical pricing,
reimbursement and coverage; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; uncertainties related to our recent management changes; the
effects of increased leverage and our resulting reliance on access to
the capital markets; any failure to recruit or retain key personnel, or
to attract additional executive and managerial talent; adverse effects
of political or economical instability, major hostilities or acts of
terrorism on our significant worldwide operations; interruptions in our
supply chain or problems with internal or third-party information
technology systems that adversely affect our complex manufacturing
processes; significant disruptions of our information technology systems
or breaches of our data security; competition for our generic
products, both from other pharmaceutical companies and as a result of
increased governmental pricing pressures; competition for our specialty
pharmaceutical businesses from companies with greater resources and
capabilities; decreased opportunities to obtain U.S. market exclusivity
for significant new generic products; potential liability in the U.S.,
Europe and other markets for sales of generic products prior to a final
resolution of outstanding patent litigation; any failures to comply with
complex Medicare and Medicaid reporting and payment obligations; the
impact of continuing consolidation of our distributors and customers;
significant impairment charges relating to intangible assets and
goodwill; potentially significant increases in tax liabilities; the
effect on our overall effective tax rate of the termination or
expiration of governmental programs or tax benefits, or of a change in
our business; variations in patent laws that may adversely affect our
ability to manufacture our products in the most efficient manner;
environmental risks; and other factors that are discussed in our Annual
Report on Form 20-F for the year ended December 31, 2013 and in our
other filings with the U.S. Securities and Exchange Commission.
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
statement, whether as a result of new information, future events or
otherwise.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix
United
States
215-591-8912
or
Ran Meir
United States
215-591-3033
or
Tomer
Amitai
Israel
972 (3) 926-7656
or
PR:
Iris
Beck Codner
Israel
972 (3) 926-7687
or
Denise
Bradley
United States
215-591-8974
or
Nancy
Leone
United States
215-284-0213