Zoek in het archief

Check the original
News breaking: 2017-10-04

Teva Comments on Anticipated At-Risk U.S. Launch of Generic Glatiram..

Previous Article
Teva and Nuvelution Pharma Partner to ...
Teva Comments on Anticipated At-Risk U.S. Launch of Generic Glatiramer Acetate 40mg/mL and Launch of Generic Glatiramer Acetate 20mg/mL
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
commented that any launch by Mylan of a generic version of COPAXONE®
40mg/ml (glatiramer acetate) prior to final resolution of the pending
patent appeals and other patent litigation should be considered an
“at-risk” launch, which could subject Mylan to significant damages among
other remedies. Additionally, Mylan also announced approval of a generic
glatiramer acetate 20mg/mL.
“We have planned for the eventual introduction of a generic competitor
to glatiramer acetate,” said Dr. Yitzhak Peterburg, Teva’s Interim
President and CEO. “We remain confident in patient and physician loyalty
to Teva’s COPAXONE® due to its recognized efficacy, safety
and tolerability profile, and we will continue to promote and support
the product. As we are closing the third quarter, it is too soon to
officially comment on any change to our full year business outlook.”
Two appeals will be argued before a single panel of judges of the U.S.
Court of Appeals for the Federal Circuit. In the first case, Teva is
appealing the December 2016 inter partes review decisions
of the Patent Trial Appeal Board that found all of the claims of three
COPAXONE® patents to be unpatentable. In the second case,
Teva is appealing the January 2017 decision of the U.S. District Court
for the District of Delaware, which declared certain claims of four
COPAXONE® patents invalid. The two appeals have been fully
briefed and await the scheduling of oral arguments. In additional
litigation, Teva brought suit against five Abbreviated New Drug
Application (ANDA) filers, including Mylan, for infringement of a patent
covering a manufacturing process for glatiramer acetate product.
Due to the anticipated launch of another generic 20mg glatiramer acetate
product and the anticipated launch of a first generic 40mg glatiramer
acetate product, Teva’s early assessment of the impact of these launches
to its earnings for the fourth quarter ended December 31, 2017 is that
it could be affected by at least $0.25 cents per share. These conditions
are subject to change based on the discount; adoption rate; and other
factors of the competitive products. Teva will provide additional
details on its 3rd Quarter Earnings Conference Call on
November 2, 2017.
About Teva
Teva 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 over 60 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:
Copaxone®, our leading medicine, which
faces competition from existing and potential additional generic
versions and orally-administered alternatives and the effectiveness of
our patents and other measures to protect its intellectual property
our specialty medicines business, including: our ability to achieve
expected results from investments in our product pipeline; competition
for our specialty products including competition from companies with
greater resources and capabilities; and our ability to protect our
intellectual property rights;
our generics medicines business, including: that we are
substantially more dependent on this business, with its significant
attendant risks, following our acquisition of Allergan plc’s worldwide
generic pharmaceuticals business (“Actavis Generics”); our ability to
realize the anticipated benefits of the acquisition (and any delay in
realizing those benefits) or difficulties in integrating Actavis
Generics; the increase in the number of competitors targeting generic
opportunities and seeking U.S. market exclusivity for generic versions
of significant products; price erosion relating to our generic
products, both from competing products and as a result of increased
governmental pricing pressures; and our ability to take advantage of
high-value biosimilar opportunities;
our substantially increased indebtedness and significantly
decreased cash on hand, which may limit our ability to incur
additional indebtedness, engage in additional transactions or make new
investments, and may result in a downgrade of our credit ratings;
our business and operations in general, including: uncertainties
relating to our 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
failure to recruit or retain key personnel, including those who joined
us as part of the Actavis Generics acquisition; the restructuring of
our manufacturing network, including potential related labor unrest;
the impact of continuing consolidation of our distributors and
customers; variations in patent laws that may adversely affect our
ability to manufacture our products; our ability to consummate
dispositions on terms acceptable to us; adverse effects of political
or economic instability, major hostilities or terrorism on our
significant worldwide operations; and our ability to successfully bid
for suitable acquisition targets or licensing opportunities, or to
consummate and integrate acquisitions;
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;
other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks; the
significant increase in our intangible assets, which may result in
additional substantial impairment charges; potentially significant
increases in tax liabilities; and 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;
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/20171004005789/en/
Source: Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
Mannix, United States, 215-591-8912Ran Meir, United
States, 215-591-3033Tomer Amitai, Israel, 972 (3) 926-7656orPR
Contacts:Iris Beck Codner, Israel, 972 (3) 926-7208Denise
Bradley, United States, 215-591-8974
Share on FacebookShare on LinkedIn