Teva Comments on Anticipated At-Risk U.S. Launch of Generic Glatiramer Acetate 40mg/mL & Launch of Generic Glatiramer Acetate...
October 04 2017 - 9:26AM
Business Wire
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 rights;
- 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 statements.
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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
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