Court Decision Invalidating AZ's Patent Supports Teva’s Launch of
DuoRespSpiromax® in UK
JERUSALEM -- (Business Wire)
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced that a
positive judgment has been given by the UK High Court in support of
Teva's case against AstraZeneca relating to the validity of EP 1,085,877
covering the SMART (Single inhaler Maintenance And Reliever
Therapy) indication for AstraZeneca's fixed dose
formoterol/budesonide combination product, Symbicort®.
The Court agreed with Teva that AstraZeneca’s patent covering the SMART
indication of Symbicort® was obvious, and rejected
AstraZeneca's proposed amendments to the patent on the basis that they
added matter. The case was brought to facilitate Teva's European launch
of its formoterol/budesonide fixed combination product, DuoRespSpiromax®
which utilizes Teva's innovative Spiromax® device technology.
“Our DuoResp Spiromax® product brings effective treatment to
the patient in a device that is intuitive and easy to use," said Rob
Koremans, MD, President and CEO, Teva Global Specialty Medicines.
“Yesterday's judgment is a big step in enabling us to make a difference
to people’s lives in the UK and all across Europe.”
This is the latest decision in Teva's favor in respect of AstraZeneca's
fixed dose, formoterol/budesonide combination product. The Teva Group
has previously successfully revoked patents EP 0,613,371 and also, EP
1,014,993, covering the use of the fixed dose combination in the
treatment of asthma and in COPD respectively, and their national
equivalents, before the European Patent Office and the Norwegian court.
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 Specialty Medicines businesses focus on CNS, respiratory,
oncology, pain, 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
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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
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the extent to which any manufacturing or quality control problems damage
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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 rightsof our specialty medicines;the
effects of reforms in healthcare regulation and pharmaceutical pricing,
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marketing practices, particularly for our specialty pharmaceutical
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effects of increased leverage and our resulting reliance on access to
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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
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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
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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
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otherwise.
Contacts:
Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
Kevin
C. Mannix, (215) 591-8912
or
United States
Ran Meir,
(215) 591-3033
or
Israel
Tomer Amitai, 972 (3)
926-7656
or
PR Contacts:
Israel
Iris Beck Codner,
972 (3) 926-7687
or
United States
Denise Bradley,
(215) 591-8974
or
United States
Nancy Leone, (215)
284-0213
Source: Teva Pharmaceutical Industries Ltd.
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