More Than 15 Clinical, Pre-Clinical and Health Economics Studies
Will Be Presented
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that
data from studies of AZILECT® (rasagiline tablets) and
Parkinson’s disease (PD) will be featured at the 16th Annual
International Congress of Parkinson’s Disease and Movement Disorders in
Dublin, Ireland, 17-21 June 2012.
More than fifteen abstracts will highlight data from ongoing and
completed studies of PD and AZILECT®, a MAO-B inhibitor for
the treatment of PD, in the areas of pre-clinical, clinical and health
economics research.
“We are proud of the variety of topics and quality of research results
that will be presented at MDS this year,” said Dr. Michael Hayden,
President of Global R&D and Chief Scientific Officer, Teva
Pharmaceutical Industries Ltd. “We are committed to ongoing
collaboration with academia, medical institutions and patient advocacy
groups to continue our understanding of the role AZILECT® may
play in the treatment landscape for the PD community – patients, their
families and friends, and healthcare professionals.”
Presentations include:
Ongoing studies assessing effects of AZILECT® treatment on
motor and non-motor PD symptoms, both as monotherapy and when added to
ongoing dopamine agonist therapy:
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[345] Evaluating the Efficacy of Rasagiline on Depressive Symptoms
and Cognition in Parkinson’s Disease Patients without Dementia: the
ACCORDO Study (Session PD Clinical Trials: 18 June 2012 at 12:45
PM IST) Paolo Barone for the ACCORDO Study Investigators, Salerno,
Italy
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[374] A Placebo-controlled, Randomized, Multicenter Study of
Rasagiline as Add-on Therapy to Dopamine Agonists for Treatment of
Early Parkinson’s Disease: the ANDANTE Study (Session PD Clinical
Trials: 18 June 2012 at 12:45 PM IST) Robert Hauser, Tampa, FL,USA;
Azhar Choudhry, Kansas City, MO, U.S.
New clinical trial results:
-
[450] A Comparative Study on Safety and Tolerability of Rasagiline
Versus Pramipexole in Early Parkinson’s Disease: the ACTOR Study
(Session PD Clinical Trials: 18 June 2012 at 12:45 PM IST) Francois
Viallet, Provence, France, Severine Pitel, Marseille, France, Sylvie
Lancrenon, Bourg la Reine, France, Oliver Blin, Marseille, France
ABOUT AZILECT®
AZILECT® tablets (rasagiline tablets) are indicated for the
treatment of the signs and symptoms of Parkinson's disease both as
initial therapy alone and to be added to levodopa later in the disease
in patients with end-of-dose fluctuations
Patients should not take AZILECT® if they are taking
meperidine, tramadol, methadone, propoxyphene, dextromethorphan, St.
John’s wort, cyclobenzaprine, or other monoamine oxidase inhibitors
(MAOIs), as it could result in a serious reaction. Patients should
inform their physician if they are taking, or planning to take, any
prescription or over-the-counter drugs, especially antidepressants and
ciprofloxacin. Patients with moderate to severe liver disease should not
take AZILECT®. Patients should not exceed a dose of 1 mg per
day of AZILECT® in order to prevent a possibly dangerous
increase in blood pressure.
Side effects seen with AZILECT® alone are flu syndrome, joint
pain, depression, and indigestion; and when taken with levodopa are
uncontrolled movements (dyskinesia), accidental injury, weight loss, low
blood pressure when standing, vomiting, anorexia, joint pain, abdominal
pain, nausea, constipation, dry mouth, rash, abnormal dreams, and fall.
See additional important information at http://www.azilect.com/Resources/PDFs/PrescribingInformation-pdf.aspx.
For hardcopy releases, please see enclosed full prescribing information.
AZILECT® is currently available in more than 40 countries
worldwide, including the U.S., Canada, Israel, Mexico, and all EU
countries. Teva has a long-term agreement for the joint development and
marketing of AZILECT® in Europe and some additional markets
with H. Lundbeck A/S. In North America, AZILECT® is marketed
by Teva's wholly-owned subsidiary, Teva Neuroscience, Inc. (www.tevaneuro.com).
ABOUT TEVA
Teva Pharmaceutical Industries Ltd. (NASDAQ: 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
largest generic drug maker, with a global product portfolio of more than
1,300 molecules and a direct presence in about 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 46,000 people around the world and reached $18.3 billion
in net revenues in 2011.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the
current beliefs and expectations of management. Such statements 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
successfully develop and commercialize additional pharmaceutical
products, the introduction of competing generic equivalents, the extent
to which we may obtain U.S. market exclusivity for certain of our new
generic products and regulatory changes that may prevent us from
utilizing exclusivity periods, potential liability for sales of generic
products prior to a final resolution of outstanding patent litigation,
including that relating to the generic version of Protonix(R), the
extent to which any manufacturing or quality control problems damage our
reputation for high quality production, the effects of competition on
sales of our innovative products, especially Copaxone(R) (including
potential generic and oral competition for Copaxone(R)), the impact of
continuing consolidation of our distributors and customers, our ability
to identify, consummate and successfully integrate acquisitions
(including the acquisition of Cephalon), interruptions in our supply
chain or problems with our information technology systems that adversely
affect our complex manufacturing processes, intense competition in our
specialty pharmaceutical businesses, any failures to comply with the
complex Medicare and Medicaid reporting and payment obligations, our
exposure to currency fluctuations and restrictions as well as credit
risks, the effects of reforms in healthcare regulation, adverse effects
of political or economical instability, major hostilities or acts of
terrorism on our significant worldwide operations, increased government
scrutiny in both the U.S. and Europe of our agreements with brand
companies, dependence on the effectiveness of our patents and other
protections for innovative products, our ability to achieve expected
results through our innovative R&D efforts, the difficulty of predicting
U.S. Food and Drug Administration, European Medicines Agency and other
regulatory authority approvals, uncertainties surrounding the
legislative and regulatory pathway for the registration and approval of
biotechnology-based products, potentially significant impairments of
intangible assets and goodwill, potential increases in tax liabilities
resulting from challenges to our intercompany arrangements, our
potential exposure to product liability claims to the extent not covered
by insurance, the termination or expiration of governmental programs or
tax benefits, current economic conditions, any failure to retain key
personnel or to attract additional executive and managerial talent,
environmental risks and other factors that are discussed in our Annual
Report on Form 20-F and other filings with the U.S. Securities and
Exchange Commission.
