JERUSALEM--(BUSINESS WIRE)--Feb. 5, 2013--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today
enrollment of the first patient in the MODERATO study – a Phase IV
clinical study designed to evaluate the effect of AZILECT®
(rasagiline tablets) on cognitive function in adults with mild cognitive
impairment (MCI) in Parkinson's disease (PD-MCI).
“Cognitive impairment in PD is a major cause of disability and increased
care partner burden,” said Robert A. Hauser, M.D., M.B.A., Director,
Parkinson's Disease & Movement Disorders Center at the University of
South Florida and co-primary investigator of the study. “As currently
there are no available treatments for cognitive impairment in
Parkinson's disease, any therapy that may demonstrate benefit would be
welcomed for this significant unmet need.”
The MODERATO study (Multicenter, Randomized, Double-Blind,
Placebo-Controlled Study to Assess the Effect of Rasagiline
on Cognition in Patients with Parkinson’s disease) is the
largest trial to-date to evaluate a treatment for PD-MCI. The
multicenter study will evaluate the effect of rasagiline on cognitive
function in adults with PD-MCI, as assessed by the Scales for Outcomes
of Parkinson's Disease-Cognition (SCOPA-COG) after 24 weeks of treatment
and will enroll approximately 170 patients at 30 sites across the United
States.
“PD-MCI is common in non-demented PD patients and is associated with
increasing age, disease duration and disease severity,” said Michael
Hayden, M.D., President of Global R&D and Chief Scientific Officer for
Teva Pharmaceutical Industries, Ltd. “MODERATO demonstrates Teva's
ongoing commitment to research with AZILECT and the development of
products aimed at meeting the specific needs of the CNS community.”
PD is a slowly progressing degenerative disorder of the brain,
characterized by tremor, stiffness, slowness of movement, and impaired
balance. An estimated five million people worldwide suffer from the
disease, with an average age of onset of about 60 years.
About AZILECT®
AZILECT® (rasagiline tablets) is indicated for the treatment
of the signs and symptoms of Parkinson's disease (PD) both as initial
therapy alone and to be added to levodopa later in the disease.
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. (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 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, including statements relating to the results
of the GALA phase III trial and the potential efficacy or future market
or marketability of glatiramer acetate 40 mg/1 ml. Following further
analysis, Teva's interpretation of the results could differ materially
depending on a number of factors, and we caution investors not to place
undue reliance on the forward-looking statements contained in this press
release as there can be no guarantee that the results from the phase III
trial discussed in this press release will be confirmed upon full
analysis of the results of the trial and additional information relating
to the safety, efficacy or tolerability of glatiramer acetate 40 mg/1 ml
may be discovered upon further analysis of data from the phase III
trial. Even if the results described in this release are confirmed upon
full analysis of the GALA study, we cannot guarantee that glatiramer
acetate 40 mg/1 ml will be approved for marketing in a timely manner, if
at all, by regulatory authorities in the EU or in the U.S. 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 innovative
orally-administered alternatives, as well as from potential generic
equivalents), competition for our generic products (including from other
pharmaceutical companies and as a result of increased governmental
pricing pressures), competition for our specialty pharmaceutical
businesses, our ability to achieve expected results through our
innovative R&D efforts, the effectiveness of our patents and other
protections for innovative products, decreasing opportunities to obtain
U.S. market exclusivity for significant new generic products, our
ability to identify, consummate and successfully integrate acquisitions
(including the acquisition of Cephalon), the effects of increased
leverage as a result of the acquisition of Cephalon, the extent to which
any manufacturing or quality control problems damage our reputation for
high quality production and require costly remediation, our potential
exposure to product liability claims to the extent not covered by
insurance, increased government scrutiny in both the U.S. and Europe of
our agreements with brand companies, 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®,
our exposure to currency fluctuations and restrictions as well as credit
risks, the effects of reforms in healthcare regulation and
pharmaceutical pricing and reimbursement, any failures to comply with
complex Medicare and Medicaid reporting and payment obligations,
governmental investigations into sales and marketing practices
(particularly for our specialty pharmaceutical products), uncertainties
surrounding the legislative and regulatory pathway for the registration
and approval of biotechnology-based products, 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 our information technology systems that
adversely affect our complex manufacturing processes, any failure to
retain key personnel (including Cephalon employees) or to attract
additional executive and managerial talent, the impact of continuing
consolidation of our distributors and customers, variations in patent
laws that may adversely affect our ability to manufacture our products
in the most efficient manner, potentially significant impairments of
intangible assets and goodwill, potential increases in tax liabilities,
the termination or expiration of governmental programs or tax benefits,
environmental risks and other factors that are discussed in our Annual
Report on Form 20-F for the year ended December 31, 2011 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 the Company undertakes 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.
IR:
United States
Kevin C. Mannix, (215) 591-8912
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR:
Israel
Hadar
Vismunski-Weinberg, 972 (3) 926-7687
or
United States
Denise
Bradley, (215) 591-8974