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Teva to Present New Research on CNS Product Portfolio and Pipeline at 2013 American Academy of Neurology Annual Meeting
JERUSALEM --(Business Wire)--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that 15
abstracts highlighting study results for Parkinson's disease (PD) and
relapsing-remitting multiple sclerosis (RRMS) will be presented during
the 65th American Academy of Neurology (AAN) annual meeting
in San Diego, Calif., March 16-23, 2013. New data for AZILECT®
(rasagiline tablets), an MAO-B inhibitor for the treatment of PD, will
be presented as part of the meeting's Emerging Science program (formerly
known as Late-Breaking Science) on Wednesday, March 20th at
5:45pm PST.
"We are pleased with the variety of topics and quality of research
results that will be presented at AAN this year," said Dr. Michael
Hayden, President of Global R&D and Chief Scientific Officer at Teva
Pharmaceutical Industries Ltd. "Teva's legacy in CNS is grounded in our
commitment to ongoing collaboration with academia, medical institutions,
and patient advocacy groups to find innovative solutions for patients
who live with chronic and debilitating diseases, such as RRMS and
Parkinson's disease."
Featured presentations include:
-
Results from a Phase IV clinical study evaluating AZILECT®
as Add on to Dopamine Agonists in
the Treatment of Parkinson's disease (ANDANTE).
-
Findings from the first year of follow-up in the Therapy Optimization
in Multiple Sclerosis (TOP MS) study, the largest
prospective Phase IV study conducted in RRMS, providing insight into
the impact of adherence to therapy, as well as data demonstrating that
more patients on COPAXONE® (glatiramer acetate) persisted
with treatment than those on beta interferon (IFN).
-
Results from the Phase III ALLEGRO study in RRMS at 36 months,
comparing the progression of disability and safety of patients treated
with laquinimod for three years (Early-Start) and in patients
originally treated with placebo in the double-blind (DB) phase and
switched to laquinimod treatment (Delayed-Start) in the open-label
(OL) phase of the ALLEGRO trial.
Platform Presentation/Poster Session Details:
AZILECT®
-
[Emerging Science Platform Session - 006] A placebo controlled,
randomized, double-blind study to assess the safety and clinical
benefit of rasagiline as an add-on therapy to dopamine agonist
monotherapy in early Parkinson's disease (PD): The ANDANTE study [Wednesday,
March 20, 2013 5:45PM] Robert A. Hauser, MD, MBA; Dee Silver, MD,
Azhar Choudhry, MD, MBA, Stuart Isaacson MD
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[P02.082] Novel Exploratory Study To Examine the Effect of
Rasagiline on Tissue Injury in the Substantia Nigra Using Multi-Modal
3T Advanced MRI Techniques in Patients with Parkinson's Disease [Session
P02, Tuesday, March 19, 2013 7:30 AM] Edwin George, Detroit, MI,
Shana Krstevska, Detroit, MI, Fen Bao, Detroit, MI, Veronica Gorden,
Detroit, MI, Carla Santiago Martinez, Detroit, MI, Natalya Shneyder,
Detroit, MI, Christina Caon, Detroit, MI, Omar Khan (News - Alert), Detroit, MI
COPAXONE®
-
[P01.193] MS Therapy Adherence and Relapse Risk [Session P06,
Monday,
March 18, 2013 2:00 PM] Bruce Cohen, Chicago, IL, Thomas Leist,
Philadelphia, PA, Patricia Coyle, Stony Brook, NY, Howard Zwibel,
Coral Gables, FL, Clyde Markowitz, Philadelphia, PA, Mark Tullman,
Saint Louis, MO
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[P03.200] MS Therapy Persistence and Treatment Patterns
[Session P03,
Tuesday, March 19, 2013 2:00 PM] Clyde
Markowitz, Philadelphia, PA, Patricia Coyle, Stony Brook, NY, Thomas
Leist, Philadelphia, PA, Bruce Cohen, Chicago, IL, Howard Zwibel,
Coral Gables, FL, Mark Tullman, Saint Louis, MO
Laquinimod
-
[S41.004] Comparison of Early and Delayed Oral Laquinimod in
Patients with Relapsing-Remitting Multiple Sclerosis: Effects on
Disability Progression at 36 months in the ALLEGRO Trial [Session
S41, Thursday, March 21, 2013 12:45 PM] Giancarlo Comi, MD,
Department of Neurology and Institute of Experimental Neurology
Università et al.
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[P05.197] Therapeutic Laquinimod Treatment Restores Axon
Myelination, Callosal Conduction and Motor Deficit in a Chronic Mouse
Model of Multiple Sclerosis [Session P05, Wednesday March 20, 2013
2:00 PM EST] Spencer Moore, Los Angeles, CA (News - Alert), Gemmy Hannsun, Los
Angeles, CA, Jane Yoon, Los Angeles, CA, Rhusheet Patel, Los Angeles,
Timothy Yoo, Los Angeles, CA, Anna Khalaj, Los Angeles, CA, Seema
Tiwari-Woodruff, Los Angeles, CA
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[P06.126] Laquinimod Treatment Reverses Cortical and Hippocampus
Pathology Due to Inflammatory Demyelination in a Chronic Mouse Model
of Multiple Sclerosis [Session P06, Thursday, March 21, 2013 7:30
AM] Anna Khalaj, Duc Nguyen, Juspreet Nakai, JaeHee Yoon, Taryn
McLaughlin, Daniel Ichwan, and Seema Tiwari-Woodruff Department of
Neurology, UCLA Shool of Medicine, Los Angeles, USA
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 Copaxone®
Copaxone® (glatiramer acetate injection) is indicated for the
reduction of the frequency of relapses in relapsing-remitting multiple
sclerosis, including patients who have experienced a first clinical
episode and have MRI features consistent with multiple sclerosis.
The most common side effects of COPAXONE® are redness, pain, swelling,
itching, or a lump at the site of injection, flushing, rash, shortness
of breath, and chest pain.
See additional important information at: http://www.sharedsolutions.com/redirect/PrescribingInformation.pdf.
For hardcopy releases, please see enclosed full prescribing information.
COPAXONE® is now approved in more than 50 countries worldwide, including
the United States, Russia, Canada, Mexico, Australia, Israel, and all
European countries.
About Laquinimod
Laquinimod is an oral, once-daily CNS-active immunomodulator with a
novel mechanism of action being developed for the treatment of MS. In
animal models, laquinimod crosses the blood-brain barrier to potentially
have a direct effect on the neurodegenerative processes of MS. The
global Phase III clinical development program evaluating oral laquinimod
in MS includes two pivotal studies, ALLEGRO and BRAVO. A third Phase III
laquinimod trial, CONCERTO, is evaluating two doses of the
investigational product (0.6mg and 1.2mg) in approximately 1,800
patients for up to 24 months. The primary outcome measure will be
confirmed disability progression as measured by the Expanded Disability
Status Scale (EDSS). In addition to the MS clinical studies, laquinimod
is currently in Phase II of development for Crohn's disease and Lupus.
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 $20.3 billion
in net revenues in 2012.
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, 2012 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.

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