Meeting to Feature Research in Multiple Sclerosis, Parkinson's
Disease and Wake-Promoting Medicine
JERUSALEM, Israel, Apr 18, 2012 (BUSINESS WIRE) --Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced new
data from the Company's expanding central nervous system (CNS) portfolio
will be featured at the 64th American Academy of Neurology (AAN) Annual
Meeting in New Orleans, LA, April 21-28, 2012. Thirty abstracts will
highlight data on multiple innovative marketed and investigational
therapies, including the market-leading treatment for
relapsing-remitting multiple sclerosis (RRMS), COPAXONE(R)
(glatiramer acetate injection); the investigational RRMS oral therapy
laquinimod; AZILECT(R) (rasagiline tablets), a MAO-B inhibitor
for the treatment of Parkinson's disease; and NUVIGIL(R)
(armodafinil) Tablets [C-IV], used to improve wakefulness in adults who
experience excessive sleepiness (ES) due to shift work disorder (SWD),
treated obstructive sleep apnea (OSA), or narcolepsy.
Featured presentations include:
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Interim data from a prospective study showing a significant reduction
in spasticity in multiple sclerosis patients who switched to COPAXONE(R)
after discontinuing interferon-beta treatment
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Study results providing data on the use of COPAXONE(R) in
clinical practice
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Pooled analyses from the two-year Phase III ALLEGRO and BRAVO studies
supporting the benefits of laquinimod in reducing annualized relapse
rates, in reducing the risk of both three-month and six-month
confirmed disability progression as well as slowing the rate of brain
volume loss.
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Additional pre-clinical data in animal model of multiple
sclerosis demonstrated that the modulation of CNS-resident cells like
astrocytes by laquinimod, is an important mechanism independent of its
effect on the peripheral immune system
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Study results demonstrating armodafinil significantly improved sleep
latency in patients experiencing excessive sleepiness associated with
mild or moderate traumatic brain injury
Platform Presentation/Poster Session Details:
COPAXONE(R)
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[P07.074] A Prospective Study of Spasticity in Individuals with
Multiple Sclerosis (MS) in Transition from Interferon-Beta to
Glatiramer Acetate (Session P07: Multiple Sclerosis: Symptoms,
April 26, 2012 at 2:00 PM CDT) Cira J. Fraser, West Long Branch, NJ
Laquinimod
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[P02.105] Laquinimod Promotes T Cell Immune Modulation in Central
Nervous System Autoimmunity Via Type II (M2) Myeloid APC (Session
P02: Multiple Sclerosis: Treatment MOA, April 24, 2012 at 7:30 AM CDT) Ulf
Schulze Topphoff, Aprana Shetty, Michel Varrin-Doyer, Nicolas
Molnarfi, Sharon Sagan, San Francisco, CA, Raymond Sobel, Palo Alto,
Patricia Nelson, Scott Zamvil, San Francisco, CA
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[S01.007] Clinical Efficacy of Laquinimod for the Treatment of
Multiple Sclerosis; Pooled Analyses from the ALLEGRO and BRAVO Phase
III Trials (Session S01: Multiple Sclerosis: Clinical Trials:
Clinical Outcomes, April 24, 2012 at 2:30 PM CDT) Timothy Vollmer,
Aurora, CO, Giancarlo Comi, Milan, Italy, Per Solberg Sorensen,
Copenhagen, Denmark, Douglas Arnold, Montreal, QC, Canada, Massimo
Filippi, Milan, Italy, Olena Statinova, Donetsk, Ukraine, Tetyana
Kobys, Dnipropetrovsk, Ukraine, Elke Becker, Berlin, Germany, Douglas
Jeffery, Advance, NC, Xavier Montalban, Barcelona, Spain, Ludwig
Kappos, Basel, Switzerland, Alexey Boyko, Moscow, Russian Federation,
Krzysztof Selmaj, Lodz, Poland, Frauke Zipp, Mainz, Germany, Eva
Havrdova, Praha 2, Czech Republic , Jeffrey Cohen, Cleveland, OH
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[P04.132] Pooled Analyses from the ALLEGRO and BRAVO Trials on the
Safety and Tolerability of Laquinimod as a Multiple Sclerosis
Treatment (Session P04: Multiple Sclerosis: Therapeutics Safety,
April 25, 2012 at 7:30 AM CDT) Giancarlo Comi, Milan, Italy,
Timothy Vollmer, Aurora, CO, Per Solberg Sorensen, Copenhagen,
Denmark, Douglas Arnold, Montreal, QC, Canada, Massimo Filippi, Milan,
Italy, Olena Statinov, Donetsk, Ukraine, Tetyana Kobys,
Dnipropetrovsk, Ukraine, Elke Becker, Berlin, Germany, Douglas
Jeffery, Advance, NC, Xavier Montalban, Barcelona, Spain, Ludwig
Kappos, Basel, Switzerland, Alexey Boyko, Moscow, Russian Federation,
Krzysztof Selmaj, Warsaw, Poland, Frauke Zipp, Mainz, Germany, Eva
Havrdova, Praha 2, Czech Republic , Jeffrey Cohen, Cleveland, OH
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[S31.002] Laquinimod Protects from Cuprizone-Induced Demyelination
through Modulation of Astrocyte Activation Via Interfering with the
NFê-B Pathway (Session S31: Multiple Sclerosis: Immunology:
Mechanism of Action, April 25, 2012 at 4:15 PM CDT) Wolfgang Bruck,
Gottingen, Germany, Gareth John, New York, NY, Ramona Pfortner,
Gottingen, Germany, Liat Hayardeny Nisimov, Victor Piryatinsky,
Netanya, Israel, Christiane Wegner, Gottingen, Germany
Armodafinil
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[P04.192] Safety, Tolerability, and Efficacy of Armodafinil Therapy
for Hypersomnia Associated with Dementia with Lewy Bodies (Session
P04: Aging and Dementia: Therapeutics, April 25, 2012 at 7:30 AM CDT) Karen
Kuntz, Bradley Boeve, Dina Drubach, Laura A. Allen, Daniel Drubach,
Rochester, MN
[P05.003] Safety and Efficacy of Armodafinil for the Treatment of
Excessive Sleepiness Associated with Mild or Moderate Closed Traumatic
Brain Injury: A 12-Week, Randomized, Double-Blind Study Followed by a
12-Month Open-Label Extension (Session P05: Sleep Disorders, April
25, 2012 at 2:00 PM CDT) Stuart Menn, Redland, CA, Craig Earl,
Ronghua Yang, Frazer, PA, Alan Lankford, Gainesville, GA
AZILECT(R)
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[S52.006] Treatment with Rasagiline Improves the Quality of Sleep
in Patients with Parkinson's Disease: Results of the Rasagiline Effect
on Sleep Trial (REST) (Session S52: Parkinson's Disease: Non-Motor
Symptoms, April 26, 2012 at 4:15 PM CDT) Michel Panisset, Sylvain
Chouinard, Montreal, QC, Canada
ABOUT COPAXONE(R)
COPAXONE(R) 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(R) 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(R) (glatiramer acetate injection) 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.
Laquinimod crosses the blood brain barrier to potentially have a direct
effect on resident CNS inflammation and neurodegeneration. The global
Phase III clinical development program evaluating oral laquinimod in MS
consists of two pivotal studies, ALLEGRO and BRAVO.
In addition to the MS clinical studies, laquinimod is currently in Phase
II development for Crohn's disease and Lupus.
ABOUT NUVIGIL(R) (armodafinil) Tablets [C-IV]
NUVIGIL(R) is indicated to improve wakefulness in patients with
excessive sleepiness associated with obstructive sleep apnea (OSA),
shift work sleep disorder, also known as shift work disorder (SWD) and
narcolepsy. In patients with OSA, NUVIGIL is used along with other
medical treatments for this sleep disorder. NUVIGIL(R) is not
approved for use in treating hypersomnia associated with dementia with
lewy bodies or excessive sleepiness associated with mild or moderate
closed traumatic brain injury. The NUVIGIL(R) label includes a
bolded warning for serious or life-threatening rash, including
Stevens-Johnson Syndrome. NUVIGIL is not approved for use in pediatric
patients for any indication.
The most common adverse events in controlled clinical trials (greater
than 5 percent) were headache, nausea, dizziness, and insomnia. Full
prescribing information for NUVIGIL(R) is available at www.NUVIGIL.com.
ABOUT AZILECT(R)
AZILECT(R) 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.
Patients should not take AZILECT(R) 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(R). Patients should not exceed a dose of 1 mg per
day of AZILECT(R) in order to prevent a possibly dangerous
increase in blood pressure.
Side effects seen with AZILECT(R) 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(R) is currently available in 40 countries, 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(R) in Europe and some additional markets with H.
Lundbeck A/S. In North America, AZILECT(R) 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.
SOURCE: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix
United
States
(215) 591-8912
or
Tomer Amitai
Israel
972
(3) 926-7656
or
PR:
Denise Bradley
United
States
(215) 591-8974
or
Shir Altay-Hagoel
Israel
972
(3) 926-7590