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Results presented from first head-to-head, open-label, study
(GLACIER) comparing the safety and tolerability of new
three-times-a-week COPAXONE® (glatiramer
acetate injection) 40 mg/mL to daily COPAXONE®
20 mg/mL
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Additional analyses from the GALA study illustrate COPAXONE®
40 mg/mL effect on relapse rates and 12-month MRI metrics
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Analyses of Phase III laquinimod studies provide additional
clinical insight
JERUSALEM--(BUSINESS WIRE)--Apr. 30, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that 14
company-sponsored COPAXONE® and laquinimod abstracts,
including three oral presentations, were highlighted at the 66th annual
American Academy of Neurology (AAN) meeting in Philadelphia, Pa. New
data presented adds to the understanding of the clinical utility of
three-times-a-week COPAXONE® 40 mg/mL and provides additional
findings on its efficacy, safety, and tolerability profile.
Results from the open-label Phase IIIb GLatiramer Acetate
low frequenCy safety and patIent ExpeRience
(GLACIER) study, comparing the safety and tolerability of new
three-times-a-week COPAXONE® 40 mg/mL to daily COPAXONE®
20 mg/mL, were presented during an oral session today by principal
investor, Dr. Jerry Wolinsky, Bartels Family and Opal C. Rankin
Professor of Neurology at The University of Texas Medical School at
Houston.
“The clinical and real-world significance of the data presented
underscore Teva’s commitment to developing solutions to address unmet
patient needs,” said Dr. Michael Hayden, president and chief scientific
officer at Teva Pharmaceutical Industries, Ltd. “Our historical
leadership, and deep understanding of MS patients' needs, keeps us at
the leading edge of MS therapy development, with a single-minded focus
on supporting the MS community in the provision of the highest standards
of care possible, now and in the future.”
Additional data presented elucidate the potential therapeutic role of
the investigational drug laquinimod in relapsing and progressive forms
of MS.
Data highlights from Teva’s MS franchise (Results available through the
AAN at http://www.abstracts2view.com/aan/sessionindex.php):
COPAXONE® (glatiramer acetate injection):
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[S31.002] GLACIER: An open-label, randomized, multicenter study to
assess safety and tolerability of glatiramer acetate 40 mg/1ml 3-times
weekly versus 20 mg/1ml daily in patients with relapsing-remitting
multiple sclerosis (Platform Session: General Neurology I,
Wednesday, April 30, 2:15 p.m.) J. Wolinsky, T. Borresen, D.
Dietrich, B. Gilder, Y. Sidi, V. Knappertz, S. Kolodny
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[S31.003] 24-Month efficacy and safety of glatiramer acetate
40mg/1ml 3-times weekly: Open-label extension study of the GALA trial
in subjects with relapsing-remitting multiple sclerosis (Platform
Session: General Neurology I, Wednesday, April 30, 2:30 p.m.) O.
Khan, P. Rieckmann, A. Boyko, K. Selmaj, H. Barkay, S. Kolodny, R.
Zivadinov
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[P1.212] Gene expression studies comparing glatiramer acetate and
proposed generics (Poster Session I: MS and CNS Inflammatory
Disease: Treatment Mechanisms of Action, Monday, April 28, 3:00
p.m.-6:30 p.m.) B. Zeskind, F. Towfic, J. Funt, K. Fowler, S.
Bakshi, E. Blaugrund, S. Kolitz, M. Artyomov, M. Hayden, I. Grossman,
L. Hayardeny, R. Schwartz
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[P3.026] Conversion of new active MRI lesions at 6 months to T1
Hypointense 'black holes' at 12 months in RRMS subjects from the GALA
study (Poster Session III: General Neurology II, Tuesday, April
29, 3:00 p.m.-6:30 p.m.) R. Zivadinov, J. Steinerman, V. Knappertz,
H. Barkay, O. Khan
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[P3.196] MRI correlates of disability: Neuroimaging substudy at 20
years in the ongoing US glatiramer acetate open-label extension study (Poster
Session III: MS and CNS Inflammatory Disease: Clinical Trials
Outcomes, Tuesday, April 29, 3:00 p.m.-6:30 p.m.) O. Khan, F. Bao,
M. Shah, G. Ramesh, C. Caon, C. Santiago, Z. Latif, R. Aronov, I. Zak,
Y. Sidi, S. Kolodny
Laquinimod:
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[S4.001] Rationale for advancing laquinimod for progressive MS:
Evidence from large clinical trials in RRMS (Platform Session: MS
and CNS Inflammatory Disease: Clinical Trials, Tuesday, April 29, 1:00
p.m.) G.Comi, M. Pia Sormani, G. Giovannoni, D. Ladkani, N. Sasson,
T. Gorfine, V. Knappertz
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[P3.195] Mediation of the effect of laquinimod on disability
progression in relapsing-remitting multiple sclerosis (RRMS) (Poster
Session III: MS and CNS Inflammatory Disease: Clinical Trials
Outcomes, Tuesday, April 29, 3:00 p.m.-6:30 p.m.) G. Comi, D.
Ladkani, T. Vollmer, M. Pia Sormani, Y. Sidi, V. Knappertz
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[P1.203] Laquinimod modulates genes encoding cell migration in
multiple sclerosis (Poster Session I: MS and CNS Inflammatory
Disease: Treatment Mechanisms of Action, Monday, April 28, 3:00
p.m.-6:30 p.m.) R. Zilkha-Falb, M. Gurevich, L. Hayardeny Nisimov,
A. Achiron
ABOUT COPAXONE®
COPAXONE® (glatiramer acetate injection) is indicated for the
treatment of patients with relapsing forms of 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: www.CopaxonePrescribingInformation.com
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.
Important Safety Information about COPAXONE®
Patients allergic to glatiramer acetate or mannitol should not take
COPAXONE®. Some patients report a short-term reaction right
after injecting COPAXONE®. This reaction can involve flushing
(feeling of warmth and/or redness), chest tightness or pain with heart
palpitations, anxiety, and trouble breathing. These symptoms generally
appear within minutes of an injection, last about 15 minutes, and go
away by themselves without further problems. During the postmarketing
period, there have been reports of patients with similar symptoms who
received emergency medical care. If symptoms become severe, patients
should call the emergency phone number in their area. Patients
should call their doctor right away if they develop hives, skin rash
with irritation, dizziness, sweating, chest pain, trouble breathing, or
severe pain at the injection site. If any of the above occurs, patients
should not give themselves any more injections until their doctor tells
them to begin again. Chest pain may occur either as part of the
immediate postinjection reaction or on its own. This pain should only
last a few minutes. Patients may experience more than one such episode,
usually beginning at least one month after starting treatment. Patients
should tell their doctor if they experience chest pain that lasts for a
long time or feels very intense. A permanent indentation under the skin
(lipoatrophy or, rarely, necrosis) at the injection site may occur, due
to local destruction of fat tissue. Patients should follow proper
injection technique and inform their doctor of any skin changes. 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. These are not all of the possible
side effects of COPAXONE®. For a complete list, patients
should ask their doctor or pharmacist. Patients should tell their doctor
about any side effects they have while taking COPAXONE®.
Patients are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
ABOUT LAQUINIMOD
Laquinimod is a once-daily oral, investigational, CNS-active
immunomodulator with a novel mechanism of action being developed for the
treatment of relapsing-remitting MS (RRMS) and progressive MS (PMS). The
global Phase III clinical development program evaluating 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 2,100
patients for up to 24 months. The primary outcome measure will be time
to confirmed disability progression as measured by the EDSS. In addition
to the MS clinical studies, studies are planned to evaluate the
efficacy, safety and tolerability of laquinimod in other
neurodegenerative diseases including Huntington’s disease.
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. Such statements 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
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential generic versions); 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 successfully
pursue and consummate suitable acquisitions or licensing opportunities;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
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 and other measures to protect the intellectual property
rights of our specialty medicines; the effects of reforms
in healthcare regulation and pharmaceutical pricing, reimbursement and
coverage; governmental investigations into sales and marketing
practices, particularly for our specialty pharmaceutical products;
uncertainties related to our recent management changes; the
effects of increased leverage and our resulting reliance on access to
the capital markets; any failure to recruit or retain executives or
other key personnel; 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
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 pharmaceutical businesses from companies with greater
resources and capabilities; decreased opportunities to obtain U.S.
market exclusivity for significant new generic products; potential
liability for sales of generic products prior to a final resolution of
outstanding patent litigation; any failures to comply with complex
Medicare and Medicaid reporting and payment obligations; the impact of
continuing consolidation of our distributors and customers; significant
impairment charges relating to intangible assets and goodwill; the
potential for significant 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 statement, whether as a result
of new information, future events or otherwise.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin
C. Mannix, 215-591-8912
or
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974
or
Nancy Leone, 215-284-0213