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GALA open-label extension study results expound upon effects of
COPAXONE® 40 mg/mL
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Study design detailed for ARPEGGIO, Phase II evaluation of
laquinimod in primary-progressive multiple sclerosis (PPMS)
JERUSALEM--(BUSINESS WIRE)--Apr. 13, 2015--
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced that
data on COPAXONE® (glatiramer acetate injection), a product
for relapsing forms of multiple sclerosis (MS), and laquinimod, an
investigational therapy under development for relapsing and progressive
forms of MS, will be presented at the American Academy of Neurology
(AAN) Annual Meeting in Washington, D.C., April 18-25, 2015.
“For more than 30 years, Teva has demonstrated its dedication to
patients with unmet needs in MS,” said Michael Hayden, MD, PhD,
President of Global R&D and Chief Scientific Officer at Teva. “We look
forward to the opportunity to showcase our steadfast progress towards
our MS franchise and to present data that underscores our position as a
world leader in MS.”
Teva-sponsored data to be presented include:
COPAXONE® (glatiramer acetate injection):
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[P7.273] Efficacy and safety of a three-times weekly dosing regimen
of glatiramer acetate in relapsing-remitting multiple sclerosis
patients: 3-year results of the Glatiramer Acetate Low-frequency
Administration (GALA) open-label extension study (Poster Session
7, April 23, 2015, 2:00PM-6:30PM) O. Khan, P. Rieckmann, A. Boyko,
K. Selmaj, N. Ashtamker, M. D. Davis, S. Kolodny, R. Zivadinov
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[P7.255] MRI indicators of brain tissue loss: 3-year results of the
Glatiramer Acetate Low-frequency Administration (GALA) open-label
extension study in relapsing-remitting multiple sclerosis (Poster
Session 7, April 23, 2015, 2:00PM-6:30PM) R. Zivadinov, M. Dwyer,
N. Bergsland, D. Ramasamy, E. Carl, M. Davis, J. Steinerman, O. Khan
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[P7.218] Patient experience with glatiramer acetate 40 mg/1 mL
three-times weekly treatment for relapsing-remitting multiple
sclerosis: Results from the GLACIER extension study (Poster
Session 7, April 23, 2015, 2:00PM-6:30PM) D. Wynn, S. Kolodny, S.
Rubinchick, J. R. Steinerman, V. Knappertz, J. Wolinsky
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[P2.192] Selective depletion of T regulatory cells reduces but does
not eliminate the ability of glatiramer acetate to ameliorate
experimental autoimmune encephalomyelitis (Poster Session 2, April
21, 2015, 7:30AM-12:00PM) R. Aharoni, T. Feferman, G. Shakhar, M.
Sela, R. Arnon
Laquinimod:
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[P7.210] ARPEGGIO: A randomized, placebo-controlled study to
evaluate oral laquinimod in patients with primary progressive multiple
sclerosis (PPMS) (Poster Session 7, April 23, 2015, 2:00PM-6:30PM) G.
Giovannoni, H. P. Hartung, B. Cree, F. Barkhof, A. Uccelli, M. Pia
Sormani, S. Krieger, B. Uitdehaag, T. Vollmer, X. Montalban, J. R.
Steinerman, N. Sasson, T. Gorfine, V. Knappertz
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[S20.005] Laquinimod regulates inflammatory gene induction in a
human model of reactive astrogliosis (Session 20, April 22, 2015,
2:00PM-3:45PM) J. N. Mariani, T. Pham, J. Zhang, J. Seto, B.
Hartmann, L. Hayardeny, G. R. John
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[P7.216] Baseline characteristics of patients enrolled in CONCERTO
- a study of 0.6 and 1.2 mg/day oral laquinimod for
relapsing-remitting multiple sclerosis (Poster Session 7, April
23, 2015, 2:00PM-6:30PM) G. Comi, T. Vollmer, X. Montalban, T.
Ziemssen, A. Boyko, P. Vermersch, T. Rachmilewitz, N. Sasson, T.
Gorfine, V. Knappertz, M. Rocca, M. Filippi
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[P7.237] Comparative utility of different progression metrics in
PPMS: re-analysis of the PROMiSe clinical trial data (Poster
Session 7, April 23, 2015, 2:00PM-6:30PM) M. W. Koch, J.
Steinerman, V. Knappertz, N. Sasson, G. Giovannoni, G. Cutter, J.
Wolinsky
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[P7.258] Long-term MRI follow-up of patients in the ALLEGRO study:
results from the yearly frequent MRI sub-cohort (Poster Session 7,
April 23, 2015, 2:00PM-6:30PM) M. A. Rocca, S. Galantucci, Y.
Dadon, T. Gorfine, D. Ladkani, N. Sasson,G. Comi, M. Filippi
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[P1.161] Laquinimod suppresses CNS autoimmunity by activation of
natural killer cells (Poster Session 1, April 20, 2015,
2:00PM–6:30PM) M. Ott, C. Wegner, L. Hayardeny, E. Ullrich, W.
Brück, S. Nessler
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[P4.107] Neuroprotective effects of laquinimod in lewis rat
experimental autoimmune neuritis (Poster Session 4, April 22,
2015, 7:30AM-12:00PM) K. Pitarokoili, B. Ambrosius, L. Schrewe, L.
Hayardeny, M. Hayden, R. Gold
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[P5.261] Laquinimod prevents NMOIg-induced disease exacerbation in
a model of neuromyelitis optica (Poster Session 5, April 22, 2015,
2:00PM-6:30PM) A.T. Argaw, L. Asp, J. Zhang, P. Waters, L.
Hayardeny, M. Levy, G. R. John
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.
The COPAXONE® brand is 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), progressive MS and
Huntington’s disease. The global, Phase III, clinical development
program evaluating laquinimod in MS includes two completed pivotal
studies, ALLEGRO and BRAVO (both 0.6mg/day). A third Phase III trial,
CONCERTO, is currently ongoing and evaluating two doses of laquinimod
(0.6mg and 1.2mg/day) in approximately 2,100 patients for up to 24
months. The primary outcome measure is time to three-month
confirmed-disability progression as measured by the Expanded Disability
Status Scale (EDSS).
In the ALLEGRO and BRAVO trials, adverse reactions observed included
headache, abdominal pain, back and neck pain, appendicitis, and mild,
asymptomatic laboratory abnormalities, including liver enzyme
elevations, hematological changes and elevation of CRP or fibrinogen
levels.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every day.
Headquartered in Israel, Teva is the world’s largest generic medicines
producer, leveraging its portfolio of more than 1,000 molecules to
produce a wide range of generic products in nearly every therapeutic
area. In specialty medicines, Teva has a world-leading position in
innovative treatments for disorders of the central nervous system,
including pain, as well as a strong portfolio of respiratory products.
Teva integrates its generics and specialty capabilities in its global
research and development division to create new ways of addressing unmet
patient needs by combining drug development capabilities with devices,
services and technologies. Teva's net revenues in 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
Teva's 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 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
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents) and our ability to
migrate users to our 40 mg/mL version; 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
identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
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,
confidentiality agreements 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; adverse effects of political or economic 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; the impact of continuing
consolidation of our distributors and customers; decreased opportunities
to obtain U.S. market exclusivity for significant new generic products;
potential liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that are
not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial talent; any
failures to comply with complex Medicare and Medicaid reporting and
payment obligations; significant impairment charges relating to
intangible assets, goodwill and property, plant and equipment; the
effects of increased leverage and our resulting reliance on access to
the capital markets; potentially significant increases in 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, 2014 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::
Kevin C. Mannix,
215-591-8912
United States
or
Ran Meir,
215-591-3033
United States
or
Tomer Amitai, 972
(3) 926-7656
Israel
or
PR:
Iris Beck Codner,
972 (3) 926-7687
Israel
or
Denise Bradley,
215-591-8974
United States
or
Nancy Leone,
215-284-0213
United States