Series of Events throughout Congress to Shed Light on New Data and
Evolving MS Landscape
JERUSALEM--(BUSINESS WIRE)--Sep. 26, 2013--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that key
data from the Company’s multiple sclerosis (MS) franchise will be
featured in over 20 presentations at the 29th Congress of the European
Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in
Copenhagen, Denmark, October 2-5, 2013. Data presentations will provide
new clinical insights on the effects of treatment with COPAXONE®
(glatiramer acetate injection), the world’s leading relapsing-remitting
multiple sclerosis (RRMS) treatment, and the novel effects of
laquinimod, Teva’s investigational oral compound, when used to treat
RRMS.
"With our sixteen year legacy in providing a safe and effective
treatment for RRMS, Teva continues to discover and develop treatments
that positively impact patients living with this complex, debilitating
disease,” said Dr. Michael Hayden, President of Global R&D and Chief
Scientific Officer for Teva Pharmaceutical Industries Ltd. “The
continued investigation of the long-term open-label study of COPAXONE
and investigation of laquinimod’s effect in MS demonstrate our ongoing
focus on increasing the body of scientific knowledge available to
neurologists for making appropriate treatment decisions in a rapidly
evolving landscape.”
In addition to presenting data at the Congress, Teva will host two
satellite symposia, “Emerging Insights in Multiple Sclerosis:
Re-evaluating the Treatment Algorithm” on Thursday, October 3, 2013 from
13:00 - 14:00 CET and “Multiple Sclerosis Management: Have We Got the
Focus Right?” on Friday, October 4, 2013 from 19:15 - 20:15 CET. Also
during the Congress, Teva will host a roundtable event for credentialed
journalists focused on the future of the MS treatment landscape and
patient journey.
Data Highlights from the Teva MS Franchise
Key data being presented during ECTRIMS from Teva’s MS franchise will
include twenty-year long-term clinical results from the US open-label
extension study of COPAXONE® in RRMS, analyses of pooled data
from the Phase 3 BRAVO and ALLEGRO clinical trials of laquinimod and
results from the open-label extension phase of the BRAVO study.
COPAXONE® (glatiramer acetate injection):
-
[P 577] Twenty years of continuous treatment of multiple sclerosis
with glatiramer acetate 20mg daily: long-term clinical results of the
US open-label extension study (Poster Session: Long-term treatment
monitoring, October 03, 15:30 - 17:00 CET) C. Ford, D. Ladkani on
behalf of the US Open-Label Glatiramer Acetate Study Group
Laquinimod:
-
[P 606] Bayesian analysis of laquinimod's effect on relapses and
disability (Poster Session: Tools for detecting therapeutic
response, October 03, 15:45 - 17:00 CET) G. Cutter, G. Comi, T.
Vollmer, D. Ladkani, N. Sasson, V. Knappertz (Birmingham, US; Milan,
IT; Aurora, US; Petah Tikva, Netanya, IL; Düssseldorf, DE / Frazer, US)
-
[P 1036] Disease progression in relapse-free patients treated with
laquinimod (Poster Session: Long-term treatment monitoring,
October 04, 15:30 - 17:00 CET) G. Comi, T. Vollmer, G. Cutter, N.
Sasson, D. Ladkani, T. Gorfine (Milan, IT; Aurora, Birmingham, US;
Netanya, Petah Tikva, IL)
-
[P 1055] Results of switching to laquinimod in the open-label
extension phase of the BRAVO study (Poster Session: Long-term
treatment monitoring, October 04, 15:30 - 17:00 CET) T. Vollmer,
P.S. Sorensen, K. Selmaj, F. Zipp, E. Havrdova, J. Cohen, Y. Sidi, T.
Gorfine, D. Arnold for the BRAVO Study Group
-
[P 1080] Evaluating the relationship between laquinimod's effects
on relapse and disability progression (Poster Session: Tools for
detecting therapeutic response, October 04, 15:30 - 17:00 CET) M.P.
Sormani, G. Cutter, G. Comi, T. Vollmer, P.S. Sorensen, D. Ladkani, N.
Sasson, V. Knappertz (Genoa, IT; Birmingham, US; Milan, IT; Aurora,
US; Copenhagen, DK; Petah Tikva, Netanya, IL; Düsseldorf, DE / Frazer,
US)
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://copaxone.com/pdfs/PrescribingInformation.aspx.
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 an oral, investigational, CNS-active immunomodulator with
a novel mechanism of action being developed for the treatment of
relapsing-remitting 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 time to confirmed disability progression as measured by
the EDSS.
In addition to the MS clinical studies, laquinimod is currently in Phase
II of development for Crohn's disease and lupus nephritis.
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. 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 purported 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, the effects of increased leverage as a result of
recent acquisitions, 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, 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 pathways for the registration and approval of
biotechnology-based products, adverse effects of political or economical
instability, corruption, 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
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.
Source: Teva Pharmaceutical Industries Ltd.