EARLY VERSUS DELAYED TREATMENT WITH LAQUINIMOD DEMONSTRATED SIGNIFICANT REDUCTION IN RISK OF DISABILITY PROGRESSION - RESULTS OF THREE-YEAR ALLEGRO STUDY IN RELAPSING-REMITTING MULTIPLE SCLEROSIS
(Thomson Reuters ONE) -
· Data presented at the 65th Annual Meeting of the American Academy of
Neurology (AAN) showed early treatment with laquinimod demonstrated significant
benefit in terms of slowing disability progression compared to delayed treatment
· 36-month data affirmed the safety profile demonstrated in the ALLEGRO
pivotal clinical trial
· Additional animal preclinical data demonstrated laquinimod restored
myelination in the brain and spinal cord
Jerusalem, Israel and Lund, Sweden, March 21, 2013 - Teva Pharmaceutical
Industries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI)
announced today top-line results from the open-label extension of the Phase III
ALLEGRO study that assessed the progression of disability and safety of oral
laquinimod in early versus delayed-start relapsing-remitting multiple sclerosis
(RRMS) patients. The study compared the effectiveness of laquinimod in patients
who received 36 months (early-start) versus those who received 24 months of
laquinimod treatment (delayed-start).
Laquinimod is an oral, once daily, investigational drug in Phase III studies for
RRMS.
Of the 864 RRMS patients who participated in the original double-blind ALLEGRO
trial, 97% participated in the open-label extension and 87% completed one year
of the open-label phase. Overall, during the entire conduct of the study (double
blind and open label phase), early start patients were less likely to experience
disease progression than those with a delayed start of Laquinimod (11.8% risk of
confirmed disability progression vs. 16.7%, HR = 0.62, p < 0.0038).
"The results of this longer-term study of laquinimod suggest a robust benefit in
terms of early treatment for RRMS and in potentially delaying disability, which
is a primary goal of RRMS treatment," said Dr. Michael Hayden, President of
Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries, Ltd.
"The development of laquinimod's clinical profile has been full of exciting
revelations about the compound's unique mechanism of action, and we were dually
encouraged by the preclinical data which demonstrated a potential direct effect
on neuroregenerative processes."
The study also supports a favorable safety and tolerability profile of
laquinimod in RRMS patients. No new safety concerns arose during the open-label
phase.
Additionally, a preclinical study in animal models demonstrated the ability of
laquinimod to increase the myelinated axons and mature oligodendrocytes in the
brain. This data suggests laquinimod has potential restorative and anti-
inflammatory properties.
Results of both studies will be shared with the scientific community following a
full analysis of the data.
ABOUT THE STUDIES
Additional detail can be found on the AAN website:
http://www.abstracts2view.com/aan/
[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
Giancarlo Comi, Milan, Italy, Douglas Jeffery, Advance, NC, Ludwig Kappos,
Basel, Switzerland, Xavier Montalban, Barcelona, Spain, Alexey Boyko, Moscow,
Russian Federation, Maria Rocca, Milan, Italy, Massimo Filippi, Milan, Italy
[P05.197] Therapeutic Laquinimod Treatment Restores Axon Myelination, Callosal
Conduction and Motor Deficit in a Chronic Mouse Model of Multiple Sclerosis
Spencer Moore, Los Angeles, CA, 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
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 resident CNS inflammation and neurodegeneration. 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, after which patients
will continue to an active treatment period with laquinimod for additional 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 clinical
development for Crohn's disease and Lupus.
ABOUT MULTIPLE SCLEROSIS
MS is the leading cause of neurological disability in young adults. It is
estimated that more than 400,000 people in the United States are affected by the
disease and that two million people may be affected worldwide. Multiple
sclerosis is a degenerative disease of the central nervous system in which
inflammation and axonal damage and loss result in the development of progressive
disability.
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 specialty pharmaceuticals and active pharmaceutical ingredients.
Headquartered in Israel, Teva is a world leading 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. Teva currently employs
approximately 46,000 people around the world and reached $20.3 billion in net
revenues in 2012.
ABOUT ACTIVE BIOTECH
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with
focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase
are laquinimod, an orally administered small molecule with unique
immunomodulatory properties for the treatment of multiple sclerosis, TASQ for
prostate cancer and ANYARA primarily for the treatment of renal cell cancer. In
addition, laquinimod is in Phase II development for Crohn's and Lupus. The
company also has one additional project in clinical development, the orally
administered compound 57-57 for Systemic Sclerosis. Please visit
www.activebiotech.com for more information.
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, 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 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.
Active Biotech's Safe Harbor Statement in Accordance with the Swedish Securities
Market Act:
This press release contains certain forward-looking statements. Such forward-
looking statements involve known and unknown risks, uncertainties and other
important factors that could cause the actual results, performance or
achievements of the company, or industry results, to differ materially from any
future results, performance or achievement implied by the forward-looking
statements. The company does not undertake any obligation to update or publicly
release any revisions to forward-looking statements to reflect events,
circumstances or changes in expectations after the date of this press release.
Active Biotech is obligated to publish the information contained in this press
release in accordance with the Swedish Securities Market Act. This information
was provided to the media for publication 1:00 p.m. CET on March 21, 2013.
-------------------------------------------------------------------------------
IR Kevin C. United States
Contacts: Mannix (215) 591-8912
Kristen Frank United States (215) 591-8908
Tomer Israel 972 (3) 926-7656
Amitai
PR Hadar Vismunski- Israel 972 (3) 926-7687
Contacts Weinberg
Denise Bradley United States (215) 591-8974
Active Tomas Leanderson Active Biotech AB +46-46-19-20-95
Biotech
Hans Kolam Active Biotech AB +46-46-19-20-44
EARLY VERSUS DELAYED TREATMENT WITH LAQUINIMOD DEMONSTRATED:
http://hugin.info/1002/R/1687014/553194.pdf
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Active Biotech via Thomson Reuters ONE
[HUG#1687014]
Unternehmensinformation / Kurzprofil:
Datum: 21.03.2013 - 13:01 Uhr
Sprache: Deutsch
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