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· 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
· 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
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
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
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 SclerosisSpencer 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
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.
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 http://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(R) (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(R), 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 Contacts: Kevin C. Mannix United States (215) 591-8912
Kristen Frank United States (215) 591-8908
Tomer Amitai Israel 972 (3) 926-7656
PR Contacts Hadar Vismunski-Weinberg Israel 972 (3) 926-7687
Denise Bradley United States (215) 591-8974
Active Biotech Tomas Leanderson Active Biotech AB +46-46-19-20-95
Hans Kolam Active Biotech AB +46-46-19-20-44
EARLY VERSUS DELAYED TREATMENT WITH LAQUINIMOD DEMONSTRATED
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Source: Active Biotech via Thomson Reuters ONE