TEVA ACQUIRES MARKETING RIGHTS FOR ORAL LAQUINIMOD IN THE NORDIC AND BALTIC REGIONS
Website: www.tevapharm.com
<http://www.tevapharm.com/>
www.activebiotech.com/ <http://www.activebiotech.com/>
Contact: Elana Holzman Teva Pharmaceutical Industries 972 (3) 926-7554
Kevin Mannix Ltd. (215) 591-8912
Teva North America
Göran Forsberg Active Biotech AB +46 (0) 46-19 11 54
For Immediate Release
Teva Acquires Marketing Rights for Oral Laquinimod
in the Nordic and Baltic Regions
-- Teva Now Holds Worldwide Commercial Rights for Laquinimod --
JERUSALEM, ISRAEL, LUND, SWEDEN, February 8, 2010 - Teva Pharmaceutical
Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI)
announced today that they have amended the marketing and distribution agreement
for oral laquinimod, an investigational treatment for relapsing-remitting
multiple sclerosis (RRMS). Under the new agreement, Teva extended its marketing
and distribution rights to include the Nordic and Baltic regions, previously
held by Active Biotech. Active Biotech will receive a higher royalty rate for
sales in these territories compared to the royalty rate set under the original
licensing agreement signed in 2004 for sales in the rest of the world.
"We are very excited about the market potential of laquinimod. We believe that
laquinimod can be a leading oral therapy for MS as it has the potential to best
combine the convenience of an oral formulation with a favorable efficacy, safety
and tolerability profile. " said Moshe Manor, Teva's Group VP, Global Branded
Products. "Licensing a promising new therapeutic option - as we did with
laquinimod - is an excellent example of how we plan to execute our branded
strategy and expand our innovative pipeline."
"After working with Teva since 2004 on developing laquinimod we believe that
Teva is the optimal marketing and distribution partner in our territory," said
Tomas Leanderson, President & CEO Active Biotech. "We are also very satisfied
with the commercial opportunity this offers to Active Biotech".
Two global Phase III clinical trials to evaluate the efficacy, safety and
tolerability of laquinimod - ALLEGRO and BRAVO - have completed enrollment in
November 2008 and June 2009, respectively, and are currently ongoing. In
February 2009, laquinimod received Fast Track designation from the U.S. Food and
Drug Administration (FDA), which may allow the drug to enter the market as soon
as late 2011.
About Laquinimod
Laquinimod is a novel once-daily, orally administered immunomodulatory compound
that is being developed as a disease-modifying treatment for RRMS. Active
Biotech developed laquinimod and licensed it to Teva Pharmaceutical Industries,
Ltd. in June 2004. A Phase IIb study in 306 patients was published in The Lancet
(June 2008) and demonstrated that an oral 0.6 mg dose of laquinimod,
administered daily, significantly reduced MRI disease activity by a median of
60 percent (51 percent mean reduction) versus placebo in RRMS patients. In
addition, the study showed a favorable trend toward reducing annual relapse
rates and the number of relapse-free patients compared with placebo. Treatment
was well tolerated, with only some transient and dose-dependent increases in
liver enzymes reported.
Laquinimod is currently in two Phase III clinical trials; ALLEGRO (assessment of
oral laquinimod in preventing progression of MS) which is a pivotal, global,
24/30-month, double-blind, Phase III study designed to evaluate the efficacy,
safety and tolerability of laquinimod versus placebo in the treatment of RRMS,
and BRAVO (benefit-risk assessment of Avonex(®) and laquinimod) which is a
pivotal, multinational, multi-center, randomized, double-blind, parallel-group,
placebo-controlled study designed to compare the safety and efficacy of
laquinimod with placebo and to provide risk-benefit data for laquinimod versus a
currently available injectable treatment.
About Multiple Sclerosis
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 over two million people may be affected
worldwide. MS is a progressive, demyelinating disease of the central nervous
system affecting the brain, spinal cord and optic nerves. Demyelination is the
destructive breakdown of the fatty tissue that protects nerve endings.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top
20 pharmaceutical companies in the world and is the leading generic
pharmaceutical company. The company develops, manufactures and markets generic
and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80
percent of Teva's sales are in North America and Western Europe.
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, as well as
ANYARA for use in cancer targeted therapy, primarily of renal cancer. Further
key projects in clinical development comprise the three orally administered
compounds TASQ for prostate cancer, 57-57 for SLE and RhuDex(TM) for RA. Please
visit www.activebiotech.com <http://www.activebiotech.com/> for more
information.
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 on February 8, 2010 at 2:30 p.m.
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 successfully develop and commercialize additional
pharmaceutical products, the introduction of competing generic equivalents, the
extent to which we may obtain U.S. market exclusivity for certain of our new
generic products and regulatory changes that may prevent us from utilizing
exclusivity periods, potential liability for sales of generic products prior to
a final resolution of outstanding patent litigation, including that relating to
the generic versions of Neurontin®, Lotrel®, Protonix® and Eloxatin®, the
current economic conditions, competition from brand-name companies that are
under increased pressure to counter generic products, or competitors that seek
to delay the introduction of generic products, the effects of competition on our
innovative products, especially Copaxone® sales, including potential oral and
generic competition for Copaxone®, dependence on the effectiveness of our
patents and other protections for innovative products, the impact of
consolidation of our distributors and customers, the impact of pharmaceutical
industry regulation and pending legislation that could affect the pharmaceutical
industry, our ability to achieve expected results though our innovative R&D
efforts, the difficulty of predicting U.S. Food and Drug Administration,
European Medicines Agency and other regulatory authority approvals, the
uncertainty surrounding the legislative and regulatory pathway for the
registration and approval of biotechnology-based products, the regulatory
environment and changes in the health policies and structures of various
countries, supply interruptions or delays that could result from the complex
manufacturing of our products and our global supply chain, our ability to
successfully identify, consummate and integrate acquisitions, the potential
exposure to product liability claims to the extent not covered by insurance, our
exposure to fluctuations in currency, exchange and interest rates, significant
operations worldwide that may be adversely affected by terrorism, political or
economical instability or major hostilities, our ability to enter into patent
litigation settlements and the intensified scrutiny by the U.S. government, the
termination or expiration of governmental programs and tax benefits, impairment
of intangible assets and goodwill, environmental risks, and other factors that
are discussed in this report and in our other filings with the U.S. Securities
and Exchange Commission ("SEC").
[HUG#1381480]
TEVA ACQUIRES MARKETING RIGHTS FOR ORAL LAQUINIMOD IN THE NORDIC AND BALTIC REGIONS : http://hugin.info/1002/R/1381480/340728.pdf
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