TEVA ACQUIRES MARKETING RIGHTS FOR ORAL LAQUINIMOD IN THE NORDIC AND BALTIC REGIONS
(Thomson Reuters ONE) - Website: www.tevapharm.comwww.activebiotech.com/ Contact: Elana Holzman Teva Pharmaceutical Industries 972 (3) 926-7554 Kevin Mannix Ltd. (215) 591-8912 Teva North America G? Forsberg Active Biotech AB +46 (0) 46-19 11 54For 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 PharmaceuticalIndustries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI)announced today that they have amended the marketing and distribution agreementfor oral laquinimod, an investigational treatment for relapsing-remittingmultiple sclerosis (RRMS). Under the new agreement, Teva extended its marketingand distribution rights to include the Nordic and Baltic regions, previouslyheld by Active Biotech. Active Biotech will receive a higher royalty rate forsales in these territories compared to the royalty rate set under the originallicensing agreement signed in 2004 for sales in the rest of the world."We are very excited about the market potential of laquinimod. We believe thatlaquinimod can be a leading oral therapy for MS as it has the potential to bestcombine the convenience of an oral formulation with a favorable efficacy, safetyand tolerability profile. " said Moshe Manor, Teva's Group VP, Global BrandedProducts. "Licensing a promising new therapeutic option - as we did withlaquinimod - is an excellent example of how we plan to execute our brandedstrategy and expand our innovative pipeline.""After working with Teva since 2004 on developing laquinimod we believe thatTeva is the optimal marketing and distribution partner in our territory," saidTomas Leanderson, President & CEO Active Biotech. "We are also very satisfiedwith the commercial opportunity this offers to Active Biotech".Two global Phase III clinical trials to evaluate the efficacy, safety andtolerability of laquinimod - ALLEGRO and BRAVO - have completed enrollment inNovember 2008 and June 2009, respectively, and are currently ongoing. InFebruary 2009, laquinimod received Fast Track designation from the U.S. Food andDrug Administration (FDA), which may allow the drug to enter the market as soonas late 2011.About LaquinimodLaquinimod is a novel once-daily, orally administered immunomodulatory compoundthat is being developed as a disease-modifying treatment for RRMS. ActiveBiotech 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 of60 percent (51 percent mean reduction) versus placebo in RRMS patients. Inaddition, the study showed a favorable trend toward reducing annual relapserates and the number of relapse-free patients compared with placebo. Treatmentwas well tolerated, with only some transient and dose-dependent increases inliver enzymes reported.Laquinimod is currently in two Phase III clinical trials; ALLEGRO (assessment oforal 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 apivotal, multinational, multi-center, randomized, double-blind, parallel-group,placebo-controlled study designed to compare the safety and efficacy oflaquinimod with placebo and to provide risk-benefit data for laquinimod versus acurrently available injectable treatment.About Multiple SclerosisMultiple sclerosis (MS) is the leading cause of neurological disability in youngadults. It is estimated that more than 400,000 people in the United States areaffected by the disease and that over two million people may be affectedworldwide. MS is a progressive, demyelinating disease of the central nervoussystem affecting the brain, spinal cord and optic nerves. Demyelination is thedestructive breakdown of the fatty tissue that protects nerve endings.About TevaTeva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top20 pharmaceutical companies in the world and is the leading genericpharmaceutical company. The company develops, manufactures and markets genericand innovative pharmaceuticals and active pharmaceutical ingredients. Over 80percent of Teva's sales are in North America and Western Europe.About Active BiotechActive Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company withfocus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phaseare laquinimod, an orally administered small molecule with uniqueimmunomodulatory properties for the treatment of multiple sclerosis, as well asANYARA for use in cancer targeted therapy, primarily of renal cancer. Furtherkey projects in clinical development comprise the three orally administeredcompounds TASQ for prostate cancer, 57-57 for SLE and RhuDex(TM) for RA. Pleasevisit www.activebiotech.com for moreinformation.Active Biotech is obligated to publish the information contained in this pressrelease in accordance with the Swedish Securities Market Act. This informationwas 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 LitigationReform Act of 1995:This release contains forward-looking statements, which express the currentbeliefs and expectations of management. Such statements are based onmanagement's current beliefs and expectations and involve a number of known andunknown risks and uncertainties that could cause our future results, performanceor achievements to differ significantly from the results, performance orachievements expressed or implied by such forward-looking statements. Importantfactors that could cause or contribute to such differences include risksrelating to: our ability to successfully develop and commercialize additionalpharmaceutical products, the introduction of competing generic equivalents, theextent to which we may obtain U.S. market exclusivity for certain of our newgeneric products and regulatory changes that may prevent us from utilizingexclusivity periods, potential liability for sales of generic products prior toa final resolution of outstanding patent litigation, including that relating tothe generic versions of Neurontin®, Lotrel®, Protonix® and Eloxatin®, thecurrent economic conditions, competition from brand-name companies that areunder increased pressure to counter generic products, or competitors that seekto delay the introduction of generic products, the effects of competition on ourinnovative products, especially Copaxone® sales, including potential oral andgeneric competition for Copaxone®, dependence on the effectiveness of ourpatents and other protections for innovative products, the impact ofconsolidation of our distributors and customers, the impact of pharmaceuticalindustry regulation and pending legislation that could affect the pharmaceuticalindustry, our ability to achieve expected results though our innovative R&Defforts, the difficulty of predicting U.S. Food and Drug Administration,European Medicines Agency and other regulatory authority approvals, theuncertainty surrounding the legislative and regulatory pathway for theregistration and approval of biotechnology-based products, the regulatoryenvironment and changes in the health policies and structures of variouscountries, supply interruptions or delays that could result from the complexmanufacturing of our products and our global supply chain, our ability tosuccessfully identify, consummate and integrate acquisitions, the potentialexposure to product liability claims to the extent not covered by insurance, ourexposure to fluctuations in currency, exchange and interest rates, significantoperations worldwide that may be adversely affected by terrorism, political oreconomical instability or major hostilities, our ability to enter into patentlitigation settlements and the intensified scrutiny by the U.S. government, thetermination or expiration of governmental programs and tax benefits, impairmentof intangible assets and goodwill, environmental risks, and other factors thatare discussed in this report and in our other filings with the U.S. Securitiesand 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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