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Agreement

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Date: 2010-02-08
Biotech partner: Active Biotech (Sweden)
Pharma Partner: Teva Pharmaceutical Industries (Israel)
Type of agreement: * commercialization/ distribution
* marketing/ promotion
Compound: laquinimod
Disease area: relapsing-remitting multiple sclerosis
Development phase: Two global Phase III clinical trials to evaluate the efficacy, safety and tolerability of laquinimod have completed enrollment in November 2008 and June 2009, respectively, and are currently ongoing. ALLEGRO (assessment of oral laquinimod in preventing progression of MS) 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. BRAVO (benefit-risk assessment of Avonex® and laquinimod) 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. In April 2009, Teva's researchers have presented new preclinical and clinical data on the mechanism of action of laquinimod (See http://www.biopharmaceutiques.com/en/article/105_1882.html).
Nature of the agreement: Teva Pharmaceutical Industries and Active Biotech have amended their marketing and distribution agreement for oral laquinimod. Under the new agreement, Teva extended its marketing and distribution rights to include the Nordic and Baltic regions, previously held by Active Biotech.
In February 2009, laquinimod received Fast Track designation from the FDA, which may allow the drug to enter the market as soon as late 2011.
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.


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