Teva Pharmaceutical Industries Ltd. (TEVA) and Active Biotech announced 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 laqunimod can be a leading oral therapy for MS as it has the potential to best combine the convenience of an oral formulation with a favourable 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 enrolment in November 2008 and June 2009, respectively, and are currently ongoing. In February 2009, laquinimod received Fast Track designation from the US Food and Drug Administration (FDA), which may allow the drug to enter the market as soon as late 2011.
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 per cent mean reduction) versus placebo in RRMS patients. In addition, the study showed a favourable 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-centre, 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.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company.
Active Biotech AB 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.