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|May 23, 2014 2:30 a.m.|
|Teva and Active Biotech to Continue with the Development of Nerventra® (Laquinimod) for Multiple Sclerosis Following Confirmation of CHMP Opinion|
Both companies remain committed to the NERVENTRA® (laquinimod) clinical development program for multiple sclerosis (MS) and are focused on evaluating the CHMP feedback to determine potential next steps.
“We are disappointed with the outcome of the re-examination and will be
working with the EMA to make NERVENTRA available to multiple sclerosis
patients in the EU,” said
To further confirm the benefits of NERVENTRA on disability progression, Teva is conducting the CONCERTO trial, the largest MS trial with disability progression as the primary endpoint. The ongoing CONCERTO trial is the third Phase III study in RRMS and explores daily doses of NERVENTRA 0.6 mg and 1.2 mg. In addition, Teva is investigating the potential of NERVENTRA in progressive forms of MS. The first trial for this indication is planned to be initiated soon.
NERVENTRA is a once-daily oral, investigational, CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of relapsing-remitting MS (RRMS) and progressive forms of MS. In extensive non-clinical and clinical studies, NERVENTRA has demonstrated both anti-inflammatory and neuroprotective properties and effects that have been shown to provide clinically meaningful results. The global Phase III clinical development program evaluating NERVENTRA in MS includes two pivotal studies, ALLEGRO and BRAVO. A third Phase III NERVENTRA trial, CONCERTO, is evaluating two doses of the investigational product (0.6mg and 1.2mg) in approximately 2,100 patients for up to 24 months. The primary outcome measure will be time to confirmed disability progression as measured by the EDSS, making CONCERTO the largest MS clinical trial with disability progression as the primary endpoint.
The safety profile of NERVENTRA is based on 2,645 MS patients that have been exposed to NERVENTRA for a total duration of 7,491 subject years, with a maximal duration of seven years. Very common or important adverse reactions include headache, abdominal pain, back and neck pain, appendicitis, and mild, asymptomatic laboratory abnormalities, including liver enzyme elevations, hematological changes, and elevation of CRP or fibrinogen levels.
In addition to the MS clinical studies, studies are planned to evaluate the efficacy, safety and tolerability of NERVENTRA in other neurodegenerative diseases including Huntington’s disease.
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competition for our innovative products, especially COPAXONE®
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development efforts invested in our pipeline of specialty and other
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during the timeframe intended by our cost reduction program; our ability
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our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; increased government scrutiny in both the U.S. and
Teva Pharmaceutical Industries Ltd.