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Nerventra® (laquinimod)

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New trial in primary progressive multiple sclerosis for Laquinimod (04/11/14)

Teva Pharmaceutical Industries Ltd. and Active Biotech today announced the expansion of the laquinimod clinical development program with the initiation of the ARPEGGIO trial, which will evaluate the potential of laquinimod to treat primary progressive multiple sclerosis (PPMS) There are no approved therapies available for the treatment of PPMS beyond symptom management.

“Teva prides itself in striving to help patients with neurodegenerative diseases through research and innovation,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries, Ltd. “Laquinimod has been shown to modulate several significant pathways common to key neurodegenerative disease. More specifically, it modulates the immune cell lineages in the periphery and in the CNS. We look forward to the results from the study.”

The ARPEGGIO study will evaluate the efficacy, safety and tolerability of laquinimod in patients with PPMS with a primary endpoint of percent brain volume change (PBVC) through MRI analysis. PPMS is characterised by the worsening of neurologic function without distinct relapses (also called attacks or exacerbations). Approximately 15 percent of MS patients fall into the PPMS category.

About ARPEGGIO
The study, A Randomized Placebo-controlled Trial Evaluating Laquinimod in PPMS, Gauging Gradations In MRI and Clinical Outcomes (ARPEGGIO) is a multinational, multicenter, randomised, double-blind, parallel-group, placebo-controlled, Phase II clinical trial.

ARPEGGIO is intended to serve as a proof-of-concept study for potential treatment with laquinimod in PPMS. The trial will evaluate two doses of laquinimod (0.6 and 1.5mg/day) in PPMS compared to placebo. The primary endpoint of the study is brain atrophy as defined by PBVC from baseline to week 48. Secondary endpoints include time to confirmed disability progression, the number of new T2 lesions and change in the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) score. ARPEGGIO has an estimated completion date of H2 2017.

Source: Finances © 2014 Finances International Ltd (04/11/14)

Teva and Active Biotech to continue with the development of Nerventra(R) (laquinimod) for multiple sclerosis(27/05/14)

Teva Pharmaceutical Industries Ltd. and Active Biotech announced that the Committee for Medicinal Products for Human Use's (CHMP) confirmed its January 23, 2014 opinion to recommend against approval for the treatment of relapsing-remitting multiple sclerosis (RRMS) in the European Union (EU) at this time.

Both companies remain committed to the Nerventra(R) (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 Michael Hayden, President of Global R&D and Chief Scientific Officer. "We believe Nerventra has a favorable risk-benefit profile and the potential to fulfill an unmet need for a treatment that decreases disability progression, and protects against brain volume loss, two important goals in the management of MS."

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.

About Nerventra(R)

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.

Source: Reuters Copyright (C) 2014 Thomson Reuters (27/05/14)