Teva and Active Biotech to continue with the development of NERVENTRA® (laquinimod) for multiple sclerosis following confirmation of CHMP opinionMay 23, 2014 08:30 (CEST)
Jerusalem & Lund, Sweden, May 23, 2014 - Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today 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® (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.
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.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva's Specialty Medicines businesses focus on CNS, respiratory, oncology, pain, and women's health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.
About Active Biotech
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer. In pivotal phase is laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis. Also tasquinimod for the treatment of prostate cancer, with a unique mode of action, is in pivotal phase. In addition, laquinimod has concluded Phase II development for Crohn's and Lupus. The company has two additional projects in clinical development, ANYARA primarily for the treatment of renal cell cancer and the orally administered compound paquinimod (57-57) for systemic sclerosis. Please visit www.activebiotech.com for more information.
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This press release contains certain forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the actual results, performance or achievements of the company, or industry results, to differ materially from any future results, performance or achievement implied by the forward-looking statements. The company does not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the date of this press release.
Active Biotech is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act. This information was provided to the media for publication 08:30 a.m. CEST on May 23, 2014.