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|January 24, 2014 8:10 a.m.|
|Teva and Active Biotech Remain Committed to the Development of NERVENTRA® (laquinimod) for Multiple Sclerosis Following the Negative Opinion from the EMA’s CHMP|
The CHMP has concluded that the risk-benefit profile of NERVENTRA is not
favorable at this time. In accordance with European regulations, Teva
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 MS (PMS). 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 1,800 patients for up to 24 months. The primary outcome measure will be time to confirmed disability progression as measured by the EDSS.
The safety profile of NERVENTRA is based on 2645 MS patients that have been exposed to NERVENTRA for a total duration of 7490.8 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. Potential risks include teratogenicity and carcinogenicity, both related to findings in rats, which are based on non-clinical data and have not been encountered in patients.
In addition to the MS clinical studies, NERVENTRA is currently in clinical development for Crohn's disease. Studies are also planned to study the efficacy, safety and tolerability of NERVENTRA in other neurodegenerative diseases, including Huntington’s disease.
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which express the
current beliefs and expectations of management. Such statements are
based on management’s current beliefs and expectations and involve a
number of known and unknown risks and uncertainties that could cause our
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include our ability to achieve expected
results through our innovative R&D efforts; risks relating to: our
ability to develop and commercialize additional pharmaceutical products,
competition for our innovative products, especially Copaxone® (including
competition from innovative orally-administered alternatives, as well as
from potential purported generic equivalents), competition for our
generic products (including from other pharmaceutical companies and as a
result of increased governmental pricing pressures), competition for our
specialty pharmaceutical businesses, , the effectiveness of our patents
and other protections for innovative products, decreasing opportunities
to obtain U.S. market exclusivity for significant new generic products,
our ability to identify, consummate and successfully integrate
acquisitions, the effects of increased leverage as a result of recent
acquisitions, the extent to which any manufacturing or quality control
problems damage our reputation for high quality production and require
costly remediation, our potential exposure to product liability claims
to the extent not covered by insurance, increased government scrutiny in
both the U.S. and
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.
Teva Pharmaceutical Industries Ltd.