Teva and Active Biotech to Continue with the Development of Nerventra (Laquinimod) for MS Following Confirmation of CHMP Opinion

Teva Pharmaceutical Industries Ltd and Active Biotech have announced that the Committee for Medicinal Products for Human Use (CHMP) confirmed its 23 January 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 programme 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 fulfil 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.