Positive results of LIBERTY Phase IIIb trial of Aimovig in episodic migraine treatmant.-Novartis

Novartis has announced full results from the Phase IIIb LIBERTY trial of Aimovig (erenumab, AMG 334) in episodic migraine patients who had previously failed two to four preventive treatments, due to lack of efficacy or intolerable side effects. The data, which will be presented at the annual meeting of the American Academy of Neurology (AAN) in Los Angeles, show the potential of investigational erenumab as an effective preventive treatment option for these patients, who have tried several treatment options without gaining relief. Erenumab is the only fully human monoclonal antibody under regulatory review that was designed to selectively block the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation.

LIBERTY is the first study to investigate a treatment targeting the CGRP pathway specifically in this challenging patient population. In LIBERTY, 246 patients who had experienced two to four previous preventive treatment failures were randomized to receive monthly subcutaneous injections of either erenumab 140mg or placebo for 12 weeks. Patients taking erenumab had nearly three-fold higher odds of having their migraine days cut by at least 50%, with more than twice as many patients taking erenumab achieving this reduction compared to placebo (weeks 9-12: 30.3% with erenumab, 13.7% with placebo, p=0.002, odds ratio 2.73). In the study, patients taking erenumab also had statistically significant and clinically meaningful improvements from baseline compared to placebo across all secondary endpoints: � Reduction in monthly migraine days. � Decrease in acute migraine-specific drug use .� 75% or greater reduction in monthly migraine days.� 100% reduction in monthly migraine days.� Improved physical functioning and ability to complete everyday activities as measured by the Migraine Physical Function Impact Diary (MPFID) scales. Over 97% of erenumab patients completed the double-blind phase of the LIBERTY study. There were no adverse events leading to discontinuation of treatment in the erenumab group while 0.8% of those in the placebo group experienced adverse events leading to discontinuation of treatment.

LIBERTY contributes to an extensive body of evidence, across the spectrum of migraine, in support of the sustained efficacy, safety and tolerability profile of erenumab including four placebo-controlled Phase II and Phase III clinical studies involving more than 3,000 patients, as well as ongoing open-label extension trials up to five years in duration. If approved, erenumab will be administered every four weeks using a self-injection device. Subject to approval, Novartis and Amgen will co-commercialize erenumab in the US. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize in the rest of the world.