Novartis announces AMG 334 significantly reduces patients' monthly migraine days in phase II study of chronic migraine prevention

Novartis International AG / Novartis announces AMG 334 significantly reduces patients' monthly migraine days in phase II study of chronic migraine prevention . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Phase II 20120295 study of AMG 334 met primary endpoint, confirming efficacy and safety in patients with chronic migraine over 12 weeks of treatment
   
• Migraine is a leading cause of disability, affecting more than 10% of people worldwide - within the overall migraine population, people with chronic migraine experience the greatest impact on daily activities and quality of life
   
• AMG 334 is being co-developed by Novartis and Amgen

Basel, 8 June 2016 - Novartis today announced positive first results from the global phase II 20120295 study, investigating the efficacy and safety of the fully human monoclonal antibody AMG 334 (erenumab) in chronic migraine prevention. The study evaluated AMG 334 at two doses, 70mg and 140mg, administered subcutaneously once a month, with both doses meeting the study's primary endpoint of a statistically significant reduction in the number of monthly migraine days versus placebo.

"Patients with chronic migraine live with the debilitating and disabling symptoms of this disease for 15 or more days each month, significantly impacting their everyday life and ability to work," said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "We are delighted that with this positive outcome, we are one step closer to providing patients with a much-needed new treatment option to prevent chronic migraine. Also, we are looking forward to assessing the benefit of AMG 334 in two ongoing phase III studies in episodic migraine, with initial data from these studies expected later this year."

Overall, patients had a mean baseline of 18 migraine days per month. Patients randomized to the 70mg and 140mg dose groups experienced a mean 6.6-day reduction from baseline in monthly migraine days in both groups. The results were statistically significant compared with 4.2 days observed in the placebo group.

The safety and tolerability profile of AMG 334 was similar to placebo in both treatment groups. No adverse event was reported in greater than five percent of patients treated with AMG 334; the most commonly reported adverse events included injection site pain, infection of the upper respiratory tract and nausea.