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April 25, 2017

Novartis and Amgen expand global collaboration to commercialise AMG 334

Novartis has entered an expanded commercialisation agreement with Amgen for AMG 334 (erenumab), which is being investigated for the prevention of migraines.

Novartis has entered an expanded commercialisation agreement with Amgen for AMG 334 (erenumab), which is being investigated for the prevention of migraines.

The expanded agreement is based on a 2015 global collaboration between the two companies.

Under the expanded collaboration, the companies will co-commercialise AMG 334 (erenumab) in the US.

Novartis will retain exclusive rights to commercialise the drug globally and will gain commercialisation rights in Canada, while Amgen retains exclusive commercialisation rights in Japan.

AMG 334 (erenumab) is a fully human monoclonal antibody designed to prevent migraines.

The product blocks the Calcitonin Gene-Related Peptide (CGRP) receptor, which is believed to play a major role in mediating the incapacitating pain of migraines.

Last year, Novartis conducted a Phase II study and two Phase III studies of AMG 334 (erenumab) that yielded positive results.

Within these studies, once-monthly subcutaneous AMG 334 (erenumab) significantly reduced monthly migraine days in comparison to placebo and demonstrated a safety profile comparable to placebo.

"There is an urgent need for effective and well-tolerated preventive treatments that positively impact the lives of people with migraines."

Detailed results of the Phase III studies were presented at the annual meeting of the American Academy of Neurology, which will also support the filing of regulatory application, anticipated to take place in the second quarter of this year.

Novartis Pharmaceuticals CEO Paul Hudson said: “Migraine is a debilitating neurological disease associated with significant personal, economic, and societal burden.

“There is an urgent need for effective and well-tolerated preventive treatments that positively impact the lives of people with migraines.

“We are excited to expand our collaboration with Amgen. We look forward to combining capabilities and leveraging our strong heritage in neuroscience in the US and Canada to bring erenumab to more patients in need, as fast as we can.”

Under the agreement, Amgen will receive milestone payments from Novartis, scheduled to begin this year.

Amgen will book sales of AMG 334 (erenumab) in the US and Japan, and will pay a royalty to Novartis on net sales.

Novartis will book worldwide sales and pay Amgen a royalty based on the net sales.

Previously in August 2015, both companies signed a global collaboration in neuroscience, including joint development and commercialisation of treatments for Alzheimer's disease and migraines.

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