Amgen Submits Biologics License Application To The FDA For Erenumab

Erenumab is an Investigative Treatment Specifically Designed to Prevent Migraine
Only Molecule in Late-Stage Development to Directly Target the Calcitonin Gene-Related Peptide Receptor
Amgen and Novartis to Co-Commercialize Erenumab in the U.S.

THOUSAND OAKS, CA, USA I May 18, 2017 I Amgen (NASDAQ:AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for erenumab to prevent migraine. Erenumab is specifically designed to prevent migraine by blocking the Calcitonin Gene-Related Peptide (CGRP) receptor. This BLA includes data from pivotal studies in patients with episodic and chronic migraine.

"People with migraine lose a substantial part of their lives enduring or managing the disease, which takes time away from their loved ones, social activities and workplace responsibilities. Approximately 3.5 million Americans currently take a preventive treatment to reduce their number of migraine days, yet 80 percent of those discontinue these treatments within one year," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "This application represents a long-awaited step towards addressing the unmet need faced by the migraine community through the potential delivery of erenumab, which has demonstrated strong efficacy, safety and tolerability in patients with episodic and chronic migraine."

The erenumab global clinical trial program has enrolled more than 2,600 patients experiencing four or more migraine days per month, with some patients receiving erenumab for up to three years. Results from the chronic migraine study were published in The Lancet Neurology in April 2017 and detailed results from Phase 3 in episodic migraine have been submitted for publication.

Results from the pivotal studies, investigating the efficacy of erenumab versus placebo in reducing the number of migraine days for patients with episodic and chronic migraine, will be presented during the 59th Annual Scientific Meeting of the American Headache Society in Boston this June.

About Erenumab
Erenumab is a human monoclonal antibody specifically designed for the prevention of migraine. Erenumab specifically inhibits the receptor of the Calcitonin Gene-Related Peptide (CGRP), which has been thought to play a causal role in migraine pathophysiology. Erenumab has been studied in several large global, randomized, double-blind, placebo-controlled trials to assess its safety and efficacy in migraine prevention.

About Migraine
Migraine is a distinct neurological disease.1 People with migraine lose a substantial portion of their lives to this illness, experiencing significant physical impairment, frequently accompanied by head pain, nausea, vomiting and meaningful disruption of daily activities.1 The World Health Organization ranks migraine as one of the most debilitating illnesses.2 For the approximately 10 million Americans whose migraine frequency or severity impacts daily activities, preventive medications may be an option.3 Approximately 3.5 million of these patients are currently on a preventive therapy, but up to 80 percent discontinue these within one year.3,4 Migraine is associated with personal and societal burdens of pain, disability, and financial cost, and it remains under-recognized and under-treated.

About Amgen and Novartis Neuroscience Collaboration
In August 2015, Amgen entered into a global collaboration with Novartis to jointly develop and commercialize pioneering treatments in the field of migraine and Alzheimer's disease (AD). The collaboration focuses on investigational Amgen drugs in the migraine field, including erenumab (Biologics License Application submitted to U.S. FDA in May 2017) and AMG 301 (currently in Phase 1 development). In April 2017, the collaboration was expanded to include co-commercialization of erenumab in the U.S. For the migraine program, Amgen retains exclusive commercialization rights in Japan, and Novartis has exclusive commercialization rights in Europe, Canada and rest of world. Also, the companies are partnering in the development and commercialization of a beta-secretase 1 (BACE) inhibitor program in AD. The oral therapy CNP520 (currently in Phase 2/3 for AD) is the lead molecule and further compounds from both companies' pre-clinical BACE inhibitor programs may be considered as follow-on molecules.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

1Lipton RB, et al. Migraine prevalence, disease burden, and the need for preventative therapy. Neurology. 2007; 68(5):343-9.
2Headache disorders - Fact sheets. World Health Organization. Accessed March 3, 2017.
3Marketscan data on file.  31March2017. Ref Type: Data File
4Hepp Z et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015; 35(6):478-88.


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