FDA Accepts Biologics License Application For Aimovig™ (erenumab)

Aimovig is an Investigative Migraine-Specific Preventive Therapy Designed for Patients With High Unmet Need

Migraine is Associated With Pain, Disability and Nearly $25 Billion in Annual U.S. Healthcare Costs[1],[2]

THOUSAND OAKS, CA, USA I July 20, 2017 I Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Aimovig™ (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month. If approved, Aimovig is expected to be the first-and-only monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, specifically designed for the prevention of migraine.

"Migraine is a serious neurological disease that has a substantial economic burden for both patients and the healthcare system, yet it continues to be under recognized and under treated," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are pleased to advance Aimovig, our migraine-specific preventive therapy, to help address the unmet need in this community and potentially mitigate the overall burden of this disease for patients who have already tried other therapeutic options."

The BLA for Aimovig includes data from pivotal studies of more than 2,600 patients experiencing four or more days of migraine per month. Phase 2 and Phase 3 clinical studies of Aimovig versus placebo have demonstrated a reduction in the number of migraine-affected days, disability and acute medication use for patients with episodic and chronic migraine. The safety profile of Aimovig was similar to placebo across all treatment arms in the Phase 2 and Phase 3 studies for up to six months. The most common adverse events across the studies were upper respiratory tract infection, injection site pain, nausea and nasopharyngitis.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 17, 2018.

Aimovig will be jointly commercialized in the U.S. by Amgen and Novartis.

About Aimovig™ (erenumab)
Aimovig is the only fully human monoclonal antibody specifically designed for the prevention of migraine that has been filed with the FDA. Aimovig specifically inhibits the receptor of the calcitonin gene-related peptide (CGRP), which is thought to play a causal role in migraine pathophysiology. Aimovig 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.3 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.3 The World Health Organization ranks migraine as one of the most debilitating illnesses.4 For the approximately 10 million Americans whose migraine frequency or severity impacts daily activities, preventive medications may be an option.5 Approximately 3.5 million of these patients are currently on a preventive therapy, but up to 80 percent discontinue these within one year.5,6 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 Aimovig (BLA accepted by the FDA in July 2017) and AMG 301 (currently in Phase 1 development). In April 2017, the collaboration was expanded to include co-commercialization of Aimovig in the U.S. For the migraine program, Amgen retains exclusive rights in Japan, and Novartis has exclusive rights in Europe, Canada and rest of world. Also, the companies are collaborating in the development and commercialization of a beta-secretase 1 (BACE) inhibitor program in AD. The oral therapy CNP520 (currently in Phase 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.

References
1 American Migraine Foundation. The Burden of Migraine. 
https://americanmigrainefoundation.org/living-with-migraines/. Accessed July 11, 2017. 
2 Hawkins K, Wang S, Rupnow M. Direct cost burden among insured US employees with migraine.
Headache. 2008;48(4):553-563.
3 Lipton RB, et al. Migraine prevalence, disease burden, and the need for preventative therapy. Neurology. 2007; 68(5):343-9. 
4 Headache disorders - Fact sheets. World Health Organization. http://www.who.int/mediacentre/factsheets/fs277/en/. Accessed March 3, 2017. 
5 Marketscan data on file. March 31, 2017. Ref Type: Data File
6 Hepp Z et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015; 35(6):478-88.

SOURCE: Amgen

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