THOUSAND OAKS, Calif., June 8, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced positive top-line results from the global Phase 2 study evaluating the efficacy and safety of erenumab (AMG 334) in chronic migraine prevention. The study met its primary endpoint of change in monthly migraine days. The reduction in migraine days was statistically significant for both the 70 mg and 140 mg doses.
"Migraine is the sixth leading cause of disability worldwide. Three to seven million Americans spend more than half of each month living with the debilitating symptoms of chronic migraine," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "These positive results are exciting because they add to the growing body of evidence supporting erenumab for the prevention of migraine. We look forward to Phase 3 episodic migraine data later this year."
At baseline, patients enrolled in this study were experiencing approximately 18 migraine days per month. Patients were randomized to receive either placebo, or one of two erenumab doses — 70 mg or 140 mg — subcutaneously, once monthly. Patients experienced a 6.6-day reduction from baseline in monthly migraine days in each of the erenumab treatment arms as compared to a 4.2-day reduction in the placebo arm, a statistically significant reduction in each erenumab treatment arm.
The safety profile of erenumab was similar to placebo across both treatment arms. No adverse event was reported in greater than five percent of patients treated with erenumab; the most common adverse events were injection site pain, upper respiratory tract infection and nausea.
Additional analyses of these data are ongoing and will be submitted to a future medical meeting and for publication.
About the 20120295 Study
The 20120295 study is a global Phase 2, randomized, 12-week, double-blind, placebo-controlled study evaluating the safety and efficacy of erenumab in chronic migraine prevention. In the study, 667 patients were randomized to receive once-monthly subcutaneous placebo or erenumab (70 mg or 140 mg) in a 3:2:2 ratio, respectively. The primary endpoint was change in monthly migraine days from baseline to the last four weeks of the 12-week treatment phase in patients with chronic migraine (the number of migraine days between weeks 9 and 12). Secondary study endpoints included reduction of at least 50 percent from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication days and change from baseline in cumulative monthly headache hours.
Erenumab is a fully human monoclonal antibody under investigation for the prevention of migraine. Erenumab specifically targets the Calcitonin-Gene-Related-Peptide (CGRP) receptor, which is believed to transmit signals that can cause incapacitating pain. Erenumab is currently under evaluation in several large global, randomized, double-blind, placebo-controlled trials to assess its safety and efficacy in migraine prevention.
Migraine involves incapacitating head pain and physical impairment, frequently accompanied by nausea, vomiting, and aura-related sound or other sensory disturbances.1 Migraine is associated with personal and societal burdens of pain, disability, and financial cost, and it remains under-recognized and under-treated with more than 40 percent of people going undiagnosed.2,3 In the U.S., between three and seven million Americans suffer from chronic migraine, with at least 15 headache days per month with at least eight days being migraine.4
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 (currently in Phase 3 studies for episodic migraine and a Phase 2 study for chronic migraine) and AMG 301 (currently in a Phase 1 study for migraine). For the migraine program, Amgen retains commercialization rights in the U.S., Canada and Japan, and Novartis has commercialization rights in Europe and rest of world. Also, the companies are partnering in the development and commercialization of a beta-secretase 1 (BACE) inhibitor program in AD. Novartis' oral therapy CNP520 (currently in a Phase 1/2a study for AD) will be the lead molecule and further compounds from both companies' pre-clinical BACE inhibitor programs may be considered as follow-on molecules.
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.
Forward Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
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1 National Institute for Neurological Disorders and Stroke. Headache: Hope Through Research. http://www.ninds.nih.gov/disorders/headache/detail_headache.htm. Accessed June 6, 2016.
2 World Health Organization. Headache disorders. http://www.who.int/mediacentre/factsheets/fs277/en/. Updated April 2016. Accessed June 6, 2016.
3 Diamond S et al. Patterns of Diagnosis and Acute and Preventive Treatment for Migraine in the United States: Results from the American Migraine Prevalence and Prevention Study. Headache. 2007; 47(3): 355-63.
4 Vimont C. "Chronic Migraine Impacts Entire Family." Practical Pain Management. http://www.practicalpainmanagement.com/patient/conditions/headache/chronic-migraine-impacts-entire-family. Updated November 19, 2015. Accessed June 6, 2016.
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