Amgen To Present AMG 334 Data At 17th Congress of the International Headache Society

Data Evaluating Safety and Efficacy of AMG 334 Provides New Insights Into Preventive Treatment of Migraine

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May 11, 2015, 04:05 ET

THOUSAND OAKS, Calif., May 11, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced it will be presenting data for its calcitonin gene-related peptide (CGRP) receptor inhibitor AMG 334 at the 17th Congress of the International Headache Society (IHC 2015) in Valencia, Spain. AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine by inhibiting the receptor of CGRP, which has long been understood to play a role in the migraine pain pathway.

"Migraine is a debilitating condition that exerts a tremendous impact on patients' everyday lives. While current therapies have the potential to reduce the number of headache days a migraneur might experience each month, many patients who start treatment discontinue within a year due to lack of efficacy or side effects," said Sean E. Harper, M.D., executive vice president, Research and Development at Amgen. "We are excited to add these positive results to our growing body of data across our global AMG 334 clinical program and are committed to evaluating this potential treatment option for the prevention of migraine to help address a significant unmet need."

Data to be presented include results from a Phase 2 randomized, double-blind, placebo-controlled, dose-ranging study evaluating AMG 334 for the prevention of episodic migraine, as well as results from two Phase 1 studies evaluating dosing and pharmacokinetic- pharmacodynamic modeling in capsaicin-induced increase in dermal blood flow.

SELECTED ABSTRACTS OF INTEREST

AMG 334 Oral Presentations

Results of a randomized, double-blind, placebo-controlled, Phase 2 study to evaluate the efficacy and safety of AMG 334 for the prevention of episodic migraine. Abstract IHC15-0284, Oral Presentation, Friday, May 15, 10:00 a.m. to
11:00 a.m. CEDT

AMG 334 Poster Presentations

Phase 1, randomized, double-blind, placebo-controlled, single-dose and multiple-dose studies of AMG 334 in healthy subjects and migraine patients. Abstract IHC15-0266. Poster available to view from Thursday, May 14 at 12:30 p.m. CEDT until Friday, May 15 at 8:30 p.m. CEDT
Pharmacokinetic/pharmacodynamics modeling of monoclonal antibody AMG 334 to characterize concentration relationship with capsaicin-induced increase in dermal blood flow in healthy subjects and migraine patients. Abstract IHC15-0285; Lunch Session I: Friday, May 15, 1:00 p.m. CEDT and poster available to view from Thursday, May 14 at 12:30 p.m. CEDT until Friday, May 15 at 8:30 p.m. CEDT

Additional Abstracts of Interest

Understanding reasons for patient non-adherence to prophylactic migraine medications. Abstract IHC15-0451. Poster available to view from Thursday, May 14 at 12:30 p.m. CEDT until Friday, May 15 at 8:30 p.m. CEDT
Treatment patterns for migraine patients receiving prophylaxis. Abstract IHC15-0273. Poster available to view from Thursday, May 14 at 12:30 p.m. CEDT until Friday, May 15 at 8:30 p.m. CEDT

About Migraine

Migraine has been declared one of the top 10 most disabling conditions in the world, with more than 10 percent of the worldwide population suffering from the condition.[1] More complex than just a headache, migraines involve incapacitating head pain and physical impairment, frequently accompanied by nausea, vomiting, and aura-related sound or other sensory disturbances.[2] Migraine has a tremendous impact on patients' everyday lives, including work productivity and social interactions.[3]^,[4] Approximately 50 percent of people living with migraine will go undiagnosed.[5]

About AMG 334

AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine. AMG 334 inhibits the CGRP receptor, rather than CGRP itself, which is believed to transmit signals that can cause incapacitating pain.

AMG 334 is currently under evaluation in several large, global, randomized, double-blind, placebo-controlled studies to evaluate its safety and efficacy in migraine prevention.

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 biologics manufacturing 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.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Forward Looking Statements

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CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Cuyler Mayer, 805-447-6332 (media)
Arvind Sood, 805-447-1060 (investors)

[1] Vos et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. The Lancet. 2012 Dec-2013 Jan;30(9859):2163-2196.
[2] National Institute for Neurological Disorders and Stroke. Headache: Hope Through Research. http://www.ninds.nih.gov/disorders/headache/detail_headache.htm. Accessed April 20, 2015.
[3] Migraine Research Foundation. Migraine Fact Sheet. http://www.migraineresearchfoundation.org/fact-sheet.html. Accessed April 17, 2015.
[4] Scher Al, Stewart WF, Ricci JA, Lipton RB. Factors associated with the onset and remission of chronic daily headache in a population-based study. Pain. 2003 Nov: 106(102:81-9)
[5] National Headache Foundation. Facts About Migraine. Available: http://www.headaches.org/press/NHF_Press_Kits/Press_Kits_-_Facts_About_Migraine. Accessed March 27, 2015.

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