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

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

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen, we or us) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. 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 Inc., including Amgen Inc.'s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, we are providing this information as of May 11, 2015, and expressly disclaim any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us and our partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.

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The scientific information discussed in this news release related to our product candidates is preliminary and investigative.  Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

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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