"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
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
AMG 334 Poster Presentations
Additional Abstracts of Interest
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. 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. Migraine has a tremendous impact on patients' everyday lives, including work productivity and social interactions., Approximately 50 percent of people living with migraine will go undiagnosed.
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.
Forward Looking Statements
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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
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