<!– imageTag: –>
<!– imageTagafter: and imageUrl: http://photos.prnewswire.com/prnvar/20081015/AMGENLOGO?max=400 –>
THOUSAND OAKS, Calif., June 19, 2015 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced positive interim results from its open-label extension of the global Phase 2, double-blind, placebo-controlled study evaluating the safety and efficacy of AMG 334 for the prevention of episodic migraine. Patients that entered the open-label phase received AMG 334 70 mg monthly and suffered a sustained reduction in monthly migraine days at week 52. The data were presented at the 57th Annual Scientific Meeting of the American Headache Society (AHS) on June 19, 2015, in Washington, D.C.
At one year, patients receiving AMG 334 70 mg suffered an standard of a -4.9-day reduction from a baseline of 8.7 mean monthly migraine days, regardless of treatment received during the blinded phase. The 50 percent responder rate (greater compared to 50 percent reduction in monthly migraine days) was 62 percent at 52 weeks. Additional responder rates were reported for the initial time: at 52 weeks the 7five percent responder rate was 38 percent and the 100 percent responder rate was 19 percent.
“These long-term data further demonstrate that AMG 334 provided meaningful benefit to these patients along with fewer migraine days and more days along with the ability to participate in job and social activities each month,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The sustained safety and efficacy shown in this interim analysis adds to the growing physique of evidence that reinforces the potential of AMG 334 for patients along with this debilitating condition. We look forward to advancing the program to recommendations fill an unmet need in migraine prevention.”
The open-label section of the Phase 2 study included 383 patients. All patients received AMG 334 70 mg starting at week 12 for up to 256 weeks. Safety and tolerability were evaluated monthly and this interim analysis includes data up to week 52. Additional efficacy endpoints included the adjustment in monthly migraine-individual medication use days and patient-reported outcomes using the Migraine Disability Assessment (MIDAS) questionnaire.
Patients reported a nearly 50 percent reduction of monthly migraine-individual medication use days of -2 at 52 weeks, from a baseline of 4.3 days per month. In addition to clinical measures, patients self-reported the impact of headache and migraine on their day-to-day activities. At one year, using the MIDAS tool, patients reported an improvement of approximately 12 days over the previous three months in their ability to function in work, estate and social situations. According to the Migraine Research Foundation, migraine costs American employers more compared to $13 billion each year as a result of 113 million lost job days.
The safety and tolerability profile during the open-label phase was similar to that observed in the blinded phase of the study. The most commonly reported side events included fatigue, influenza, nasopharyngitis, arthralgia and spine pain. No Grade 4 or five side events were reported. Serious side events were reported in 13 patients, one of which was deemed treatment-related. much less compared to five percent of patients discontinued the study during the open-label phase because of side events.
Migraine has actually been declared one of the top 10 most disabling conditions in the world, along with more compared to 10 percent of the international population suffering from the condition.1 More complex compared to simply a headache, migraines involve incapacitating head pain and physical impairment, frequently accompanied by nausea, vomiting, and aura-related sound or others sensory disturbances.2 Migraine poses a considerable burden to society, costing American employers more compared to $13 billion each year as a result of 113 million lost job days because of migraine.3 Migraine additionally has actually a tremendous impact on patients’ day-to-day lives, including job productivity and social interactions.3,4 More compared to half of people living along with migraine will certainly go undiagnosed.5
About AMG 334
AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine. AMG 334 targets the calcitonin gene-related peptide (CGRP) receptor, which is believed to transmit signals that can easily 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.
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 higher 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 actually grown to be the world’s largest independent biotechnology company, has actually reached millions of patients around the globe and is producing a pipeline of medicines along with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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, others compared to statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, others financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and others such estimates and results. Forward-looking statements involve considerable 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 short article on the uncertainties and risk factors related to our business. Unless otherwise noted, we are providing this short article as of June 19, 2015, and expressly disclaim any duty to update short article contained in this news release.
No forward-looking statement can easily be guaranteed and actual results may differ materially from those we project. Discovery or identification of brand-new product candidates or development of brand-new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can easily be no make certain that any particular product candidate or development of a brand-new indication for an existing product will certainly be successful and become a commercial product. Further, preclinical results do not make certain safe and effective performance of product candidates in humans. The complexity of the human physique cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture units or animal models. The length of time that it takes for us and our partners to finish clinical trials and obtain regulatory approval for product marketing has actually in the past varied and we expect similar variability in the future. We Create product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships could be subject to disputes between the parties or may prove to be not as effective or as safe as we may have actually believed at the time of entering in to such relationship. Also, we or others could identify safety, adverse effects or manufacturing complications along with our products after they are on the market. Our business could 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 considerable sanctions. We depend on third parties for a considerable section 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.
In addition, sales of our products (including products of our wholly-owned subsidiaries) are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and could be affected by regulatory, clinical and guideline developments and domestic and global trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete along with others companies along with respect to some of our marketed products as well as for the discovery and development of brand-new products. We believe that some of our newer products, product candidates or brand-new indications for existing products, may face competition as quickly as and as they are approved and marketed. Our products may compete versus products that have actually lower prices, established reimbursement, superior performance, are less complicated to administer, or that are otherwise competitive along with our products. In addition, while we and our partners routinely obtain patents for our and their products and technology, the protection of our products offered by patents and patent applications could be challenged, invalidated or circumvented by our or our partners’ competitors and there can easily be no make certain of our or our partners’ ability to obtain or maintain patent protection for our products or product candidates. We cannot make certain that we will certainly have the ability to make commercially successful products or maintain the commercial triumph of our existing products. Our stock price could be affected by actual or perceived market opportunity, competitive position, and triumph or failure of our products or product candidates. Further, the discovery of considerable complications along with a product similar to one of our products that implicate an entire class of products could have actually a material side effect on sales of the affected products and on our business and results of operations. Our efforts to integrate the operations of companies we have actually acquired may not be successful. We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our restructuring plan. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase common stock.
The scientific short article discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Meals and Drug Administration, and no conclusions can easily or must be drawn regarding the safety or effectiveness of the product candidates.
CONTACT: Amgen, Arvind Sood, 805-447-1060 (investors)
1 Vos et al. Years lived along 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: Chance Through Research. http://www.ninds.nih.gov/disorders/headache/detail_headache.htm. Accessed June 4, 2015.
3 Migraine Research Foundation. Migraine Fact Sheet. 2015. Available: http://www.migraineresearchfoundation.org/fact-sheet.html. Accessed June 4, 2015.
4 Scher Al, Stewart WF, Ricci JA, Lipton RB. Factors associated along with the onset and remission of chronic day-to-day headache in a population-based study. Pain. 2003 Nov: 106(102:81-9).
5 National Headache Foundation. Migraine. Oct 2007. Available: http://www.headaches.org/2007/10/25/migraine/. Accessed June 4, 2015.
Logo – http://photos.prnewswire.com/prnh/20081015/AMGENLOGO