Enclose phrases in quotes. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Dyspnea was reported in 35% of patients enrolled in clinical trials. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen's products after they are on the market. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen's business and results of operations. Amgen wanted to get in early to tap an expected surge in the blood-cancer drug's growth, Bradway said. Those line extensions didn’t exactly go as planned. Full prescribing information is available at http://www.kyprolis.com. 1National Cancer Institute. There were 37 deaths in the Phase 2 studies, or 7% of patients. Amgen, for its part, pointed to double-digit volume increases for the drug on its third-quarter earnings conference call. 2International Agency for Research on Cancer, GLOBOCAN 2012 database. Unless otherwise noted, Amgen is providing this information as of Aug. 4, 2014 and expressly disclaims any duty to update information contained in this news release. Last year, for example, Bristol-Myers Squibb bought Inhibitex and Amylin Pharmaceuticals to gain individual treatments for diabetes and hepatitis C. The chief executives for both Pfizer and Merck & Co. have said this year that they prefer similar "bolt-ons," rather than mergers that come with a slate of products. Reproduction in whole or part is prohibited. Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. We do many things differently, leveraging our people’s ideas along with the latest technology to solve real problems Patients treated with Kyprolis® (carfilzomib) for Injection in combination with Revlimid® (lenalidomide) and low-dose dexamethasone (KRd) lived significantly longer without their disease worsening (median 26.3 months) compared to patients treated with Revlimid and low-dose dexamethasone (Rd) (median 17.6 months) (HR=0.690, 95 percent CI, 0.570, 0.834, p<0.0001). Alexion engaged Goldman Sachs as an adviser as it prepared for a possible takeover offer from Roche Holding, people with knowledge of the matter said last month. Onyx is an innovative eCommerce technology company focused on creating custom infrastructure and unique user experience for niche marketplaces. At the same time, the deal may signal that prices may be dropping for biotechnology generally, Schoenebaum said. Onyx has an important and growing multiple myeloma franchise, with Kyprolis ® (carfilzomib) for Injection already approved in the United States (U.S.). E-mail: darmstrong17@bloomberg.net, FILE - This March 1, 2005 file photo shows one of many buildings at Amgen's wooded, sprawling headquarters complex in Thousand Oaks, Calif., Amgen Inc. releases its quarterly earnings Tuesday, July 30, 2013. Amgen Announces Phase 3 ASPIRE Trial of Kyprolis in Patients with Relapsed Multiple Myeloma Met Primary Endpoint THOUSAND OAKS, Calif.... | September 25, 2020 "Kyprolis grew 15% year-on-year driven primarily by 12% volume growth with the breadth of prescribers continuing to increase. And then there are Kyprolis’ myeloma competitors, which have multiplied in recent years. 3Cancer Research UK. Securing your long-term growth for $10 billion, I think you made a good acquisition.". The next buyout within the drug industry may involve Alexion Pharmaceuticals, another single-product company whose blood-disease treatment Soliris generated $1.1 billion in sales last year as one of the world's most expensive medicines. Sorafenib has also been evaluated in other types of cancer, including those of the thyroid (as a treatment of last resort) and breast (in comparison to capecitabine). Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. That’s still up for debate. The results of the ASPIRE study demonstrate that Kyprolis can significantly extend the time patients live without their disease progressing," said Pablo J. Cagnoni, M.D., president, Onyx Pharmaceuticals, Inc. "The ability of novel therapies to produce deep and durable responses may, one day, transform this uniformly fatal disease to one that is chronic and manageable.". The safety profile observed in this study is consistent with the current U.S. Kyprolis label, including the rate of cardiac events. Clinical benefit, such as improvement in survival or symptoms, has not been verified. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. Particularly with Amgen’s top sellers staring down a future full of biosimilar competition, it sounded like a nice prospect. "It's a steal for Amgen," said Ori Hershkovitz, a partner at Sphera Funds Management, a healthcare hedge fund. THOUSAND OAKS, Calif., Oct. 1, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it has successfully completed its previously announced tender offer to purchase all outstanding shares of common stock of Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) for $125 per share in cash. Death due to cardiac arrest has occurred within a day of Kyprolis administration. Amgen Inc. agreed to buy Onyx Pharmaceuticals Inc. in a $10.4 billion transaction that gives Amgen access to a rapidly expanding cancer-drug market with … The international, randomized Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial evaluated Kyprolis in combination with lenalidomide and low-dose dexamethasone, versus lenalidomide and low-dose dexamethasone alone, in patients with relapsed multiple myeloma following treatment with one to three prior regimens. Amgen's deal for Onyx follows similar agreements featuring a small number of already-marketed or late-stage experimental drugs. Important warnings and precautions include cardiac arrest, congestive heart failure, myocardial ischemia; pulmonary hypertension, pulmonary complications, infusion reactions, tumor lysis syndrome, thrombocytopenia, hepatic toxicity and embryo-fetal toxicity. - Aug 04, 2014, Kyprolis Helped Patients Live 8.7 Months Longer Without Their Disease Worsening, Results to Form Basis of Regulatory Filings Beginning in 1H 2015. Amgen's stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. While the data for overall survival, a secondary endpoint, are not yet mature, the analysis showed a trend in favor of KRd that did not reach statistical significance. Onyx conducted the ASPIRE study under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) and has received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the study. "Amgen has a unique opportunity to add value to Kyprolis, a product which is at an early and promising stage of its launch," CEO Bob Bradway said in a statement the day the companies unveiled the deal. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. With $778 million in worldwide sales through the first nine months of the year, Kyprolis is in position to eke its way across the blockbuster barrier in 2019 for the first time. Cases of hepatic failure, including fatal cases, have been reported (< 1%). 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. When Amgen agreed to nab Onyx for $10.4 billion back in 2013, some analysts were predicting up to $3 billion in peak sales for multiple myeloma drug Kyprolis—but Kyprolis didn’t come anywhere close. 3 Speen Street, Suite 300, Framingham, MA 01701. Drew Armstrong is a Bloomberg reporter. http://seer.cancer.gov/statfacts/html/mulmy.html, http://www.cancerresearchuk.org/cancer-info/cancerstats/types/myeloma/incidence/uk-multiple-myeloma-incidence-statistics#europeandworldwide. One reason? Kyprolis can cause elevations of serum transaminases and bilirubin. Administration of dexamethasone prior to Kyprolis reduces the incidence and severity of reactions. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. In Europe, approximately 89,000 people are living with multiple myeloma, and approximately 39,000 new cases are diagnosed annually3. No new safety signals were identified. Amgen agreed to buy Onyx Pharmaceuticals of South San Francisco in a $10.4 billion transaction that gives Amgen access to a rapidly expanding cancer-drug market with a … Onyx gained nearly 6 percent. The next wave of immuno-oncology R&D includes drugs that interact with a wide range of emerging immune targets, including TIGIT and CD47. Formerly based in South San Francisco, California, Onyx Pharmaceuticals was engaged in the development and commercialization of innovative therapies for improving the lives of … Kyprolis is an important building block in our robust, differentiated pipeline. 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