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Share Name | Share Symbol | Market | Type |
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Amgen Inc | NASDAQ:AMGN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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33.02 | 11.86% | 311.41 | 311.40 | 320.00 | 322.54 | 308.68 | 313.42 | 9,644,684 | 05:00:03 |
THOUSAND OAKS, Calif., June 3, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the launch of KYPROLIS CENTRAL, an online media resource about the impact of living with relapsed or refractory multiple myeloma. Intended to drive awareness of a rare blood cancer that is increasingly becoming more prevalent in the United States (U.S.), KYPROLIS CENTRAL provides real-life stories from relapsed multiple myeloma patients, as well as educational materials and third party resources.1
Experience the interactive Multimedia News Release here: http://www.multivu.com/players/English/7811631-kyprolis-central/
"In my opinion, one of the most difficult parts of living with multiple myeloma is the uncertainty. Relapse is always in the back of my mind," said Michele A., a relapsed multiple myeloma patient from Ludlow, Mass. "I've found that talking to others helps me cope with this uncertainty, and I hope that sharing my story publicly will generate more awareness and help others navigating relapsed multiple myeloma."
Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.2 It is a disease that, in 2012, accounted for approximately one percent of all cancers globally.3,4 In the U.S., there were more than 95,000 people living with, or in remission from, multiple myeloma in 2013.1
Each of the patients featured on KYPROLIS CENTRAL has been treated with Kyprolis® (carfilzomib) following a relapse. Kyprolis is a second-generation proteasome inhibitor indicated in the U.S. in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.5,6 Kyprolis is also indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.6
Resources available on KYPROLIS CENTRAL are intended to share the experiences of patients living with relapsed multiple myeloma and educate about this complex disease. With each relapse, disease burden worsens, which can have a great impact on patients.7 The journey back to remission requires teamwork and patients need to know they are not alone.
About Kyprolis® (carfilzomib)
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.8 Kyprolis has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.8 In some cells, Kyprolis can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.8,9
Kyprolis is approved in the U.S. for the following:
Kyprolis is also approved in Argentina, Israel, Kuwait, Mexico, Thailand, Colombia, Korea, Canada, Switzerland, Russia, and the European Union. Additional regulatory applications for Kyprolis are underway and have been submitted to health authorities worldwide.
For more information, please visit www.kyprolis.com.
Patient Support Program
Onyx Pharmaceuticals 360™ is a patient support program that provides patients prescribed Kyprolis with an Onyx Oncology Nurse Ambassador (ONA). The ONA is a single point of contact who takes the time to help Kyprolis patients and their caregivers identify supports and resources most important to them based on their particular needs, and helps facilitate those connections allowing patients and their caregivers time to focus on treatment. Whether it's helping patients with insurance verification for Kyprolis, with connections to local independent third-party organizations that may provide transportation and lodging assistance, helping connect to programs that may be able to help to make treatment more affordable, or helping connect with other patients through a network of independent third-party organizations, program ONAs are available. Connections with independent third-party organizations are made as a courtesy and Amgen has no influence over program requirements or eligibility/acceptance criteria. For more information, please visit www.kyprolis.com/assistance-during-treatment.
Important Safety Information Regarding Kyprolis® (carfilzomib) for Injection
INDICATIONS
IMPORTANT SAFETY INFORMATION
Cardiac Toxicities
Acute Renal Failure
Tumor Lysis Syndrome
Pulmonary Toxicity
Pulmonary Hypertension
Dyspnea
Hypertension
Venous Thrombosis
Infusion Reactions
Thrombocytopenia
Hepatic Toxicity and Hepatic Failure
Thrombotic Microangiopathy
Posterior Reversible Encephalopathy Syndrome (PRES)
Embryo-fetal Toxicity
ADVERSE REACTIONS
Please see full Prescribing Information at www.kyprolis.com.
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 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.
About Amgen's Commitment to Oncology
Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen's supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.
Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. 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, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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 to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. 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 results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. 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. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. 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. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. We are increasingly dependent on information technology systems, infrastructure and data security. Our stock price is volatile and may be affected by a number of events. 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 our common stock.
The scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.
References
1. National Cancer Institute. SEER Stat Fact Sheets: Myeloma.
2. Jakubowiak A. Management Strategies for Relapsed/Refractory Multiple Myeloma: Current Clinical Perspectives. Semin Hematol. 2012; 49(suppl 1):S16-S32.|3. International Agency for Research on Cancer, GLOBOCAN 2012 database.
4. American Cancer Society. Multiple Myeloma.
5. Orlowski RZ and Kuhn DJ. Proteasome Inhibitors in Cancer Therapy: Lessons from the First Decade. Clin Cancer Res. 2008; 14(6):1649-1657.
6. KYPROLIS® [prescribing information]. Thousand Oaks, CA: Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 2016.
7. Song X, Cong Z and Wilson K. Real-world tretatment patterns, comorbidities, and disease-related complications in patients with multiple myeloma in the United States. Curr Med Res Opin. 2016;32(1):95-103.
8. Moreau P, Richardson PG, Cavo M, et al. Proteasome Inhibitors in Multiple Myeloma: 10 Years Later. Blood. 2012; 120(5):947-959.
9. Kortuem KM and Stewart AK. Carfilzomib. Blood. 2012; 121(6):893-897.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/amgen-announces-launch-of-kyprolis-carfilzomib-central-an-online-news-resource-demonstrating-the-impact-of-relapsed-multiple-myeloma-on-the-lives-of-patients-and-caregivers-300279583.html
SOURCE Amgen
Copyright 2016 PR Newswire
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