Full Press Release Details
THOUSAND OAKS, Calif. , Nov. 1, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced that new clinical data will be presented at the 60 th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego , Dec. 1-4, 2018 . Data across an array of malignancies will be featured in 45 abstracts, including nine oral presentations, from the Company's broad portfolio and early-stage pipeline.
The breadth of data to be presented at ASH this year represent Amgen's continued search for answers to complex scientific questions, leveraging its long-standing expertise in blood cancers to develop early immuno-oncology pipeline candidates and innovative biologics in areas of significant unmet need. Notable data include two oral presentations on first-in-human studies evaluating two early-stage bi-specific T cell engager (BiTE ® ) molecules – AMG 420 and AMG 330. BiTE ® molecules are designed to harness the immune system and can be modified in an effort to enable cytotoxic T cells in the body to recognize cancer cells and destroy them. Additional data from Amgen's hematology franchise will also be featured, including long-term overall survival (OS) data for BLINCYTO ® (blinatumomab) in patients who had achieved complete minimal residual disease (MRD) response and for once-weekly dosing of KYPROLIS ® (carfilzomib) in combination with dexamethasone.
"For nearly four decades, Amgen has been at the forefront of cutting-edge science that has helped change treatment paradigms for patients with difficult-to-treat blood cancers. Today, we are on the cusp of a new wave of advances that harness the body's own immune system to transform cancer care," said David M. Reese , M.D., executive vice president of Research and Development at Amgen. "We're excited to present the first data from our early oncology pipeline, including two investigational BiTE ® candidates, which demonstrate our commitment to tackling the toughest scientific questions for cancer patients."
A complete listing of abstracts can be found on the ASH website. Notable abstracts of interest include:
Expanding Investigation of BiTE ® Across Hematologic Malignancies
Evaluating Outcomes in Multiple Myeloma
Amgen Webcast Investor Meeting Amgen will host a webcast investor meeting at ASH 2018 on Monday, Dec. 3 at 8 p.m. PT . David M. Reese , M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's clinical development team and clinical investigators, will participate at the investor meeting to discuss Amgen's oncology program and data presented at ASH 2018.
Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
About BiTE ® Technology Bispecific T cell engager (BiTE ® ) antibody construct is an innovative technology that can be engineered to target any tumor antigen expressed by any type of cancer. The protein molecules are designed to kill malignant cells using the patient's own immune system by bridging T cells to tumor cells. BiTE ® antibody construct helps connect the T cells to the targeted cell, with the intent of causing T cells to inject toxins which trigger cancer cell death (apoptosis). Amgen is developing BiTE ® antibody constructs to uniquely (or specifically) target numerous hematologic malignancies and solid tumors.
About BLINCYTO ® (blinatumomab) BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE ® ) immunotherapy that binds to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of effector T cells. BLINCYTO was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration (FDA) in 2014, and now carries full approval in the U.S. for the treatment of relapsed or refractory B-cell precursor ALL in adults and children. In the U.S., BLINCYTO is also approved under accelerated approval for the treatment of adults and children with B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent.
BLINCYTO is now approved in 57 countries, including all member countries in the European Union and the European Economic Area, Canada , Japan , and Australia .
BLINCYTO ® U.S. Product Safety Information
Indication and Important Safety Information, including Boxed WARNINGS, for BLINCYTO ® (blinatumomab) for injection, for intravenous use
BLINCYTO is indicated for the treatment of adults and children with:
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
Contraindications
BLINCYTO ® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.
Warnings and Precautions
Adverse Reactions
Dosage and Administration Guidelines
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for BLINCYTO ® .
About Multiple Myeloma Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse. 1 It is a rare disease that accounts for approximately two percent of all cancers. 2 Worldwide, approximately 114,000 people are diagnosed with multiple myeloma each year and 80,000 patient deaths are reported on an annual basis. 2
About KYPROLIS ® (carfilzomib) Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed. 3 KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells. 4 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. 3,4
Since its first approval in 2012, approximately 80,000 patients worldwide have received KYPROLIS. KYPROLIS is approved in the U.S. for the following:
KYPROLIS is also approved in Argentina, Australia, Bahrain, Canada, Hong Kong, Israel , Japan , Kuwait, Lebanon, Macao, Mexico, Thailand, Colombia, South Korea, Turkey, United Arab Emirates, Qatar, Switzerland , Russia, Brazil, India, Oman and additional U.S. regulatory applications for KYPROLIS are underway and have been submitted to health authorities worldwide.
Important U.S. KYPROLIS ® (carfilzomib) Safety Information
Cardiac Toxicities
Acute Renal Failure
Tumor Lysis Syndrome
Pulmonary Toxicity
Pulmonary Hypertension
Venous Thrombosis
Infusion Reactions
Thrombocytopenia
Hepatic Toxicity and Hepatic Failure
Thrombotic Microangiopathy
Posterior Reversible Encephalopathy Syndrome (PRES)
Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible Patients
Embryo-fetal Toxicity
ADVERSE REACTIONS
Please see full Prescribing Information at www.kyprolis.com .
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.
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.
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 current reports on 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, including our devices, 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. 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, including in Puerto Rico , 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. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. 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. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. 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. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
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 European Medicines Agency 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.
CONTACT: Amgen, Thousand Oaks Kristen Davis , 805-447-3008 (Media) Andrea Fassaceisa, 805- 905-2575 (Media) Arvind Sood , 805-447-1060 (Investors)
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