Press Release

THOUSAND OAKS, Calif., Oct. 9, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the 观看比赛直播 观看比赛直播 U.S. Food and Drug Administration ( FDA) has accepted for review the Biologics License Application (BLA) for the investigational bispecific T cell engager (BiTE^®) antibody construct, blinatumomab. The BLA is for the 世界杯直播频道 世界杯直播频道 世界杯直播频道 treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer 世界杯直播频道 of the blood and 世界杯直播频道 bone marrow.¹ As part of the acceptance, 世界杯直播频道 世界杯直播频道 the FDA granted blinatumomab priority review with a Prescription Drug User Fee Act (PDUFA) action date of 世界杯直播频道 观看比赛直播 May 19, 2015.

A Marketing Authorization Application (MAA) has also been submitted to the 观看比赛直播 世界杯直播频道 European Medicines Agency (EMA) via the centralized procedure for approval to market blinatumomab for the treatment of adults with Ph- relapsed/refractory B-precursor ALL.

The submissions include data from a Phase 2 trial of adult patients with 世界杯直播频道 Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which met its primary endpoint.

"The 观看比赛直播 世界杯直播频道 FDA's acceptance of our BLA submission and designation of 观看比赛直播 世界杯直播频道 priority review for blinatumomab underscores the need to provide new treatment approaches for adult patients with relapsed or refractory 观看比赛直播 世界杯直播频道 ALL, and we are encouraged by the Agency's expedited review," said 世界杯直播频道 Sean E. Harper, M.D., executive vice president of Research and Development at 观看比赛直播 Amgen. "Blinatumomab has the potential to make a significant impact for these patients, and this milestone, along with other ongoing filings around the world, represents the potential of BiTE^® 世界杯直播频道 technology in cancers that are challenging to treat."

BiTE^® antibody constructs represent an innovative immunotherapy approach that helps the body's immune system target cancer cells. Blinatumomab, the first of the investigational BiTE^® 世界杯直播频道 antibody constructs, 世界杯直播频道 has received orphan drug designation from the EMA and 世界杯直播频道 观看比赛直播 FDA, and breakthrough therapy and priority review designation from the 观看比赛直播 观看比赛直播 FDA for the treatment of ALL.

According to the FDA, priority review designation is assigned to applications for drugs that treat serious conditions and would, if approved, 世界杯直播频道 provide significant improvements in the safety or effectiveness of the 世界杯直播频道 世界杯直播频道 treatment, diagnosis, or prevention of serious conditions. A priority review designation will set a goal date for taking action on an application within six months of receipt.

In the U.S., more than 6,000 cases of ALL will be diagnosed in 2014, and in the 世界杯直播频道 世界杯直播频道 European Union, it is estimated that more than 7,000 cases of ALL are diagnosed each year.^2,3 In adult patients 世界杯直播频道 with relapsed or refractory ALL, median overall survival is just three 世界杯直播频道 世界杯直播频道 观看比赛直播 to five months.⁴

About BiTE^® Technology
Bispecific T cell engager (BiTE^®) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the 世界杯直播频道 body's immune system 世界杯直播频道 to detect and target malignant cells. The modified antibodies are designed to engage two 观看比赛直播 different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell 世界杯直播频道 观看比赛直播 capable of killing 世界杯直播频道 other cells perceived as threats) to cancer cells. BiTE^® antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T 观看比赛直播 世界杯直播频道 世界杯直播频道 cells to inject toxins 世界杯直播频道 and trigger the cancer cell to die (apoptosis). BiTE^® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers. For more information, visit http://www.biteantibodies.com/.

About Blinatumomab
Blinatumomab is an investigational BiTE^® antibody construct designed to 世界杯直播频道 direct the 观看比赛直播 body's cell-destroying T cells against target cells expressing CD19, a protein 世界杯直播频道 观看比赛直播 found on the surface of B-cell derived leukemias and lymphomas. Blinatumomab is the first of the BiTE^® antibody constructs and 世界杯直播频道 Amgen 世界杯直播频道 has received orphan drug designation from the 世界杯直播频道 世界杯直播频道 FDA for the 观看比赛直播 treatment of ALL, chronic lymphocytic leukemia (CLL), hairy cell leukemia, prolymphocytic leukemia and indolent B-cell lymphoma and from the 观看比赛直播 世界杯直播频道 European Medicines Agency for the treatment of indolent B-cell lymphoma, ALL, CLL and mantle cell leukemia (MCL). Blinatumomab is also being investigated for its potential to treat pediatric relapsed/refractory 观看比赛直播 观看比赛直播 ALL, relapsed/refractory 世界杯直播频道 Philadelphia positive (Ph+) B-precursor ALL, minimal residual disease positive (MRD+) B-precursor ALL, relapsed/refractory non-Hodgkin's lymphoma ( 世界杯直播频道 世界杯直播频道 NHL), including relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

About ALL
Acute lymphoblastic leukemia (ALL) is an aggressive cancer of the blood and bone marrow, the spongy tissue inside bones where blood cells are made.¹ The 世界杯直播频道 disease progresses 世界杯直播频道 观看比赛直播 rapidly and affects immature blood cells. Worldwide, ALL accounts for more than 12 percent of leukemia. Of the 42,000 观看比赛直播 people diagnosed worldwide, 31,000 will die from the disease. Patients with ALL have 观看比赛直播 abnormal white blood cells (lymphocytes) that crowd 观看比赛直播 out healthy white 世界杯直播频道 blood cells, red blood cells and platelets, leading to infection, anemia (fatigue), easy bleeding and other serious side effects.⁵

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing 观看比赛直播 and 观看比赛直播 delivering innovative human therapeutics. This 世界杯直播频道 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 biologics manufacturing expertise to strive for solutions that 观看比赛直播 improve health outcomes and dramatically improve 观看比赛直播 people's lives. A biotechnology pioneer since 1980, 世界杯直播频道 世界杯直播频道 世界杯直播频道 Amgen has grown to be the 世界杯直播频道 world's largest independent biotechnology company, has 观看比赛直播 reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 世界杯直播频道 观看比赛直播 世界杯直播频道

For more information, visit http://www.amgen.com/ and follow us on www.twitter.com/amgen.

Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen 世界杯直播频道 Inc. and its subsidiaries ( 观看比赛直播 观看比赛直播 世界杯直播频道 Amgen or us) 观看比赛直播 and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements 世界杯直播频道 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 观看比赛直播 below and more fully described in the 世界杯直播频道 世界杯直播频道 Securities and Exchange Commission ( 世界杯直播频道 SEC) reports filed by 观看比赛直播 Amgen Inc., including 世界杯直播频道 世界杯直播频道 世界杯直播频道 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 观看比赛直播 Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of 世界杯直播频道 Oct. 9, 2014, and expressly disclaims any duty to update information contained in this news release.

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 世界杯直播频道 development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no 世界杯直播频道 guarantee that any particular product candidate or development of a new indication 世界杯直播频道 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 世界杯直播频道 观看比赛直播 of the human body cannot be perfectly, or sometimes, even adequately 观看比赛直播 modeled by computer or cell culture systems or animal models. The length of time that it takes for us 世界杯直播频道 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 世界杯直播频道 the future. We develop product candidates internally and through licensing 世界杯直播频道 collaborations, partnerships and joint ventures. Product candidates that are 世界杯直播频道 derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as 世界杯直播频道 we may have believed at the time of entering into such relationship. Also, 世界杯直播频道 we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our 世界杯直播频道 观看比赛直播 business may be 观看比赛直播 impacted by government investigations, litigation and product liability claims. If we fail 观看比赛直播 to meet the compliance obligations in the corporate integrity agreement between us and the U.S. 世界杯直播频道 世界杯直播频道 世界杯直播频道 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 世界杯直播频道 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 观看比赛直播 世界杯直播频道 世界杯直播频道 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 as well 世界杯直播频道 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 with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product 观看比赛直播 candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against 观看比赛直播 products that have lower prices, established reimbursement, 世界杯直播频道 superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while Amgen 世界杯直播频道 and its partners routinely obtain patents for their products and technology, the protection of our products offered by patents and patent applications may be challenged, invalidated or circumvented 世界杯直播频道 世界杯直播频道 by our or our partners' competitors and there can be no guarantee of our or our partners' ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee 世界杯直播频道 that 世界杯直播频道 we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive 世界杯直播频道 position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our 观看比赛直播 products that implicate an entire class of 世界杯直播频道 products could have a material adverse effect on sales of the affected products and on our business and results 世界杯直播频道 of operations. Our efforts to integrate the operations of companies we have acquired may 世界杯直播频道 世界杯直播频道 not be successful. Cost saving initiatives may result in us incurring impairment or other related charges on our assets. We may experience difficulties, delays or unexpected costs and not achieve anticipated 世界杯直播频道 benefits and savings from our recently announced restructuring plans. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or their ability to pay 观看比赛直播 世界杯直播频道 世界杯直播频道 a dividend 观看比赛直播 or repurchase our common stock.

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 U.S. Food and Drug Administration ( 世界杯直播频道 FDA), the European Medicines Agency (EMA) or other similar 世界杯直播频道 regulatory authorities, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

CONTACT: 世界杯直播频道 观看比赛直播 世界杯直播频道 Amgen, 观看比赛直播 世界杯直播频道 Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Arvind Sood, 805-447-1060 (investors)

References
1. Mayo Clinic. "Acute lymphocytic leukemia." 世界杯直播频道 Available at: 观看比赛直播 http://www.mayoclinic.com/health/acute-lymphocytic-leukemia/DS00558. Accessed on 世界杯直播频道 世界杯直播频道 观看比赛直播 世界杯直播频道 September 29, 世界杯直播频道 2014.
2. Gatta G, Maarten van der Zwan J, Casali P, et. al. Rare cancers are not so rare: The rare cancer burden in 世界杯直播频道 Europe. Eur J Cancer. 2011;47:2493-2511.
3. 观看比赛直播 世界杯直播频道 观看比赛直播 American Cancer Society. "Leukemia-Acute Lymphocytic." Available at: http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-key-statistics. Accessed 观看比赛直播 September 15, 2014.
4. 观看比赛直播 世界杯直播频道 Advani A.S. 观看比赛直播 New immune strategies for the treatment of acute lymphoblastic leukemia: Antibodies and chimeric antigen receptors. Hematology Am Soc Hematol Educ Program. 2013;2013:131-7. 观看比赛直播 Retrieved from: http://asheducationbook.hematologylibrary.org/content/2013/1/131.long.
5. Mayo Clinic. "Acute lymphocytic leukemia: symptoms". Available at: http://www.mayoclinic.com/health/acute-lymphocytic-leukemia/DS00558/DSECTION=symptoms. Accessed 世界杯直播频道 on September 29, 2014.

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