Amgen Oncology Highlights Upcoming Data Presentations at the 2007 European Conference on Clinical Oncology

New Data on Targeted and Supportive Care Cancer Therapies

Underscores Amgen's Commitment to Patients

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Sept. 21, 2007--Amgen (NASDAQ:AMGN), today announced several presentations of interest featuring its portfolio of supportive care, and therapeutic agents being highlighted at the 14th European Conference on Clinical Oncology (ECCO) to be held in Barcelona, Spain, between Sept. 23 - 27, 2007.

Clinical data from an extended dosing study and safety and efficacy integrated patient level analyses of Aranesp(R) (darbepoetin alfa) will be presented, along with data from a study in cancer patients receiving Neulasta(R) (pegfilgrastim) as primary prophylaxis of neutropenia. Additionally, new biomarker data from a study in patients with metastatic colorectal cancer receiving Vectibix(TM) (panitumumab) will also be presented, along with early clinical data on AMG 386 - an investigational compound.

"We have made a commitment as a company to continue advancing the science and treatment of cancer," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "The breadth and diversity of the data we're presenting at ECCO this year reflects our commitment to exploring multiple pathways and serving the individual treatment needs of patients."

Marketed Products

Aranesp(R) (darbepoetin alfa)

 --  Evaluation of extended dosing intervals versus weekly dosing of darbepoetin alfa: A Phase 2 study in cancer patients with chemotherapy-induced anemia Abstract No. 1.141 (Wednesday, Sept. 26, 9:00 a.m. - 12:00 p.m., Poster Session, Level 0)

 --  Evaluation of the association between hemoglobin events and safety outcomes in cancer patients with chemotherapy-induced anemia: an integrated analysis of patient-level data from 6 randomized, placebo-controlled trials of darbepoetin alfa Abstract No. 1.120 (Wednesday, Sept. 26, 9:00 a.m. - 12:00 p.m., Poster Session, Level 0)

 --  Patient-level integrated analysis of data from 6 randomized, double-blind, placebo-controlled trials of darbepoetin alfa in patients with chemotherapy-induced anemia Abstract No. 1.104 (Wednesday, Sept. 26, 12:15 p.m. - 1:15 p.m., Poster Discussion, Room 113)

 --  Study of the importance of Novel Erythropoiesis Stimulating Protein (Aranesp(R)) for the effect of radiotherapy in patients with primary squamous cell carcinoma of the head and neck (HNSCC)
     - the Danish Head and Neck Group DAHANCA 10 randomized trial (Tuesday, Sept. 25, 12:30 p.m. - 2:30 p.m., Presidential Session II, Forum)(1)

      --  The data being presented has been submitted by an independent investigator-sponsored trial, which is part of Amgen's pharmacovigilance program for Aranesp. Amgen does not monitor the execution of investigator-initiated studies and does not control the data. --

Vectibix(TM) (panitumumab)

 --  Association of gene copy number of the epidermal growth factor receptor and clinical outcome in patients with metastatic colorectal cancer treated with panitumumab monotherapy Abstract No. 3019 (Monday, Sept. 24, 12:15 p.m. - 1:15 p.m., Poster Discussion, Room 115/116)

 --  Analysis of KRAS mutations in patients with metastatic colorectal cancer receiving panitumumab monotherapy Abstract No. 3014 and 0007 (Tuesday, Sept. 25, 12:30 p.m. - 2:30 p.m., Presidential Session II, Forum)

Neulasta(R) (pegfilgrastim)

 --  Improved chemotherapy delivery in breast cancer patients receiving pegfilgrastim primary prophylaxis compared with current practice neutropenia management - results from an integrated analysis (NeuCuP) Abstract No. 2.033 (Wednesday, Sept. 26, 10:45 a.m., Proffered
Papers, Forum)

Investigational Compound

AMG 386

 --  AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumors (Thursday, Sept. 27, 8:00 a.m. - 11:00 a.m., Poster Session, Level 0)(1)

About Aranesp
Aranesp was approved by the U.S. Food and Drug Administration (FDA) in September 2001 for the treatment of anemia associated with chronic renal failure (CRF) for patients on dialysis and patients not on dialysis. In July 2002, the FDA approved weekly dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies and in March 2006, the FDA approved every-three-week dosing in these patients.

Important Aranesp Safety Information for Europe

Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic and other serious events; regional guidelines should be referred to for target and maximum hemoglobin levels, and dose adjustment rules should be performed in line with regional prescribing information.

The most commonly reported side effects in clinical trials were arthralgia, edema, injection site pain, and thromboembolic event reactions.

Important Aranesp Safety Information for U.S.

Use the lowest dose of Aranesp(R) that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusion.

Aranesp(R) and other erythropoiesis-stimulating agents (ESAs) increased the risk for death and for serious cardiovascular events when administered to target a hemoglobin of greater than 12 g/dL

    Cancer Patients: Use of ESAs

    --  Shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a hemoglobin of greater than 12 g/dL,

    --  Shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a hemoglobin of greater than 12 g/dL,

    --  Increased the risk of death when administered to target a hemoglobin of 12 g/dL in patients with active malignant disease receiving neither chemotherapy or radiation therapy. ESAs are not indicated for this population.

Patients receiving ESAs pre-operatively for reduction of allogeneic red blood cell transfusions: A higher incidence of deep venous thrombosis was documented in patients receiving Epoetin alfa who were not receiving prophylactic anticoagulation. Aranesp(R) is not approved for this indication.

Aranesp is contraindicated in patients with uncontrolled hypertension.

About Vectibix

Vectibix(TM) is indicated for the treatment of EGFr-expressing, metastatic colorectal cancer with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

The effectiveness of Vectibix for the treatment of EGFr-expressing, metastatic colorectal cancer is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.

Important Product Safety Information

Dermatologic toxicities, related to Vectibix(TM) blockade of EGF binding and subsequent inhibition of EGFr-mediated signaling pathways, were reported in 89 percent of patients and were severe (NCI-CTC grade 3 and higher) in 12 percent of patients receiving Vectibix monotherapy. The clinical manifestations included, but were not limited to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Severe dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. Vectibix may need to be withheld or discontinued for severe dermatologic toxicities.

Severe infusion reactions occurred with Vectibix in approximately 1 percent of patients. Severe infusion reactions were identified by reports of anaphylactic reaction, bronchospasm, fever, chills, and hypotension. Although fatal infusion reactions have not been reported with Vectibix, fatalities have occurred with other monoclonal antibody products. Severe infusion reactions require stopping the infusion and possibly permanently discontinuing Vectibix, depending on the severity and/or persistence of the reaction.

About Neulasta

Neulasta (pegfilgrastim) is approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Similar indications for Neulasta were approved in Europe and Australia in 2002.

Important Product Safety Information

Splenic rupture (including fatal cases), acute respiratory distress syndrome, and sickle cell crises have been reported. Allergic reactions, including anaphylaxis, have also been reported. The majority of these reactions occurred upon initial exposure. However, in rare cases, allergic reactions, including anaphylaxis, recurred within days after discontinuing anti-allergic treatment.

In a placebo-controlled trial, bone pain occurred at a higher incidence in Neulasta(R)-treated patients as compared to placebo-treated patients (31% vs 26%). The most common adverse events reported in either placebo- or active-controlled trials were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, with the exception of bone pain.

Prescribers are recommended to consult regional prescribing information before prescribing Neulasta, particularly in relation to side-effects, precautions and contra-indications.

About AMG 386

AMG 386 is an investigational recombinant Fc-peptide fusion protein (peptibody) targeting angiopoietins. It is designed to bind angiopoietins, thereby inhibiting Tie2 dependent stimulation of endothelial cells. Angiopoietins, together with vascular endothelial growth factors (VEGFs), are key cytokines that regulate neovascularization.

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.

Forward-Looking Statements

This news release contains forward-looking statements that are based on management's current expectations and beliefs 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 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 (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen'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 Sept. 25, 2007, 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 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. 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 business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion 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 are affected by the reimbursement policies imposed by third-party payors, 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 health care 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 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 candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, 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 and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that 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 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 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.

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 (FDA) or European Medicines Agency (EMEA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA, EMEA or comparable regulatory body can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, 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 FDA or EMEA 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. Only the FDA, EMEA or comparable regulatory body can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the applicable FDA- or EMEA-approved labeling for the products, and not the information discussed in this news release.

(1) Please note that abstract numbers were not available at the time of the release.


    CONTACT: Amgen, Thousand Oaks
             Christine Regan, 805-447-5476 (US media)
             Sabeena Ahmad, +41 41 3692 530 (European media)
             Arvind Sood, 805-447-1060 (investors)

    SOURCE: Amgen

 

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Posted: September 2007

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