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Leukemia Cancer News - Return to Menu Aranesp® Effective in Myelodysplastic Syndromes According to a recent article published in the Annals of Oncology, Aranesp (darbepoetin afla) is effective in the treatment of anemia in patients with low or intermediate-risk myelodysplastic syndromes. As well, it improves quality of life in these patients. Myelodysplastic syndromes are a group of diseases involving the bone marrow. MDS results in inadequate production of red blood cells, white blood cells, and platelets. Therefore, initial treatment is often aimed at restoring levels of these cells to normal. This group of diseases ultimately leads to bone marrow failure or acute leukemia. However, some MDS patients achieve long-term survival with minimal intervention. MDS tends to occur in elderly people who may have other significant medical problems that prevent aggressive treatment. Current treatments for MDS generally fall into the category of supportive care, particularly with agents that restore red or white blood cell levels. Patients with more advanced disease may also be treated with chemotherapy drugs. The recent availability of treatment options for MDS has resulted in an increase in the documented incidence of MDS from 12,000 cases per year in the U.S. to more than 20,000 cases. This is because more bone marrow studies are now performed in elderly patients with mild low blood cell counts in order to reach a precise diagnosis; this may diagnose MDS and allow for early intervention. Of the many classification systems, the International Prognostic Scoring System (IPSS) is now commonly used. The IPSS divides patients into low, intermediate, and high risk groupsclassifications are associated with decreasing duration of survival. The IPSS is based on the percent of marrow blasts (leukemia cells in the bone marrow), karyotype (cytogenetic abnormalities of bone marrow cells), and degree of cytopenias (numbers of red blood cells, white blood cells, and platelets). Researchers from Italy recently conducted a trial to evaluate the effectiveness of Aranesp in the treatment of low or intermediate-risk MDS. Aranesp is an agent that stimulates the production of red blood cells and is administered only once per week. This trial included 53 patients; they received treatment for approximately 6 months. Aranesp improved anemia in a significant portion of patients: - 45% of patients achieved a significant increase in red blood cell levels. - At a follow-up of 9.4 months, 17 patients have maintained their responses. - There were no relevant side effects associated with Aranesp. - Patients diagnosed with low or intermediate-risk MDS and associated anemia may wish to speak with their physician regarding their individual risks and benefits of treatment with Aranesp. Reference: Stasi R, Abruzzese E, Lanzetta G, Terzoli E, Amadori S. Darbepoetin alfa for the treatment of anemic patients with low- and intermediate-1-risk myelodysplastic syndromes. Annals of Oncology. 2005; 16: 1921-1927. Related News: Aranesp® Effective in Low-Intermediate Risk MDS European Commission Approves Kepivance(TM) (Palifermin) for Oral Mucositis in Cancer Patients Undergoing Blood and Bone Marrow Transplant THOUSAND OAKS, Calif., Oct 28, 2005 (BUSINESS WIRE) -- Amgen (Nasdaq:AMGN), the world's largest biotechnology company, today announced that Kepivance(TM) (palifermin) has received regulatory approval in the European Union (EU). Palifermin is now authorized in the EU to decrease the incidence, duration and severity of oral mucositis (mouth sores) in patients with hematologic (blood) cancers undergoing myeloablative therapy associated with a high incidence of severe oral mucositis, and requiring autologous blood and bone marrow transplant. In the EU, approximately 13,000 cancer patients undergo autologous blood and bone marrow transplant each year. "The European Commission's approval of palifermin marks a significant advance for patients with blood cancers undergoing blood and bone marrow transplant as it is the first and only product available in the EU that will help physicians to protect patients from the devastating consequences of oral mucositis," said Willard Dere, M.D., chief medical officer and senior vice president of Global Development at Amgen. "Amgen is proud to offer this innovative medicine to address an important unmet medical need for these cancer patients." In patients with oral mucositis, the cells lining the mouth and throat are damaged by the chemotherapy drugs and/or radiation used in cancer treatment. Oral mucositis can be extremely painful and can have a devastating impact on patients. In fact, oral mucositis has been rated one of the most debilitating side effects by patients with blood cancers undergoing blood and bone marrow transplantation. Patients suffering from these debilitating mouth sores may require high doses of narcotics, such as morphine, and intravenous feeding to receive nutrition and maintain hydration. "Now, physicians in the EU have an option to decrease the incidence, duration and severity of oral mucositis, rather than only trying to control the pain and discomfort caused by it," said Dietger Niederwieser, M.D., elected president of the European Group for Bone and Marrow Transplantation (EBMT). "With palifermin, we can help protect patients undergoing blood and bone marrow transplant from this extremely painful side effect that can impact their ability to eat, drink and swallow." About the Pivotal Phase 3 Study The European Commission approval is based on a pivotal Phase 3 double-blind study that compared palifermin with placebo in the development of oral mucositis in patients with hematologic malignancies. Participants were randomized to receive palifermin 60 micro-g/kg/day (n=106) or placebo (n=106) intravenously for three consecutive days immediately before conditioning therapy (fractionated total body radiation plus high-dose chemotherapy) and for an additional three days immediately following blood and bone marrow transplant. The incidence of the most debilitating grade of oral mucositis (grade 4) was three times less with palifermin (20 percent versus 62 percent with placebo), and the incidence of grade 3-4 mucositis where patients can only swallow liquids, if anything, was reduced by approximately one-third (63 percent versus 98 percent with placebo). Palifermin reduced the duration of painful oral mucositis (grades 2-4) by almost half or approximately one week (8 days versus 14 days with placebo). The study found that patients treated with palifermin reported significantly less mouth and throat soreness, as well as improvements in their ability to eat, drink, swallow and talk. In addition, patients receiving palifermin required fewer days of morphine for their pain than patients receiving placebo (7 days versus 11 days, respectively). Palifermin was shown to be effective and well-tolerated in this study. Adverse reactions seen in the study, such as rash, pruritus (itching), erythema (redness of the skin), edema, pain, fever, arthralgia (joint pain), mouth/tongue disorders and taste alteration were primarily mild-to-moderate in severity and transient. About Kepivance Kepivance, a recombinant human keratinocyte growth factor, reduces the incidence and duration of severe oral mucositis by helping to protect existing epithelial cells that line the mouth and throat from the damage caused by chemotherapy and radiation, and stimulating the growth and development of new epithelial cells to build up the mucosal barrier. By reducing the incidence and duration of severe mouth sores, Kepivance helps patients continue normal daily activities, like eating, drinking, swallowing and talking. Kepivance was approved by the U.S. Food and Drug Administration (FDA) in December 2004. In the U.S., Kepivance is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic cancers undergoing high-dose chemotherapy, with or without radiation, followed by a bone marrow transplant. The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies. In patients with hematologic malignancies, the most common serious adverse reaction in clinical trials attributed to Kepivance was skin rash reported in less than one percent of patients. Other serious adverse reactions occurred at a similar rate in patients who received Kepivance or placebo with the most frequent being fever, gastrointestinal events and respiratory events. The most commonly reported adverse reactions attributed to Kepivance were rash, erythema, edema, pruritus, dysesthesia, mouth/tongue thickness/discoloration and taste alteration. Amgen has also received approval for Kepivance in Australia and has applied for regulatory approval in Canada and Switzerland. 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 broad and deep 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 Statement This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2004, and in Amgen's periodic reports on Form 10-Q and Form 8-K. 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. 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 side effects or manufacturing problems with our products after they are on the market. In addition, sales of our products are affected by the availability of reimbursement and the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government 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), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA 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 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 can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release. EDITOR'S NOTE: An electronic version of this news release may be accessed via our Web site at www.amgen.com. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Media section of the Web site. SOURCE: Amgen Amgen, Thousand Oaks FDA Expands Neulasta(R) Label; New Label Extends First-Cycle Protection From Infection To Cancer Patients Receiving Moderately Myelosuppressive Chemotherapy THOUSAND OAKS, Calif., Sep 15, 2005 (BUSINESS WIRE) -- Amgen (Nasdaq: AMGN), the world's largest biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) approved an update to the Neulasta(R) (pegfilgrastim) prescribing information to include data from a landmark Phase 3 study demonstrating the white blood cell booster helps protect patients with most types of cancer undergoing moderately myelosuppressive chemotherapy from infection, as manifested by febrile neutropenia (low white blood cell count with fever), one of the most serious side effects of chemotherapy. Previously, first and subsequent cycle administration of Neulasta to stimulate production of infection-fighting white blood cells was indicated for patients receiving myelosuppressive chemotherapy associated with a more than 30 to 40 percent risk of febrile neutropenia. Administration of Neulasta beginning in the first cycle of chemotherapy is now approved for patients receiving myelosuppressive chemotherapy associated with at least a 17 percent risk of febrile neutropenia. Myelosuppressive chemotherapy is toxic to the bone marrow where white blood cells, red blood cells and platelets are produced. "The Phase 3 study demonstrated that administering Neulasta beginning in the first chemotherapy cycle reduced the incidence of febrile neutropenia by 94 percent," said Willard Dere, M.D., chief medical officer and senior vice president of Global Development at Amgen. "With this approval and Neulasta's once-per-cycle dosing, physicians can help protect appropriate patients proactively before their white blood cell counts become dangerously low." The expanded label was based on a randomized, placebo-controlled study of 928 metastatic or non-metastatic breast cancer patients that was published in the Journal of Clinical Oncology earlier this year. First and subsequent-cycle administration of Neulasta resulted in a 94 percent reduction in the incidence of febrile neutropenia (1 percent versus 17 percent with placebo), a 93 percent reduction in the incidence of hospitalization (1 percent versus 14 percent with placebo) and an 80 percent reduction in the incidence of intravenous anti-infective use (2 percent versus 10 percent with placebo), compared to placebo, in patients receiving moderately myelosuppressive chemotherapy. "Approximately two-thirds of neutropenic complications happen in the first cycle of chemotherapy," said study lead investigator Charles Vogel, M.D., Cancer Research Network, Plantation, Fla. "This study demonstrates that administering Neulasta beginning in the first cycle of chemotherapy reduces the chance of patients developing an infection." About Neutropenia Neutropenia is an abnormally low level of neutrophils, important infection-fighting white blood cells, in the blood stream. Neutropenia can put some patients at risk for severe infections and interruptions in cancer treatment. In fact, complications associated with a low white blood cell count are a common cause of dose reductions or delays in chemotherapy. Febrile (or feverish) neutropenia is the most common presentation of infection in patients receiving chemotherapy. Infection in this setting can be serious and even life threatening because chemotherapy can compromise the patient's ability to fight infection. Although white blood cell boosters have been available for more than a decade, only 17 percent of patients receiving myelosuppressive chemotherapy currently receive proactive first-cycle protection from neutropenic complications, which include infection, hospitalization and anti-infective use. Approximately half of the 1.3 million patients receiving chemotherapy are at risk for developing neutropenia. About Neulasta Neulasta was approved by the U.S. Food and Drug Administration (FDA) in 2002 for decreasing 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 the same year. Rare cases of splenic rupture and sickle cell crises have been reported in postmarketing experience. 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 treated patients as compared to placebo-treated patients (31 percent vs. 26 percent). The most common adverse events reported in either active or placebo controlled trials were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, with the exception of bone pain. While not reported in patients receiving Neulasta, rare events of adult respiratory distress syndrome have been reported in patients receiving the parent compound, Filgrastim. 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 broad and deep 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 Statement This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2004, and in Amgen's periodic reports on Form 10-Q and Form 8-K. 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. 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 side effects or manufacturing problems with our products after they are on the market. In addition, sales of our products are affected by the availability of reimbursement and the reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government 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), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA 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 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 can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release. Full prescribing information for Neulasta is available at www.NEULASTA.com or via fax by calling (800) 772-6436. Consumers can call (866) 611-DRUG (3784) for more information. EDITOR'S NOTE: An electronic version of this news release may be accessed via our Web site at www.amgen.com. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Media section of the Web site. SOURCE: Amgen Inc. Amgen, Thousand Oaks Interim Data Suggest Major Response with Aranesp(R) in Anemic Patients with Myelodysplastic Syndromes (MDS) THOUSAND OAKS, Calif., Jul 06, 2005 (BUSINESS WIRE) -- Amgen Inc. (NASDAQ:AMGN), the world's largest biotechnology company, today announced new interim data from a Phase 2 study evaluating the use of 500 mcg of Aranesp(R) (darbepoetin alfa) every three weeks to treat anemia in patients with a bone marrow disorder known as myelodysplastic syndromes (MDS). The data were presented at the 17th International Symposium of the Multinational Association of Supportive Care in Cancer (MASCC) in Geneva. (Abstract #02-007) "The majority of MDS patients develop clinically significant anemia during the course of their disease, which often leads to fatigue and increased red blood cell transfusions," said Janice Gabrilove, M.D., professor of medicine, hematology and medical oncology at Mount Sinai School of Medicine, New York and the study's lead investigator. "In this study, low risk MDS patients receiving Aranesp every three weeks, who had no prior erythropoietic therapy, exhibited an overall response of 77 percent, increased hemoglobin levels and improvements in patient reported fatigue." Results of an interim analysis were presented from the first 100 patients of an approximately 200 patient, Phase 2, single arm study of low risk MDS patients (those with a low risk of progressing to acute myeloid leukemia) with anemia and treated with Aranesp 500 mcg administered every three weeks. Of the 100 patients evaluated, 63 percent had no prior erythropoietic agent use. The primary endpoint of the study was the proportion of patients achieving an erythroid response (defined in accordance with the International Working Group Response Criteria) during the 13-week test period. Secondary endpoints included changes in hemoglobin level from baseline, incidence of transfusions and impact on patient reported fatigue. Results were presented for all 100 patients for incidence of transfusion and patient reported fatigue and 90 patients were evaluated for erythroid response and target hemoglobin. In the group who had no previous treatment with an erythropoietin (n=57), 77 percent of patients had an erythroid response with 47 percent classified as major (greater than or equal to 2 g/dL increase from baseline hemoglobin or transfusion independence). In the previously erythropoietin treated group (n=33), 36 percent experienced an erythroid response with 21 percent classified as major. Two-thirds of patients achieved hemoglobin levels above 11 g/dL, the target range for patients with chemotherapy-induced anemia. Eighteen percent in the erythropoietin-naive group had a least one transfusion during the 13-week observation period. "In these interim results MDS patients who have never been treated for their anemia responded to Aranesp and those who had prior erythropoietic therapy continued to respond," added Gabrilove. "There are currently no recombinant erythropoietic products approved by the FDA for the treatment of anemia in MDS patients. These interim data are encouraging and we look forward to the final results." During the 13-week test period, 74 percent of patients experienced at least one adverse event. Sixteen percent (n=16) of patients experienced a serious adverse event, with anemia, neutropenia and chest pain as the most common. Five percent (n=5) had treatment-related adverse events, with injection-site pain as the most common. No thrombotic events have been reported to date in this study. About MDS Myelodysplastic Syndromes (MDS), also known as pre-leukemia or "smoldering" leukemia, encompass a group of disorders in which the bone marrow does not produce enough blood cells. MDS causes abnormal blood counts or poorly functioning blood cells and often results in anemia (low red blood cell count), neutropenia (low white blood cell count) and thrombocytopenia (low blood platelet count). Approximately 21,000 new cases of MDS are diagnosed each year in the United States. MDS is more prevalent in men and Caucasians, and primarily occurs in people older than 60. About Aranesp Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of oxygen-carrying red blood cells). Amgen revolutionized anemia treatment with the development of recombinant erythropoietin, Epoetin alfa. Building on this heritage, Amgen developed Aranesp, a unique erythropoiesis stimulating protein, which contains two additional sialic acid-containing carbohydrate chains than the Epoetin alfa molecule and remains in the bloodstream longer than Epoetin alfa because it has a longer half-life. 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, also known as chronic kidney disease (CKD), for patients on dialysis and patients not on dialysis. In July 2002, Aranesp was approved by the FDA for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. In May 2005, Amgen announced the submission of a biologics license supplement to the FDA for every- three-week dosing in the treatment of chemotherapy-induced anemia. Aranesp was initially granted marketing authorization by the European Medicines Agency (EMEA) in 2001 for the treatment of anemia associated with chronic renal failure in adults and pediatric subjects 11 years of age or older. In 2002, the EMEA approved Aranesp for the treatment of anemia in adult cancer patients receiving chemotherapy with solid tumors. This patient population was subsequently expanded in 2003 to include all adult cancer patients with non-myeloid malignancies receiving chemotherapy. In 2004, Aranesp was approved by the EMEA for every-three-week dosing in patients with chemotherapy-induced anemia and up to once-per-month dosing in the treatment of anemia in chronic kidney disease patients not on dialysis. Important Safety Information Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic and other serious events. Seizures have occurred in patients with chronic renal failure participating in clinical trials. 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. In a study of Epoetin alfa-treated hemodialysis patients with clinically evident cardiac disease, where the target Hct was 42% (Hb =14 g/dL), an increased incidence of thrombotic events and mortality was seen. The reason for increased mortality observed in this study is unknown. In an oncology study with another erythropoietic product, where the target Hb was 12 - 14 g/dL, an increased incidence of thrombotic events, disease progression, and mortality was seen. Pure red cell aplasia (PRCA) has been observed in patients treated with recombinant erythropoietins. This has been reported predominantly in patients with chronic renal failure. Aranesp should be discontinued in any patient with evidence of PRCA and the patient evaluated for the presence of antibodies to erythropoietin products. The most commonly reported side effects in Aranesp trials for chronic renal insufficiency were infection, hypertension, hypotension, myalgia, headache, and diarrhea. The most commonly reported side effects in Aranesp trials for chemotherapy-induced anemia were fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea. About Amgen Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology. Forward-Looking Statement This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2004, and in Amgen's periodic reports on Form 10-Q and Form 8-K. 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. 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 side effects or manufacturing problems with our products after they are on the market. In addition, sales of our products are affected by the availability of reimbursement and the reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government 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), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA 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 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 can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release. Aranesp prescribing information can be accessed by calling 800-772-6436 or by logging on to www.aranesp.com. SOURCE: Amgen Inc. Amgen Final Results of Phase 3 Head-to-Head Study Demonstrate Aranesp Dosed Every Two Weeks is Comparable to Epoetin Alfa Dosed Weekly in Cancer Patients with Chemotherapy-Induced Anemia ORLANDO, Fla.--(BUSINESS WIRE)--May 15, 2005--Amgen Inc. (NASDAQ:AMGN): Randomized Head-to-Head Study of Anemia Treatments Shows Comparability in Transfusion Rates and Achievement of Target Hemoglobin in More Than 1,200 Patients with Chemotherapy-Induced Anemia Amgen Inc., (NASDAQ:AMGN) the world's largest biotechnology company, today announced that final results of a Phase 3 randomized, head-to-head study demonstrated that 200 mcg of Aranesp(R) (darbepoetin alfa) administered every two weeks is as effective as 40,000 U of Epoetin alfa dosed once a week in boosting hemoglobin levels and reducing the need for red blood cell transfusions in cancer patients with chemotherapy-induced anemia. The data were presented today at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). (Abstract #8125) "This is the largest, randomized head-to-head comparison of darbepoetin alfa dosed every two weeks to Epoetin alfa dosed weekly, as they are most often used in current oncology practice," said John Glaspy, MD, professor, David Geffen School of Medicine, University of California at Los Angeles. "Less frequent dosing provides anemia management with less frequent injections, and for patients receiving chemotherapy every two or three weeks, less frequent office visits. Our data demonstrate that less frequent injections can be accomplished without a compromise in efficacy in terms of decreased transfusion risk or improved quality of life." In the Phase 3 head-to-head study, a total of 1,220 patients with chemotherapy-induced anemia were randomized to receive either Aranesp 200 mcg every two weeks (n=613) or Epoetin alfa 40,000 U once a week (n=607). The majority of patients in both groups achieved the target hemoglobin of greater than or equal to 11 g/dL. Both groups of patients had similar blood transfusion rates, patient reported outcomes, and safety endpoints. In this study, at least 90 percent of patients in both arms of the study achieved target hemoglobin of greater than or equal to 11 g/dL. Seventy-four percent of patients in the Aranesp group remained in the target range compared to 80 percent in the Epoetin alfa group. The study's primary endpoint was designed to evaluate non-inferiority with respect to transfusion rate. Transfusions were similar in the two treatment groups (21 percent in the Aranesp group and 16 percent in the Epoetin alfa group) demonstrating non-inferiority of Aranesp and Epoetin alfa with respect to transfusion requirements. The number and type of adverse events were similar between the two groups and were consistent with the adverse event profile for this population of anemic cancer patients receiving Aranesp. New interim data from a study of Aranesp administered every three weeks were also presented during the ASCO Annual Meeting (Abstract #8129). In May, Amgen announced submission of a supplemental biologics license application to the U.S. Food and Drug Administration (FDA) for every-three-week dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. About Chemotherapy-Induced Anemia Chemotherapy can reduce the bone marrow's ability to produce red blood cells that transport oxygen from the lungs to all of the body's muscles and organs. Anemia occurs when there are too few red blood cells and the body's tissues are "starved" of oxygen, which can make a patient feel short of breath, very weak, faint and tired. This year, an estimated 1.3 million cancer patients will undergo chemotherapy in the United States; approximately 800,000 (67 percent) will become anemic. More than half of these patients report that fatigue associated with anemia affects their daily lives more than any other side effect of treatment, including nausea, pain and depression. Although anemia is a common and often debilitating side effect of chemotherapy, it is often not recognized and frequently under-treated. In fact, 42 percent of patients with a hemoglobin level less than the recommended target level of 11 g/dL in the National Comprehensive Cancer Network(R) (NCCN) guidelines for "Cancer and Treatment-Related Anemia" are never treated with erythropoietic therapy. About Aranesp Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of oxygen-carrying red blood cells). Amgen revolutionized anemia treatment with the development of recombinant erythropoietin, Epoetin alfa, which is currently marketed in the U.S. by Amgen as EPOGEN(R) (Epoetin alfa)(i) and by Ortho Biotech Products, L.P., as Procrit(R) (Epoetin alfa)(ii). Building on this heritage, Amgen developed Aranesp, a unique erythropoiesis stimulating protein, which contains two additional sialic acid-containing carbohydrate chains than the Epoetin alfa molecule and remains in the bloodstream longer than Epoetin alfa because it has a longer half-life. By virtue of its longer half-life, Aranesp should be administered less frequently than Epoetin alfa in patients with chronic kidney disease (CKD). Aranesp is approved for multiple indications with varying dosage instructions in the U.S., European Union, Canada and Australia. Aranesp was approved by the FDA in September 2001 for up to every-two-week dosing for the treatment of anemia associated with chronic renal failure, also known as CKD, for patients on dialysis and patients not on dialysis. In July 2002, Aranesp was approved by the FDA for weekly dosing for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. In 2004, the European Committee for Medicinal Products for Human Use approved Aranesp for extended dosing intervals of once every three weeks in the treatment of anemia in adult cancer patients with non-myeloid malignancies who are receiving chemotherapy and monthly in the treatment of anemia associated with CKD. Important Safety Information Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic events, and other serious events. The target hemoglobin (Hb) should not exceed 12 g/dL. If the Hb increase exceeds 1.0 g/dL in any two-week period, dose reductions are recommended. In a study with another erythropoietic product, where the target Hb was 12-14 g/dL, an increased incidence of thrombotic events, disease progression and mortality was seen. Pure red cell aplasia (PRCA) has been observed in patients treated with recombinant erythropoietins. This has been reported predominantly in patients with chronic renal failure. Aranesp should be discontinued in any patient with evidence of PRCA and the patient evaluated for the presence of antibodies to erythropoietin products. The most commonly reported side effects in clinical trials were fatigue, edema, nausea, vomiting, diarrhea, fever and dyspnea. About Amgen Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology. Forward-Looking Statement This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2004, and in Amgen's periodic reports on Form 10-Q and Form 8-K. 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. 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 side effects or manufacturing problems with our products after they are on the market. In addition, sales of our products are affected by the availability of reimbursement and the reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government 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), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA 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 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 can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release. Aranesp prescribing information can be accessed by calling 800-772-6436 or by logging on to www.aranesp.com. (i) Epogen(R) is a registered trademark of Amgen Inc. (ii) Procrit(R) is a registered trademark of Ortho Biotech Products, L.P. CONTACT: Amgen SOURCE: Amgen Inc.
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