European Commission Approves Kepivance(TM) (Palifermin) for Oral Mucositis in Cancer Patients Undergoing Blood and Bone Marrow Transplant

Amgen (Nasdaq:AMGN), the world's largest biotechnologycompany, today announced that Kepivance(TM) (palifermin) has receivedregulatory approval in the European Union (EU). Palifermin is nowauthorized in the EU to decrease the incidence, duration and severityof oral mucositis (mouth sores) in patients with hematologic (blood)cancers undergoing myeloablative therapy associated with a highincidence of severe oral mucositis, and requiring autologous blood andbone marrow transplant. In the EU, approximately 13,000 cancerpatients undergo autologous blood and bone marrow transplant eachyear.

"The European Commission's approval of palifermin marks asignificant advance for patients with blood cancers undergoing bloodand bone marrow transplant as it is the first and only productavailable in the EU that will help physicians to protect patients fromthe devastating consequences of oral mucositis," said Willard Dere,M.D., chief medical officer and senior vice president of GlobalDevelopment at Amgen. "Amgen is proud to offer this innovativemedicine to address an important unmet medical need for these cancerpatients."

In patients with oral mucositis, the cells lining the mouth andthroat are damaged by the chemotherapy drugs and/or radiation used incancer treatment. Oral mucositis can be extremely painful and can havea devastating impact on patients. In fact, oral mucositis has beenrated one of the most debilitating side effects by patients with bloodcancers undergoing blood and bone marrow transplantation. Patientssuffering from these debilitating mouth sores may require high dosesof narcotics, such as morphine, and intravenous feeding to receivenutrition and maintain hydration.

"Now, physicians in the EU have an option to decrease theincidence, duration and severity of oral mucositis, rather than onlytrying to control the pain and discomfort caused by it," said DietgerNiederwieser, M.D., elected president of the European Group for Boneand Marrow Transplantation (EBMT). "With palifermin, we can helpprotect patients undergoing blood and bone marrow transplant from thisextremely 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 3double-blind study that compared palifermin with placebo in thedevelopment of oral mucositis in patients with hematologicmalignancies. Participants were randomized to receive palifermin 60micro-g/kg/day (n=106) or placebo (n=106) intravenously for threeconsecutive days immediately before conditioning therapy (fractionatedtotal body radiation plus high-dose chemotherapy) and for anadditional three days immediately following blood and bone marrowtransplant.

The incidence of the most debilitating grade of oral mucositis(grade 4) was three times less with palifermin (20 percent versus 62percent with placebo), and the incidence of grade 3-4 mucositis wherepatients can only swallow liquids, if anything, was reduced byapproximately 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 withplacebo).

The study found that patients treated with palifermin reportedsignificantly less mouth and throat soreness, as well as improvementsin their ability to eat, drink, swallow and talk. In addition,patients receiving palifermin required fewer days of morphine fortheir pain than patients receiving placebo (7 days versus 11 days,respectively).

Palifermin was shown to be effective and well-tolerated in thisstudy. 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 alterationwere primarily mild-to-moderate in severity and transient.

About Kepivance

Kepivance, a recombinant human keratinocyte growth factor, reducesthe incidence and duration of severe oral mucositis by helping toprotect existing epithelial cells that line the mouth and throat fromthe damage caused by chemotherapy and radiation, and stimulating thegrowth and development of new epithelial cells to build up the mucosalbarrier. By reducing the incidence and duration of severe mouth sores,Kepivance helps patients continue normal daily activities, likeeating, 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 todecrease the incidence and duration of severe oral mucositis inpatients with hematologic cancers undergoing high-dose chemotherapy,with or without radiation, followed by a bone marrow transplant. Thesafety and efficacy of Kepivance have not been established in patientswith non-hematologic malignancies.

In patients with hematologic malignancies, the most common seriousadverse reaction in clinical trials attributed to Kepivance was skinrash reported in less than one percent of patients. Other seriousadverse reactions occurred at a similar rate in patients who receivedKepivance or placebo with the most frequent being fever,gastrointestinal events and respiratory events. The most commonlyreported adverse reactions attributed to Kepivance were rash,erythema, edema, pruritus, dysesthesia, mouth/tonguethickness/discoloration and taste alteration.

Amgen has also received approval for Kepivance in Australia andhas applied for regulatory approval in Canada and Switzerland.

About Amgen

Amgen discovers, develops and delivers innovative humantherapeutics. A biotechnology pioneer since 1980, Amgen was one of thefirst companies to realize the new science's promise by bringing safeand effective medicines from lab, to manufacturing plant, to patient.Amgen therapeutics have changed the practice of medicine, helpingmillions 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, Amgenremains committed to advancing science to dramatically improvepeople's lives. To learn more about our pioneering science and ourvital medicines, visit www.amgen.com.

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