FDA Approves Kepivance for Severe Oral Mucositis in Cancer Patients Undergoing Bone Marrow Transplant; Pivotal Phase 3 Study Published in This Week's New England Journal of Medicine

THOUSAND OAKS, Calif., Dec 15, 2004 (BUSINESS WIRE) -- Amgen Inc. (Nasdaq:AMGN), the world's largest biotechnology company, today announced that following priority review, the U.S. Food and Drug Administration (FDA) has approved Kepivance(TM) (palifermin), the first and only therapy to decrease the incidence and duration of severe oral mucositis (mouth sores) in patients with hematologic (blood) 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.

"Until now, severe painful oral mucositis has been considered an unmet medical need for which no effective therapies existed to reduce either its incidence or duration. The most we could do for our patients was to give them ice chips and narcotics to try and manage their pain," said Patrick Stiff, M.D., director of the Cardinal Bernardin Cancer Center, Loyola University Health System and professor of Hematology/Oncology, Loyola University Chicago Stritch School of Medicine, Maywood, Ill., and one of the lead investigators in the Kepivance pivotal trial. "We are excited to have a new option that will enable physicians to focus on helping to protect their patients with hematologic malignancies from this complication rather than solely managing its consequences."

"As a science-based, patient-focused organization, Amgen works to discover and develop innovative therapies to treat grievous illnesses," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of research and development at Amgen. "We are excited that Kepivance is now available to transplant patients with hematologic malignancies who suffer from severe oral mucositis. We are also investigating the safety and efficacy of Kepivance in other cancer treatment modalities."

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. Severe mouth sores can make patients' everyday activities, such as eating, drinking, swallowing and talking, difficult or impossible. Patients suffering from these debilitating mouth sores may require longer hospitalization, high doses of narcotics such as morphine, and intravenous feeding to receive nutrition and maintain hydration.

Approximately 11,000 adult Americans with hematologic malignancies, including non-Hodgkins lymphoma, Hodgkin's disease, leukemia and multiple myeloma undergo bone marrow transplantation each year. Bone marrow transplantation is a procedure in which a patient's bone marrow is destroyed by anticancer drugs or radiation and is then replaced. Bone marrow transplants make it possible to use more effective, very high doses of chemotherapy that would otherwise be impossible, and nearly all patients undergoing this treatment suffer from oral mucositis. In fact, oral mucositis is rated as the most debilitating side effect by patients undergoing this cancer treatment.

Pivotal Phase 3 Study Published in This Week's New England Journal of Medicine

The pivotal phase 3 double-blind study published in this week's New England Journal of Medicine, compared Kepivance with placebo in the development of oral mucositis in patients with hematologic malignancies. Participants were randomized to receive Kepivance 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). Then all patients received bone marrow transplantation, followed by an additional three days of either Kepivance or placebo.

The incidence of the most debilitating grade of mucositis (grade 4) was three times less with Kepivance (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). Kepivance 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 Kepivance reported significantly less mouth and throat soreness, as well as improvements in their ability to eat, drink, swallow and talk. In addition, patients receiving Kepivance required fewer days of morphine for their pain than patients receiving placebo (7 days versus 11 days, respectively).

Kepivance was shown to be safe and well-tolerated in this study. Adverse events seen in the study, such as rash, pruritus (itching), erythema (redness of the skin), paresthesia (tingling skin), mouth/tongue disorders and taste alteration were mild-to-moderate and transient.

About Kepivance

Kepivance is a recombinant human keratinocyte growth factor that works at the cellular level to help protect patients with hematologic malignancies undergoing high-dose chemotherapy and/or radiation followed by bone marrow transplant from severe oral mucositis. Kepivance reduces the incidence and duration of severe oral mucositis in these patients by protecting the epithelial cells that line the mouth and throat from the damage caused by chemotherapy and radiation and by stimulating the growth and development of new epithelial cells to build up the mucosal barrier.

The most common serious adverse reaction in clinical trials attributed to Kepivance was skin rash reported in less than 1% of patients. Other serious adverse reactions occurred at a similar rate in patients who received Kepivance or placebo. The most frequently reported serious adverse event in Kepivance and placebo-treated patients were fever, gastrointestinal events, and respiratory events. The most commonly reported adverse reactions were rash, erythema, edema, pruritus, dysesthesia, mouth/tongue thickness/discoloration, and taste alteration.

For more information about ongoing Kepivance clinical trials, please visit www.amgentrials.com.

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.

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SOURCE: Amgen Inc.

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