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

THOUSAND OAKS, CA -- October 28, 2005 -- Amgen, 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, MD, 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, MD, 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.


SOURCE: Amgen

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