West Coast Editor

As expected, Amgen Inc. won FDA approval of Kepivance (palifermin), its fast-track keratinocyte growth factor for mucositis in chemotherapy patients with blood cancers who get bone marrow transplants.

Kepivance will be launched in late January with pricing disclosed "right around then," said Trish Hawkins, spokeswoman for Thousand Oaks, Calif.-based Amgen.

The company's stock (NASDAQ:AMGN) closed Thursday at $63.24, down 30 cents.

Although it has not yet proved its mettle in non-hematologic malignancies, tests are ongoing.

"We're enrolling a Phase II trial in non-small-cell lung cancer," Hawkins said.

Kepivance is the only treatment available that's indicated specifically for mouth sores, which often become so painful that patients can't eat or drink comfortably and must be put on total parenteral nutrition.

"In some cases, they can't even swallow their own saliva," Hawkins said. "Patients describe it as like having raw hamburger for a mouth, or having a mouthful of glass." The sores can be as large as a centimeter and a half, she said.

Chemotherapy, which attacks quickly proliferating cells such as cancer cells, also hits normal cells in the body that multiply rapidly, such as those in the mucous membranes. Kepivance makes those epithelial cells in the mouth and gastrointestinal tract grow even faster, to keep ahead of chemo's often-devastating effects. Until now, patients have been given ice chips and narcotics - sometimes even morphine - to deal with sores.

Every year, about 11,000 adult Americans with hematologic malignancies, including non-Hodgkin's lymphoma, Hodgkin's disease, leukemia and multiple myeloma, undergo bone marrow transplants in order to get more effective, very high doses of chemo that otherwise would not be possible. The Amgen drug is dosed three times before the conditioning regimen that precedes the transplant, and three times after the procedure.

"Without Kepivance, we know that almost all of these patients develop severe mucositis," Hawkins told BioWorld Today. "Until now, there was nothing patients could do, so they went ahead and did the [chemo and bone marrow transplant] treatment, and had the morphine to get through" the difficult period afterward.

Phase III Kepivance data disclosed in the summer of 2003 at the American Society of Clinical Oncology meeting made quite a splash, and a year later Amgen submitted its fast-track biologics license application. Full data from the pivotal trial were published in this week's New England Journal of Medicine. (See BioWorld Today, June 3, 2003, and June 25, 2004.)

The National Institutes of Health first cloned human keratinocyte growth factor, and Amgen licensed the rights in 1991, Hawkins said.

Kepivance adds to Amgen's oncology franchise, which includes Neulasta (pegfilgrastim), used to decrease infection during chemotherapy, and Neupogen (Neulasta's first and shorter-acting version). For anemia, the company offers Aranesp (darbepoetin alpha), which competes against New Brunswick, N.J.-based Johnson & Johnson's version of epoetin alfa, called Procrit.

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