Amgen's Chemotherapy Side-Effect Drug Advances

Amgen(AMGN) on Thursday reported preliminary positive results from a late-stage clinical trial for its drug to treat oral mucositis, a painful side-effect of chemotherapy.

Separately, the world's largest biotech firm made some changes to a partnership with Immunomedics (IMMU) to develop a new cancer drug to treat non-Hodgkin's lymphoma.

Amgen's oral mucositis drug, called rHu-KGF, decreased the duration and incidence of the condition, which is characterized by painful mouth sores that can make swallowing difficult or impossible. The preliminary results were derived from a phase III study of patients undergoing bone marrow transplantation as a treatment for certain blood cancers.

"There is no currently approved therapy to treat oral mucositis," said Amgen's research chief Roger Perlmutter in a statement. "We are looking forward to discussing our phase III results that address this critical unmet need with regulatory agencies in the near future."

Amgen is also testing rHu-KGF in other cancer patient populations.

Meantime, Amgen and Immunomedics said they will no longer pursue development of the cancer drug, Epratuzumab, as a stand-alone treatment for patients with non-Hodgkin's lymphoma. But the companies are continuing midstage studies that use the drug in combination with the approved cancer drug, Rituxan.

Amgen licensed Epratuzumab from Immunomedics and is responsible for the drug's development in North America and Australia. There have been persistent rumors since last year that Amgen was going to drop the Epratuzumab program altogether. Today's announcement appears to put those fears to rest, although the drug's development has been slowed since the stand-alone program was in phase III testing, while combination therapy remains in phase II testing.

Amgen reports fourth-quarter and 2002 results after the closing bell Thursday. Wall Street is looking for fourth-quarter earnings of 35 cents per share.

Shares of Amgen were up 8 cents, or 0.2%, to $52.58 in recent trading. Shares of Immunomedics were off 17 cents, or 3.7%, to $4.48.

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