AMGEN BEGINS HUMAN TRIALS ON NEW PROTEIN.

Byline: Dave McNary Daily News Staff Writer

Biotechnology giant Amgen Inc. announced Tuesday that it has started human trials with a genetically engineered protein that could complement its flagship red blood cell booster Epogen.

The Phase I trials are designed to evaluate the safety and effectiveness of Novel Erythropoiesis Stimulating Protein, or NESP, for the treatment of anemia in patients with kidney failure.

Thousand Oaks-based Amgen, the world's largest biotech concern, said initial results will be available within a year.

James McCament, editor of the Medical Technology Stock Letter, said Amgen will be competing against several other biotech companies that already have started trials for similar drugs designed to challenge Epogen.

``It will be difficult to tell how effective Amgen's drug is until they get to Phase II,'' McCament said.

Amgen currently generates more than $2 billion a year in annual revenues from sales of Epogen and white-cell booster Neupogen. It has been trying to develop other drugs, but recently suffered a setback in the test results for its drug to treat Lou Gehrig's disease.

``Amgen is smart to be working in areas to replace its two drugs,'' McCament said. ``They are very conscious of protecting their franchises.''

The drug is designed to help stimulate production of red blood cells in people with failing kidneys, which do not produce sufficient amounts of the hormone erythropoietin. Without adequate amounts of the hormone, there are too few red blood cells to deliver oxygen through the body, leaving patients fatigued.

Amgen announced an agreement with Japan's Kirin Brewery Co. in July to jointly develop and market NESP.