AMGEN PROFITS BEAT ODDS BIOTECH GIANT OUTPACES ANALYSTS' ESTIMATES.

Byline: Gregory J. Wilcox Staff Writer

THOUSAND OAKS - Biotech giant Amgen Inc. reported a 6.4 percent jump in second-quarter profits on Thursday and expressed frustration that federal approval of a new drug is taking longer than expected.

For the quarter, Amgen - the world's largest biotechnology company - recorded net income of $321.9 million, or 30 cents a share, on revenues of $986.7 million. The company earned 2 cents more per share than expected by 24 analysts polled by Thomson Financial/First Call.

In the prior year's second quarter, Thousand Oaks-based Amgen earned $302.6 million, or 28 cents a share, on revenue of $914.4 million.

Business is expected to remain good, but Amgen did slightly lower the sales forecast for its two key products, Epogen, an anemia treatment given dialysis patients, and Neupogen, which fights infection in chemotherapy patients.

Double-digit growth is still expected for both, though.

``In the second quarter, our core business ... generated solid sales growth,'' said Kevin Sharer, Amgen's chairman and chief executive officer.

Worldwide product sales increased to $859 million versus $807 million in the year-ago period.

But Sharer's impatience with the lengthy approval process for Aranesp, a longer-lasting form of Epogen, was evident during a conference call with analysts.

The company, he said, is no longer going to speculate on when that approval will be forthcoming.

`I'm just out of the prediction business,'' Sharer said. ``I'm just frustrated about the process. No doubt about it, it's taking too long.''

The company and federal Food and Drug Administration officials are now discussing the language that should be included on the label, and those talks are positive, he said.

There is no doubt that the drug works.

In June, it was approved by the European Commission and was immediately made available in Germany, the United Kingdom, Austria, Denmark, Finland,the Netherlands and Sweden. Sales there are promising, the company said.

In six to nine months, the drug should be available in Italy, Spain and France after reimbursement approvals.

``Aranesp represents the first therapeutic advance in anemia management in more than 10 years,'' said Sharer.

Also on Tuesday, Guilford Pharmaceuticals Inc., which with Amgen is developing a drug to treat Parkinson's disease, said that the Phase II clinical trial was disappointing. The drug was well-tolerated but did not produce a substantial reversal of the disease's symptoms.

Craig West, an analyst at A.G. Edwards & Sons Inc., said the company had a good quarter and that the Guilford matter should not be a big deal.

``I don't think it's a cause for concern. Some products are going to work and some aren't. They (Amgen) are big enough and rich enough to be a good partner to other innovative biotechs out there,'' he said.