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Amgen First-Quarter Profit Rises 15% on Anemia Drugs (Update6)

By Luke Timmerman

April 23 (Bloomberg) -- Amgen Inc., the world's largest biotechnology company, said first-quarter profit rose 15 percent on sales of drugs to treat anemia and said it will apply for approval of another medicine this year.

Net income climbed to $1.11 billion, or 94 cents a share, from $1 billion, or 82 cents, a year earlier, the company, based in Thousand Oaks, California, said today in a statement. Profit excluding certain items was $1.08 a share, matching the $1.08 average estimate of 21 analysts surveyed by Bloomberg.

Amgen said it will reduce expenses and update its revenue forecast because sales of its two top-selling anemia drugs, Aranesp and Epogen, may fall after studies showed the medicines increased the risk of death in high doses. Amgen also reported positive trial results for drugs in development, giving a boost to the stock after it sank to a 52-week low earlier this month.

``It's good to see, it appears there is nothing inherently, structurally wrong with Amgen's R&D effort,'' said Shiv Kapoor, an analyst with Montgomery & Co. in San Francisco, in a telephone interview after the report. ``It redeems them from some of the pipeline issues we've been worried about.''

Aranesp and Epogen, which treat anemia in dialysis and cancer patients, accounted for 45 percent of total revenue of $3.69 billion in the quarter.

Update in Second Quarter

Amgen expects to provide an updated financial forecast for 2007 in its second-quarter earnings report, Chief Executive Officer Kevin Sharer said on a conference call today. The company plans to slow down the rate of spending growth, particularly on general and administrative items, while continuing to invest in its pipeline of new drugs, Sharer said.

In January the company forecasted $15.4 billion to $16 billion in 2007 revenue, an 8 to 12 percent increase from a year earlier. It expected profit, excluding certain items, of $4.30 to $4.50 a share for the year. Today Amgen said profit will be at the low end of that range.

The company said it had positive results from clinical studies of two drugs in development. Denosumab, a treatment for osteoporosis, reached all of its main and secondary goals in a trial of 332 patients.

Another drug, AMG 531, also reached all of its goals in a late-stage clinical trial to treat an autoimmune disorder called ITP. Amgen said it plans to ask for regulatory approval of the treatment for ITP in 2007 in both the U.S. and Europe.

Denosumab could be ``very meaningful'' to Amgen in the future, because osteoporosis is a large potential market, and the product is differentiated from rivals, Montgomery & Co.'s Kapoor said. He doesn't own any shares in Amgen and his firm hasn't done banking with the company.

More Aranesp Studies

The company also provided updates on two more Aranesp studies. Independent monitoring committees for trials called TREAT and RED-HF recommended that both studies continue as planned. TREAT is testing Aranesp in anemic patients with improperly functioning kidneys, and RED-HF is testing Aranesp for treatment of heart failure.

Sales of Aranesp, Amgen's top-selling drug for patients who get anemia after taking chemotherapy, rose 14 percent to $1.02 billion. Aranesp sales were little changed from $1.1 billion in the fourth quarter.

Epogen, for patients with anemia who are on kidney dialysis, rose 3.5 percent to $625 million in first-quarter sales. That's down 5 percent from $661 million in sales in the fourth quarter. Last month U.S. regulators required the company to stiffen drug- package warnings for both anemia medicines and told doctors to use the lowest possible dose.

Aranesp sales could fall by 20 percent this year because of the negative results and new warnings, said analyst Michael Aberman of Credit Suisse in a note to clients April 4.

``We cannot predict the long-term impact,'' said George Morrow, Amgen's head of commercial operations, about the future sales of the company's anemia drugs.

The company is trying to gauge how doctors and patients will respond this year to the warnings about its anemia drugs. Almost all Medicare reimbursement has been cut for Aranesp in cancer patients with anemia who aren't on chemotherapy, Amgen said. For patients who have anemia caused by chemotherapy, an approved use, doctors remain comfortable prescribing the drug, Morrow said.

About 4 million patients have taken Amgen's anemia medicines since the first was introduced in 1989, the company said.

``We believe there is a substantial core of Aranesp business that is rock solid,'' Morrow said.

Safe Use

The company has data on more than 9,000 patients on its anemia drugs and is confident they are safe when prescribed for an approved use, Sharer said on the conference call. The company will make that case to a panel of expert advisers to the Food and Drug Administration on May 10.

Shares of Amgen added 41 cents to $62.60 as of 7:11 p.m. New York time in extended trading after the report. Earlier they rose 22 cents to $62.19 as of 4 p.m. in Nasdaq Stock Market composite trading today. They have declined 9 percent this year.

Sales of Enbrel, Amgen's drug for rheumatoid arthritis and other autoimmune diseases, rose 11 percent to $730 million.

Amgen's newest drug for colorectal cancer, Vectibix, was approved in September and brought in $51 million in sales in its second full quarter on the market. The drug was priced 20 percent below a rival drug, ImClone Systems Inc.'s Erbitux.

Vectibix suffered a setback March 22, when a clinical trial showed that survival rates worsened when patients took a combination regimen that included Vectibix. The negative result means Amgen won't be able to expand sales of Vectibix as a first- choice therapy, analysts said.

Based on the finding, two trials of Vectibix that were planned have been put on hold, Amgen said. One study is in pancreatic cancer and another for colorectal cancer patients following surgery, the company said.

To contact the reporter on this story: Luke Timmerman in San Francisco at ltimmerman@bloomberg.net.

Last Updated: April 23, 2007 19:18 EDT