Amgen Says Drug OKd for Cancer Patients

Amgen Inc., the world’s largest biotechnology company, said Monday that U.S. regulators approved its Aranesp drug to treat anemia in cancer patients undergoing chemotherapy, creating competition for Johnson & Johnson’s top-selling product Procrit.

Thousand Oaks-based Amgen said the Food and Drug Administration would allow the sale of Aranesp, a longer-lasting form of the company’s older anemia drug Epogen, as well as Procrit.

“Obviously, there is a benefit in terms of lower frequency of dosing. The drugs are similar in efficacy, but there is a dosing advantage,” said Fariba Ghodsian, an analyst at Roth Capital Partners.

Amgen sells Epogen as a treatment for anemia in kidney dialysis patients, but rights to the drug for other indications were licensed early on to Johnson & Johnson, which sells the same drug in the U.S. under the brand name Procrit for patients undergoing chemotherapy.

Studies have shown that Aranesp is effective when given once every two weeks, compared with Procrit’s weekly dosage schedule. Both drugs must be injected or given intravenously.

Aranesp was launched last year as a treatment for patients with chronic kidney disease. The drug, which saw first-quarter sales of $39 million, has so far been targeted mainly at kidney patients who are not on dialysis.

With the approval for cancer patients, analysts estimate combined sales of Epogen and Aranesp will reach $4 billion a year by 2005-2006, compared with 2001 Epogen sales of $2.2 billion and J&J;’s total anemia drug sales last year of $3.4 billion.

All three drugs are versions of epotein, the bioengineered form of a human protein that stimulates production of red blood cells.

Anemia results from a shortage of oxygen-rich blood cells, leaving patients feeling weak and unable to perform daily tasks. The condition occurs frequently in patients undergoing chemotherapy, which kills both cancerous and healthy cells in the body.

UBS Warburg analyst John Sonnier in a research note said he believes the Aranesp approval for cancer patients represents “the single most important growth opportunity for Amgen.”

Anemia will strike about two-thirds of the 1.2 million cancer patients in the United States treated with chemotherapy this year.

Recent reports that another Johnson & Johnson anemia drug, Eprex, has caused 141 cases of a rare but potentially fatal blood disorder called pure red blood cell aplasia also could benefit Amgen, analysts said.

Eprex is sold only outside of the United States.

“Clearly, this could help Amgen get market share in Europe ... but even in the U.S. some physicians would rather go with something that doesn’t have that sort of shadow hanging over it,” Ghodsian said.

With annual revenue of more than $4 billion, Amgen has relied on Epogen and Neupogen, an immunity booster for cancer patients, for nearly all of its sales.

Amgen said the FDA approved Aranesp for the treatment of patients with nonmyeloid cancers, which are solid-tumor cancers.

Myeloid cancers, such as leukemia, involve disease of the bone marrow.

Amgen’s shares closed down 18 cents at $35.28 in trading on Nasdaq. J&J; shares closed up 68 cents at $42.53 on the New York Stock Exchange.