Amgen Inc., the world's largest biotechnology company, said Thursday that earnings rose 6.2% for the second quarter on higher sales of its blockbuster drugs, Epogen and Neupogen.
The company reported profit of $322 million, or 30 cents a share, up from $303 million, or 28 cents, a year earlier. Revenue rose 6.4% to $859 million. The results, released after the market closed, beat analysts' forecasts.
Amgen's shares tumbled earlier in the day on news that a Parkinson's disease drug under development performed poorly in a clinical trial. Its stock closed at $57.72, down $1.46 on Nasdaq.
Chairman and Chief Executive Kevin Sharer told analysts that the company needs to review the test results before deciding what steps to take. Amgen is developing the drug, NIL-A, with Guilford Pharmaceuticals.
Amgen has faced a spate of disappointing news on the drug-development front. The Food and Drug Administration last month issued a nonapprovable letter for a prostate cancer treatment the company is developing with Praecis Pharmaceuticals. Also, the regulatory review of its second-generation anemia treatment, Aranesp, is taking longer than expected.
But Amgen said Thursday its rheumatoid arthritis treatment, Kineret, was moving through the regulatory process and an FDA advisory committee planned to review it Aug. 16. It is an important step as the FDA frequently follows the advice of its committee.
Sharer said Amgen and its partner plan to meet with the FDA this quarter to discuss the prostate drug, called Plenaxis. "We think the drug should be approved, but for what use and exactly how broadly and for what population remains to be seen."
Sharer said Amgen might abandon the drug "if the population is so narrow that it is not appropriately commercial." Praecis is the lead developer of the medication, which analysts said is not financially significant for Amgen.
Sharer said he remains confident the FDA will approve Aranesp, expected to be a blockbuster drug. Amgen had anticipated regulatory clearance in June.
Sharer wouldn't set a new approval timeline but said, "it feels close to me." Amgen, based in Thousand Oaks, remains in discussions with the FDA on what information to put on the Aranesp label, he said.
Aranesp is a longer-lasting version of EPO, an engineered copy of the natural protein that spurs red blood cell production. Amgen, which developed EPO, sells it under the brand name Epogen in the kidney dialysis market. Its marketing partner, Johnson & Johnson, sells EPO under the name Procrit in other U.S. markets and as Eprex in foreign markets.
Aranesp allows Amgen to compete with J&J;, whose EPO sales last year totaled $2.7 billion. Amgen is seeking approval to market Aranesp for anemia due to kidney disease and renal failure. It expects to seek approval for the cancer market later this year.
Amgen said it continues to expect 2001 sales growth in the low double digits, despite delayed approval of Aranesp. Amgen, which previously forecast Aranesp sales of $100 million to $150 million this year, has removed the drug from its forecasts.
Aranesp received European Commission approval in June and is sold in seven European nations.