将讨论作上标志推动Amgen公司的下一代贫血药物获得批准
WASHINGTON (Reuters Health) -The US approval of Amgen Inc.'s long-acting anti-anemia drug Aranesp (darbepoetin alfa) will take longer than initially expected, the biotechnology concern announced on Friday.
The Thousand Oaks, California-based firm originally said that it expected the approval of the drug to take place in the first half of 2001.
The company filed the original application in December 1999, seeking approval to help patients with kidney failure produce more red blood cells.
There are no significant issues, but the company is going back and forth with the US Food and Drug Administration over the appropriate labeling, explained Amgen spokesman David Kaye in an interview with Reuters Health.
If there is any change in the company's earnings forecast due to these labeling discussions, then that announcement will be made on July 26, when the company is scheduled to provide updated guidance, Kaye added.
"As of today, there is no change," he told Reuters Health.
Kaye also refused to disclose whether Amgen would begin phasing out its short-acting anemia treatment Epogen (epoetin alfa), once it receives FDA approval for Aranesp.
"I don't want to reveal our strategy to Johnson & Johnson," Kaye said.
Johnson & Johnson is the maker of Procrit (epoetin alfa), which contains the same active ingredient as Epogen.
However, analysts have suggested that Aranesp may trump the Johnson & Johnson blockbuster treatment since published trial data has shown that a once-weekly injection of Aranesp is equivalent to the thrice-weekly regimen of Epogen.
In 2000, sales of Johnson & Johnson's Procrit were about $2.7 billion. In contrast, first quarter sales of Epogen were about $503 million.
Aranesp recently was approved in Europe and Australia, where Kaye said that it has received a very warm welcome. But he noted that the preliminary sales figures for Aranesp would not be disclosed until July 26, when the company updates its guidance to investors and analysts.
In midday trading on the NASDAQ, shares of Amgen edged down 0.798 to 61.88, while shares of Johnson & Johnson slipped 0.38 to 51.82 on the New York Stock Exchange., 百拇医药
The Thousand Oaks, California-based firm originally said that it expected the approval of the drug to take place in the first half of 2001.
The company filed the original application in December 1999, seeking approval to help patients with kidney failure produce more red blood cells.
There are no significant issues, but the company is going back and forth with the US Food and Drug Administration over the appropriate labeling, explained Amgen spokesman David Kaye in an interview with Reuters Health.
If there is any change in the company's earnings forecast due to these labeling discussions, then that announcement will be made on July 26, when the company is scheduled to provide updated guidance, Kaye added.
"As of today, there is no change," he told Reuters Health.
Kaye also refused to disclose whether Amgen would begin phasing out its short-acting anemia treatment Epogen (epoetin alfa), once it receives FDA approval for Aranesp.
"I don't want to reveal our strategy to Johnson & Johnson," Kaye said.
Johnson & Johnson is the maker of Procrit (epoetin alfa), which contains the same active ingredient as Epogen.
However, analysts have suggested that Aranesp may trump the Johnson & Johnson blockbuster treatment since published trial data has shown that a once-weekly injection of Aranesp is equivalent to the thrice-weekly regimen of Epogen.
In 2000, sales of Johnson & Johnson's Procrit were about $2.7 billion. In contrast, first quarter sales of Epogen were about $503 million.
Aranesp recently was approved in Europe and Australia, where Kaye said that it has received a very warm welcome. But he noted that the preliminary sales figures for Aranesp would not be disclosed until July 26, when the company updates its guidance to investors and analysts.
In midday trading on the NASDAQ, shares of Amgen edged down 0.798 to 61.88, while shares of Johnson & Johnson slipped 0.38 to 51.82 on the New York Stock Exchange., 百拇医药