分析家因FDA延迟批准而担忧(下)
In the biotech sector, the analysts said that Actelion and Inhale Therapeutic Systems stand out as most exposed to a more stringent FDA regulatory environment. Actelion filed Tracleer in November 2000 for pulmonary hypertension while Inhale expects to file its key inhaled insulin drug Exubera in December.
Among the mid-level and big pharmaceutical firms, the report said that Forest Labs and Lundbeck may be exposed with the follow-on compound to the Celexa SSRI anti-depressant, which was filed with the FDA for approval in March 2001.
For AstraZeneca, it said that the risk is largely related to the cholesterol-lowering drug Crestor, which was filed with the FDA last month. Akzo Nobel was exposed because of its anti-clotting agent Arixtra and Xyvion for osteoporosis, while Roche was exposed because of its long-acting interferon Pegasys.
Eli Lilly had nine new compounds, in addition to Xigris, that it hoped to file in the next 30 months while Bristol-Myers Squibb had to resubmit its application for its potential hypertension blockbuster Vanlev, the report added.
Other analysts have also criticised the FDA in recent weeks.
Richard Stover of investment and research firm Arnold & S. Bleichroeder said, "I've been at this for 34 years and I have never, ever seen the FDA this dysfunctional. This reflects a totally dysfunctional FDA that has adopted the attitude, borrowing from Nancy Reagan, 'Just say no to drugs.'"
Robert Hazlett of Robertson Stephens said that he believes the recent regulatory setbacks for drug and biotech companies represent a combination of a more scrutinizing FDA and the introduction of new classes of drugs that demand more thorough reviews.
But Ira Loss, of Washington Analysis, said that the Xolair and the Contak CD reviews were separate decisions, as were the other setbacks recently issued by the FDA and its advisory panels. "In both cases there was a data shortfall and the fact that they happened at the same time can lead people to conclude that suddenly there's a major sea change at the FDA and there's a great conspiracy underway to undermine American industry. But it's not true," Loss said., http://www.100md.com
Among the mid-level and big pharmaceutical firms, the report said that Forest Labs and Lundbeck may be exposed with the follow-on compound to the Celexa SSRI anti-depressant, which was filed with the FDA for approval in March 2001.
For AstraZeneca, it said that the risk is largely related to the cholesterol-lowering drug Crestor, which was filed with the FDA last month. Akzo Nobel was exposed because of its anti-clotting agent Arixtra and Xyvion for osteoporosis, while Roche was exposed because of its long-acting interferon Pegasys.
Eli Lilly had nine new compounds, in addition to Xigris, that it hoped to file in the next 30 months while Bristol-Myers Squibb had to resubmit its application for its potential hypertension blockbuster Vanlev, the report added.
Other analysts have also criticised the FDA in recent weeks.
Richard Stover of investment and research firm Arnold & S. Bleichroeder said, "I've been at this for 34 years and I have never, ever seen the FDA this dysfunctional. This reflects a totally dysfunctional FDA that has adopted the attitude, borrowing from Nancy Reagan, 'Just say no to drugs.'"
Robert Hazlett of Robertson Stephens said that he believes the recent regulatory setbacks for drug and biotech companies represent a combination of a more scrutinizing FDA and the introduction of new classes of drugs that demand more thorough reviews.
But Ira Loss, of Washington Analysis, said that the Xolair and the Contak CD reviews were separate decisions, as were the other setbacks recently issued by the FDA and its advisory panels. "In both cases there was a data shortfall and the fact that they happened at the same time can lead people to conclude that suddenly there's a major sea change at the FDA and there's a great conspiracy underway to undermine American industry. But it's not true," Loss said., http://www.100md.com