Where have all the new drug's gone: Industry's medicine cabinet running empty on compounds
Wednesday, January 09, 2008
BY GEORGE E. JORDAN
Star-Ledger Staff
The pharmaceutical industry's research drought is showing no signs of getting better.
The Food and Drug Administration last year approved only 18 drugs, according to the agency's preliminary 2007 data. Only twice in the past three decades has the number of novel treatments cleared by the FDA been lower than last year's figure.
The numbers confirm what company executives and bureaucrats already know: The research pipeline that regularly pumped out billion-dollar drugs like Lipitor and Plavix is running dry as regulators are exacting more demands on drugmakers.
It's an ominous development for New Jersey, home to tens of thousands of pharmaceutical workers. Fewer approvals factored into widespread financial problems that led drugmakers last year to announce sweeping layoffs and deep spending cuts in the face of flat sales. Sales have been hurt not only by the lack of new "blockbuster" drugs, but also by increasingly fierce competition older medicines face from cheap generic drugs.
Drug companies are fighting back by squeezing more uses out of medicines already on the market, and the effort is paying off. The last few years have seen a spike in FDA approvals for so-called new indications of existing drugs, especially expensive biotechnology medicines to fight cancer.
Still, the number of new drug approvals has fallen near historic lows.
Last year, according to the FDA's figures, only 16 "new molecular entities" and vaccines and two biotech drugs, known as biologics, won approval for sale. That compares with a peak of 53 drugs in 1996, and lows of 17 in 2002 and 14 in 1983, according to FDA records.
Christopher DiFrancesco, an FDA spokesman, said data on 2007 drug approvals posted on the agency's Web site are not final. He said final figures would be released in March.
Elliot Sigal, research chief at drugmaker Bristol-Myers Squibb, said the low number of FDA approvals "is one measure of how hard it is" to discover therapies.
"And that gives all of us concerns about developing drugs for unmet medical needs," he said.
编译：
根据FDA初步统计的数据显示，2007年通过该机构批准上市的新药仅有18个，包括了16个新化学实体、疫苗以及2个生物制品。这一数字在过去的三十年里排名倒数第三，更低的记录分别是2002年的17个和1983年的14个。
这个结果对于美国“药谷”新泽西州的几十万制药从业人员来说，显然不是个好消息。面对日益枯竭的产品线，各大制药公司纷纷采取了大幅裁员和削减开支的手段。尽管如此，制药公司还不得不面对越来越激烈的廉价仿制药竞争，能否保住其原有畅销药的市场份额也是个问题。
新药上市乏力，制药公司只能通过拓展老药的适应症来提升销量。但是过去几年FDA在老药新适应症的批准，尤其是那些昂贵的生物制品。
FDA发言人表示这个数据并不是最终版本，最后的结果会在今年3月份公布。但是相比于1996年53个新药的“盛世年代”，如今的制药行业只能哀叹“流年不利”。
Wednesday, January 09, 2008
BY GEORGE E. JORDAN
Star-Ledger Staff
The pharmaceutical industry's research drought is showing no signs of getting better.
The Food and Drug Administration last year approved only 18 drugs, according to the agency's preliminary 2007 data. Only twice in the past three decades has the number of novel treatments cleared by the FDA been lower than last year's figure.
The numbers confirm what company executives and bureaucrats already know: The research pipeline that regularly pumped out billion-dollar drugs like Lipitor and Plavix is running dry as regulators are exacting more demands on drugmakers.
It's an ominous development for New Jersey, home to tens of thousands of pharmaceutical workers. Fewer approvals factored into widespread financial problems that led drugmakers last year to announce sweeping layoffs and deep spending cuts in the face of flat sales. Sales have been hurt not only by the lack of new "blockbuster" drugs, but also by increasingly fierce competition older medicines face from cheap generic drugs.
Drug companies are fighting back by squeezing more uses out of medicines already on the market, and the effort is paying off. The last few years have seen a spike in FDA approvals for so-called new indications of existing drugs, especially expensive biotechnology medicines to fight cancer.
Still, the number of new drug approvals has fallen near historic lows.
Last year, according to the FDA's figures, only 16 "new molecular entities" and vaccines and two biotech drugs, known as biologics, won approval for sale. That compares with a peak of 53 drugs in 1996, and lows of 17 in 2002 and 14 in 1983, according to FDA records.
Christopher DiFrancesco, an FDA spokesman, said data on 2007 drug approvals posted on the agency's Web site are not final. He said final figures would be released in March.
Elliot Sigal, research chief at drugmaker Bristol-Myers Squibb, said the low number of FDA approvals "is one measure of how hard it is" to discover therapies.
"And that gives all of us concerns about developing drugs for unmet medical needs," he said.
编译：
根据FDA初步统计的数据显示，2007年通过该机构批准上市的新药仅有18个，包括了16个新化学实体、疫苗以及2个生物制品。这一数字在过去的三十年里排名倒数第三，更低的记录分别是2002年的17个和1983年的14个。
这个结果对于美国“药谷”新泽西州的几十万制药从业人员来说，显然不是个好消息。面对日益枯竭的产品线，各大制药公司纷纷采取了大幅裁员和削减开支的手段。尽管如此，制药公司还不得不面对越来越激烈的廉价仿制药竞争，能否保住其原有畅销药的市场份额也是个问题。
新药上市乏力，制药公司只能通过拓展老药的适应症来提升销量。但是过去几年FDA在老药新适应症的批准，尤其是那些昂贵的生物制品。
FDA发言人表示这个数据并不是最终版本，最后的结果会在今年3月份公布。但是相比于1996年53个新药的“盛世年代”，如今的制药行业只能哀叹“流年不利”。