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Where have all the new drug's gone: Industry's medicine cabinet running empty on compounds
  Wednesday, January 09, 2008
NJ 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.
Pharmaceutical companies and Wall Street analysts blame the dearth of new products in part on a regulatory crackdown since the withdrawal of Vioxx, a once-popular painkiller Merck pulled from the market in 2004 due to mounting safety concerns.
The FDA has denied Vioxx prompted any change in its stance. But the agency's records show in the three years since Vioxx's removal, the FDA's Center for Drug Research has approved, on average, six fewer drugs per year than in the three years before Vioxx was removed from the market.
Swiss drugmaker Novartis and GlaxoSmithKlein of the United Kingdom where the only drug companies in 2007 to win approval of multiple drugs. The FDA awarded them two approvals each.
Two major drugs hit a regulatory wall in 2007.
In April, the FDA rejected Merck's Arcoxia, an arthritis painkiller in the same drug class as Vioxx, even though it is widely available overseas. In June, French drugmaker Sanofi-Aventis withdrew its diet drug Accomplia from the review process after an FDA advisory board rejected it.
Wyeth, a big drugmaker based in Madison, had three products potentially worth a total of $4 billion in annual sales delayed by FDA, which requested more information on each.
With few new treatments emerging from the drug development pipeline, drugmakers are pouring money into finding new uses for specialized biotech drugs that may be effective against multiple diseases.
In the past, drugmakers typically sought approval for one indication for a new drug -- meaning the medicine could be marketed for just one purpose, such as fighting cholesterol. Now, they are launching a spectrum of clinical trials in an effort to win approvals for multiple indications. In some cases, the same drug is being marketed under different names for different diseases.
The trend is apparent in the FDA's approval of expanded indications for biotech drugs. The agency approved 29 such expansions between 2000 and 2003. Over the next three years, the number leaped to 58. Figures were unavailable for 2007.
"We are in fact being much more rigorous and disciplined in evaluation of the likely potential of any compound across multiple indications," said Steve Romano, Pfizer's vice president of global medicine. "The mechanisms we're pursuing ... can have an effect across a number of disease states."
Pfizer's pain pill Lyrica, for example, is approved for three types of neuropathy, and the company plans to seek additional indications for still more forms of neuropathy and as a treatment for epilepsy.
Bristol-Myers, which has major research operations in New Jersey, is betting on novel products like Orencia, an injectable medicine approved for rheumatoid arthritis that is under study for Lupus, Crohn's disease, psoriatic arthritis and ulcerative colitis.
"The more molecular insights we have, the more optimistic I am we will use our technology to discover new therapies," Sigal said. "But it's tough."
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