인도제약공장에 HPLC 가 10%밖에 되지않는다는 기사내용

Drug discovery down, despite quicker approvals


Dec 11, 2006
By: Heidi Belden, Pharm.D.
Drug Topics


Despite better tools, decreased time to Food & Drug Administration approval, and an unbelievable figure for 2006 projected pharmaceutical sales—$321.1 billion—the payoff for drug innovation in the United States has been lagging. Over the past 10 years, there has been an annual average of only 10 to 15 new molecular entities (NMEs) to receive a nod from the FDA through fast-track approval, and only five through the regular approval process. This was the news coming from the 2006 Annual Meeting of the American College of Clinical Pharmacy (ACCP), held in St. Louis in October.

Roger L. Williams, M.D., executive VP and CEO of U.S. Pharmacopeia (USP) Convention, said, "All the energy going into NMEs doesn't seem to have the payoff that one would expect." The fact is, at an estimated cost of $800 million to $1 billion to bring a new therapeutic to market, it is an expensive venture. "It is also a time-consuming and torturous process," said Williams of drug discovery. "Nine out of 10 medicines are dropped out of the process."

Still, according to Williams, the United States currently leads the world with nearly 3,000 new drugs in development, including 83 for HIV/AIDS, 194 for pediatrics, 122 for heart disease/stroke, 256 for infectious disease and bioterrorism threats, 103 for mental illness, and 176 for neurological diseases. Cancer is at the top of the list, with 395 drugs currently in development.

One reason for the drop in NMEs may be the rate at which patents on brand-name drugs are expiring. "This creates an opportunity, and we've seen a huge increase in generic drug applications," said Williams. In 2005 alone, 777 applications for generic drugs were received. "This is overwhelming the Office of Generic Drugs," said Williams, who ran the office for 10 years, ending in 2000. He said that currently 56% of all drugs are generic, a percentage he predicts will approach 70% in coming years.

According to Williams, a lot of business is coming from India. "In the past, they just manufactured the active ingredients, but now they are making the completed dosage form."

Still, 49% of all active ingredients used to manufacture drugs in the United States come from China and India. "There is also a strong link there to counterfeiting and drug diversion. In addition, only 10% of Indian pharmaceutical companies even have high-pressure liquid chromatography [HPLC], a machine used to separate drugs and metabolites to ensure purity. So there is a need to follow up on the quality of products being imported, Williams noted. To help combat this problem, the USP now has an office in both India and Shanghai.

In a related presentation at the ACCP meeting, Thomas S. Foster, Pharm.D., FCCP, professor at the University of Kentucky, predicted that pharmacists will be focusing on pharmacogenomics and how to individually tailor drugs to patients. He envisions "singularity" between man and machine over the next 40 years, where there is no distinction between biological and mechanical. "The key elements will be genetics, nanotechnology, and robotics. They will converge in the next few years and drive us into the future," he explained.

The drug development process as we know it will morph into something completely different within the next five to 10 years, according to Foster. "The whole way we test patients will change dramatically. In the new trial designs, we will use biomarkers and genetic tests," he predicted. Also, pharmaceutical care will be "bench to bedside" and "bedside to bench"—a circular and streamlined process. "Pharmacists must be able to practice this way in order to be successful."

Foster also thinks the ability to produce biogenerics is close at hand. "The goal is an interchangeable generic, not like the generic growth hormone, recently approved, that was not interchangeable," he said. "When that biologic was approved, I asked myself, 'How does this benefit us?'" According to Foster, the technology already exists in both India and China. "The problem with the Office of Generic Drugs is that it does not receive user fees and is always struggling for money. Its budget is too low at $1.7 billion per year and should perhaps be two or three times that," Foster declared.

In conclusion, Williams stated that the genomic revolution is at hand, where there is simultaneous development of both NME and diagnostic testing. He reminded pharmacists, "Learn these things early on, and be a part of them, or else the train will be leaving town and you will not be on it."