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Fig. 1.18. R&D Productivity: NDAs, NDAs & NMEs (Copyright 2005, Thomson CenterWatch) Source: © 2005 Thomson Center Watch formulations. Generic product approvals are a separate statistic. Again, we can observe that the added research investment has yet to pay off for the public and the industry. NDA filings reached a high above 120 for two years in the late 1990s, but they were at the rate of 90-110 annually for the following 4 years. The year 2004 is an encouraging sign with an increase in NDA approvals. NDA approvals followed a similar pattern, from more than 100 down to 65-75 in any one year. NMEs similarly changed from 30-40 down to about 20 in any one year. Success rates for product approvals by the FDA were studied. For an NME (drug), only about 15-20% of them were successfully approved; the rate for individual biologicals was 30-40%, according to work at the Tufts Center for the Study of Drug Development. The therapeutic category of an NME can impact success rates, for example, infectious disease, 28.1% (highest); cancer, 15.8%; immunology, 15.4%; and CNS, 14.5%, in the estimates for products approved for 1983-1992 in one study [10, 22, 26, 32].

The research activity for individual companies is presented in the next table for the years 2000, 2002, and 2004 (Fig. 1.19). The top 12 companies had 1,105 product candidates in late research (usually indicating preclinical research) or in development, which increased by 13% to 1,250 product candidates in 2002 and also 2004. The range in the number of product candidates per company was wide, even for the top 10 companies, from 56 to 188 in 2004. GlaxoSmithKline with 188 candidates led the pack by a large margin, followed by Pfizer, Johnson & Johnson, and Aventis, which is not surprising given their high R&D budgets noted earlier in the chapter. Consolidation in the industry alters this line-up with Pfizer adding in Pharmacia and its candidates to its portfolio for 2002 and Aventis being added with Sanofi-Synthelabo for 2004 and forward in time. Usually, companies report the product candidates licensed in from other small companies, such as the biotechnology companies, along with their own discovered molecules, in such figures [22].

Figure 1.20 lists more than 1,800 molecules in clinical research pipeline, in phases 1 through 3 or under consideration for approval by regulatory authorities in 2004, for many diseases responsible for much morbidity and mortality in the world. Cancer was and is the predominant disease category for new products, well exceeding (twofold) the next categories, infectious diseases, cardiovascular/heart diseases, and collectively, central nervous system/depression/migraine/ Alzheimer disease. This high number of potential cancer products should be no surprise in 2004, given the number of diseases in the cancer area, the mortal consequences of them, the excellent payer environment in oncology, the many discoveries for cancer mechanisms in the past decade, the engagement of most pharmaceutical and many biotechnology companies, as well as the National Cancer Institute, and the dramatic benefits now occurring from drug therapy, cures and longer life with better quality of life.

The time frame for product development is lengthy, often requiring 4 to 5 years for research and preclinical workup, followed by 4 to 5 more years or more for all the clinical development work, and finishing with an FDA review process that can require as little 3-4 months but can take up to 2 years or more (Fig. 1.21). The total time for the clinical phases of development is now very similar for biologicals and drugs, 6.1 years vs. 6.8 years, respectively. The average FDA review time for a standard NDA in the USA is now down to about 12 months for all drugs (average of 1.6 months) and for priority reviews at 7 months. Regulatory authorities around the world vary in the time necessary for review and approval (U.S. NME review time of 384 days); Europe and Japan with more time for their product reviews (460 and 508 days, respectively). In the USA, laws and regulations have been promulgated to strengthen the review process and shorten the

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