Nearly half of the drugs approved by the FDA from 1998 to 2007 originated with biotech companies or academia
A new study reveals that biotechnology companies or universities discovered 42 percent of all scientifically innovative drugs approved by the U.S. Food and Drug Administration over a 10-year period. Half of the drugs that responded to unmet medical needs also fell into this category.
This analysis comes courtesy of Robert Kneller, a professor of biomedicine and law in the University of Tokyo’s Research Center for Advanced Science and Technology. Kneller traced all 252 new drugs approved by the FDA from 1998 to 2007 back to their origins and analyzed “the extent to which they addressed unmet medical needs and their scientific innovativeness.” His findings appear in the November 2010 issue of Nature Reviews Drug Discovery, a monthly journal that focuses on drug discovery and development.
In a 16-page article titled “The importance of new companies for drug discovery: origins of a decade of new drugs,” Kneller notes that the “current environment for drug research and development (R&D) is characterized by major challenges, including pharmaceutical industry pipelines that are insufficient to replace revenues from drugs that are becoming generic, diminishing venture capital funding for early-stage companies and mounting criticism of university technology licensing practices.” He further argues that “understanding the factors that promote the discovery and development of new drugs — particularly truly innovative drugs that respond to unmet medical needs — could have an important role in developing strategies to address these challenges.”
Behind the Numbers
Kneller’s evaluation of FDA-approved drugs for this period reveals the following:
* 58 percent of them originated with pharmaceutical companies;
* 18 percent were discovered by biotechnology companies;
* 16 percent were university discoveries first transferred to a biotech company; and
* 8 percent were university discoveries first transferred to a pharmaceutical company.
To assess the extent to which new drugs addressed unmet medical needs, Kneller considered whether the FDA had assigned them “priority review status,” noting in his article that the designation “is granted to drugs that are anticipated to provide substantial benefit over currently marketed drugs.” Of the 123 whole drug equivalents in the priority review category, 46 percent were attributed to pharmaceutical companies, 23 percent were attributed to biotech companies and roughly 30 percent were attributed to universities.
Of the 118 drugs considered scientifically novel, 44 percent originated with pharmaceutical companies, 25 percent originated with biotech companies and 31 percent originated with universities.
The United States led all drug-discovering countries, with roughly 47 percent of the new drugs studied originating in U.S. pharmaceutical and biotech companies or universities. Countries in continental Europe (principally Italy, Denmark, Belgium, Sweden, the Czech Republic and Spain) were the source of the second-highest number of new drugs (roughly 11 percent), followed by Japan (9 percent).
Derek Lowe parsed Kneller’s findings in a Nov. 4, 2010, post to his In the Pipeline blog for Corante, a blog media company offering news and commentary on technology, business, law, science and culture by leading commentators and thinkers in their respective fields. He wrote, among other things, that the numbers “sound about right,” adding that “biotech- and university-derived drugs” outperformed pharmaceutical industry–based ones in earning priority review status and that “the majority of the novel stuff from universities gets taken up by biotech companies rather than by pharma.”
The key take-away from Kneller’s research, Lowe concluded, is that the “great majority of drugs come from industry, but the industry is not homogeneous. Different companies are looking for different things,” he continued, “and the smaller ones are, other things being equal, more likely to push the envelope.”