With so much emphasis on me-too drugs, drying pipelines and R&D cutbacks over the past several years, it is hardly surprising that so many have an impression that big pharma hardly discovers anything innovative anymore. And guess what? A new analysis of 252 drugs that were approved by the FDA between 1997 and 2008 finds that drugmakers were responsible for less than half of the innovative meds discovered during that period.
For starters, the analysis found that 58 percent of the approved drugs were discovered by pharmaceutical companies, compared with 18 percent by biotechs. Universities accounted for the remaining 24 percent, although the study determined that 8 percent were transferred to drugmakers and 16 percent to biotechs. This would appear to contrast with contentions that federal funding is responsible for most innovative discoveries.
Of the total, 123 were designated for priority review, which the study used as an indication of unmet medical needs. An analysis of this subset found that pharma companies generated 46 percent of the meds, while biotechs were responsible for 30 percent and universities notched 23 percent. In other words, drugmakers succeeded in winning approval for less than half of such drugs.
As for scientific innovation, the author looked at the novelty of the mechanism of action and chemical structure and found 118 drugs of the total that was approved. Of those, pharma came up with 44 percent, while biotech notched 25 percent and universities delivered the remaining 31 percent. Once again, pharma trailed and roughly two-thirds of its approved drugs were classified as follow-ons.
The study also found orphan drugs accounted for 35 percent of drugs categorized by novelty and priority review. Orphans also accounted for more than 40 percent of all university-discovered drugs, half of the university-discovered drugs developed initially by biotechs, and more than a quarter of those discovered in biotechs themselves. Looked at another way, biotechs discovered more than 20 percent and about 35 percent were discovered in universities and developed initially by biotechs.
The upshot is that orphan meds may represent significant opportunities in select therapeutic areas, but drugs for the largest populations appear to continue to dominate strategic priorities at the largest pharma companies. You can read the full study, which was published in Nature Reviews Drug Discovery right here, and gazing at Table One may be helpful.
Hat tip to In The Pipeline