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
9 Comments
To me, the most important point in this study is that 0% of drugs were launched by universities. For everyone that thinks that pharma/biotech aren't developing anything innovative, this study points out yet again that nothing becomes a drug without significant effort by pharma/biotech.
What? Your comments do not follow from the data. What is clear from this study is that "Pharma" discovers and develops more than half of all drugs including about or ore than half of all novel and priority drugs...way better than most assume. Universities contribute fewer than a quarter..way less than most assume. That Pharma also does a lot of follow-ons is rational and expected and does not change their share of novelty.
What is not clear is the relative yield on R&D investment, normalized to target diffculty.
What is also very loose is what is included in the biologic/NTB and as always the cut between "pharma" and "biotech."
Tak..I mean Pharmalot not you..
TAK APPEARS TO BE ON TARGET. WHAT IS ALSO OMITTED IS "SAFETY" AND SIDE EFFECTS AS MEASURES OF INNOVATION. IF A NEW DRUG INCREASES PATIENTS COMPLIANCE/ADHERENCE, THAT CAN BE A HUGE BENEFIT. EVEN WITH NO INCREASE IN "EFFICACY". ALSO, DOESN'T ANYONE EVER DISCUSS SCALE UP OR MANUFACTURING? SIMPLY "DISCOVERING" A TREATMENT IS ONLY A PART OF WHAT FDA REQUIRES FOR APPROVAL.
Having been in Business Development and Licensing for Big Pharma, and having been approached by many a university with the "next great idea", I can say that 98% of the time what university considers to be adequate proof of concept falls WAY short of what my company would consider even for the most meager of funding. Most of these folks have no concept of commercialization or the extent of money and work done to make a proposal attractive. My BD&L Committee would annually screen about 1000 proposals/year, about 100 would make it to committee review, and of the 100 only about 20 new proposals would get any kind of serious funding. Bottom line, we would fund about 2% of university propsals annually.
For once, theres no evil attached to pharma
Interesting article, but a key point is missing in that innovation is also the ability to take an idea or discovery and make it manufactureable and marketable. If biotechs or universities could do that we wouldn't need big Pharma, but they cannot because of the regulatory requirements, resources and investment required to bring new drugs to the patients in need. I would imagine there are a number of innovative ideas and potential breakthroughs left on the laboratory floors of academia that could have saved lives.
We did a similar study and found the following:
Of the 25 drugs approved in 2009 by the FDA, 2/3rds started outside of big pharma (universities and startups)
Big pharma spent multiples of what the others spent on early stage innovation but had very little to show for it
Big pharma needs to changes its innovation model from being that of an Innovation Originator to an Innovation Aggregator
Looking at the organization who got the FDA approval to measure innovation is a poor measure, you need to look at where it came from and who advanced it throughout its lifecycle
Chris Wasden: can you please provide reference to the study you mention? Tks.