While the volume of drugs in the biopharmaceutical industry’s research and development pipelines was essentially flat in 2010/11, the period saw an encouraging 13% rise year on year in products entering Phase III clinical trials.
This was the largest such increase recorded to date by Citeline, which has released its 2011 Annual Review of Trends in Pharmaceutical R&D. Less encouraging was the lack of any marked innovation bounty during this period, at least in terms of new chemical entities or drugs entering the market with a new mechanism of action.
According to Citeline’s review, the total number of active drugs currently on its database is 9,713, down slightly from 9,737 at the same point in 2010. “This would appear to confirm a trend, the beginnings of which were seen last year, of a plateauing off [in] the longer-term trend of year-on-year increases,” Citeline comments.
Phase III increase
The volume of drugs currently in Phase III trials, however, is 637 – 83 or 13% more than in the 2009/2010 review. “This is indeed a positive signal, as in recent years, there has been a noteworthy trend of increases in the numbers of Phase I and II drugs failing to translate through to Phase III,” Citeline points out.
The trend of increasing attrition at Phase II was “not what the industry was looking for as it sought to limit its expenditure on expensive clinical trials to drugs which had a better chance of success”, it adds. The Phase III figure was almost flat in the years 2008-2010, despite rising numbers of pipeline drugs at Phases I and II during that time.
There have been similar, although proportionally smaller, increases in the number of drugs at Phase I (from 1,399 to 1,433), Phase II (from 1,798 to 1,836), and at pre-registration (from 134 to 141), continuing the trends seen in recent years, the review notes.
What kept the overall pipeline more or less static in 2010/2011 was a decline from 4,818 to 4,696 in drugs at the preclinical stage.
Citeline cautions, though, against reading too much into this shift, as “the preclinical figure is the most subjective and volatile, and the decrease of 132 preclinical drugs can almost entirely be accounted for by an increase in 133 in the number of drugs moved to the No Development Reported status over the course of the year, a reflection primarily of more rigorous editorial reviewing policies”.
New chemical entities
There were 42 new drug launches in 2010 compared with 36 in the previous year, although “this modest increase is somewhat flattened by the approval of nine new anti-infective launches mostly for the H1N1 influenza pandemic”, Citeline observes.
The number of new chemical entities among these launches was “again in the low twenties, and if we examine the list further for drugs with a new mechanism of action hitting the market for the first time, we come up with just three drugs”, the review points out.
Amgen’s Prolia (denosumab) for osteoporosis, Mitsubishi-Tanabe’s Gilenya (fingolimod) for relapsing and remitting multiple sclerosis and Santen’s Diquas (diquafosol tetrasodium) for dry eye syndrome were all first-in-class approvals with a novel mechanism of action. Diquas did not, however, secure approval in the US, Citeline notes.
Overall, comments editorial director Ian Lloyd, 2010-11 “was a year which has seen little wholesale change, which in the shadow of the world’s woes following the financial crisis should arguably be seen as more of a comfort than a concern”.