Business and Science for BD & others
#72, June 2012
Celebrating a bit
So far this year, I’ve worked on 7 signed deals (in- and out-licensing, ranging from research collaborations to Phase II) for my clients, and numerous term sheets are in the works. This is up a bit over last year. YEAH! May the 2nd half of 2012 be good to us all!
Outcomes Research rushing ahead, before the rules are set
In the 2010 Healthcare Act, a new entity, Patient Centered Outcomes Research Institute (PCORI) was set up to fund outcomes research. This year, $96M will be given out, with letters of intent due June 15th, and applications due July 31st. http://www.pcori.org/2012/webinars-and-reviewers/. But, the methodology guidelines for the comparative effectiveness research are just up for public comment, published June 4th. http://www.pcori.org/assets/Preliminary-Draft-Methodology-Report.pdf. So it seems that applications must be submitted before it is clear what the methodologies will be. Doing meaningful comparative effectiveness research is bound to be difficult under the best of circumstances!
T cells move like sharks and other predators
Sharks (and other predators) hunting for food move in a mix of long distance moves and short clusters of Brownian motion, termed a Levy walk. Now, it is reported that T cells move in a similar pattern. The chemokine CXCL10 increased the speed of CD8+ T cells in the brains of mice infected with the parasite T. gondii, but it did not result in a highly directed movement. Instead the chemokine stimulated that pattern of Brownian motion interspersed with long distance moves. The statistical analysis said such a Levy walk pattern was about 10x more efficient at finding rare targets than is Brownian motion. http://www.nature.com/nature/journal/vaop/ncurrent/full/nature11098.html
FDA faster than EMEA or Health Canada, but with more review cycles
The median first-review time was 303 days for the 225 new drugs approved by FDA, versus 352 for 99 new drugs by Health Canada and 366 for 186 new drugs by EMA. But FDA approved the lowest percentage after 1 cycle, just 61.8% of new drugs (139), compared with 68.7% (68) by Health Canada and 96.2% (179) by EMA. http://www.nejm.org/doi/full/10.1056/NEJMsa1200223#t=articleResults
With big Phase III expenses, should we have more conditional approvals?
The Manhattan Institute highlights that Phase III trials are 90% of the expenses for 1 drug’s development (but ~40% if you count the failures of other drugs before Phase III as part of the cost of developing the 1 successful drug). Phase III complexity has been climbing, with 65% more procedures, and 70% more clinical trial days, in 2005 than in 1999. The cardiovascular Factor Xa drugs Xarelto and Eliquis each had 60,000 patients in their Phase III trials, costing almost $3B for each drug. Small companies can’t afford these huge trials, and thus fewer drugs are being developed for cardiovascular diseases (237) than cancer (878), despite the larger number of people dying from cardiovascular disease.
The Manhattan Institute advocates expanding conditional approval beyond the accelerated approvals now available for cancer and AIDS. The drug approval could be restricted to the most severe cases, and advertising prohibited. But even smaller sales would enable companies to fund the required Phase III trials, and the experience in patients would help build confidence in the safety for a broader approval later.
Old targets versus the challenge of pitching the new
Bruce Booth of Atlas Ventures highlights that 8 targets represent more than 20% of the ~990 programs in oncology, with 70 clinical programs aiming at VEGF. I agree completely that the risk of not being differentiated outweighs the reduction in risk in biology, and that innovation will be demanded by the marketplace. http://lifescivc.com/2012/06/cancer-drug-targets-the-march-of-the-lemmings/
However, it is tough to work on a novel target or even a less validated target, requiring lots of biology to persuade an investor, or a partner, that intervention at the target will be important in disease. Even if you get the funds and pull together the data, it is harder to pitch a new story, requiring much more attention and time. On old targets, the pitch can be grasped in a short slogan, “it is just like Avastin, but safer”. With a new target, investors and partners must work hard putting all the pieces together. And it is hard to remember the essence of the arguments later. In drugs, as in movies, we get sequels in part because they are easier to pitch.
See you at the next meeting?
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