Business and Science for BD & others
#68, February 2012
R&D Costs and Dropping Productivity
A Forbes analysis divided the number of new drugs approved for each big pharma company over the last 15 years by the R&D expenditure for the same time for each big pharma company, and found astronomical dollars (up to almost $12B) spent per drug. It was highly variable from AstraZeneca, the worst at $11.7B R&D dollars per NME (new medical entity), to Amgen’s still amazingly big $3.7B in R&D spent per NME approved.
And while per drug expenditures are up, the value of the drugs is down. Oliver Wyman found that in the period of 1996-2004, the average approved NME had 5thyear sales of $515M, compared to $430M in the period of 2005-2010. This means that 5th year sales per $1B in R&D went from $275M over 1996-2004, to $75M in the 2005-2010 period.
Of course, there are lots of caveats and arguments about what the data really say (and the comments on the Forbes blog discuss bad decision making and over-cautious FDA reviewers among other factors). Some of the problem is the hurdle for superior efficacy and cost-effectiveness is made higher by blockbuster drugs going generic. With generics, the rate of change in health care spending has actually decreased from its peak in 2002. http://online.wsj.com/article/SB10001424052970204792404577227050656680024.html
But, for the future, these statistics points to 3 strategies:
Who owns what? Agios deal triggers lawsuit
Craig Thompson, Tak Mak and Lewis Cantley created Agios while Craig was at U Penn’s Abramson Family Cancer Research Institute. Celgene paid $130M upfront for an option to develop drugs resulting from Agios cancer metabolism platform. Now, Abramson says Thompson “knowingly misrepresented" to Agios and Celgene that he had sole rights to the cancer-metabolism research he led at the institute. http://mobile.philly.com/business/?wss=/philly/business&id=137228458&deliver=bb&c=y&clmob=y&viewAll=y#more
This new dispute on who owns the work of academics involved in companies will undoubtedly make the language in future licenses a bit more complex.
www.e-Prognosis.org – a web tool to predict likelihood of death
Aimed at aiding physicians, these tools can also help families make appropriate decisions. The index indicates, for example, that a man in his late 80s with congestive heart failure, failing kidneys, weight and appetite loss, declining cognitive ability and the need for extensive assistance has a 69 percent chance of dying within six months. Doctors and family members could reasonably conclude that such a person is a candidate for hospice without fearing that they have jumped the gun.
The creators debated letting the public have access, but I support their decision to allow more patient access to evidence-based medicine.
Science behind the benefits of exercise and massage
A new study reports that exercise induces autophagy (the cellular mechanism of digesting the broken down pieces of proteins and other cellular debris). They also report that the apoptotic regulator BCL2 is a crucial regulator of exercise- (and starvation)-induced autophagy in mice, and conclude autophagy induction may contribute to the beneficial metabolic effects of exercise, such as resistance to diabetes.
In another study, 11 volunteers vigorously exercised and then received a massage of 1 leg prior to biopsies (ouch!) of both the massaged and untreated leg. They found that massage activated the signaling proteins for mitochondrial biogenesis and reduced inflammatory cytokines, benefitting the sore muscles.
Tau versus Amyloid in Alzheimer’s Disease
Alzheimer’s has two important pathologies, the accumulation of amyloid A-beta in plaques and the formation of neurofibrillary tangles made from tau. Nearly a dozen drugs in the past decade have tried to stop buildup of the amyloid plaques or to remove them, but none have made real headway in the clinic.
Lilly is waiting for the results this summer of its big bet on the amyloid hypothesis. Solanezumab is an antibody to amyloid A-beta peptide, the main component of amyloid plaque deposits in the brains of patients with Alzheimer's disease. An independent data safety monitoring board just gave approval to continue the Phase III trials.
Now researchers working with a transgenic mouse expressing pathological human tau only in the entorhinal cortex have shown the early pathology of Alzheimer’s may spread from neuron to neuron, recapitulating the early spread of Alzheimer’s through the brain. An antibody to the specific conformation of tau showed staining of neurons spreading out from the entorhinal cortex, increasing with age and correlating with neurofibrillary tangles.
See you at the next meeting?
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