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A recent report from the Government Accounting Office (GAO) was released a couple of months ago and I’d not yet commented on it.

New Drugs Declining, Research Costs Increasing, GAO Says - washingtonpost.com:

This Washington Post article gives a good overview of the situation but what is interesting ot me is the wide range of opinions on what the underlying data means. Some in congress use this data to prove this the system need to change. I don’t think that is necessarily the case. There could be many reasons why costs increase and why productivity hasn’t increased. I tend to be of the opinion that the low lying fruit has been picked over and that more research is needed to find better ways to get the fruit higher up on the tree. Adding additional regulation that does not directly effect safety would be counter-productive.

Heres the actual report.

GAO Report on New Drug Development

Technorati Tags: drug cost, drug development

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Eli Lilly is acquiring a small company in Mass. called Hypnion that focuses on sleeping disorders. No financial details were released.

Lilly Announces Acquisition of Hypnion

Hypnion lead candidate is HY10275 and has completed phase I and II trials earlier this year. It would likely be a non-schedule sleeping pill and is suppose to be better than those on the market.

More importantly though is the technology Lilly acquires, the SCORE-2004™ platform which is predictive software for a sleep-wake bioassay system. This could be used to make predictions of what compounds would have the best overall profile. Here is the companies quote:

Using SCORE- 2004™, the world’s only predictive sleep-wake bioassay system, we have profiled and evaluated the universe of sleep-wake pathways, screened known marketed CNS drugs which act on those targets, and optimized the sleep or wake-inducing effects of those compounds in order to produce novel, patentable New Chemical Entities (NCE’s) ready for preclinical development.

We are moving ahead with a robust program which includes multiple scaffolds and clinical candidates that have proven themselves to have distinct advantages in efficacy and safety over the market leaders in insomnia and fatigue including Lunesta™, Ambien™ and Provigil™ as well as soon to be marketed drugs including indiplon.

Interesting to note they don’t mention Rozarem (ramelteon).

If it is indeed predictive, it could be a major step forward in terms of being able to test compounds “in silico” without having to make numerous drugs and test them. It remains to be seen and I personally think these “in silico” system are overhyped and still do not take into account side effects or toxicology problems. However, it is a step forward just not as large a ne as many in the industry make it out to be, at least in my opinion.

As an aside, DTC Marketing Blog has an interesting article from back in November about Rozarem, Ambien, and Lunesta in terms of website traffic. They also have an article of Lilly acquiring Hypnion.

Technorati Tags: Eli Lilly, pharma M&A, pharmaceutical deals, Hypnion

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