Orphan drugs to make paradigm shift in Pharma industry

Frost and Sullivan predict that there will be a large upsurge in pursuit of orphan drugs as Big Pharma makes move to niche markets to plug their pipelines. 

Licensing "niche buster" (aka orphan) drugs to augment their revenue shortfalls will be less risky then continuing to pursue internal development of those increasingly more elusive, small molecule blockbusters. 

More orphan applications though can be expected to slow down this process somewhat and result in somewhat longer timelines to approval. There may also be more of a move toward collaborations between larger players to further reduce risk and costs associated with getting orphans licensed.  

Orphan drugs to create paradigm shift in Industry , says Frost &Sullivan - - Pharma Letter

This is just another example of adaptation and changing models that we can continue to expect to emerge as the industry goes through some significant change and restructuring.

Posted by Bruce Lehr April 8th 2010

Comments

[bigredbruce]

Here's an article from thepharmaletter reviewing 10 yr history of orphan drugs in EU
http://www.thepharmaletter.com/file/95268/10-years-of-orphan-medicines-legislation-in-europe-emea-reviews-success-and-looks-ahead.html

[Bruce Lehr]

This is an interesting abstract from the Journal of Commercial Biotechnology that speaks to the current M&A environment in biotech industry. It passes advice on strategy small biotech's should employ in developing their product pipelines and IP, and importantly in looking at their exit strategy. The author's suggest these type of companies will continue to be attractive acquisition targets for larger companies as their pipelines dry up.
http://www.palgrave-journals.com/jcb/journal/v16/n2/abs/jcb200935a.html

[Bruce Lehr]

This article in the San Diego Union talks about the upsurge in Big Pharma interest in "neglected diseases" that is similar in flavor to increased interest with niche or orphan applications. Bascially, the economic winds have shifted to make it more favorable to work in these new areas.
http://www.signonsandiego.com/news/2010/apr/11/scientists-target-common-diseases/