Blog & Resources Camargo Blog November 8th, 2007

P&G Drops Out of a 505(b)(2) Development

Nastech announced on 11/7/2007 that P&G had dropped out of their co-development of a nasally delivered version of Lilly’s osteoporosis drug Forteo (teriparatide). As reported, the Nastech CEO speculated that the reason for P&G’s termination of its participation was that original timescales for product development have had to be extended, meaning that the product may not be able to fully exploit patent expiration of Fosamax (alendronate) in 2008. When P&G and Nastech signed their agreement in January 2006, the plan was to deliver their parathyroid hormone product to the market in 2008 or early 2009 following US Food and Drug Administration (FDA) approval.

Camargo has experience developing drug products for osteoporosis. We would never had suggested that a 505(b)(2) drug development program like this one could be completed in 3 years (actually, the entire development would have had to be completed within about 2 years to allow FDA’s 10 month PDUFA review). One limiting factor is human physiology – bone resorption takes time and these studies take many months.

As we have seen many times, drug companies can jump into projects without a complete due diligence. Camargo’s process takes into account both science and market factors to provide a detailed timeline and cash flow – before the project starts.

It would appear that the Phase 2 study wasn’t anticipated. Nor does it appear that they considered combining phase 2 & 3.

We have seen J&J and Amgen drop their 505(b)(2) development projects entirely – projects that competed for resources that were targeting blockbusters. Perhaps this is what P&G is doing as well – this project may have been dropped simply because it didn’t look likely to meet expected returns.

Categories: 505(b)(2) Development

Get Our Expertise Working for You

To learn how you can benefit from our regulatory and strategic development expertise, view our solutions or contact us.

Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.

9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
800 Taylor Street
Suite 101
Durham NC, 27701
Montreal Office
507 Place d'Armes
Suite 1101
Montreal, QC H2Y 2W8, Canada
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights