• Seattle Post-Intelligencer, Monday, April 14, 2008 10:45 AM

Generic drug maker Nastech Pharmaceutical has been forced to cut its budget and lay off more than half its staff in the months since Procter & Gamble withdrew from a lucrative partnership with the company. For almost three years now, a mystery company has foiled Nastech's hopes of bringing its first product to market.

The product--Calcitonin--would provide patients who have postmenopausal osteoporosis with an alternative to Miacalcin, a nasal spray treatment with nearly $145 million in sales last year. The FDA agreed to review Calcitonin for approval in February 2004. But an unnamed pharmaceutical company, represented by an attorney who once worked for the FDA, challenged the application. He argued that the active ingredient in Miacalcin and Nastech's product--a hormone derived from salmon--might not necessarily be the "same" because there could be contaminants in the production process.

The resulting standstill is a case study in how difficult it can be to bring generic drugs to market, even though that process is designed to be relatively quick, according to the FDA.

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