Nastech Pharmaceutical Company Inc., a pharmaceutical company developing innovative products based on proprietary molecular biology-based drug delivery technologies, announced that a written notification from the US FDA was received on July 10, 2006 stating that Nastech's abbreviated new drug application (ANDA) for intranasal calcitonin-salmon is not approvable at this time.
In a subsequent conference call on July 11, 2006, Nastech reviewed the status of the ANDA with the FDA. The FDA expressed a concern relating to the potential for immunogenicity that might result from a possible interaction between calcitonin-salmon and chlorobutanol, the preservative in the formulation. No allergic reactions have been observed in any of the clinical trials conducted by Nastech. Other existing marketed nasal spray products contain chlorobutanol as the preservative.
Nastech intends to engage in further discussions with the FDA to determine which, if any, additional data Nastech can submit to the FDA in order for the FDA to approve the ANDA. If Nastech is not successful at keeping this application as an ANDA then a 505(b)(2) NDA may be pursued.
Nastech's formulation of calcitonin-salmon nasal spray was specifically developed to be similar to Novartis' currently marketed calcitonin-salmon nasal spray, Miacalcin, in order to submit the application as an ANDA. Thus, Nastech's formulation does not utilize the company's advanced tight junction drug delivery technology, which is currently being used in development of its proprietary pipeline of peptide and protein therapeutics.