Unigene Laboratories Inc (fka UGNEQ)

[cfoofme]

Competitor?

****
Useful Links


Nastech Provides Calcitonin Salmon Nasal Spray Complete Response To FDA
Main Category: Pharma Industry News
Article Date: 30 Sep 2006 - 0:00am (PDT)
| email this article | printer friendly | view or write opinions |





Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) announced today it has submitted a complete response to the FDA's Office of Generic Drugs regarding the potential for immunogenicity that might result from a possible interaction between calcitonin-salmon and chlorobutanol, the preservative in Nastech's salmon calcitonin nasal spray formulation.

Nastech's response consisted of an extensive comparison of Nastech's product with the innovator drug Miacalcin(R) (called the Reference Listed Drug or RLD) using multiple analytical and bio-analytical methods. Neither peptide- preservative interactions nor peptide-peptide aggregation were affected by a change in preservative by any method evaluated. Data obtained using numerous different measurement techniques indicate that there is no evidence of a structural or conformational change in the peptide, and no increase in the potential to aggregate as a result of the preservative change. Finally, both immunoassay and bioassay studies indicate no difference associated with either preservative or an absence of preservative in the formulation.

In addition, studies where the product is stressed by accelerated temperature, pH levels above or below that of the RLD, or extended storage demonstrate no significant difference between the RLD and Nastech's product.

There was no clinical safety signal raised during the 600+ doses of each product administered during the development of Nastech's generic product. In particular, there were no cases of immediate hypersensitivity.

Nastech will look forward to working with the FDA to seek to resolve any outstanding issues with the company's abbreviated new drug application (ANDA) filing.

Nastech's formulation of calcitonin-salmon nasal spray was specifically developed to be similar to Novartis' currently marketed calcitonin-salmon nasal spray, Miacalcin(R), 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.

About Nastech

Nastech is a pharmaceutical company developing innovative products based on proprietary molecular biology-based drug delivery technologies. Nastech and its collaboration partners are developing products for multiple therapeutic areas including osteoporosis, diabetes, obesity, respiratory diseases and inflammatory conditions. Additional information about Nastech is available at http://www.nastech.com.