BOTHELL, Wash., Nov. 2 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical Company Inc. announced the presentation of two abstracts this week at the American Association of Pharmaceutical Scientists Annual Meeting in San Antonio, Texas. The abstracts presented included:
*A 2x2 Replicate Bioequivalence Study of Two Formulations of Salmon Calcitonin Administered via Intranasal Spray (Nastech and Miacalcin(R)) in Normal Healthy Male and Female Subjects
The abstract presented data from a 199 subject trial conducted to evaluate whether Nastech’s calcitonin-salmon nasal spray formulation is bioequivalent to Novartis’ Miacalcin(R) nasal spray formulation. The study was done as part of Nastech’s Abbreviated New Drug Application (ANDA) for its product that is currently under review at the FDA. The FDA typically considers two products bioequivalent if the blood concentrations following administration of each drug are within a standard statistical definition of “equivalent.” The data presented in the abstracts demonstrated that Nastech’s formulation met these requirements, indicating that according to these standards the two treatments were bioequivalent regarding their rate and extent of absorption. Additionally, both products were safe and well tolerated in normal healthy male and female subjects.
*In vitro and In vivo Screening of Intranasal Insulin Formulations
The abstract presented data from the screening of Nastech’s insulin nasal spray formulations that utilize the Company’s proprietary non-invasive, large molecule drug delivery technology. Formulations that were developed showed a 105-fold increase in drug permeation compared to simple formulations in an in vitro model of the nasal mucosa. Additionally, formulations tested in vivo demonstrated excellent bioavailability of insulin and a strong pharmacodynamic response, with blood glucose response similar to the standard insulin injection products. The screening program was used to select appropriate formulations which are now being tested in a Phase 1 human clinical study.
The abstracts are available at http://www.nastech.com.
“We are pleased with the presentation of these abstracts at AAPS as it demonstrates our formulation science and clinical capabilities,” stated Steven C. Quay, M.D., Ph.D., Chairman, President and CEO of Nastech. “We have shown that Nastech’s generic calcitonin-salmon nasal spray meets the industry standard definition of ‘bioequivalence’ when compared to the innovator product, Novartis’ Miacalcin(R). We continue to work with the FDA to resolve any outstanding items with our ANDA for this product. Additionally, we are excited to be in the clinic with our insulin nasal spray formulation that was selected from our screening program.”
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 diabetes, respiratory disease, inflammatory conditions, obesity and osteoporosis. Additional information about Nastech is available at http://www.nastech.com.
Nastech Forward Looking Statements
Statements made in this press release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Nastech to obtain additional funding; (ii) the ability of Nastech to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) Nastech’s and/or a partner’s ability to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) Nastech’s and/or a partner’s ability to obtain required governmental approvals; and (v) Nastech’s and/or a partner’s ability to develop and commercialize products that can compete favorably with those of competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Nastech’s most recent periodic reports on Form 10-K and Form 10-Q that are filed with the Securities and Exchange Commission. Nastech assumes no obligation to update and supplement forward-looking statements because of subsequent events.
CONTACTS: Nastech Ed Bell Senior Investor Relations Manager (425) 908-3639 ir@nastech.com Noonan Russo Matthew Haines (Investors/Media) (212) 845-4235
Nastech Pharmaceutical Company Inc.
CONTACT: Ed Bell, Senior Investor Relations Manager of Nastech,+1-425-908-3639, ir@nastech.com; or Investors/Media: Matthew Haines ofNoonan Russo, +1-212-845-4235
Web site: http://www.nastech.com/
