Nascobal
Treatment for Vitamin B12 DeficiencyNastech Receives FDA Approvable Letter for Nascobal Nasal Spray
BOTHELL, Wash., November 1, 2004 -- Nastech Pharmaceutical Company Inc. (NASDAQ:NSTK) , a leader in drug delivery technology, announced receipt of an approvable letter from the U.S. Food and Drug Administration (FDA) on Nascobal (Cyanocobalamin, USP) Nasal Spray for the treatment of vitamin B-12 deficiency. Nascobal Nasal Spray was developed by Nastech as an alternative to Nascobal Nasal Gel and worldwide marketing rights to both products were divested to Questcor Pharmaceuticals, Inc. in June 2003. Nastech will manufacture the product for Questcor following final approval by the FDA under terms of a supply agreement with Questcor.
Remaining items to be completed for product approval are an FDA inspection of a supplier's B-12 raw material manufacturing facility and finalization of the product labeling. There were no FDA requirements for additional work related to manufacturing, preclinical, or clinical studies.
"We are encouraged by the timely review of the Nascobal Nasal Spray application by the FDA and we believe that we can close these issues resulting in NDA approval in the near future," said Gordon C. Brandt, M.D., Executive Vice President, Clinical Research and Medical Affairs of Nastech. "FDA approval of this application will potentially provide the approximately 116,000 patients who currently receive monthly intramuscular B-12 injections with access to a more convenient, patient friendly treatment for vitamin B-12 deficiency."
About Nascobal Nasal Gel
Nascobal Nasal Gel has been approved and marketed in the U.S. since
1997 for the treatment of various vitamin B-12 deficiencies and has
a proven track record of safety and efficacy. Nascobal Nasal Gel is
indicated for use in patients with pernicious anemia, Crohn's
Disease, HIV/AIDS, and Multiple Sclerosis as well as other
mal-absorptive conditions that can result in vitamin B-12
deficiency. Symptoms of vitamin B-12 deficiency include fatigue,
weakness, sore tongue, forgetfulness, weight loss, lack of
coordination and difficulty walking. Left untreated, vitamin B-12
deficiency may lead to anemia, intestinal problems, and
irreversible nerve damage. Questcor currently markets this product
and others to neurologists and gastroenterologists.
About Nastech
Nastech Pharmaceutical Company Inc. is a pharmaceutical company
dedicated to the development and commercialization of innovative
drug delivery technologies and products. The company's proprietary
technologies focus on the delivery of small and large molecule
drugs by nasal administration. These drugs include peptides,
proteins and RNAi therapeutics. Intranasal drug delivery may lead
to greater drug efficacy, speed of action, safety, and patient
compliance. Nastech has patent applications directed to the
treatment of diabetes and other metabolic diseases. The company
also has published patent applications directed to intranasal
delivery of acetylcholine esterase inhibitors for treatment of
Alzheimer's disease and other neurological diseases. Nastech is
developing a diverse product portfolio across multiple therapeutic
areas, including products targeted for the treatment of obesity,
sexual dysfunction, pain management, and osteoporosis.
Additional information about Nastech is available at www.nastech.com.
Posted: November 2004
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