NascobalTreatment for Vitamin B12 Deficiency
Nastech 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.
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
- Nascobal Nastech Pharmaceutical Company Inc. - Treatment for Vitamin B12 Deficiency - January 31, 2005