Nastech Pharmaceutical Company Inc. and Questcor Pharmaceuticals Company, Inc. announced the submission to the US FDA of a New Drug Application (NDA) seeking marketing approval for Nascobal (cyanocobalamin) nasal spray for treatment of vitamin B12 deficiency. Nastech originally developed Nascobal Nasal Gel and Nascobal nasal spray. Questcor owns worldwide rights to both products.
Nascobal Nasal Gel has been approved and marketed in the US since 1997 for the treatment of various vitamin B12 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 malabsorptive conditions that can result in vitamin B12 deficiency. Symptoms of vitamin B12 deficiency include fatigue, weakness, sore tongue, forgetfulness, weight loss, lack of coordination and difficulty walking. Left untreated, vitamin B12 deficiency may lead to anemia, intestinal problems, and irreversible nerve damage. Questcor currently markets products to neurologists and gastroenterologists.
"Nascobal Nasal Spray is a more convenient, patient friendly dosage form that is intended to provide equivalent safety and efficacy to Nascobal Nasal Gel," stated Steven Quay, MD, PhD CEO of Nastech.
"We are extremely pleased that Nastech has submitted the Nascobal Nasal Spray NDA for marketing approval on schedule," commented Charles Casamento, CEO of Questcor. "The nasal spray dosage form represents a natural line extension of the nasal gel product. The approval for the spray formulation along with the pending patent application on the spray formulation could extend the product life of intranasal vitamin B12."
In June 2003, Nastech divested Nascobal to Questcor. The transaction included all Nascobal intellectual property, marketing rights, inventory, trademarks, confidential know-how, contracts, and records. Under terms of the divestiture agreement, Nastech will receive up to $18.2 million, including $1214.0 2 million received to date and $2.2 million payable on or before December 31 2003. Nastech will also receive $2.0 million upon FDA approval of the Nascobal Nasal Spray dosage form and $2.0 million upon the issuance of a US patent. Nastech will continue to manufacture Nascobal at its FDA-approved, cGMP manufacturing facility in Hauppauge, New York, and in Bothell, Washington upon FDA approval of that facility under terms of a long term supply agreement.
Questcor Pharmaceuticals, Inc. is a specialty pharmaceutical company that acquires, develops, markets and sells brand name prescription drugs through a US direct sales force and overseas distributors and marketing partners.
Nastech Pharmaceutical Company Inc. has developed a platform technology for delivering both small and large molecule drugs by nasal administration. Intranasal drug delivery may lead to greater drug efficacy, speed of action, improved safety, and patient compliance.