Washington Editor

Questcor Pharmaceuticals Inc. and Nastech Pharmaceutical Co. Inc. filed a new drug application requesting approval of Nascobal Nasal Spray for the treatment of vitamin B-12 deficiency.

The companies already produce and market Nascobal in a nasal gel form, which is rubbed on the inside of the nose. The spray form is more convenient and Matthew Haines, director of corporate communications for Bothell, Wash.-based Nastech, said market research indicates that patients would prefer the spray delivery system.

FDA approval is expected in 2004, Haines said, though he would not speculate on a specific date.

Nastech developed both the gel and spray forms of Nascobal (cyanocobalamin) but in June sold all rights to Questcor, of Union City, Calif., in an $18.2 million transaction. Questcor thus far has paid Nastech $14.2 million and will pay $2 million upon FDA approval of the spray. Questcor will owe Nastech another $2 million when a U.S. patent is issued. (See BioWorld Today, June 18, 2003.)

Nastech divested Nascobal in order to focus on larger market opportunities and to develop nasal spray dosage forms of proteins and peptides, Haines said. Nascobal gel generates about $6 million in worldwide annual sales.

Questcor officials were unavailable for comment. However, Charles Casamento, the company's chairman, president and CEO, said in a prepared statement: "The nasal spray dosage form represents a natural line extension of the nasal gel product. The approval of the NDA for the spray formulation along with the pending patent application on the spray formulation could significantly extend the product life of intranasal vitamin B-12."

Nastech doesn't receive royalties on product sales; instead it has a long-term supply agreement to make both formulations of the candidate. Nastech will continue manufacturing at its facility in Hauppauge, N.Y.

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 B-12 deficiency, the companies said. Symptoms of B-12 deficiency include fatigue, weakness, sore tongue, forgetfulness, weight gain, lack of coordination and difficulty waking. If untreated, the deficiency could lead to anemia, intestinal problems and irreversible nerve damage.

Haines said the spray and gel forms are bioequivalent.

Nastech also is developing a nasal delivery of PYY for obesity and a nasal delivery of apomorphine for male and female sexual dysfunction.

Questcor's stock (AMEX:QSC) rose 9 cents Tuesday, or 14.5 percent, to close at 71 cents. Nastech's stock (NASDAQ:NSTK) climbed 5 cents to close at $9.51.