Nastech Pharmaceutical Co. Inc., a drug delivery firm, said the FDA approved Nascobal (cyanocobalamin) nasal spray for treating vitamin B-12 deficiency in patients with pernicious anemia, Crohn's disease, HIV/AIDS and multiple sclerosis.
News of marketing clearance triggered a $2 million milestone payment to the Bothell, Wash.-based company from Questcor Pharmaceuticals Inc. The approval was expected in short order following an approvable letter from the FDA that dealt with third-party manufacturing issues. Upon issuing its letter late last year, the agency said it needed to inspect a supplier's B-12 raw material manufacturing facility and finalize product labeling before authorizing the product. (See BioWorld Today, Nov. 2, 2004.)
Nastech developed Nascobal nasal spray as an alternative to a gel formulation also used for intranasal administration. That FDA-approved product was launched in 1997, and both products' worldwide marketing rights were sold to Union City, Calif.-based Questcor almost two years ago. That deal resulted in an $18.2 million up-front payment to Nastech. (See BioWorld Today, June 18, 2003.)
Under the companies' long-term agreement, Nastech will manufacture both the nasal gel and spray with Questcor.
Symptoms of vitamin B-12 deficiency include fatigue, weakness, sore tongue, forgetfulness, weight loss, lack of coordination and difficulty walking. If not treated, vitamin B-12 deficiency can lead to anemia, intestinal problems and irreversible nerve damage.
On Tuesday, Nastech's stock (NASDAQ:NSTK) gained 5 cents to close at $10.76.