FDA’s OK sought for B-12 spray

Published 9:00 pm Tuesday, December 30, 2003

BOTHELL — Nastech Pharmaceutical Co. wants the U.S. Food and Drug Administration to approve a nasal spray form of the company’s vitamin B-12 supplement.

The Bothell-based firm, along with Questcor Pharmaceuticals Inc. of Union City, Calif., said Tuesday that they’ve submitted a new drug application for the Nascobal nasal spray. At present, the supplement is available to patients only as a nasal gel.

"The primary advantage is the convenience for the patient," said Matthew Haines, spokesman for Nastech. "All the research shows patients prefer a spray to the gel."

The new form of Nascobal also would extend the life of the drug’s exclusive patent, Haines added.

Investors, who had expected the new drug application, pushed Nastech’s stock up by a nickel Tuesday, to $9.51 a share.

Nascobal has been Nastech’s lead product since the gel was approved by the FDA in 1997. Sales of the drug were expected to exceed $5 million this year.

The supplement is aimed at patients who have diseases that make them vulnerable to vitamin B-12 deficiency, including those with multiple sclerosis, Crohn’s disease and AIDS. Left untreated, the vitamin deficiency can cause anemia, intestinal problems and nerve damage.

While many patients can take vitamin pills to supplement their diets, patients with certain diseases can’t absorb it well in that form. As a result, more than 90 percent of the vitamin B-12 given to these patients is by injection, giving the Nascobal spray a potentially large market.

Nastech hopes the FDA will give the nasal spray a relatively quick approval, Haines said.

"We really don’t have a specific expectation, but certainly it should be in 2004," he said.

Questcor’s chief executive officer, Charles Casamento, said he was happy Nastech submitted its application for the nasal spray on schedule. Earlier this year, Questcor agreed to pay Nastech $18 million for the rights to Nascobal. That came after Nastech ended a previous partnership on the drug.

As part of the agreement with Questcor, Nastech continues to make the drug at its manufacturing facility on Long Island, New York. The company hopes to make the drug in Bothell as well.

Reporter Eric Fetters: 425-339-3453 or fetters@heraldnet.com.