By Jim Shrine

Nabi won FDA approval for its product to treat hepatitis B, and expects that action to take the company back to profitability after two years in the red.

The FDA granted approval to Nabi-HB, a 5 percent protein formulation of hepatitis B immune globulin that contains antibodies to the virus. It is indicated for treatment following sexual exposure with a partner positive for hepatitis B surface antigen (HbsAg), household exposure to the virus, acute exposure to blood containing HbsAg, or perinatal exposure of infants born to HbsAg-positive mothers.

¿In developing the pharmaceutical side of our business, this is a major first step, having a product approved that we¿ve taken through the clinic and through the FDA,¿ David Gury, Nabi¿s chairman and CEO, told BioWorld Today.

¿We¿ve been working with this product for more than six years,¿ Gury said. ¿We¿ve had a couple [of] products drop out of the clinic, so this clearly represents a success in taking it through and going all the way.¿

Nabi, of Boca Raton, Fla., has licenses to sell WinRho, which primarily is used to treat idiopathic thrombocytopenic purpura, an immune-mediated bleeding disorder, and Autoplex T, for a hemophilia-related indication. The company has several others aspects to its business, much of it centered on the areas of antibodies and plasma, and generated 1998 sales of $243 million. Nabi¿s net loss was $7.2 million last year. It also lost money in 1997, but was profitable in 1996.

¿We¿re looking at revenues this year [from Nabi-HB] of somewhere in the $30 million range,¿ Gury said, adding that would be enough to ensure profitability. ¿Over time, the next five years, we¿re taking that estimate up. We clearly think this is a $100 million opportunity.¿

Nabi¿s 30-person sales force will start marketing Nabi-HB right away, in addition to WinRho and Autoplex T, he said. Six salespeople will be added this year, Gury said.

Nabi¿s stock (NASDAQ:NABI) gained 71.87 cents Thursday, or 24 percent, to close at $3.75 per share. The company has about 34.9 million shares outstanding.

¿We have a pharmaceutical focus,¿ Gury said, ¿but we¿re also in the antibody product area, supplying material to major pharmaceutical companies as raw material. We collect our own antibodies used to make this product. It continues to be a natural connection between antibody collection and our pharmaceutical products.¿

Next in the pipeline at Nabi is StaphVax vaccine, for which an interim analysis of data from a Phase III trial is expected in the third quarter. Nabi-Altastaph, for use with low birth-weight neonates, is in Phase I/II trials, and Nabi-Civacir ¿ which is similar to Nabi HB, but used for hepatitis C ¿ is expected to be taken into the clinic later this year.

Nabi-HB neutralizes the hepatitis B antigen and stops viral replication. A predecessor Nabi product, H-BIG, was used in the area of hepatitis B accidental exposure.

Gury said there has been significant off-label use of Nabi-HB in liver transplant patients. A number of patients are being treated in an extended-use investigational new drug program in that area, and marketing authorization will be sought for that indication later this year.

Nabi said Nabi-HB is the first hepatitis globulin to incorporate nano-filtration into the manufacturing process. In clinical trials, most adverse events were mild, the company said, and included headache and pain at the injection site. No serious reactions were reported.