Univax Biologics Inc. laid off about 40 employees and altered itsdrug research programs to concentrate on marketing its firstpolyclonal antibody product, WinRho SD, and to cut expenses byabout $800,000 a month.

The Rockville, Md.-based company's "strategic refocusing"primarily involves postponing development of StaphVAX, a vaccinefor staphylococcus infections, following disappointing Phase II data.

Univax said it will shift its drug development efforts to clinicalstudies of two other polyclonal antibodies: StaphGAM, also forstaphylococcus, and HyperGAM+CF for cystic fibrosis.

The restructuring and a decision to delay Phase III trials forStaphVAX sent Univax's stock (NASDAQ:UNVX) down $1.63 toclose Monday at $5.50, a 23 percent drop.

WinRho was approved for marketing by the FDA in March toprevent Rh isoimmunization in pregnant women and to treat immunethrombocytopenic purpura (ITP). Rh isoimmunization involves Rhincompatibility in pregnant women who are Rh negative while theirfetuses are Rh positive. ITP is a platelet disorder that can causeuncontrolled bleeding.

Judith Hautala, Univax's vice president for corporatecommunications and planning, told BioWorld Today, "The firstshipments of WinRho are going out to distributors this week."

Univax projected WinRho sales for the first 12 months at $10 millionto $12 million. The drug contains high levels of antibodies to the Rhantigen derived from plasma donors with Rh-positive blood cells.

Delay of the StaphVAX program accounted for most of the costsavings in the restructuring. The layoffs reduced Univax's work forceto about 132 people.

Hautala said the changes made by the company should slash Univax'sprojected $2 million-a-month burn rate this year by 40 percent, or$800,000 a month.

At the end of the first quarter, March 31, the company said it had$28.1 million in cash and posted a net loss of about $4.9 million.

Hautala said the company postponed Phase III trials of StapVAXafter a preliminary analysis of Phase II data showed the vaccine,which was tested in kidney dialysis patients, did not stimulateantibody production at levels high enough to justify a broader study.A full analysis of the 240-patient Phase II trial will be completedduring the third quarter of this year.

The StaphVAX vaccine is the same one that is used to createantibodies to staphylococcus from healthy blood donors, which ishow the StaphGAM drug is made. Treatment with StaphGAMantibodies is targeted for hospital patients at risk of getting aninfection and it is designed to protect them for 30 days.

Hautala said when the StaphVAX vaccine was given to dialysispatients, many of whom have compromised immune systems, itapparently was not able to stimulate sufficient levels of antibodies toguard against infections.

The preliminary analysis included data from 100 of the 240 patientsinvolved in the study six months after they were given either thevaccine or a placebo. The complete analysis will involve 12-monthfollow-up examinations of all the patients.

"We'll concentrate on the antibody project [StaphGAM] and once wedemonstrate that the antibodies are effective then we can decidewhether to go back to reformulate the vaccine for dialysis patients,"Hautala said. n

-- Charles Craig

(c) 1997 American Health Consultants. All rights reserved.