Investors agreed with Univax Biologics Inc.'s positive assessment ofthe status of its product license application (PLA) with the FDA forWinRho SD to treat certain blood disorders, as the company's stockclimbed 25 percent on Friday.Univax (NASDAQ:UNVX) stock was up $1.38 Friday, closing at $7per share after trading as high as $7.50 per share during the day.Univax released news of its receipt of a PLA "action letter" from theFDA after the market closed Thursday.Univax officials said Friday they expect "minor clarifications" askedfor in the FDA letter to be answered within a few weeks, and if theFDA is satisfied, approval for WinRho would come no more than sixmonths later. The product is indicated for acute and chronic immunethrombocytopenic purpura (ITP) in children; acute and chronic ITP inadults; ITP secondary to HIV infection; and prevention of Rhisoimmunization.WinRho SD is a hyperimmune intravenous polyclonal antibodyproduced by stimulating plasma donors with Rh-positive red bloodcells. Univax, of Rockville, Md., licensed the rights to the product inNovember 1992 from Rh Pharmaceuticals Inc., of Winnipeg,Manitoba.Scott Harkonen, vice president, medical and regulatory affairs forUnivax, told BioWorld "there is an addressable ITP market of $170million in the U.S.," referring to "patients with ITP who couldreasonably be candidates for therapy." Univax's Cabot Caskie saidbetween 5 and 15 percent of HIV patients have ITP secondary to thedisease.Brandon Fradd, an analyst with Montgomery Securities, told BioWorldthat his estimate of a $25 million to $30 million ITP market includesonly the actual market, not its potential. But he said WinRho is clearlyan improvement over what's currently used for the disease.Current standard therapies for the treatment of ITP include immuneglobulin intravenous (IGIV), steroids and splenectomy, or removal ofthe spleen."Our main marketing thrust would be against standard IGIV,"Harkonen said, adding that WinRho would have fewer side effects andbe easier to administer in that it could be given in minutes rather thanhours, and be done in a doctor's office instead of a hospital. "We havenot set a price," he said, "but we are saying publicly the direct costs ofWinRho will be less than IGIV. Our hope is that doctors will treat ITPmore frequently than they do now."Caskie, Univax's vice president and chief financial officer, toldBioWorld that the company does not plan to assemble a sales forcebefore gaining marketing approval. But he said the strategy may entailidentifying sales people and making them offers conditional upongetting FDA approval.Rh Pharmaceuticals would produce the product at its manufacturingfacility in Winnipeg and sell it at cost to Univax, Caskie said. Univaxthen will be responsible for sales, marketing and distribution. Theresulting profit would be split equally, he said.The licensing deal with Rh Pharmaceuticals, which sells WinRho inCanada for prevention of Rh isoimmunization, entailed a $100,000payment by Univax when the agreement was signed, a $400,000payment when the PLA is approved, and a 60-40 split of the first $50million in profits, with Rh Pharmaceuticals getting the larger share.Harkonen said clinical studies testing the ability of WinRho to increaseplatelet counts in those with ITP showed the drug was able to increaseplatelets in 80 to more than 90 percent of patients in the differentsubgroups analyzed. "We maintain the response rate is roughly thesame for WinRho and standard IGIV," he said. "We're going to domore studies comparing them head to head." n

-- Jim Shrine

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