Univax Biologics Inc. announced Monday an agreement with RhPharmaceuticals (Rh) of Winnipeg, Manitoba, giving Univax ofRockville, Md., exclusive marketing rights for Rh's WinRho SDproduct in the U.S.
WinRho consists of antibodies to the Rh factor used for theprevention of Rh disease in mothers.
WinRho SD is a new formulation of Rh's WinRho productcurrently sold in Canada and, according to Mike Woloski, Rh'sdirector of clinical research, is a second-generation Rho "D"immunoglobulin that includes a solvent detergent (SD) factorable to inactivate viruses such as HIV and hepatitis.
The product may be used to treat idiopathic thrombocytopenicpurpura (ITP), an autoimmune disease that reduces thenumber of platelets (a component of blood that promotesclotting) and increases susceptibility to uncontrolled bleeding.ITP affects 100,000 to 150,000 people in the U.S. annually,including 10 percent of those infected with HIV.
Under the agreement, Univax and Rh will each commit$500,000 to expand the hyperimmune immunoglobulin processdevelopment performed at Rh's facility. Univax has granted Rhmanufacturing rights to certain Univax products indevelopment and exclusive marketing rights in Canada for anyof Univax's products manufactured at Rh's Canadian facility.
According to Woloski, WinRho SD is produced by columnchromatography and is purer than other commonly usedpreparations for ITP, such as ethynol-based products. Forexample, Ortho's Rhogam product is made by ethynolprecipitation and can only be administered intramuscularly, amethod that doesn't work for the majority of ITP patients,Woloski told BioWorld.
"These patients will need to use WinRho," Woloski said, "so weare looking at the ITP market as a new market for a Rho Dimmunoglobulin product."
Woloski said Canadian sales of WinRho for prophylaxis of Rhdisease are about $2.5 million. Woloski said Canadian salesusually run about one-tenth of U.S. sales.
Having completed Phase III U.S. clinicals, Univax is helping Rhmove WinRho SD's product license application through the U.S.regulatory channels. "There's a good chance we'll be on theAIDS fast track, so we expect an expeditious review andoptimistically hope for approval in about a year," said Woloski.
Univax stock (NASDAQ:UNVX) closed unchanged on Monday at$9.25 a share.
-- Michelle Slade Associate Editor
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