Reuters: Global Markets: Halozyme shares dive after FDA asks for more drug data

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Halozyme shares dive after FDA asks for more drug data Aug 1st 2012, 21:01 Wed Aug 1, 2012 5:01pm EDT (Reuters) - U.S. regulators have asked for additional testing in animals before considering Halozyme Therapeutics Inc (HALO.O) application for an injected version of Baxter International Inc's (BAX.N) treatment for immune deficiency disorders. The news sent shares of Halozyme down 54 percent, while Baxter shares were off by less than 1 percent. Halozyme is developing a number of subcutaneous versions of biological drugs that can now be given only by infusion, including Roche AG (ROG.VX) cancer drugs Herceptin and Rituxan. Baxter and Halozyme said on Wednesday that issues raised by the FDA in a "complete response letter" included the possible effects of non-neutralizing antibodies on reproduction, development and fertility. The FDA requested that patients should no longer be dosed with the experimental immunodeficiency drug, known as HyQ. ViroPharma Inc (VPHM.O) said the FDA also placed a similar hold on clinical studies of a version of its genetic disorder drug, Cinryze, that also uses Halozyme's technology for subcutaneous delivery. Halozyme shares, which closed at $8.56 on Nasdaq, were trading at $3.99 after hours.

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