by Meera Venu 14 Jun 10
Human Genome Sciences HGSI announced Monday that it received feedback from the Food and Drug Administration about its application for hepatitis C drug Zalbin. The FDA cast doubt about the risk-benefit profile of the bimonthly dosing regimen. The firm had already withdrawn the drug's application in Europe after the European regulatory authority indicated it would require more data on the risk-benefit profile to approve the drug. Now Human Genome and its partner Novartis NVS need to decide whether to pursue the drug in a monthly dose format, which is currently under development. We previously had doubts about Zalbin and have incorporated pessimistic projections for the drug in our forecasts. At this point, we do not expect to change our fair value estimate, as lowering the U.S. probability of approval to 50% and pushing the potential launch back two years does not significantly alter our valuation. However, we would consider lowering our fair value estimate modestly if the partners decide not to pursue Zalbin
http://torontostar.morningstar.ca/globalhome/industry/news.asp?articleid=340805
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