-- On January 11, 2009, Pharmasset announced that the company and its development partner, Roche, had agreed with the FDA on the design for a phase 2b trial with R7128, a nucleoside inhibitor of HCV, slated to initiate in the first calendar quarter of 2009;
-- On January 30, 2009, Pharmasset filed an IND for PSI-7851, a nucleotide inhibitor of HCV, with the FDA and expects to initiate a Phase 1 clinical trial to study safety and pharmacokinetics in healthy volunteers at the end of the first calendar quarter of 2009;
-- On January 30, 2009, Pharmasset and Bukwang Pharm. Co., Ltd. entered into an amendment of their license agreement covering clevudine. The amendment expands the territories in which Pharmasset has been granted rights to include Australia, Japan, New Zealand and Taiwan;
-- On February 5, 2009, Pharmasset completed a registered direct offering that raised net proceeds of $43.5 million.
"We had a very productive start to 2009, filing an IND for PSI-7851, our second generation nucleotide for HCV and, strengthening our balance sheet by raising $43.5 million in a tough financial market" stated Schaefer Price, President and Chief Executive Officer. "Our goal remains to build a leading franchise of nucleoside inhibitors for hepatitis C and B. Our plan is to provide updates throughout the year on all of our programs, including the first antiviral data on PSI-7851 in the second half of 2009."
Calendar Year 2009 Anticipated Milestones:
-- Roche initiates phase 2b study of R7128 in first quarter of 2009;
-- Complete enrollment of clevudine registration trials at end of first quarter of 2009;
|SOURCE Pharmasset, Inc.|
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