MericitabineRoche is currently conducting a number of phase 2 studies with mericitabine, including the INFORM-SVR study in combination with ritonavir-boosted danoprevir with and without ribavirin for 12 or 24 weeks in patients with HCV GT1. Roche recently announced an additional arm added to INFORM-SVR to assess a 24 week regimen of mericitabine, boosted danoprevir and ribavirin in HCV genotype 1 patients contraindicated for or intolerant of interferon. In June 2011, Roche initiated a second trial, MATTERHORN, to evaluate ritonavir-boosted danoprevir and ribavirin in combination with mericitabine and/or pegylated interferon. The study is expected to enroll approximately 420 subjects with HCV GT1 who failed previous therapy. Roche has stated that it intends to file mericitabine for marketing approval in 2014.
Financial ResultsFor the fiscal year ended September 30, 2011 Pharmasset reported revenues of $0.9 million, compared with revenues of $1.0 million for fiscal year 2010. Revenues during each fiscal year primarily consist of amortization of up-front and subsequent collaborative and license payments received from Roche previously recorded as deferred revenue.
Total costs and expenses for the fiscal year ended September 30, 2011 were $92.5 million compared to $64.7 million for the same period in 2010. The increase in operating expenses was primarily the result of increased clinical development costs associated with the initiation and ongoing conduct of the Phase 2 studies ELECTRON and ATOMIC, as well as the advancement of PSI-938 in NUCLEAR and the large Phase 2b study, QUANTUM.
Pharmasset reported a net loss of $91.2 million, or $1.25 per share for the fiscal year ended September 30, 2011, as compared to a net loss of $66
|SOURCE Pharmasset, Inc.|
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