Possible and Probable 2007 News Flow
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April 2007 - Presentation of abstracts at EASL, primarily
1. End of treatment or week 48 data from HCV treatment naive Phase IIb trial.
2. Treatment refractory Phase IIb trial final data including end of treatment response as well as sustained virologic response data. As a reminder this study assessed various doses of valopicitabine in combination with pegylated interferon versus standard of care.
3. In vitro experiments with valopicitabine and Schering 503034, Schering - Plough's HCV proteases inhibitor.
April 2007 - File a traditional IND for IDX-899 and advance this compound into Phase I IIa clinical testing shortly thereafter.
May / June 2007 - EU approval (SEBIVO).
May 2007 - Submit to the FDA 12 week drug drug interaction and efficacy study which is assessing the pharmacokinetic and pharmacodynamic activity of valopicitabine when used in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C to the FDA.
June 2007 - Receipt of $20 million in telbivudine related milestones for regulatory approvals in the EU and China.
June 2007 - Press release with top line 12 week drug interaction data.
June / Sep 2007 - Phase II data for valtorcitabine plus telbivudine
June 2007– Dec 2007 – meet with FDA and discuss further study to advance the clinical developments of valopicitabine NM283 (end of Phase 2 meeting).
June / Dec 2007 – Meet with FDA to discuss pathway forward for polymerase-protease combo study(s) … new paradigm in development of HCV drugs.
Fall 2007 – Analysis of TYZEKA / SEBIVO sales to date.
Fall 2007 – Presentation of ribavirin interaction study @ scientific meeting
By end of 2007 – File IND for second generation of nucleoside analog for HCV.
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