Biotech Values

[DewDiligence]

Notes from IDIX’s JMP webcast on 10/5/09:

1. IDIX submitted the IDX184 dossier (including results of the 3-day monotherapy study) to NVS during 3Q09, starting the 90-day period during which NVS has the exclusive right to license IDX184 under terms to be negotiated.

2. The phase-2 trial of SoC ± IDX184 is expected to start soon and to finish in mid 2010. The start of this study does not need to wait for NVS’ decision on licensing IDX184, although NVS’ decision may end up being made before the study gets underway.

3. The phase-2 trial will test SoC ± IDX184 for 14 days using IDX184 qD doses of 50mg, 100mg (the highest doses in the 3-day study), and one or two higher doses (my guess is either 150mg and 200mg or just 200mg). Patients in all trial arms will receive SoC alone during days 15-28 and will be evaluated for RVR.

4. IDIX has already had discussions with several prospective IDX184 partners other than NVS; thus, if NVS does not opt-in, IDIX will be prepared to strike a deal with another company at the end of NVS’ 90-day exclusivity window.

5. IDIX submitted a CTA (the European analogue of a US IND) during 3Q09 for the IDX375 non-nucleoside polymerase inhibitor. Thus, we may assume that, if there is no problem with the CTA filing, a European phase-1 trial for IDX375 will start soon.

6. IDIX plans to submit an IND or CTA for the IDX316 protease inhibitor before year-end 2009 and to start a phase-1 trial during 1Q10.