Biotech Values

[DewDiligence]

IDIX pre-AASLD and 3Q06 CC notes:

[These notes merely scratch the surface of what was discussed in today’s presentations; I recommend the full 2 hour 10 minute webcast because it covers a lot of ground and includes talks by two of the PI’s for key studies: Ira Jacobson of Cornell Medical College (Tyzeka) and Dr. Doug Dieterich of Mt Sinai School of Medicine (NM283).]


Background Information

1. The “72-week” recommendation by the panel was not a recommendation for something new; rather, it was a recommendation that HCV pivotal trials should have at least one arm with 48 weeks of treatment and 24 weeks of follow-up, i.e. the status quo.

2. Dr Dieterich thinks the official numbers for HCV prevalence in the U.S. and most of the world are understated by a factor of 2 or 3. (As evidence for his assertion, Dieterich noted that 23% of Russian émigrés in NYC test positive for HCV!)


Tyzeka Commercial Operations

3. Tyzeka will be in pharmacies during November. Sales reps will be working the docs during the next four days AASLD. (Isn’t it nice how the FDA granted approval five days before the PDUFA date? Another perq of having a partner like NVS.)

4. Tyzeka price to be announced next week.

5. Major commitment to post-marketing studies; details to come.

6. Tyzeka will be the brand name of telbivudine in the U.S. only. Everywhere else, it will be Sebivo.

7. Sebivo has been approved in India and Brazil (in addition to the earlier approval in Switzerland). NVS handles all commercial operations in these countries (as it does in all countries outside of the U.S. and western Europe), but IDIX will earn an undisclosed transfer price/royalty on sales.

8. IDIX and the two visiting doctors think that the lack of a food interaction with Tyzeka provides a good opportunity for detailing against Baraclude, which has a 2-hour before/after window in which food may not be taken. (Dr. Dieterich noted that he has several Baraclude patients with OCD who use stop-watches to time their meals.)

9. IDIX and NVS are discussing whether—and when—to give sales guidance for Tyzeka. My guess is that it will start on IDIX’s 4Q06 CC in early 2007.


HBV Development

10. Final (one-year) data from the combination study of Tyzeka and Valtorcitabine will be available in 2007. If this shows an incremental benefit vs Tyzeka monotherapy, it could eventually become the first approved combination therapy in HBV, where to date no combination regimen has provided any incremental benefit.


HCV Development

11. No new GI side effects have been encountered for NM283 since the dose reduction seven months ago, even at the 400mg dose, which is double the 200mg dose that will probably be taken into phase-3 for the treatment-naïve setting.

12. Dr Dieterich thinks the GI issue is much ado about nothing and that starting NM283 one week before giving interferon or ribavirin will eliminate most of all of the problem that was formerly seen at 800mg. (This is just his opinion, however, and as the PI for an NM283 study he may be biased.)

13. No comment was made about the alleged “creative solution” that NVS/IDIX are planning for the treatment-refractory setting, but Dr Dieterich’s comment about deferring the start of concomitant therapy to improve tolerability may be a clue.

14. Efficacy data at 36 days from the phase-2 NM283+ribavirin study will be reported in 1Q07. (The study will continue for 12 weeks to assess safety: #msg-13614225.)

15. JP Sommadossi re-iterated intention to start an NM283 trial in HCV/HIV co-infected patients, but no details were given.

16. JP expects to file an IND for a drug arising from the recently-announced collaboration with MBRX within 18 months.


Other Development Programs

17. IDIX has filed a pair of exploratory IND’s for two very similar NNRTI’s for HIV. A short phase-0 trial will be conducted to select one of the two , and then a regular IND will be filed on that compound in 1Q07. The long-term goal is to capture the part of the market held by BMY’s Sustiva.

Dew