Biotech Values

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If I could add a little from notes (not memory), I think it is dead unless Valiant is interested from the 11/29/05 call when they divested Infergen, indicated the following (not an exact quote from my notes):
80 patient trial Infergen + Actimmune in light of Infergen divesture decided not to go to expansion phase effectively terminating.

This was a very complicated study with the primary objective to evaluate two dose of Actimmune 50 and 100 and Infergen 9 and 15 with and without Ribavirin. Was to try to find optimal dose for expansion:
(Phase 2b Combo study)
. 3 cohorts but reality 8 arms
. 20 patients Alpha 9 mg daily with 50-100 Gamma TIW (2 arms)
. 15 mg daily with 50-100 Gamma TIW another arm starting to use 9 mg Ribavirin Gamma 50-100
. 15 mg daily with 50-100 Gamma and addition of Ribavirin
Treatment period is 48 weeks and 24 week observed for SVR.

The trial was encouraging though maybe not too well tolerated an Investigator sponsored trial found the following in my notes from past calls:
Dr. Carol Leevy study combining two in PEG non-responders in patients who did not have 2 log drop in 12 weeks. App. 44% HCV negative awaiting sustained biological response data. Encouraging as taking patients who had no response and getting 6 log drop in over 40% of patients.
and
When combine interferon’s worry about side effects. ALP within normal limits overtime. Hemoglobin was rising over time and having healthy amount by week 24 and also case at week 48. Biggest worry neutropenia saw a lowering of neutropfils but no severe grade 4 (< 500 neutrophils) some had grade 3 (less then 750 neutrophils) so gave growth factors in 8 patients out of 50. - From Dr. Maria Sjogren talk at an Investor Day


Had hoped (OK wishful thinking) Roche may consider doing something with Actimmune and Pegasys but absolutely no mention and I think it is a real long shot!

FYI, don’t have any other sources but InterMune would say generally believed non-responders retreated with other PEG have about 5-10% SVR.