Replies to post #65000 on Biotech Values

[jawwx3]

Early approval will likely be for the unmet need of treatment failure patients. Telaprevir is clearly better than boceprevir in treatment failure patients. I think telaprevir and boceprevir both work, which only makes it more clear to the fda that one of them should get early approval, telaprevir is the better choice for early approval for treatment failure patients. Remember, there are 300,000 and 9000 a year are dying.

[DewDiligence]

HCV: Most Likely to Succeed (IMHO)

[Updated for latest R7128 results.]


The following paragraphs are in descending order of likelihood of success. (Paragraphs 6 and 8 are “catchall” groupings that do not explicitly mention all of the applicable drug candidates within the grouping.)

1. Telaprevir (VRTX/JNJ; phase-3) and Boceprevir (SGP; phase-3). Both drugs are protease inhibitors and they have shown comparable efficacy in the genotype-1, treatment-naïve setting (#msg-31190433). Background posts: PROVE-1/2 trials made simple: #msg-29019931; PROVE-1/2 detailed results: #msg-28746843; overview of Telaprevir phase-3 program: #msg-26228377; Telaprevir interim results from ‘107’ study: #msg-28749322; Boceprevir starts phase-3: #msg-29474929.

2. ITMN-191/R7227 (ITMN/Roche; phase 1b): #msg-28091523.

3. Locteron (OctoPlus/Biolex; phase-2), a long-acting interferon made in transgenic plants: #msg-28786162.

4. Various oral agents in phase-1 or phase-2 trials that use an established MoA. These include TMC435350 (Medivir/JNJ; entering phase-2): #msg-28785830; R7128 (VRUS/Roche; phase-1b): #msg-31218459; and R1626 (Roche; phase-2): #msg-28821034.

5. The “other” interferons: Albuferon (HGSI/NVS; dose reduced in phase-3): #msg-26199740; IFN-alpha-XL (FLML; phase-1): #msg-28837983; and IFN-Lambda (ZGEN; phase-1): #msg-16610804. I’m excluding MAXY’s Maxy-alpha, which has been on life support since Roche dropped the program: #msg-24801678.

6. Miscellaneous very-early-stage compounds that use an established MoA; e.g. IDX184 from IDIX: #msg-28715477, #msg-26915921.

7. GS9190 (GILD; phase-1), which has caused QT-prolongation: #msg-24268443.

8. Miscellaneous early-stage compounds that use novel MoA’s; e.g. Sirna-034, now owned by MRK: #msg-12665661.

JMHO, FWIW