Biotech Values

[DewDiligence]

BMY’s 3-DAA cocktail achieves results similar to ABBV/ENTA’s TURQUOISE-2 study in cirrhotic GT1 patients:

http://finance.yahoo.com/news/phase-3-unity-trials-demonstrate-140000959.html

The Phase 3 UNITY clinical trial program is an ongoing study investigating 12-week regimens of the DCV-TRIO fixed-dose combination (daclatasvir 30 mg plus asunaprevir 200 mg plus beclabuvir 75 mg) in non-cirrhotic and cirrhotic genotype 1 patients. [Daclatasvir (Daklinza) is an NS5A inhibitor, Asunaprevir is a PI, and Beclabuvir (BMS-791325) is a non-nuke.]

…In the UNITY-2 study, both cirrhotic treatment-naïve and treatment-experienced patients received the DCV-TRIO fixed-dose combination, one arm without ribavirin (n=102) and one with ribavirin (n=100). The study was double-blinded to ribavirin, and the majority of the patients (74%) were genotype 1a. The study showed 96% of all patients who received the DCV-TRIO with ribavirin achieved SVR12, and 90% of those who received the DCV-TRIO without ribavirin achieved SVR12.

Although these data are quite good, there is no statement in the above PR about plans to submit a marketing application to any regulatory body.

As far as I know, BMY does not plan to commercialize the “DCV-TRIO” 3-DAA regimen or any other regimen including Asunaprevir (#msg-106957091). If anyone knows differently, please post!