Biotech Values

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Re: Albuferon vs Locteron

Locteron:

>> After 12 weeks of treatment, plasma hepatitis C RNA was reduced to undetectable levels ( < 28 IU/ml) in 63% (5/8) and 63% (5/8) of the patients in the 320 and 480 µg dose cohorts, respectively, compared to 13% (1/8) of the patients in the lowest-dose group of 160 µg <<

>>The percentage of patients who achieved early virologic response (EVR), defined as at least a two-log reduction in hepatitis C virus after 12 weeks of treatment, was 88% (7/8) and 100% (8/8) in the 320 and 480 µg dose cohorts, respectively<<

Compare to Albuferon:

>>The data show the following percentages of patients with hepatitis C (HCV) RNA viral load below the level of quantitation (43 IU/mL) at Week 12: 66% (75/114) in the treatment group receiving 180- mcg doses of Pegasys at 7- day intervals; 75% (82/110) in the treatment group receiving 1200 mcg of Albuferon at 14- day intervals (p=0.15 vs. Pegasys); 69% (82/118) in the treatment group receiving 900 mcg of Albuferon at 14- day intervals (p=0.55 vs. Pegasys <<

>>Data also are available on early virologic response at Week 12 (EVR12). (Early virologic response is defined as a >2 log - 99% or greater - reduction in HCV RNA viral load.) The data show the following percentages of patients achieving EVR12: 89% (101/114) in the treatment group receiving 180- mcg doses of Pegasys at 7- day intervals; 90% (99/110) in the treatment group receiving 1200 mcg of Albuferon at 14- day intervals (p=0.73 vs. Pegasys); 84% (99/118) in the treatment group receiving 900 mcg of Albuferon at 14- day intervals (p=0.30 vs. Pegasys)<<

http:/ /www.natap.org/2006/HCV/031606_02.htm

At a glance, I'd say Locteron is on the way to pass an equivalence test against Albuferon.

My guess is that all four of Albuferon, Locteron, Pegasys and Peg-Intron have similar efficacy and *if* at the end of the day Albuferon and Locteron are determined to be as safe as Pegasys, then Albuferon and Locteron will have an opportunity to take the place of Pegasys and Peg-Intron as the IF-alphas of choice for HCV.

Of course Albuferon has first-mover advantage over Locteron and Novartis is the senior partner ...

micro