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Replies to #36524 on Biotech Values
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DewDiligence

10/30/06 12:25 PM

#36531 RE: dewophile #36524

Re: Baraclude vs Tyzeka

Agree on all counts.

>…so again this highlights the pitfalls of comparing response rates in 2 separate populations, and I would welcome a head to head study (which i humbly disagree may very well be done in the future, albeit without pharmaceutical support)…<

Without pharma support is the point I was making. Such a study is just too risky for either NVS/IDIX or BMY.

There’s no doubt that someone will want to do such a study within the next few years, but the results won’t be available in time to affect the early sales ramp of these products. Regards, Dew
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DewDiligence

10/30/06 12:36 PM

#36532 RE: dewophile #36524

Re: Yaron Werber

>I find it curious that Werber feels Baraclude is a best in class. Someone ought to challenge him on the basis of this statement.<

Given that Werber is forecasting $11M in Tyzeka sales for 2007 and $28M for 2008 (#msg-14371716), it’s clear to me that Werber has a motive here other than truth seeking. However, I think Werber blew it by giving Tyzeka such preposterously low sales projections as to render his entire hepatitis report suspect.
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biomsmdawg

10/30/06 8:09 PM

#36592 RE: dewophile #36524

When you compare Entecavir/Telbivudine 1 year data, they look pretty close. All are nucleoside naive pts.

From the pIII Telbivudine trial (GLOBE) @ 52 wks:
VL redn (HbeAg+): T-6.4 log vs Lamiv -5.5 log
VL redn (HbeAg-): T-5.2 log vs Lamiv -4.4 log
VL < 400(HBeAg+): T 60% vs L 40%
VL < 400(HBeAg-): T 88% vs L 71%
ALT normalization (HBeAg+): T 77 vs L 75%
ALT normalization (HBeAg-): T 74 vs L 79%

From the pIII Entecavir trials (AI463-022,AI463-027) @ 48 wks:
VL redn (HBeAg+): E -6.98 log, Lamiv -5.46 log
VL redn (HbeAg-): T-5.2 log vs Lamiv -4.4 log
VL < 400(HBeAg+): E 67% vs L 36%
VL < 400(HbeAg-): E 91% vs L 73%
ALT normalization (HBeAg+): E 78% vs L 70%
ALT normalization (HBeAg-): T 89% vs L 84%

These numbers are from my db, but I believe they're accurate. Based on the above, considering the similar responses to Lamivudine, you'd need to run a very large head to head trial to see any distinction at one year.