Replies to post #36888 on Biotech Values

[DewDiligence]

IDIX Bear Stearns webcast notes:

1. After taking into account discounts offered to managed care for Hepsera and Baraclude, the effective U.S. price of Tyzeka will be a ~15% discount to Hepsera and a ~20% discount to Baraclude (rather than the ~30% discount implied by list prices).

2. NVS/IDIX will initiate a phase-4 trial of Tyzeka+Hepsera in Lamivudine-refractory patients to seek a label expansion into second-line treatment. My take: wide off-label use of both Tyzeka and Baraclude monotherapy in Lamivudine-refractory patients will probably come even without second-line studies, but a favorable outcome in the planned study should allow Tyzeka to gain some share at the expense of Baraclude. (Note that Hepsera is a nucleotide drug while Tyzeka and Baraclude are nucleoside drugs [#msg-14548291].)

3. In addition to the advantage in convenience Tyzeka enjoys vs Baraclude from its lack of a food interaction, Tyzeka has a marketing advantage vs Baraclude in safety for pregnant patients. Tyzeka is the only approved antiviral drug for HBV that is classified as “Pregnancy Category B” (not teratogenic) in the product label (#msg-14322606).

[DewDiligence]

Re: Tyzeka competition

[Reposted from Yahoo, in reply to ‘flatlander.’]

>Anyone have any insights on how the trials for viread and clevudine are going? How real is the potential near term threat from additional HBV drugs reaching the market which might be deemed more effective?<

Viread, like Hepsera, is a nucleotide (rather than a nucleoside) analog. The future of HBV therapy is likely to be a regimen including one nucleoside and one nucleotide (#msg-14548291), and hence Viread may be more complementary to Tyzeka than competitive.

Clearly, the main competitor to Tyzeka is Baraclude. Perhaps Clevudine deserves to be considered a bona fide competitor; however, it’s a little early to say because Clevudine is not yet even in phase-2 in the U.S. and its sponsors (Phramasset and Bukwang), to my knowledge, never released the complete data from the Clevudine trials in Korea.

In any event, I think my Tyzeka forecast of 33% market share in 2010 (#msg-14289297) is low enough to allow for some uptake by newly approved HBV agents, should there be any.