Idenix Pharmaceuticals (IDIX)

[gofishmarko]

>>> Baraclude was not added to the AASLD treatment guidelines for HBV until Feb 2007, almost two years after its FDA approval in Mar 2005.

This blows your assertion that Tyzeka is deficient for not being on the AASLD guidelines right out of the water. <<<


The previous AASLD guidelines were done in 2003 , I believe. Most of these guidelines are updated only when there is a significant change in best practices. However , Baraclude received a positive endorsement in the U.S. prior to the recent AASLD guideline update. The treatment algorithm that was updated in summer of '06 , like the AASLD guidelines , is also cited frequently in discussions of HBV treatment. See :

http://www.natap.org/2006/HBV/072706_01.htm

Baraclude did not suffer from lack of a positive endorsement in the time between launch and the publication of this treatment algorithm because it was so clearly superior to the only other approved HBV Ns , lamivudine.

It also didn't suffer because at no time was there such a damaging disapproval from an organization like AASLD , as has occurred recently re: Tyzeka. Remember , Lok et al. didn't say that there was insufficient data to make a judgement on Tyzeka , they said Tyzeka was " not preferred " and " telbivudine monotherapy has a limited role in the treatment of hepatitis B".

I saw a recent Morningstar report on Smithbarney.com where they project that Tyzeka will capture about 5% of the U.S. and E.U. HBV markets by 2010. I think that's probably about right , plus or minus a percent or so.

I think the door is still wide open as regards combo therapy , however , for the reasons mentioned by dewophile. I don't think monotherapy results will automatically translate to the combo space , and Tyzeka could get a second wind if its antiviral potency adds more to a combo than its resistance rate and profile subtracts. That's all a few years worth of clinical data down the road , however.