Replies to post #163898 on Biotech Values

[mcbio]

GILD

There may be rational explanations for this beyond inferring that something is wrong with Ledispavir.

I don't think we're inferring something is wrong; rather, we are seeking answers. At a minimum, this new trial raises some questions.

For instance, GILD may want to position SOF+RBV as a pan-genotypic "good-enough" regimen - why bother with tailored therapy if you can just prescribe SOF+RBV to anyone without even bothering with genotype testing?

Is it worth it to undergo at least 4 additional weeks of treatment, if not 12, simply to avoid genotype testing?

More importantly, this may be driven by pricing considerations, especially with respect to emerging markets - there is more room for premium pricing SOF if there is no additional cost of LED or Peg-IFN. SOF is the crown jewel of their portfolio, they need to price it at max around the world to even have a chance at positive return on the VRUS purchase.

It is precisely these reasons you cite, namely the fact that GILD has a lot to recoup from the VRUS purchase, that leads me to believe that the competition will be able to carve out a nice niche competing on price.

[oc631]

There may be rational explanations for this beyond inferring that something is wrong with Ledispavir

Just to be clear I see nothing wrong with Ledispavir use in GT1. My position is it's a safe and tolerable drug that works well in this genotype.

For instance, GILD may want to position SOF+RBV as a pan-genotypic "good-enough" regimen - why bother with tailored therapy if you can just prescribe SOF+RBV to anyone without even bothering with genotype testing?

GILD did early testing of Sofo/Riba in GT1. The combo isn't potent enough to be approved within this genotype. Even if there was a slight uptick in efficacy using longer durations of therapy this wouldn't be apparent in larger studies. The bottom line is GILD has an NS5A within their pipeline that works very well in GT1 when combined with Sofosbuvir. The Sofo/Riba study in GT1 is nothing more than a ploy. Why not test longer durations in GT2? Sofo/Riba is the choice combo within this genotype. Does GILD expect 100% 12-week SVR rates in GT2 within the real world setting?

More importantly, this may be driven by pricing considerations, especially with respect to emerging markets - there is more room for premium pricing SOF if there is no additional cost of LED or Peg-IFN.

GILD isn't planning on pushing into emerging markets with Sofosbuvir at this point in time. It's hard to defend GT1 Sofo/Riba use anywhere in the world. By adding interferon SVR rates could be boosted well over 90% in all genotypes.

[DewDiligence]

GILD—this [new trial] may be driven by pricing considerations, especially with respect to emerging markets - there is more room for premium pricing SOF if there is no additional cost of LED or Peg-IFN.

Your explanation is consistent with the information in #msg-89871936.