Replies to post #33521 on Biotech Values

[DewDiligence]

Re: Rasilez

> [3.] Actually, despite how the PR words it, the combination [Rasilez + HCT] is better than both as monotherapy (see abstract #1 from American Society of Hypertension below).<

If the combo is better, it certainly is not materially better. In fact, the diastolic BP was worse for the combo treatment:

http://urlcut.com/1cbcp

>>
The results showed Rasilez on its own cut mean systolic and diastolic blood pressure levels by 17.4 and 13.3 millimetres of mercury (mmHg) over one year, while the reduction was 18.7 and 12.1 mmHg in combination with hydrochlorothiazide.
<<

> [4.] They announced that BP reduction of the combo was better than that over 5 mg norvasc alone. Are you drawing a distinction between synergy and additive?

I always draw such a distinction :-) e.g. #msg-10932350 items #4 and #7.

> [5.]There is controversy as to which are better, ace-i or arb, so perhaps this discrepancy in the spp100 combo trial outcomes is a window into the differences for ace-i vs. arb<

There may be a controversy from a medical standpoint, but ARB’s have won this debate in the marketplace. Moreover, the efficacy of Rasilez in combination with Diovan, specifically, is very important to NVS' CV franchise during the next decade.

>The additional change in BP for a combo over a monotherapy need not be very large in order to see a downstream difference…<

Again, I’m calling you out here for thinking like an MD/PhD rather than an investor. From a business standpoint, a combo pill has to be superior to its constituents by more than a smidgeon if it is to become a big-selling drug. I would not like to be a sales rep whose best argument is the one you just made.

>I sold Speedel so I've not been following as closely.<

What led you to sell it?

[DewDiligence]

More on Rasilez with Norvasc:

Speedel’s investigators appear to be using a loose definition of additive:

http://www.siliconinvestor.com/readmsg.aspx?msgid=22781979

In a meta-analysis including studies of various durations, the investigators found that Rasilez added to 5mg of Norvasc worked about as well as 10mg of Norvasc alone. I might call this incremental but I would not necessarily call it additive.

To call the combination of Rasilez and Norvasc additive, I would want to see that the combo produced a clinical benefit that was as great as the sum of the benefits of Rasilez monotherapy and Norvasc (5mg) monotherapy. So far, I have not seen any evidence that it does. Hence the comment in #msg-13100149: “Rasilez is apparently not synergistic with Norvasc (the leading calcium-channel blocker) and the clinical benefit may not even be additive.”