This post will highlight comments on the Sanofi $SNY year-end 2012 conference call relevant to Isis Pharmaceuticals $ISIS, partner for the development and commercialization of KYNAMRO (mipomersen) for familial homozygous hypercholesterolemia.
The US approval of Kynamro was mentioned in the earnings press release but this drug was not discussed on the conference call. Note that the rejection of this drug in Europe was recently upheld after the companies appealed.
The rest of the comments below pertain to the development program against PCSK9, another target for lowering cholesterol, which is partnered with Regeneron $REGN.
Transcript quotes c/o SeekingAlpha.
"In addition, as I said, we're trying to reinforce our presence in the cardio-metabolic area. And we try to do this by selecting programs within our research that would fit with our historical legacy in Plavix and other areas of cardiovascular care, Aprovel. But we have quite a bit of experience and this is why we chose PCSK9 as one of the topics of our collaboration with Regeneron in 2009, and accelerated its development. We're now, as you know, in Phase III, it's a first-in-class fully-human antibody targeting PCSK9, a novel mechanism that was discovered through genetics research. Where, in fact, we showed that loss of function of this particular enzyme, actually created a reduction in the risk of coronary disease. And a huge reduction in low density cholesterol, which is the main risk factor. So you're seeing here, for example, the effect of the drug -- dose response. And you can see a flattening of the curve, with minus 40% to minus 70% reduction in the level sustained over a period of time, with injections every 2 weeks at different doses. So when you really look at the impact of this, you have to ask yourself, "Where is the place of such a therapy in a field where statins have been quite effective?" The target populations, when you really think about it, it's about 21 million patients globally. What is it composed of? First, the patients who are first familially very susceptible to hypercholesterolemia because of genetic differences. The second are the significant number of patients who cannot tolerate statins, who have complications from statins, muscular or others, and those 2 populations make about 3 million, 4 million patients. The big population that we are targeting in our Phase III trials is the population of secondary prevention. The patient who is treated, has been followed, and who comes to the hospital with an acute coronary event. That patient is known epidemiologically to be at a very high risk of recurrence of the event and death.
So these patients in secondary prevention make up almost the bulk of these patients with 12 million, 13 million patients entering into that category. And then we know that we have patients at high risk because of diabetes, for example, underlying conditions, and those will be the primary prevention target.
When you look at our strategy, ODYSSEY is the name of the large Phase III programs that we have launched. There will be 22,000 patients and those involved in this particular categories, this target category that I just defined for you. And we are going to go after that in a sequential fashion. So we've already enrolled in immunotherapy in a trial, for example, we'll read out this during this year, and we're going to expand into our ability to understand the impact of this approach in terms of benefit in the patients with acute coronary syndromes."
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