Some More Color -- On the Keytruda® (f/k/a Lambrolizumab/ Now Pembrolizumab) Launch. . .

Very little of any moment was said at the Manhattan Morgan Stanley Global Health Care presetntation this morning.

However, I thought I'd offer this bit of additional color -- on the launch of what used to be called lambrolizumab -- for the readership. Now branded as Keytruda^® -- from a bit of Merck's own edited transcript, then:

. . . .Morgan Stanley Analyst David Risinger: Maybe you could speak to -- and this is really a question for any of you -- but maybe you could speak to how investors should think about the launch of pembro. Obviously, there will be a lot of demand for it off label for which Merck won't promote or discuss, but it would seem like the super wealthy in the country with a variety of cancers would be interested in accessing pembro now that it's going to be commercially available this month. So maybe you could talk about the commercialization strategies, the launch plans and how you manage that. . . .

Adam Schecter, EVP Merck:

. . .So obviously, we are very excited about the commercialization of Keytruda. We received our first orders yesterday and we are shipping today so the product should be available sometime this week. So that is a big moment for us to have the product available so quickly after the approval. We have our salesforce in place. We have a global oncology business unit, as Ken mentioned. In the US specifically, our salesforce is being trained as we speak and they will begin to call on physicians that treat melanoma patients in the very near future. . . .

At the same time, we are going to focus on the indication that we have, which is for utilization after failure on other products for melanoma. If you look, there is about 10,000 patients with metastatic melanoma that are treated every year in the United States. About 5,000 of them are treated on Yervoy first. The other 5,000 usually get a BRAF inhibitor. If you then look at the number of patients available based on our indication for Keytruda, we figure there's about 300 to 350 patients that will be available per month based upon the flow of patients that will fail on either the two pathways for our indication. We think there is somewhere between 1,000 and 1,500 patients that are currently available in the marketplace based upon previous failures. . . .

So although the indication is relatively restrictive and small and that is where we will focus our promotion and only where we will focus our promotion, we do realize, as you said, that there are physicians that will utilize the product off-label. We won't promote that, but we realize that that is the reality of what occurs. From a manufacturing perspective, we have a significant amount of supply. Whatever happens in the marketplace, we believe we'll be able to manufacture and supply immediately, but our focus will be on the indication that we have. But we have reimbursement support lines up and running already. We have everything ready to launch and we are in the middle of it as we speak. . . .

So it goes -- but Merck admits, as I noted many months ago (January of 2014, in fact) -- the initial FDA approved indication is pretty darn narrow. Under 1,000 patients overall. And Merck cannot lawfully chase off-label 'scrips. Add to this, that BMS is well ahead in lung study submission timeline -- with Opdivo^® (Nivolumab). A great horse race, indeed!