Tuesday, June 13, 2017

A Few (Largely-Belated) Updates -- On Merck's Keytruda®...

Overnight, Kenilworth disclosed (on the recommendation of the DSMBs) a pause, in two late stage clinical trials -- each using pembrolizumab in combination with other chemo agents -- including Celgene’s Pomalyst®, and Revlimid®, in patients with multiple myeloma. Merck did so, in an abundance of caution, in order to study some additional data related to unexpected patient deaths, more closely -- before restarting the trials' enrollments.

I don't expect to see any widespread downturn in Merck's NYSE price though, as overall Keytruda® has posted very impressive data in a wide array of cancers. [Backgrounder here from August 2016.] Celgene's stock, meanwhile, may ride a down-bubble on the news.

Separately, over the weekend, AB Bernstein analyst Tim Anderson suggested skepticism about the wisdom of Merck's relatively late entry in early stage studies of pembrolizumab -- in combination with CTLA4 (as opposed to chemo-). Here is FiercePharma reporting, as of June 9, 2017:

. . . .In light of the competition, Bernstein analyst Tim Anderson said Merck needs to “go big or go home” with its duo. “Unless Merck believes it has a differentiated product, it is difficult to justify development of this new molecule given the substantial lead-time advantage that its two competitors have in this area,” he wrote in a Thursday note to clients.

What would make the study “easier to justify,” in Anderson’s opinion? Simultaneously launching another combination trial—this one marrying Keytruda and Bristol’s CTLA4 med, Yervoy -- the only one currently on the market. This way, as he sees it, if Bristol or AZ succeed with their trials, “Keytruda would remain relevant in the nearer-term” in the setting.

“As long as Merck generates clinical data like this, physicians would likely feel comfortable mixing-and-matching” Merck and BMS’ products, he hypothesized. “Then, Merck has more time to eventually come in with a CTLA4 of its own. . . .”

Now you know -- but as I say, Merck isn't likely to see much of a buying opportunity on the NYSE, here -- most of this is already baked into Merck's stock price.

Finally, and also largely unrelated: I will note that if -- in some mythical Brigadoon-like land, 45 is able to pass a tax package -- and if that tax package includes some of what US House alt-right folks are whispering about -- Pfizer and Apple might reap additional one time windfalls -- and Merck and Microsoft might have to come up with new cash for tax payments.

This is so, because Merck and Microsoft have reserved proportionately much smaller amounts for repatriation taxes than Pfizer and Apple, respectively. But none -- literally none -- of any such tax package exists on paper even, in any legislative chamber. So this is mostly the reporting of rumor and innuendo -- just to be clear -- by the Denver Post. Onward -- now you know.


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