Tuesday, January 14, 2014

Finally, Overnight -- Into The Wee Hours -- On MK-3475 (Lambrolizumab), It IS Materially Good News

This morning's announcement of a so-called Lambrolizumab rolling FDA submission, combined with "fast track" FDA review -- may speed this very promising oncology candidate (MK-3475) to market, in the US. That is plainly what drove the over 5.7 per cent increase in Merck's NYSE price, today -- Whitehouse Station's best day on Wall and Broad, since 2009. [Talk of deals for Animal Health and/or Consumer Health, far less so -- and vorapaxar's favorable FDA review. . . actually. not. at. all. Heh.]

While today's MK-3475 announcement makes it official, I do want to (perhaps immodestly) point out that I said months ago that the MK-3475 Anti-PD-1 candidate would likely be on US markets, some time in late 2014. [If the NDA packet is complete and in DC, en todo, by July 2014, an approval could come in December 2014.] I was pretty much alone in that assessment -- but the way Merck was/is spending on additional studies, in other cancers, a rolling submission seemed a real possibility.

Now, as I say, it is official -- and that is materially good news. Midday tomorrow -- when I get a break -- I'll get a closer look (i.e., do an independent literature review) to get a bead on whether nivolumab, the competing BMS Anti-PD-1 candidate (once almost two full years ahead of Merck's MK-3475) -- is still looking likely to beat Merck to market by six months -- or more -- in the US. Now, I am not so sure. The two drugs might be approved, and on-market within three months of one another -- and in practical terms, a six month (or greater) lead is geometrically more meaningful than a three month lead. This is so, because oncologists don't immediately write prescriptions, for the new drug. . . there is a tangible "burn in" period -- for oncology drugs, in particular. Often patients will need to be tapered off of other meds, etc. -- or entirely new patients identified for the drug, once the study period ends, and revenue is the model.

We shall see, come lunch-time tomorrow. I'll file my homework report then. In the mean time, here is the Reuters version of a guess at it (mine soon):

. . . .Merck's drug is designed to treat patients with advanced melanoma who have previously been treated with Bristol-Myers' melanoma drug Yervoy. The company is also testing the drug in other cancers, including lung and renal cancer.

Bristol is testing its own PD-1 drug nivolumab in a variety of cancers, with lung cancer likely to be one of the first to move forward.

"This is probably one of the most important classes of new drug," said Damien Conover, an analyst at Morningstar, who forecasts peak sales for Merck's drug, including multiple cancer indications, of $3 billion. He forecasts peak sales for Bristol's drug of $6 billion. . . .

While Bristol has more clinical trials and data to show for nivolumab, Merck's move in filing for MK-3475 early "is a way to fight Bristol. . . ."

The drugs are designed to restore the natural ability of the immune system to recognize and target cancer cells. . . .

If nothing else, this will make for an entertaining drug company horse race. And it is wonderful to see these "big science" advances, in some of the most intractable cancers. My "flannel sheets are calling, chanting my name, soft and low, but chanting, just the same" -- so, off to bed I go. . . . now.

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