Friday, January 24, 2014

Bristol Myers Squibb Year End Conference Call Confirms Status Of Nivolumab: We Will Learn More At ASCO

I'll pop in on lunch-hour, just to briefly update the readership, on the state of the race between MK-3475 and Nivolumab, the BMS oncology candidate -- to reach US markets perhaps later this year.

I listened to a replay of the BMS year end earnings call, and in Q&A with management, and Dr. Tim Anderson (Sanford Bernstein), Jami Rubin (Goldman Sachs), Seamus Fernandez (Leerink Swann) and Mark Schoenebaum (at ISI), no matter how the questions were asked -- the answers were consistent and unchanged. BMS remains very encouraged by its candidate, across a very broad array of cancers. In short, there is nothing to Mr. Schoenebaum's now-definitively unfounded conjecture -- that the Checkmate 012 study might have turned up anything worrisome. In the future something might turn up -- to be sure -- but as far as anyone knows, nothing has. [The only people who might know more (independent clinicians/academicians actually overseeing the safety and efficacy parameters of the studies) are blinded to the company, for obvious reasons.]

That said, we will all have to wait to see the full nivolumab study results here at ASCO in Chicago, over Memorial Day Weekend 2014. If that data rolls out as expected, a submission to FDA for approval might occur almost immediately thereafter. Then my much bally-hooed dead-heat race is really on. It seems very unlikely that Whitehouse Station would have a completed FDA filing package in, before late June 2014. So the two are very likely within six months of one another, on either side.

Of course, BMS was careful, and generally taciturn on the call, as this nivolumab news -- whatever shading might occur, as to the disclosures, here on a call -- would be material to BMS, and in some ways, possibly also material -- to Merck. So the repeated mantra was that BMS is very encouraged, and is spending lots -- starting new studies in several other cancers. . . renal/kidney, hematological and lung. But they have very nearly reached the finish line with melanoma -- just like mother Merck.

I'll likely pop in on ASCO in downtown Chicago this Spring, but the likely next "big date" on this horserace will be Merck's year end earnings conference call in a few weeks, on the morning of February 5, 2014 -- to see if the same cast of questioners can tease additional color out of Ken Frazier and crew, on MK-3475 -- and its lung cancer study. Okay -- stay warm and be excellent to one another, this weekend.

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