Thursday, September 3, 2015

The Strange Tale Of Rolapitant -- Now To Compete With Merck -- A Legacy Schering-Plough Chemo- Nausea Med

While I don't expect this will matter much in any negative way to Merck, given its size, and long leading position -- with Emend® in this US market space -- I do find these "Post-Script -- Epilogue" stories interesting, given that the narrative here directly involves the genesis of this blog. [My much earlier backgrounders -- here, and here.] It bears mentioning that the candidate did hit a few clinical trial bumps along the way -- as we might expect for any drug that Fred Hassan was seen touting.

I suppose one object lesson here is that a robustly active anti-trust/pro-competition FTC and/or DoJ in the US is a good thing. And -- though it took five or more years, we now have an on-market competitor, for this segment. [My experienced conjecture is that the rolapitant program would have been deep-sixed -- post the Schering-Merck deal in 2010 -- had the HSR antitrust review not required divestiture.] And that is good for patients, and payers. What a path this candidate had: from legacy S-P, to Opko, to Tesaro. . . now, to meet Merck (the old Schering-Plough entity, just renamed), head on, in late 2015. Here is FierceBiotech on the latest (an FDA thumbs up):

. . . .The FDA has given Tesaro a green light to start marketing rolapitant to help prevent some of the common side effects of chemotherapy. And now Tesaro will wage a David-vs.-Goliath battle for market share with a dominant Merck.

The Waltham, MA-based biotech had gone through an extended R&D journey before it hit the regulatory finish line with this drug, to be marketed as Varubi. The company in-licensed the drug from Opko back in 2010 for a small upfront, then ran into a bitter backlash from investors after the initial Phase III program failed to hit key secondary endpoints in late 2013.

A second Phase III that wrapped up last year, though, rang all the right clinical bells in preventing nausea and vomiting, setting up the regulatory package and today's approval. Analysts believe this drug could earn a few hundred million dollars a year. . . .

As I say, a few hundred million is peanuts to Kenilworth, but will nicely augement Tesaro's post IPO price and volume. Onward -- on a hot clear wonderful late summer afternoon -- with airport runs a'comin'!

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