Tesaro gets a green light for rolapitant, triggering Merck showdown

Tesaro CEO Lonnie Moulder

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

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.

But it won't be easy.

Tesaro still has to prove that it can compete with the pharma giant Merck, which earns more than $500 million a year from the rival drug Emend. But Tesaro was taking an optimistic view as it preps a Q4 rollout for its first approved drug.

Tesaro's stock was up 5% this morning.

"The approval of Varubi, our first product, represents a significant milestone in Tesaro's evolution into an integrated biopharmaceutical company with strong development and commercialization capabilities," said Lonnie Moulder, CEO of Tesaro. "Results from the Phase III trials of Varubi demonstrated that patients receiving emetogenic chemotherapy agents, including platinum and cyclophosphamide-containing regimens, benefitted from the addition of Varubi to their antiemetic regimen. Data from multiple well-controlled trials demonstrate that patients who receive only a 5-HT3 receptor antagonist and dexamethasone often continue to suffer from nausea and vomiting for several days following chemotherapy administration." 

- here's the release

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