Orexigen Therapeutics' ($OREX) obesity med, Mysimba, has Europe's green light as of Thursday. But it doesn't come without conditions.
At the recommendation of the EMA's Committee for Medicinal Products for Human Use (CHMP), regulators on the continent advised that patients should discontinue Mysimba treatment after 16 weeks if they haven't lost at least 5% of their initial body weight. That suggestion comes thanks to cardio safety concerns, which prompted the FDA to tag the drug with a black-box warning when it approved it last year.
In response to those worries, Orexigen earlier this month released an interim study analysis suggesting the therapy could actually reduce major adverse cardiac events. And while the announcement angered the FDA--the data were too premature to share, it figures, and it's asked Orexigen for a second outcomes study--the news impressed analysts nonetheless.
Mysimba--or Contrave, as it's called in the U.S.--could certainly use a cardio marketing edge to set it apart from its competitors. Earlier this week, Novo Nordisk's ($NVO) rival med Saxenda beat the Orexigen therapy to the regulatory finish line, snagging the EMA's go-ahead for a launch the Danish company says will start in several European countries this year.
Stateside, the competition is even thicker, with slightly older meds Qsymia from Vivus ($VVUS) and Belviq from Arena ($ARNA) in the mix. But analysts expect the Orexigen and Novo treatments to eventually eclipse their slow-starting rivals. Wells Fargo's Matthew Andrews has said he sees Contrave generating $634 million in 2020 sales, which could grow to $1.2 billion if it snags a diabetes indication. That measures up to forecasts of $481 million for Belviq and $396 million for Qsymia; Bloomberg analyst estimates put Saxenda's 2017 top-line haul at $429 million.
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