The drug: Lu AA21004/vortioxetine
The disease: Major depression
The developers: Lundbeck, Takeda
Peak sales potential: Lundbeck estimates $2 billion, and they need it.
Just over the past few days, Lundbeck and its partner Takeda filed for regulatory approval of vortioxetine in Europe as well as the U.S. An approval would trigger a $43 million milestone for Lundbeck, but that's peanuts compared to the significance of this therapy for the long term.
Lundbeck already faces an earnings slide as Lexapro comes off patent. An experienced player in the field of major depression, Lundbeck can boast of a broad slate of data from multiple trials, most of which came in positive. That's the kind of conclusive data that regulators demand, and there's always a steady demand for new therapies, as currently available drugs often miss their mark with patients or eventually lose their effectiveness.
The drug offers a one-two punch against depression, for receptor activity modulation and reuptake inhibition. There's the 5-HT3 and 5-HT7 receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the serotonin transporter on one side and improved levels of serotonin, noradrenaline, dopamine, acetylcholine and histamine on the other.
Last May the partners announced positive data from the last three Phase III studies, setting up the regulatory action. Both companies plan to co-promote in the U.S. and Japan.
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