Alprostadil-containing "pellets" -- inserted inside the opening of the penis -- have been approved years but generate minimal sales due to competition from the ED pills.
Vitaros was approved in Canada in 2010 but has still not been launched commercially. Apricus signed Abbott (now Abbvie (ABBV)) as a Canadian marketing partner in January 2012 but the drug's commercial launch has been delayed because of formulation problems. Abbott is trying to create a shelf-stable formulation of Vitaros that won't require refrigeration. The latest launch date is 2014, or more than two years later than expected.
Apricus has partners lined up to launch Vitaros in Germany and Italy, but there, the drug will have significant marketing challenge from generic versions of Viagra expected soon.
In the U.S., Apricus sold rights to Vitaros to Warner Chilcott (WCRX) in 2009. [Actavis (ACT) is in the process of acquiring Warner Chilcott.] The drug is not approved here yet but even if FDA does approve eventually, Apricus receives no royalty on U.S. sales, only manufacturing revenue if Actavis/Warner Chilcott decide to buy Vitaros supply from Apricus.You see now why Apricus has real challenges ahead with Vitaros. I won't get into Femprox here, except to say Apricus still hasn't disclosed its regulatory filing strategy for the U.S. The company conducted a phase III study in China. Whether these data are sufficient to warrant an approval filing in the U.S. isn't clear. PMTaster writes: I notice you were having fun last night on Twitter with Avanir Pharmaceuticals (AVNR) and its deal for OptiNose, but seriously, do you think this device has any value? Avanir isn't paying much for OptiNose (yes, the best device name -- ever), which is the nicest thing I can say about the deal right now. For a $20 million upfront payment, Avanir gets North American rights to OptiNose's nasally delivered migraine therapy, which reportedly has all the data collected already that will be necessary for an FDA approval filing in the beginning of next year. Avanir is on the hook for another $90 million in payments to OptiNose tied to regulatory and sales milestones. In conjunction with this licensing deal, Avanir took on $50 million in new debt, which will be used to pay for the $20 million upfront payment and pay back $30 million in old debt.
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