- The FDA on Thursday approved a revised label for Vivus' erectile dysfunction pill Stendra.
- Auxilium, which won marketing rights to Stendra in a deal that could be worth as much as $300 million, can now market the drug for use 15 minutes before sex rather than the 30 minutes listed under the previous label.
- Stendra sales for the first half of 2014 were almost $18 million. That figure could go up considerably in the second half of the year.
PA-based Auxilium telegraphed its plans to take on ED market giants like Pfizer's Viagra and Lilly's Cialis earlier this year. With a pill that promises results in half to a quarter of the time as those drugs, the smaller biotech may just have a real competitor on its hands.
“We believe this label expansion helps position Stendra as an exciting ‘on-demand’ ED treatment, and assists with the very important aspect of spontaneity for men and their partners in real world use,” said Auxilium CEO Adrian Adams. “We believe this provides a meaningful benefit for men with ED.”
The timing of the label revision is particularly fortuitous for Auxilium, which is grappling with an unsolicited $2.2 billion takeover bid by Endo. Auxilium has stayed relatively coy about its intentions so far. The company says it plans to go through with a $345 million tax-inversion merger with Canadian biotech QLT, seen by many as a defensive poison pill strategy to bolster its position against Endo's takeover proposal. That position was certainly bolstered today.