Vivus' experimental therapy for erectile dysfunction hit its endpoints in a Phase III trial, leaving the developer on track for a 2011 FDA filing and igniting a rally for shares that are now up 61 percent this year.
The numbers look good for Vivus (VVUS), which set out to prove that Avanafil could prove attractive for patients looking for a drug that works quickly and more safely than existing therapies. In the trial, 646 patients with ED were either given one of three doses--50, 100 or 200 milligrams--or a placebo. At 200 milligrams, 80 percent of attempts to gain an erection were successful with full efficacy in less than 30 minutes. Jason Butler, an analyst with JMP Securities, estimated that the drug could earn $350 million in 2015.
"Erectile dysfunction is a significant problem among more than half of all men over the age of 40," said Vivus CEO Leland Wilson "While sales of currently available ED therapies exceed $3.8 billion a year, persistent switching by patients suggests that patients are less than satisfied with current therapies." Vivus is best known for its obesity drug, which will soon be turned over to the FDA for consideration. Its stock, already buoyed by its success with the obesity program, shot up 17 percent this morning.
- check out the Vivus release
- here's the Bloomberg piece
- here's the Dow Jones report