The
FDA has approved Vivus’ erectile dysfunction drug Stendra, and the firm hopes
its rapid mode of action will help take market space away from its key
competitors.
Stendra (avanafil) will rival Pfizer’s Viagra (sildenafil), which was the
first ED drug to market. But Vivus believes that Stendra as an edge over Viagra, as it can provide
an erection in around 15 minutes – half the time of Pfizer’s drug. Vivus’ drug, which is licensed from Mitsubishi Tanabe Pharma Corporation,
may see peak annual revenue of $450 million by 2017, according to
analysts.
But they warn that sales may be slowed at first by Vivus’ inability to
market the drug at a high level.
The firm has said it was discussing deals with
potential partners to sell the medicine. “Stendra is the first of a new generation of PDE5 inhibitors, and the
approval marks an exciting new milestone for the millions of men suffering from
erectile dysfunction who are in need of a new treatment option,” said Dr Wayne
Hellstrom, Professor of urology and chief of andrology at Tulane University
School of Medicine in New Orleans.
Victoria Kusiak, deputy director of the office of drug evaluation, said:
“This approval expands the available treatment options to men experiencing
erectile dysfunction, and enables patients, in consultation with their doctor,
to choose the most appropriate treatment for their needs.”
Stendra belongs to a class of drugs called phosphodiesterase type 5 (PDE5)
inhibitors, which are used to help increase blood flow to the penis.
Vivus said the market opportunity for ED medical treatments continues to
grow, with worldwide sales of PDE5 inhibitors exceeding $5 billion in
2011.
Stendra will need to compete with Lilly’s Cialis and GSK/Bayer’s Levitra,
as well as Viagra.
Pfizer’s drug has patent protection in the US until 2019, and made the firm
over $2 billion in sales last year - patents for Cialis and Levitra will expire
sooner in 2016 and 2018.