(VVUS) is raising the bar on erectile dysfunction drugs, potentially becoming the latest formidable competitor to Viagra and Cialis in the $3.8 billion market.
Investors in the California-based pharmaceutical company jumped on Wednesday, when the company cited positive results from a late-stage study of its erectile dysfunction drug avanafil. The stock shot up almost 6% in early morning trading, while shares of Pfizer
(PFE), which makes Viagra, and Eli Lilly
(LLY), maker of Cialis, remained relatively flat.
Vivus announced the results from its phase 3 Revive study, which tested the safety and efficacy of avanafil for the treatment of erectile dysfunction in 646 patients. The drug met all primary endpoints across all three doses tested in the study and showed that full efficacy, measured by the patients’ ability to successfully perform intercourse, was reached within 30 minutes. The drug demonstrated a low incidence of side effects. Avanafil works by inhibiting the PDE5 enzyme, similar to Viagra and Cialis.
"Many patients living with chronic ED become frustrated by the occasional treatment-limiting side effects associated with currently available therapies,” said LeRoy Jones, MD, clinical associate professor of Urology at the University of Texas Health Science Center in San Antonio and an avanafil trial investigator. “Patients often switch therapies in search for an improved experience."
The company insists that the rapid onset of the drug sets it apart from the competition -- Viagra takes 60 minutes to kick in, while Cialis can take up to two hours to become effective.
Vivus is still conducting two other phase 3 trials and hopes to file for regulatory approval with the US Food and Drug Administration by the end of next year or early 2011.
"These compelling data for avanafil follow the recent positive phase 3 obesity data for Qnexa, for which we expect to file an NDA before the end of the year, placing Vivus in the fortunate position of having two late-stage products addressing large markets with significant unmet needs and near-term regulatory and data milestones on the horizon,” said
Vivus Chief Executive Leland Wilson.
Vivus promises to be a major pharmaceutical stock to watch if Qnexa, its treatment for obesity, can garner regulatory approval. It has the potential to be a $10 billion drug, according to analysts. Diet pills typically have a hard time getting past the FDA due to side effects and minimal efficacy.
Historically, weight loss drugs have been unpleasant to use, highly dangerous, and mostly ineffective. Wyeth’s Fen-Phen, while effective in causing weight loss, was withdrawn from the US market in 1997 after a slew of deaths occurred from extended use of the drug. Both Merck
(MRK) and Sanofi-Aventis
(SNY) have scrapped obesity treatment development programs in recent years after the FDA determined that the side effects were too lofty compared with the minimal benefits.
Qnexa has yet to exhibit any major side effects and patients in the trial lost more than 10% of their body fat on the drug, as compared to about 1% weight loss for those patients that were given the placebo. The FDA requires 35% of patients to lose 5% of their body weight and for the results to be at least double the placebo group.
Yet, competition for the weight loss market is fierce. Arena Pharmaceuticals
(ARNA) and Orexigen
(OREX) are both developing similar diet pills. The company to get its drug on the market first could win the whole pie. So far, it appears Vivus is in the lead. For more on the pharmaceutical sector, please see Glaxo and Nabi Team Up for Nicotine Vaccine, For Big Pharma, Diabetes Means Big Business and Big Pharma Scrambles for a Piece of the Vaccine Pie.
No positions in stocks mentioned.
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