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Vivus Preps a New ED Drug Just as the Market Is Set to Implode

By Jim Edwards | Nov 18, 2009

Vivus (VVUS)’s stock rose on news that a phase 3 study showed its new erectile dysfunction drug, avanafil, produced “erections sufficient for intercourse” 80 percent of the time. So far, so good. But the devil is in the details with this drug.

Look closely at the results charts in Vivus’ press release. Even at the highest dose, only 57 percent of patients “experienced successful intercourse.” This chart gives stats for that measure, per Vivus:

Doesn’t 57 percent seem a little low? Not compared to the baseline scores, of 12 - 14 percent. The numbers are rather squishy, because they’re based on a self-administered diary-questionnaire, “the Sexual Encounter Profile.” What is SEP? According to MedScape:

… the Sexual Encounter Profile (SEP), [is] a diary consisting of yes/no-type questions that enables both the patient and his partner to evaluate sexual encounters.

For example, questions 2 and 3 of the SEP read, respectively, “Were you able to insert your penis into your partner’s vagina? [yes/no]” and “Did your erection last long enough for you to have successful intercourse? [yes/no].”

So even on the highest dose of avanafil, 43 percent of patients couldn’t keep it up even during sex. You can judge for yourself how reliable self-reported failure is among men, even when anonymous.

Add to that the fact that Pfizer (PFE)’s Viagra goes off patent in 2012, which will devastate the category, forcing steep discounts and lost revenue for Bayer (BAY)’s Levitra and Eli Lilly (LLY)’s Cialis alike.

Put the two factors together. Who, exactly, is going to want the new, branded, expensive version that Vivus will be marketing at that time?

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

BNET User Analysis

Web Buzz:
  • Rexahn, Vivus Believe the World Needs 2 More ED Drugs

    BNET Pharma - 362 days 14 hours 22 minutes ago

    Two companies are developing new erectile dysfunction drugs, even though there's already three on the market and one of those -- Pfizer's Viagra - is set to go generic between 2011 and 2013. Rexahn is developing a compound called Zoraxel and Vivus is developing Avanafil. Rexahn is in Phase 2 and Vivus is in Phase 3 with their research, according...

  • Biotech Stocks: Drug stocks move lower; Vivus, Poniard gain

    MarketWatch - 83 days 9 hours 54 minutes ago

    Drug stocks slip early Wednesday, while shares of Vivus jump on a positive Phase III clinical study for the company’s new erectile-dysfunction drug

  • Vivus's erectile dysfunction candidate meets goals of first Phase III study

    Scrip News - 78 days 6 hours 48 minutes ago

    Vivus's phosphodiesterase-5 inhibitor (PDE-5) avanafil has been shown to improve erectile function in the first of the drug's four pivotal Phase III studies for the treatment of erectile dysfunction (ED). The company is aiming to

  • On a hot streak, Vivus posts positive ED data

    FierceBiotech - 83 days 11 hours 34 minutes ago

    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...

  • Viagra not harmful to vision - study

    Sky News - 301 days 2 hours 14 minutes ago

    Treatments for erectile dysfunction such as the hugely popular drug Viagra do not appear to pose long-term damage to men's sight, a new study has shown. Doctors had been concerned that Viagra, and its competitor drug sold in the United States as Cialis, might prove harmful after some men reported blurred and blue-tinged vision. The two drugs...

 

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