Vivus in talks to out-license ED drug Stendra

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Stendra's speed of onset may confer an edge over older erectile dysfunction pills like Viagra—and possibly a warm reception in the marketplace—but drugmaker Vivus won't launch the drug itself. The specialty firm wants another to handle marketing, an analyst says.

Vivus's Friday FDA approval for Stendra (avanafil) has drawn media focus on the pill's rapid onset of action. Patients take Stendra on an “as-needed basis 30 minutes before sexual activity,” the FDA noted in a statement.

By comparison, patients prescribed Pfizer's Viagra are instructed to take it about an hour prior to sex. Ditto for Bayer/GlaxoSmithKline's Levitra, while dosing for the Eli Lilly drug Cialis is listed as “at least 30 minutes before anticipated sexual activity.”

But Vivus, which also has an obesity drug in late-stage development, won't take aim at those rivals, at least not on its own. It's currently in discussions with potential partners to commercialize Stendra in the US and in other territories, except Asia.

The firm is not only shopping for a partner; it wants to completely divest or monetize the asset, said Credit-Suisse analyst Lee Kalowski in a note to investors today. “VVUS is most likely to find a partner in either a mid-sized specialty pharma company looking for de-risked assets or a big pharma company with excess GP sales force capacity,” Kalowski wrote, especially “given how competitive and promotionally sensitive the ($4.3B worldwide) ED market is.”

A company spokesperson told MM&M that its discussions with potential partners are confidential. A launch is planned for late 2012, but manufacturing has yet to start.

Over 60% of Viagra prescriptions are written by GPs, Kalowski says. As such, Stendra might make a nice fit for a pharma company with an existing primary care sales force of 750-1,000 reps or more, one that could layer on an additional product without requiring much incremental sales force expense, just promotional expense.

Vivus would rather direct its promotional budget toward gearing up for its launch of obesity pill Qnexa, whose PDUFA date is coming up on July 17, especially considering the kinds of outlays typical in the ED space.

Indeed, it would take a substantial amount of money to commercialize this asset. Viagra spent $128 million on DTC advertising in 2011, according to Nielsen, while Cialis spent $144 million on consumer ads. And that's not including detailing expenses.

As far as takers for Stendra, big pharma might be leery. Levitra, which Bayer out-licensed to GSK at one point, hasn't been a great story. The drug generated global sales of just $332 million last year.

Then again, Levitra is a completely undifferentiated product vs. Viagra and Cialis, and a niche might be available for Stendra. According to Leerink Swann analyst Steve Yoo, “while some prefer the longer duration of effect that LLY's (MP) Cialis offers, there will likely be a subset of patients who would welcome a faster on/faster off drug such as VVUS's (OP) avanafil.”

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