National Editor

Neither ICOS Corp.'s erectile dysfunction drug Cialis (partnered with Eli Lilly and Co.) nor Levitra, from Bayer AG and GlaxoSmithKline plc, will remove the market dominance of Viagra, according to a recent physician survey.

But the key will be pricing, and pricing - at least in the U.S. - is uncertain.

"We've made the argument that in increasingly cost-conscious markets and in those [such as ED] where you have substantial out-of-pocket payments, consumers are much more responsive to cost pressures and cost decreases," said Kat Neumeyer, an analyst with Decision Resources Inc., which conducted the survey.

Among its findings: "While Cialis and Levitra both have improved attributes that make them attractive to physicians and patients, they will not be able to overtake Viagra's position in the market."

A year after the FDA has asked for clarity on issues related to Cialis (taladifil), ICOS has not yet submitted a complete response to the FDA, which means the drug could fail to reach the market before a close runner-up, Levitra (vardenafil), filed with the FDA three months behind Cialis by Leverkusen, Germany-based Bayer and GlaxoSmithKline, of London. (See BioWorld Today, May 1, 2002.)

ICOS and Indianapolis-based Lilly said earlier this month they still expect FDA approval for Cialis in the second half of this year, and Lilly ICOS LLC - the joint venture formed to promote the drug - said it intends to "vigorously defend itself" against a patent infringement claim by Pfizer, which also sued Bayer and GlaxoSmithKline. (See BioWorld Today, Oct. 24, 2002.)

Decision Resources polled 75 primary care physicians and 21 pharmacy directors of health maintenance organizations.

"We feel it's a good enough sample, certainly a robust enough sample size that we're capturing pertinent trends," Neumeyer said, adding that the respondents are "pretty well distributed across regions of the country."

The PCPs said they were "ready" to begin prescribing Cialis and Levitra within three months of launches, but HMO directors said they would likely not add either of the drugs to formularies for six months, if at all.

Both sectors cited the likely problem as cost, which is also the most common reason why patients discontinue or refuse Viagra (sildenafil citrate). Sixty-seven percent of pharmacy directors said they would add one of the drugs if it were priced 50 percent below Viagra, and almost half of the pharmacy directors said they would do it if Cialis or Levitra cost 40 percent less.

Cialis, Neumeyer noted, "has not come in at a discount in Europe. Down to the penny, Cialis' price was identical in the UK with Viagra's" - even given Cialis' much-touted longer action.

On the other hand, "following the loss of the Prozac patent, Lilly has been looking for something to make up the difference," she said. Lilly lost a court bid to extend patent protection for the anti-depressant.

"A couple of recent products Lilly has come out with have been at extremely premium prices," Neumeyer said, pointing to the osteoporosis drug Forteo (teriparatide) as an example, priced at $20 per dose.

Lingering fears about the overall safety of inhibitors of the enzyme phosphodiesterase 5 - which describes all three drugs - will have an effect, she told BioWorld Today.

"Many thought leaders we've spoken with are worried that if you give patients the PDE5 inhibitor, extending that range of action could put them at an increased risk of side effects," Neumeyer said. "If you give it to older men who are not physically active, and all of a sudden you make them physically active [during sex], you have problems. It's likely Cialis is not going to be the first choice for patients in less than optimal overall health."

At the same time, Bayer and GlaxoSmithKline "have done a good job of quickly getting into clinical trials with diabetics," who often have ED problems, she said. "Physician opinion right now is that they saw diabetics with Levitra first, so they are much more skewed toward diabetics."

An even better way to broaden the market, though, may be to try to "bump that age threshold down another decade," Neumeyer said, thereby reaching people with money to spend and with fewer overall health woes. "I guess it could depend on who sponsors what sports team."

The picture may be able to include all three ED drugs comfortably.

Some urologists predict "it's going to look like hypertension," Neumeyer said. "There are any number of anti-hypertensives, and it's not that any drug is necessarily the front-runner, but you're able to better tailor the therapies and come in with second and third-line patients."