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Levitra ®

Two drugs to rival Viagra | Associated Press - September 24,2002

Bothell-based ICOS has competition in its bid to offer an alternative to the erectile dysfunction drug. Levitra is the new name for an erectile dysfunction drug that's racing to be on the market before Cialis, the other Viagra rival that's made by Bothell-based ICOS Corp.

Bayer AG and GlaxoSmithKline PLC announced the brand name for their drug, which formerly had been called by its generic name of vardenafil, on Monday at a medical meeting in Montreal. The companies also released research data on the drug's effectiveness.

But the news shouldn't give ICOS any more reasons to be worried about the competing drug, said Andrew Hayward of Ragen McKenzie.

"There was nothing new here," said the Seattle analyst, who keeps tabs on ICOS and other biotechnology companies.

Still, the news and a horrible day in the stock markets, pushed ICOS' share price down $1.31 to $20.68.

ICOS, which is co-producing Cialis with Eli Lilly & Co., hopes to receive Food and Drug Administration approval and bring its drug to market in the second half of 2003. Levitra may come out at about the same time, although it is running behind Cialis in approval for the European market.

Cialis and Levitra originally were expected to be approved this year, but the FDA granted only conditional approval, seeking further study on each drug.

The first one available as an alternative to Viagra could have the advantage in a lucrative market, making up to $1 billion in the first few years after introduction, according to industry estimates.

Some doctors believe, however, it will be difficult for Cialis and Levitra to establish themselves because Viagra's safety and effectiveness have been well documented in its five years on the market.

"None of these drugs is a major breakthrough, and the biggest advantage Viagra has is that now 20 million guys have taken it," said Dr. Dominick Carbone, an assistant professor of urology at Wake Forest University.

Hayward said Cialis may be able to market itself better as a true alternative to Viagra.

"In marketing the drugs, Cialis has a lot of differentials from Viagra," he said. "Vardenafil doesn't have those points. It's a lot more like Viagra, from what we know."

At the International Society for Sexual and Impotence Research meeting Monday, Bayer and Glaxo released data showing that 74 percent of men taking a 20 mg dose of Levitra and 77 percent taking a 10 mg dose were able to have intercourse on their first attempt, compared with 45 percent taking placebo.

That compares with earlier studies showing Cialis is effective in up to 81 percent of patients with mild to severe erectile dysfunction. A Pfizer study found that about 55 percent of men using Viagra can complete sexual intercourse on the first try.

Bayer, which has suffered several disappointing earnings and decided to lay off 13,000 people by 2005, has much at stake with its erectile dysfunction drug.

"Levitra is quite important to Bayer. It is the most important drug in our pipeline for the foreseeable future, and it would be nice to have it out as soon as possible," Bayer spokesman Guenter Forneck said.

It took more than a year to whittle about 700 name candidates down to Levitra, derived from "le," which is the French masculine pronoun, and "vita," which is Latin for life.

The brand name chosen for ICOS and Lilly's drug has drawn opposition from several members of a family with the last name of Cialis. Lilly and ICOS have said they are considering a possible name change for their drug.


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