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Associated Press

Bayer, Glaxo Prepare To Market Erectile Dysfunction Drug
September 23, 2002

NEW YORK (AP) -- When a drug's name is designed to conjure up thoughts of men and life and its logo is a symbol of passion, it can only mean one thing: the latest would-be Viagra competitor has been christened.

It's called Levitra, the entry from Bayer AG and GlaxoSmithKline PLC into the erectile dysfunction market, which is virtually owned by Viagra. The Pfizer Inc. drug sales totaled dlrs 1.5 billion last year.

Levitra's name was to be released Monday at a medical meeting in Montreal along with data that may find its way into what is expected to be a very expensive marketing campaign set to begin next year, when the drug is introduced.

The companies declined to say how much they'll spend to promote Levitra, but the drug will get "whatever it takes" to resonate with consumers and doctors, said David Pernock, Glaxo's senior vice president and general manager of the pharmaceutical business unit.

Last year, Pfizer spent dlrs 101 million marketing Viagra to consumers, making it the fourth most heavily promoted drug in the United States. And that's when Viagra had the market all to itself. Next year, Cialis, a drug from Eli Lilly & Co and Icos Corp., is also expected to hit the market.

The battle for dominance in a condition that affects about 30 million American men - about half of them over 40 - is expected to be fierce. The new entrants will probably persuade more men to see a doctor about their problem, broadening the market, experts said.

But men are notoriously reticent about visiting doctors and generally embarrassed to discuss erectile dysfunction.

"This is a market that is driven by direct-to-consumer advertising," said Dr. Harin Pademan-Nathan, a urology professor at University of Southern California's Keck School of Medicine. "You have to spend millions to get men to the doctor."

Levitra and Cialis were both expected to be greenlighted this year but the Food and Drug Administration granted only conditional approval, seeking further study on each drug. All three drugs work in the same way so the FDA wanted to ensure the new medicines were absolutely safe and effective before granting final approval, doctors said.

Some doctors believe 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.

There have been no published studies which directly compare the drugs. Each marketer has a raft of data to discuss its overall effectiveness as well as usefulness in various groups, such as men with diabetes or prostate cancer. Such data is especially useful for doctors.

"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.

Dr. Irwin Goldstein is excited about the prospect of having new drugs for patients where Viagra hasn't proven effective. He noted that at the International Society for Sexual and Impotence Research meeting Monday, Bayer and Glaxo will be releasing 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 complete penetration on their first attempt, compared with 45 percent taking placebo.

A Pfizer study found that about 55 percent of men using Viagra can complete sexual intercourse on the first try.

The FDA's conditional approval helped Pfizer, but hurt Glaxo and Lilly, both of which are struggling because some of their top-selling drugs have lost patent protection. The delay was especially painful for Bayer, which had its cholesterol lowering agent removed from the market in 2000 after it was linked to at least 40 deaths.

Those problems have contributed to Bayer's disappointing earnings and decision to lay off 13,000 people by 2005. The company also is seeking a partner for its pharmaceutical business.

"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.

Bayer developed the drug and is co-promoting it with Glaxo. The details of the arrangement have not been released but Catherine Arnold, an analyst with Sanford C. Bernstein, estimates Glaxo will eventually receive 50 percent of Levitra's profits, which she expects to reach dlrs 1 billion by 2007. She estimates it will take three years for Levitra to become profitable because of its high development and marketing costs.

It took over a year to whittle roughly 700 name candidates down to Levitra, which was formerly know by its generic name vardenafil.

Levitra is derived from "le," which is the French masculine pronoun and "vita" which is Latin for life. The flame was chosen as the logo because "it is a primal symbol for sexuality and vitality," said Robert Recobs, managing director of the New York office of Brand Institute Inc., which helped name Levitra.

The new name is the only hint of the marketing campaign. Glaxo, Bayer and Lilly all declined to comment on specific plans because FDA regulations prohibit companies from making statements about unapproved drugs.

Pfizer has used celebrity spokesmen such as Bob Dole, race car driver Mark Martin and baseball player Rafael Palmeiro to promote its product. And Lilly says it's likely to use a similar approach.

"When your target market is men 40 to 60, it is pretty clear what your avenues for advertising are," said Matt Beebe, a Cialis brand manager.

Copyright 2002 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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