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The Honolulu Advertiser

Posted on: Sunday, July 20, 2003

Drug rivals putting Viagra's market potency to test

By Linda Loyd
Knight Ridder News Service

The drugs are about sex and love, but for the pharmaceutical companies, it's war.

The famous blue pill Viagra that transformed treatment of impotence in men five years ago is about to face two new rivals.

Levitra, the erectile-dysfunction drug from GlaxoSmithKline PLC and Bayer AG, is expected to receive U.S. regulatory approval as early as next month — in time for a marketing blitz during National Football League games this fall.

A third contender — Cialis from Eli Lilly & Co. and Icos Corp. — is likely to be approved by the Food and Drug Administration later this year, setting the stage for a ferocious marketing battle to try to dethrone Viagra, which raked in $1.7 billion in sales for Pfizer Inc. last year. Industry analysts say the potential market is huge.

Although no patient studies have been done on how the three drugs compare against one another, just how long each drug works and how quickly is hotly disputed.

Levitra's backers say their orange pill works fast and is highly potent.

Viagra boasts a five-year track record, and the confidence of millions of men.

Makers of the Cialis yellow tablet contend it lasts longer than the other two — maybe the whole weekend — and bet that is what men are looking for.

All three pills are sold in Europe and several dozen other countries. And although Viagra is No. 1 in sales, the two newcomers are expanding the number of men getting treatment.

London-based Glaxo, with a U.S. headquarters in Philadelphia, and Bayer of Germany soon will try to win over American men to Levitra (pronounced luh-VEE-tra).

The companies have signed a three-year sponsorship deal with the NFL. Former Chicago Bears coach Mike Ditka will be a spokesman for Levitra, according to Street & Smith's SportsBusiness Journal and Advertising Age.

"The concept of heavy marketing during sports activities is a good thing," said David Pernock, Glaxo's senior vice president of pharmaceutical ads and marketing. "Guys watch sports a lot."

All three drugs work by blocking an enzyme called PDE-5, and increasing blood flow in the penis.

However, the three have different biochemical properties, and each offers advantages, experts say.

Glaxo says that Levitra helped some men attain an erection in 16 minutes and others in 25 minutes, and that Levitra lasts four to six hours, roughly the time span that Viagra works.

Levitra was launched in Europe in March.

Cialis (pronounced see-ALL-iss) claims to work up to 36 hours.

In Europe, where Cialis was launched in February, it has been dubbed the weekend pill — take it once and it lasts all weekend.

"Most men tell us they don't like to have sex timed to a pill," said Lilly spokeswoman Carole Copeland. "Cialis is allowing men to return to a more normal type of sex life, to choose the moments when they want to have intimacy."

But some physicians say having a drug in the body for 24 or 36 hours may not necessarily be a good thing because all drugs have side effects, even if mild.

Andrew Axilrod, a urologist at the University of Pennsylvania Health System, said: "There's a subjective sense Levitra is a better drug in laboratory tests, that you need less of it to block the enzyme."

"Until head-to-head studies have been done, you can't say one drug is better than the other definitively. You can only go by studies available, but you have to question who paid for them," said Axilrod, a frequent prescriber of Viagra who has worked on a Levitra clinical trial and will consult later this month on a Cialis study.

The most common side effects for Viagra and Levitra are mild to moderate headache, facial flushing, upset stomach, nasal stuffiness, and a bluish hue to vision. Cialis patients complain of headache, upset stomach and back pain.

In Europe, Viagra remains dominant.

"Cialis took about one-third of the market. It took away some Viagra users, but it's expanded the market," Axilrod said. "There's a big market out there. Only 10 percent (of men) get treated. That's why these drugs are going to make a lot of money for these drug companies."

Viagra is expected to reach $2.5 billion in annual sales by 2006, said Mark Tracey, senior pharmaceutical analyst at Goldman Sachs Group Inc., in London.

Tracey estimates that Cialis will hit $1 billion in sales by 2006, and Levitra will reach $900 million — possibly more than $1 billion — by 2008.

James Culverwell, an analyst with Merrill Lynch & Co. Inc. in London, said Levitra will be "at least a $500 million drug" and possibly a $1 billion drug, within five years.

"Half the people who try Viagra don't try it again," Culverwell said. "There's a big opportunity for market expansion."