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Saturday, November 22, 2003

36-hour erection drug Cialis gets U.S. approval
Bothell biotech's first product will take on Viagra


After 10 years and hundreds of millions of dollars in development costs, Icos Corp. and Eli Lilly and Co. yesterday received U.S. approval for the erectile dysfunction drug Cialis.

The yellow pill, which allows men to achieve an erection up to 36 hours after ingestion, is the third anti-impotence drug to win approval from the U.S. Food and Drug Administration in the past five years. Competitors are Viagra, the blockbuster pill from Pfizer Inc., and Levitra, a medication from Bayer AG and GlaxoSmithKline that was approved in August.

Cialis is the first marketable drug for Icos, a 13-year-old Bothell biotechnology company whose largest investor is Microsoft co-founder Bill Gates. With yesterday's approval, Icos becomes one of a handful of Seattle-area biotechnology companies to successfully bring a drug to market.

Balloons and Champagne corks were popping at the company's Bothell headquarters yesterday in celebration of the milestone.

"After 13 years and a lot of work, it sure feels good to have our first U.S. approval," said Icos Chief Executive Paul Clark. "It is a momentous occasion for a biotech company to have their first product on the market and especially one that has blockbuster potential."

Cialis, which is manufactured at Eli Lilly's plant in Puerto Rico, will be on the shelves of more than 40,000 pharmacies in early December, Clark said. It will sell for about $10 per pill.

"Locked and loaded," said Clark, when asked if the drug is ready to ship.

Cialis is already available in 50 countries, including France, where its long-lasting effects have won it the nickname "Le weekend" pill. Sexual therapists, urologists and patients cite the 36-hour time frame as a potential advantage over competing products.

"That is the differentiating thing as far as I know," said Robert Weissman, a urologist at Overlake Hospital Medical Center in Bellevue. "I am glad we have something like this."

Unlike Viagra, it takes about 30 minutes to kick in and can quickly take effect on a full stomach. Of the 40,000 records of sexual attempts chronicled during Icos' research, only a handful of men had sex more than once during the 36-hour period on one dose.

Elizabeth Rae Larson, co-founder and director of the Seattle Institute for Sex Therapy, Education and Research, believes there is a niche for a pill that allows men some flexibility in choosing when they want to have sex. In the past five years, Larson has dealt with some Viagra users who become obsessed with performing sex during its four-hour window.

"I have heard from women who say when their men take Viagra there is this sort of rush to sex," said Larson, who counsels couples on sexual issues, including erectile dysfunction. "The other partner starts feeling harassed or rushed, and the big crisis becomes 'I have this pill and I am anxious about it wearing off.' "

With Cialis lasting up to 36 hours, Larson said, that stressful situation could be alleviated. She also said the drug could help couples who are courting but have a relationship in which sexual activity is not predetermined.

That appeals to a 63-year-old Seattle man who has not been in a committed relationship for 10 years. A frequent dater and former Viagra user, the man said he would like more spontaneity in sex.

"I can't wait to try (Cialis)," said the man, who has suffered from erectile dysfunction for 30 years and experienced side effects with Viagra. "One of the things I have discovered with Viagra is that you take the stuff and you have your hour to wait before it is going to work and then the bait doesn't work? Then your system has the stuff in it, you have the side effects" even when you don't have sex. "It is frustrating."

While Cialis has been used by more than 1 million men in Europe, South America and Australia, it is still relatively new. And as with any new medication there remains some uncertainty. To take a bite out of the Viagra franchise, Cialis must prove that it is just as safe as its rival.

"The thing you can always say about Viagra is that it must be safe, because everybody and their brother was taking it when it first came out," said Larson, the Seattle sexual therapist. "Any medicine that comes after it has to compete for safety to make it worth it."

Introduced in 1998, Viagra now accounts for $1.7 billion in annual sales. About 23 million men have popped the $10 pill, including former U.S. Sen. Bob Dole and baseball player Rafael Palmeiro. The drug, approved in 120 countries, is one of Pfizer Inc.'s best-selling medications. While Pfizer spokesman Daniel Watts admits that some men will be curious about Cialis, he thinks they will eventually come back to Viagra.

"Viagra is true blue," said Watts. "It has been out for five years. Men can count on it and they know what side effects they are going to get, which is not much."

He also discounted the importance of the 36-hour effect of Cialis.

"It is not like there is a marathon session that is requiring a drug for 36 hours," Watts said. He added that there are no plans at Pfizer to try to increase the time that Viagra stays in the bloodstream.

Research indicates that Viagra may be tough to dethrone. According to a study presented at the Society for Sexual Medicine this week, only 21 percent of men preferred Cialis and Levitra to Viagra.

"Most long-term users of Viagra find the medicine works for them and are content to stay with the treatment," said Hubert Claes, author of the study and a doctor with the University Clinic in Gatuisberg, Belgium. Research by Pfizer shows that 96 percent of men are satisfied with the drug.

But Cialis already has won more than 20 percent of the market in Europe and Australia, where it has been sold for less than 10 months. And further research by Lilly and Icos indicates that up to 50 percent of men chose to wait 12 hours or more before engaging in sex after taking the medication.

"Patients really want the freedom to choose the moment for their intimacy," said Clark, a former vice president at Abbott Laboratories. "They don't want to have their sexual actions controlled by the clock. Market research study after market research study has told us this."

Cialis works by relaxing blood vessels in the penis, allowing increased blood flow that causes an erection. Like Viagra and Levitra, it does have several side effects and restrictions. The drug should not be used in combination with nitroglycerin tablets or medicines used to treat high blood pressure. It is also not recommended for men who have suffered a stroke or heart attack in the past six months. Side effects include headache, indigestion, back pain, muscle aches, flushing and stuffy nose. A small number of patients also have experienced blurred vision, according to the FDA.

Now that Cialis has won approval in the largest market for erectile dysfunction, Clark said, the company is ready to begin its next phase. A marketing blitz will begin in the coming months, with television advertisements and sponsorship of the PGA Tour. Icos also has hired a 165-person sales staff to start calling on doctors.

Clark said he is ready to compete against Viagra -- the drug that put erectile dysfunction on the map.

"We have already taken them on in Europe and literally in only a few months we have achieved those impressive market share (numbers)," said Clark. "And we are quite excited about getting going in the U.S. It is a tremendous opportunity for us."

Shares of Icos fell $1.37 to close at $43.66. Indianapolis-based Eli Lilly closed at $69.61, down $1.92.


1993: Icos begins research on IC351, a compound that inhibits the PDE5 enzyme. 1994: Icos receives its first patent on IC351.

1995: Phase one clinical trials begin.

1997: Icos conducts its first study in patients with erectile dysfunction.

1998: Icos and Eli Lilly and Co. form a joint venture to commercialize drugs for the treatment of sexual dysfunction.

1999: Phase III clinical studies begin on IC351.

2001: New drug application is filed with the U.S. Food and Drug Administration for IC351. The company renames the drug Cialis.

April 2002: FDA reviews drug application, saying the company must complete more clinical studies, resolve manufacturing issues and complete labeling.

November 2002: Cialis is approved in Europe.

February 2003: Marketing of Cialis begins in Europe.

November 2003: Lilly and Icos win U.S. approval for Cialis.

P-I reporter John Cook can be reached at 206-448-8075
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