BOTHELL — Cialis, the erectile dysfunction drug developed by ICOS Corp., won long-awaited approval Friday from the U.S. Food and Drug Administration.
It’s the first drug to be released by the company in the United States.
"After 13 years and a lot of hard work by a lot of people, it sure feels good to get FDA approval," said Paul Clark, chief executive officer at the Bothell-based biotechnology firm. "We’ve moved from a research company to a fully integrated company. The first chapter of our dream has now been realized."
The first doses could be in pharmacies early in December, Clark said. The company and its development and marketing partner for the drug, Eli Lilly &Co., plan to launch an advertising blitz to accompany its debut.
Urologist Gary Stack says patients have been asking about Cialis, the newest erectile dysfunction drug, for months.
"I’ve told them when they hear about it (winning approval) to give me a call," said Stack, who practices at the Western Washington Medical Group in Everett.
Cialis’ main selling point is the fact it can work for up to 36 hours. Competitors Viagra and Levitra both last about four hours. That’s earned Cialis the nickname "Le Weekend" in France, one of the 50 countries where it already has been approved.
The long duration of effectiveness could help some patients who suffer from erectile dysfunction, Stack said.
"I think it will be a tremendous advantage to my patients," he said.
Despite the drug approval news, ICOS’ stock price fell $1.37 to $43.66 a share. Lilly’s stock also fell about 3 percent.
"That ought not stop the champagne from flowing over at ICOS," said Paul Latta, an analyst with McAdams Wright Ragen Inc. in Seattle, who said the expected approval already has boosted ICOS stock in recent months. "We haven’t had a drug of this magnitude since Enbrel."
Unlike Enbrel, the successful rheumatoid arthritis treatment developed by Seattle-based Immunex Corp., Cialis is entering perhaps the most competitive category among prescription drugs.
"This is really the first time the biotech industry has produced a molecule in a competitive, consumer-driven market where we’re going toe-to-toe with the No. 1 and No. 2 biggest pharmaceutical companies in the world," said Leonard Blum, senior vice president for sales and marketing at ICOS.
That No. 1 company is Pfizer Inc., which virtually created the category of erectile dysfunction drugs with the release of Viagra in 1998. The No. 2 company is GlaxoSmithKine, the British pharmaceutical firm that, in partnership with German giant Bayer AG, released Levitra in this country three months ago.
Viagra recorded sales of $1.7 billion last year, Pfizer spokesman Daniel Watts said.
Analysts have made various estimates for Cialis’ potential, but several say Cialis could rack up annual sales of $1 billion after the first few years.
To date, Enbrel is the biggest drug to come from the Puget Sound’s biotech community. That blockbuster posted sales of $800 million in 2002, according to Amgen, the California-based firm that bought Immunex last year.
Since that merger, ICOS has become the largest biotech firm based in Washington state. ICOS also is the largest public company headquartered in Snohomish County, with a market value above $2.7 billion and a payroll of about 700 employees.
ICOS has hired 165 sales representatives this year specifically to market Cialis. Lilly also has a large sales force in place.
The two companies will spend up to $100 million in the next year for commercials and other advertising related to Cialis. They also have a sponsorship agreement with the PGA Tour to promote the drug.
"We think we’ll do very well," Clark said. "When you look at how we’ve already done in Europe …. we’re off to a strong start."
In Germany, France and Australia, Cialis has captured more than 30 percent of the market for erectile dysfunction drugs. Viagra’s share is around 60 percent in those three nations, with Levitra well behind.
Watts, the Pfizer spokesman, said his company wasn’t doing anything different in the face of the new competition.
But Stack, who said he isn’t impressed by Levitra, said Pfizer has been trying to shore up its reputation with doctors.
"With Viagra, the reps over the last three or four months have been all over us," he said.
Reporter Eric Fetters: 425-339-3453 or fetters@heraldnet.com.
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