By Eric Fetters
Herald Writer
BOTHELL — ICOS Corp. says it’s on track for approval and market introduction of its anti-impotence drug later this year.
The Bothell biotech firm, which is developing Cialis with Eli Lilly &Co., submitted the drug last year to the Food and Drug Administration for approval. It also is seeking approval from the European regulatory agency.
"It’s still in the review process," said Lacy Fitzpatrick, spokeswoman for ICOS. "But we are expecting to have Cialis approved and launched in the second half of 2002."
Assuming it’s approved by that time, Cialis would likely beat Vardenafil, another potential rival to Pfizer’s well-known Viagra, to market. Vardenafil, developed by GlaxoSmithKline and Bayer, was submitted for approval late last year.
According to Bayer, Vardenafil could be approved by the end of 2002 or early 2003.
Cialis and Vardenafil act in the same basic way as Viagra, by blocking an enzyme called phosphodiesterase-5, or PDE-5, and in the process relaxing muscle cells to increase blood flow.
Lilly ICOS LLC, the joint venture firm set up for the development of Cialis —has reported in clinical trials that the drug is effective in up to 81 percent of patients with mild to severe erectile dysfunction. In the clinical tests, the drug worked for up to 24 hours and as early as 16 minutes after ingestion.
Cialis, also referred to scientifically as tadalafil or IC351, would be ICOS’ first drug to reach the market if it is approved.
The road to approval hasn’t been without a few bumps. ICOS and Lilly acknowledged this week that their drug may need a warning label for heart patients and others taking nitrates.
Like Viagra, Cialis can reduce blood pressure, which nitrates also do. Research has shown blood pressure dropped significantly in some patients taking both Cialis and nitrates. For that reason, the drug may carry a warning label similar to Viagra’s, which warns against its use by patients taking nitrates for chest pain or other ailments.
Fitzpatrick said that was expected.
"We think all PDE-5 inhibitors should carry a warning against mixing them with nitrates," she said.
In January, the FDA ordered ICOS and Lilly to remove statements touting Cialis from its Web site. The agency charged that information about the drug violated regulations that ban the promotion of experimental drugs as "safe and effective." Bayer also has been warned in the past for making similar promotional statements about Vardenafil, according to FDA records.
You can call Herald Writer Eric Fetters at 425-339-3453
or send e-mail to fetters@heraldnet.com.
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