Lilly Icos reports product launch of Cialis in Mexico

Eli Lilly & Co. has received approval from the Mexican regulatory authorities for Cialis, an oral PDE5 inhibitor for the treatment of erectile dysfunction.

The drug, which was developed through a collaboration between Eli Lilly and Icos Corporation, is now available in pharmacies by prescription in Mexico.

With the product introduction in Mexico, Cialis is now available in more than 40 countries on six continents. In the US, Cialis is currently under review by the FDA with Lilly Icos expecting a regulatory decision late in 2003.

"Mexico is one of the top ten world markets for ED therapies. There are an estimated five million Mexican men who suffer from erectile dysfunction and, with the regulatory approval of Cialis, they now have a new treatment option," said Edmundo Jimenez, director of marketing at Eli Lilly, Mexico.

Vivus presents promising new TA-1790 data in erectile dysfunction

Vivus has released positive data on TA-1790, its investigational PDE -5 inhibitor for treatment of erectile dysfunction.

Results from the pharmacokinetic (PK) study show that TA-1790 was rapidly absorbed after ingestion with median peak plasma levels achieved at 40 minutes (range 20-90 min). For an on-demand erectile dysfunction (ED) medication, this rate of absorption compares favorably to the median peak plasma level of 60 minutes (range 30-120 min) for Pfizer's Viagra.

Importantly, 89% (24/27) of patients on 50mg TA - 1790 achieved greater than 60% penile rigidity in the 20-40 minute time frame as compared to only 46% (12/26) of patients on 50mg of sildenafil. Based on these results, Vivus is proceeding with patient enrollment in an at-home study of TA 1790.

Lilly Icos completes US regulatory submission for Cialis

Lilly Icos LLC, a joint venture between Eli Lilly [LLY] and the Icos Corporation [ICOS], have submitted the additional data requested by the FDA on their Cialis anti-impotence drug.

In a media release Lilly Icos said the FDA had now accepted its submission as complete, after the regulator had earlier this year requested extra clinical pharmacology and other data.

Lilly Icos expects a final regulatory decision on Cialis late in the second half of 2003, following the FDA's review of the complete response, approval of Lilly's manufacturing facilities and completion of labeling discussions.

Cialis Postponed Until 2003

Although Eli Lilly received an approvable letter from the Food and Drug Administration for impotence drug Cialis (tadalafil), it will still be talking with the agency about additional clinical data.

The drug's new potential launch date is now 2003 or later.

Viagra, a Pfizer drug, is the best-selling medication in this category with U.S. sales of $1.5 billion in 2001, according to Pfizer.


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