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.

Stress Urinary Incontinence Update

FDA requests further data before approval of Eli Lilly's duloxetine

Eli Lilly and Company [LLY] has received an approvable letter from the FDA's division of reproductive and urologic drug products for duloxetine for the treatment of stress urinary incontinence. Final FDA approval is contingent upon successful completion of additional acute preclinical and clinical pharmacology studies.

Satisfactory resolution of manufacturing issues at Lilly's Indianapolis manufacturing facilities, including the completion of a pre-approval site inspection; and completion of label negotiations will be factors in the FDA approval process. Lilly plans to conduct discussions with the FDA concerning the company's plans to provide the information the agency has requested. The results of these discussions will allow the company to provide a better estimate of the potential US approval date. Currently, pending more precise information, Lilly anticipates a US approval of duloxetine for SUI in late 2004 or the first half of 2005.

Duloxetine for depression, known as Cymbalta, is also currently under review by the FDA's division of neuropharmacologic drug products. Lilly received an approvable letter from the FDA for Cymbalta in September 2002.

"We are committed to bringing our innovative late stage products as quickly as possible to the patients who need them, to that end, we will work rapidly to provide the additional data requested by the agency and to resolve our outstanding manufacturing issues." said Sidney Taurel, chairman, president and CEO, Eli Lilly and Company, in a media release.

In November 2002, Lilly and Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialize Duloxetine hydrochloride.

Duloxetine is currently being developed for the treatment of stress urinary incontinence (SUI) and depression. This partnership covers most countries worldwide with few exceptions. In the US, the collaboration is for SUI only.

Duloxetine reduces stress urinary incontinence in phase III study

Duloxetine significantly reduced the number of weekly incontinence episodes among women with stress urinary incontinence, according to a phase III study published in the Journal of Urology. Additionally, women on duloxetine experienced significant improvements in quality of life measures, when compared with women taking placebo.

Eli Lilly and Company and Boehringer Ingelheim signed a long-term agreement in November 2002, to jointly develop and commercialize duloxetine hydrochloride. Duloxetine is currently being developed for the treatment of stress urinary incontinence (SUI) and depression.

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.

Vivus drug ineffective in premature ejaculation

All was not well for Vivus however, as the company released data from a trial showing that its experimental PDE5 inhibitor failed to show an effect in treating premature ejaculation. Previous studies had suggested that the drug class, which includes Pfizer's Viagra, were associated with an increased time to ejaculation in men suffering from premature ejaculation.

However, Vivus' proof-of-concept trial, investigating Viagra alongside the company's investigational compound VI-0162 and placebo, did not demonstrate an increase in the time to ejaculation.

Vivus intends to continue developing its drug for the treatment of erectile dysfunction.

GSK and Bayer achieve impressive results in long-term trials of Levitra New clinical findings on the long-term efficacy, safety and tolerability of Levitra show that men with erectile dysfunction reported clinically significant, sustained improvement in erectile function over a two-year period.

"It was impressive that 90% of men reported improvement in erectile function after taking Levitra (vardenafil HCl) over a two-year period," said Dr Wayne Hellstrom, professor of urology and chief of infertility and sexual dysfunction at Tulane University School of Medicine in New Orleans.

"These findings showed sustained efficacy with Levitra, which is an important consideration when evaluating erectile dysfunction (ED) treatment options."

In the first year of the clinical program, a total of 755 men completed a one-year treatment period with Levitra. Of those, 566 men continued to receive the drug in 10 or 20mg doses in a doubleblind study for an additional year. Of the 479 men who completed the study, two-year results showed that 92% taking Levitra 20mg and 90% taking Levitra 10mg reported improved erections at two years.

Furthermore, men were five times more likely, on average, to report success in maintaining erections sufficient for successful intercourse after taking Levitra 20mg than before they took the drug. Similar findings were seen in men taking the 10mg dose.

Levitra was well tolerated in the trial. The most commonly reported adverse events were generally mild to moderate, including headache, flushing, rhinitis (nasal congestion) and dyspepsia.

Bayer Pharmaceuticals (a subunit of Bayer AG) and GlaxoSmithKline signed a worldwide copromotion and co-development agreement for Levitra in November 2001. The FDA issued an approvable letter for the drug in July 2002, and Levitra was approved on March 6, 2003, by the European Commission based on the quality, safety and efficacy data submitted.

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.

Rugby world cup joke grrrrrr!!

Ritchie McCaw was walking dejectedly past the changing room doors after the game when he came accross a cellphone.

After picking it up and taking a brief look at it he knocked on the referee's door.

"here you go mate I found your cellphone"
"cheers" says the ref. "But how did you know it was mine?"
"look for yourself - 15 missed calls"