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Archive for September, 2007

Once-daily Cialis looks to outsell rival Viagra

Add comment September 20th, 2007

When Eli Lilly and Co. thought about how to market its erectile-dysfunction drug in Italy, the answer seemed natural: hold a series of tango workshops to help couples revive their passions.

As a professional couple danced on stage, Lilly and its partners in medical associations provided counselors and medical experts to talk to consumers about sexual health problems.

How Cialis plays in Europe is important to Lilly, which recently won approval to market a one-a-day version of the erectile-dysfunction drug there. The company also hopes to get U.S. approval later this year.

Neither Viagra nor Levitra is sold in once-daily doses, which could give Lilly an edge.

The once-a-day version will be marketed for men who anticipate having sex two or more times a week, without confining it to a limited time. The current dosage of Cialis works for about 36 hours. Viagra and the other major erectile-dysfunction drug, Levitra, work for about four hours.

Cialis trails rival Viagra in the U.S., but it’s the leader in 22 nations, from France to Mexico, in the $3 billion worldwide market for erectile dysfunction.

The pills all work the same way, by blocking an enzyme in men’s bodies, allowing men to get and maintain an erection.

Doctors say they expect Cialis’ once-a-day version to catch on. “The baby boomer population is growing. I think a certain patient group could benefit. They want to take it now and be ready whenever,” says Dr. Ronald Suh, who works at Urology of Indiana.

Some analysts say the once-a-day version could increase Lilly sales, but only modestly. But it could provide a steadier revenue stream than the current dosage of Cialis, which men take sporadically.

“Giving consumers more options is a positive step, but I don’t think it’s going to be a game-changing development for Lilly or the erectile-dysfunction market, at least in the short run,” says Jason Fox, a drug analyst at H&R Block in Detroit.

Source:http://www.app.com/apps/pbcs.dll/article?AID=/20070918/LIFE11/709180345/1006/LIFE

Acomplia (Rimonabant) Diet Drug Similar to New Drug by Vernalis

Add comment September 14th, 2007

UK biopharmaceutical company Vernalis on Sept. 13th announced that a diet drug it is developing similar to Acomplia (rimonabant), V24343, had produced “striking weight loss” in patients in two small phase I clinical trials, with one patient losing 24 pounds in just over two weeks.

The Vernalis drug, like Acomplia, is a CB-1 receptor antagonist that acts by targeting the CB-1 receptor in the brain and suppressing a person’s appetite. Vernalis said its drug produced weight-loss results that compared “very favorably” with results for rimonabant.

Average weight loss after 16 days was 1 pound for the overweight and mildly obese patients given a placebo, 6 pounds for those on a 5 mg dose of V24343 and 11 pounds for those on a 100 mg dose.

But Vernalis said results for V24343 from its early trial showed “a markedly reduced propensity for neurological adverse events” and “a lower propensity to induce nausea and GI disturbance.”

While Acomplia has been approved and is on sale in Europe, developer Sanofi-Aventis pulled back its application in the United States after it was unanimously thumbed down by an FDA advisory committee concerned over side-effects that included suicidal thoughts and behavior.

Vernalis said the concerns over “risks associated with depression, may be relevant to this class of drug.  However, the question as to whether or not other CB-1 antagonists can achieve similar or improved efficacy without major side effects remains open.”

Pharmaceutical giants Merck and Pfizer are far ahead of Vernalis in exploring this, with drugs that target the CB-1 receptor already in large phase III trials.

Vernalis CEO Simon Sturge, nevertheless, said his company was “very excited by these preliminary results which, if confirmed over longer studies, will be of significant benefit to overweight and obese patients.

“We stated from the outset of this trial that it is our intention to seek a partner for this program, a process which is enhanced by such promising data,” he added.

Source: http://www.acompliareport.com