Posted by jrbecker on February 24, 2006, at 11:42:01
Released studies from the newly touted "diet pill blockbuster," Accomplia (rimonabant), show that depression might be a potential side effect of taking the drug. This is certainly not a surprise considering the fact that THC (active ingredient in marijuana) - which has the exact opposite effect on cannabinoid CB(1) receptors - has recently been reported to have potential antidepressant properties.
http://www.jci.org/cgi/content/full/115/11/3104
http://www.biopsychiatry.com/cannabinoid-antidepressants.htm
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Sanofi to Introduce Acomplia as Diet Pill This Year (Update3)http://www.bloomberg.com/apps/news?pid=email_us&refer=europe&sid=ak5l3134kCvM
Feb. 24 (Bloomberg) -- Sanofi-Aventis SA, the French drugmaker that suffered a setback to its potential blockbuster medicine Acomplia last week, said it still plans to introduce the drug as a weight-loss treatment this year.
The Paris-based company will meet with U.S. regulators next month to discuss the product, Gerard Le Fur, who oversees the company's research, told reporters at a meeting. Sanofi also said net income last year rose 26 percent to 6.34 billion euros ($7.56 billion), matching analyst estimates.
Sanofi is counting on Acomplia to spur growth as best- selling drugs including the blood thinner Plavix age and face patent challenges. The U.S. Food and Drug Administration last week rejected Acomplia for people who want to quit smoking and said it needs more information to clear it for weight loss.
``Acomplia is the most significant sales and profit driver for growth going forward,'' Navid Malik, an analyst at Collins Stewart in London, said in an interview before the results were released. ``That's why there's such a heavy focus on what's going on with the regulator right now. Any nervousness around this product is going to have an impact on the share price.''
Profit last year was 4.74 euros a share compared with 3.77 euros a year earlier. Sanofi said it expects earnings per share to rise about 10 percent this year.
The FDA hasn't requested any new studies of Acomplia in weight loss, Sanofi said. The regulator has asked the company to conduct another study for approval to help patients quit smoking. Sanofi said it plans to pursue that indication.
Depression
``In the next few weeks, we'll be meeting with the FDA to answer the questions that have been put to us,'' Le Fur told reporters. ``We expect to introduce the drug this year.''
Clinical trials show that use of the drug is associated with a loss of about 5 kilograms (11 pounds) after a year of use. Trials have also shown that weight is gained back once the patient stops taking the medicine. Patients weighed over 100 kilograms at the start and also followed a reduced calorie diet.
Because of this ``modest'' weight loss, Sanofi needs to convince regulators that Acomplia can help control risk factors leading to heart disease if it wants insurers to reimburse the drug, Mirabaud Securities analyst Nick Turner said this week. This would be reflected on the drug's label.
Le Fur declined to comment on the drug's label, saying the company needs to meet with the regulators first.
Acomplia has been linked to side effects including depression in clinical trials and Sanofi excluded patients that were clinically depressed in late-stage studies. This illness is twice as prevalent in an obese population, Deutsche Bank analysts said in a note to investors this week.
Generic Competition
Sanofi needs Acomplia because between 2008 and 2012, it's likely to face generic competition on products that make up about 40 percent of operating profit, Deutsche bank analysts Paul Mann and Mark Purcell said in a note to investors this week. Products that are at risk include the cancer drugs Eloxatin and Taxotere as well as Plavix and Avapro, for high blood pressure.
While eight of the company's products each had one billion euros or more in revenue last year, generic competition wiped almost 6 percentage points off revenue growth in the fourth quarter, Sanofi said in January. The company declined to give an estimate for sales growth this year.
``It's difficult to give a specific number when you have generics on the radar screen,'' Chief Financial Officer Jean- Claude Leroy told reporters. ``We're going to stay cautious and not give a forecast.''
Sanofi, formed by the 2004 merger of France's two biggest drugmakers, is targeting cost saving of 1.6 billion euros by the end of this year to help offset generic erosion. The company has already cut 1.4 billion euros since the merger.
Sales from diabetes drug Amaryl, which lost patent protection in October, slid 29 percent to 135 million euros in the fourth quarter, the company said last month.
Allergy medicine Allegra saw sales slump 59 percent in the quarter. Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals Inc. have started selling a low-cost version of the drug amid a patent dispute with Sanofi. In January, a U.S. judge said they could continue to do so.To contact the reporter on this story:
Carey Sargent in Geneva at at csargent3@bloomberg.net.
Last Updated: February 24, 2006 02:34 ESTofficial Sanofi-Aventis drug release...
http://en.sanofi-aventis.com/Images/20040309_Acomplia_rimonabant_en_tcm24-3806.pdf
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