Despite Sanofi-aventis' recent delays in getting Acomplia approved in the United States, an analyst report predicts the drug will top Roche/GlaxoSmithKline's Xenical as the gold standard for the treatment of obesity by 2010.
The report, issued by Decision Resources, predicts Acomplia's success will stem from its positive effects beyond weight loss and the dearth of competing agents in the pipeline.
"It has an intriguing mechanism of action and there's nothing in the pipeline that really compares," Nancy Li, an analyst with Decision Resources and author of the report, told United Press International.
The beneficial effects include improving insulin sensitivity, increasing HDL and lowering LDL cholesterol levels, greater reduction in waist circumference and reducing triglycerides.
Although Xenical is an effective drug, its side effects, which include oily stools and fecal urgency, are enough to keep patients looking for an alternative.
"Acomplia doesn't have those side effects," Li said. "Xenical patients don't like the side effects and are very excited to try out Acomplia."
However, the Food and Drug Administration's approval of Acomplia remains uncertain. The agency previously issued an approvable letter for Acomplia, and Sanofi said last month the FDA pushed back its timeframe for making a decision on the drug from April 26 to July 27.
Sanofi has not divulged details about the FDA's delay, but Li said based on the available data about Acomplia, she anticipates it will win approval.
"Judging from the positive data from the SERENADE trial, I think it has a really good chance of launching," she said.
The drug is projected to be a blockbuster, generating more than $1 billion by 2015 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
However, the bulk of this will come from the United States, so if the drug doesn't get approved by the FDA, expectations would have to be dialed back.
"If it doesn't get approved in the United States, it will not reach blockbuster status," Li said. She projects the drug will generate $350 million from other nations by 2015.
Sanofi has already launched Acomplia in 12 countries; it generated 31 million euros in sales last year.
Pfizer and Merck are developing two drugs that could compete with Acomplia, but the manufacturers have revealed few details about them so their potential remains an uncertainty.
Both drugs are in phase 3 trials, "but they're keeping it hush-hush," Li said. "If they're able to launch successfully, they'll be able to cut into Acomplia," Li said.
The agents -- Pfizer's CP-945598 and Merck's MK-0364 -- are both cannabinoid-1 receptor antagonists, the same mechanism as Acomplia.
Bank of America analyst Chris Schott likes both Acomplia's chances of approval and the rest of Sanofi's pipeline.
"Despite a conservative and increasingly unpredictable FDA (as seen with the recent Galvus delay), we continue to anticipate a U.S. approval for Acomplia in late July," Schott stated in a research report released Friday.
"Based on the side profile (including suicide rate) seen in the 300,000 European patients prescribed Acomplia since its (third quarter 2006) European launch, we remain comfortable with Acomplia's safety profile," he added.
However, the drug may have to get by an FDA advisory committee in June before the FDA gives it the green light, he said.
Regarding the rest of Sanofi's pipeline, Schott said his confidence was bolstered by a meeting with company officials.
"Following recent meetings with Sanofi-aventis management, we remain encouraged by the breadth of Sanofi's pipeline," he stated. "As we gain clarity on these opportunities over the next 6-12 months, we see room for multiple expansion in Sanofi shares, particularly with the stock trading at a 20 percent discount to the overall pharmaceutical group."
The pipeline compounds Schott favors include the anti-thrombin agent idraparinux, a cholesterol-lowering agent in phase 2b, the cancer drug VEGF Trap AVE 005 and two anti-depression agents in phase 3 -- saredutant and amibegron.
Sanofi's Lovenox and Plavix are both facing generic competition, but Schott said he's seeing signs Plavix is rebounding from the hit it took from the now suspended launch of Apotex's generic version and could eventually recover some of the price reductions next year.
"Branded Plavix pricing could be impacted by 10-20 percent as (Sanofi/Bristol-Myers Squibb) seeks to regain lost formulary status as generic volumes dwindle," he stated. "We believe that strong underlying demand (low-double-digit volume growth) will offset some of this price impact. In addition, we believe Sanofi/Bristol could recapture some of these price reductions in '08.
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