Fewer Opportunties for Companies to Get Fat Off Obesity Products
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October 24, 2008 Fewer opportunties for companies to get fat off obesity products Lisa Urquhart European regulators yesterday seemingly gave with one hand and then took away with the other in the world of weight loss. An announcement that the watchdog had decided to rescind marketing approval for Sanofi- Aventis' drug Acomplia following reports of adverse psychological effects was released almost at the same time as one giving the go-ahead for over-the-counter sales of GlaxoSmithKline’s alli. The decision by the regulator to suspend sales of Acomplia in all European Union states caused shares in Sanofi-Aventis to fall 6% today to €42.97. It almost certainly spells the end for the anti-obesity treatment that failed to launch in the US following an advisory committee unanimously recommending against its approval, because of concerns over psychiatric effects. Some analysts have now completely removed the drug from their models, but the psychiatric problems that have stalked the drug had already seen many analysts heavily downgrade their sales expectations. According to historic forecasts from EvaluatePharma, 2012 sales consensus has fallen by $499m in the last 12 months to $522m, and are a long cry from the $3.9bn predicted in January 2007. Even in Europe, where the drug was approved in 27 countries, there had been reluctance to prescribe it due to those concerns. Germany turned it down for insurance cover twice this year and France placed restrictive prescription criteria on the drug and only offered to reimburse at a third of the price. The decision by the regulator could also hammer the final nail into the coffin of the cannaboid type 1 antagonist drugs for weight loss, coming only weeks after the decision by Merck & Co to abandon development of taranabant, due to psychological issues. It also raises questions about how approvable broad brush anti-obesity products that act on brain chemistry are, as demonstrated by NeuroSearch’s positive news earlier this week. Ripple factor The Danish company published phase II results that suggested tesofensine has the potential to produce twice the weight loss as Abbott Laboratories' Reductil or Acomplia, in half the time. But any hopes that were raised by the data have been largely dashed by the European withdrawal of Acomplia. Shares in NeuroSearch have lost 31% since the study was published, which even considering the plunging stock markets today, is a heavy loss. Tesofensine acts on three neurotransmitters; dopamine, noradrenaline and serotonin, effectively tricking a person into feeling full up. With regulators seemingly extremely concerned about the psychiatric effects of such drugs, investors seem to have taken the view that the chances of tesofensine making it to market, or NeuroSearch finding a partner, have dimmed considerably. Other companies with obesity drugs in development are likely to be taking a long hard look at their plans, those with cannabinoid antagonists in particular, such as Pfizer, Bristol-Myers Squibb, Solvay and AstraZeneca. Anti-obesity agents in late-stage development R&D Product Company(s) Pharmacological Class Status Phase III CP-945,598 Pfizer Cannabinoid type 1 antagonist Lorcaserin Arena Pharmaceuticals 5HT2C agonist Hoodia gordonii extract Phytopharm Anti-obesity agent Qnexa VIVUS Anti-obesity agent Contrave Orexigen Therapeutics Anti-obesity agent ATL-962 Alizyme / Takeda Lipase inhibitor AVE-1625 Sanofi-Aventis Cannabinoid type 1 antagonist Bristol-Myers Squibb / Phase II SLV 319 Cannabinoid type 1 antagonist Solvay Surinabant (SR 147778) Sanofi-Aventis Cannabinoid type 1 antagonist PYY3-36 MDRNA Peptide YY (PYY) 3-36 Noradrenaline & dopamine reuptake Tesofensine (NS2330) NeuroSearch inhibitor Empatic Orexigen Therapeutics Anti-obesity agent S-2367 Shionogi Neuropeptide Y inhibitor Pramlintide/Metreleptin Amylin Pharmaceuticals Anti-obesity agent AZD2207 AstraZeneca Cannabinoid type 1 antagonist CE-326597 Pfizer Anti-obesity agent Adyvia BELLUS Health Anti-obesity agent The problems experienced by both NeuroSearch and Sanofi-Aventis might be avoided by Glaxo’s drug alli, a low-dose version of Roche's Xenical. Launched in 2007 in the US as an OTC product, sales of the drug are expected to increase from $143m this year to $269m according to forecasts from Cowen & Co. Launch in Europe is now expected in the first half of 2009. Rather than interfering with brain processes, the drug works by cutting down the amount of fat that is absorbed in the gut, thereby avoiding the psychological effects seen in taranabant and Acomplia. But because of the problems in the market, that have seen big names like Pfizer announce their decision to abandon future work in the therapy area, sales of alli, like other drugs in the sector, are not expected to grow significantly. Obesity drugs currently on the market Annual Sales WW - Sales Generic Product Pharmacological Class Company 2007 2014 CAGR Name Cannabinoid type 1 Acomplia/Zimulti rimonabant Sanofi-Aventis 108 685 30% antagonist Abbott Meridia/Reductil sibutramine SNRI 345 380 1% Laboratories alli orlistat Lipase inhibitor GlaxoSmithKline 300 269 (2%) Xenical orlistat Lipase inhibitor Roche 527 213 (12%) More from Evaluate Vantage Evaluate HQ 44-(0)20-7377-0800 Evaluate Americas +1-617-573-9450 Evaluate APAC +81-(0)80-1164-4754 © Copyright 2021 Evaluate Ltd..