Sanofi-Aventis Needs Successes, Not Failures
Total Page：16
File Type：pdf, Size：1020Kb
May 01, 2008 Sanofi-Aventis needs successes, not failures Amy Brown With the threats to Sanofi-Aventis’s two biggest-selling drugs, Lovenox and Plavix, looking more ominous by the day, pipeline progress is desperately needed. However, what came with the first-quarter results, the failure of saredutant in a phase III trial, certainly was not the required medicine. The experimental anti-depressant is, or was, one of the company’s most valuable R&D projects, with consensus for 2012 sales sitting at a respectable $730m. Admittedly, the group believes the product may not be dead, and at the same time it announced the phase III success of insomnia drug eplivanserin, which will be filed for approval later this year. But 2012 sales are seen reaching only $374m, and Sanofi-Aventis needs much bigger products, or more of them, to maintain growth. Ambien and Eloxatin are already being eroded by cheaper copycat pills, and the approaching genericisation of Taxotere, Plavix and Lovenox will be even more painful. According to consensus forecasts, Lovenox and Plavix are considered Sanofi-Aventis’s second and third most important growth drivers over the next five years, with sales forecast to increase by $987m and $1.44bn respectively, according to consensus data from EvaluatePharma. The products' respective patents expire in 2012 and 2011, and whether exclusivity can last that long is in serious doubt, so those sales forecasts are probably based on best-case scenarios. Concern that they both might disappear sooner is partly responsible for the 20% decline in Sanofi-Aventis’s share price this year. Compounding this, is a lack of confidence in the company’s ability to bring new drugs drug to the market. The table below shows the rate of NME approval in the US among the global majors since the beginning of the decade, with Sanofi-Aventis thoroughly mid rank, with zero approvals in the last two years. US NMEs Approved Per Year 2000 2001 2002 2003 2004 2005 2006 2007 Total GlaxoSmithKline 4 3 3 4 2 3 2 2 23 Pfizer 2 2 5 2 4 - 3 1 19 Novartis 5 4 1 1 1 1 1 2 16 Merck & Co - 2 1 1 - 1 5 1 11 Johnson & Johnson - 4 - 2 - - 2 3 11 Sanofi-Aventis 1 1 3 1 2 1 - - 9 Roche - 1 1 3 1 1 1 1 9 Schering-Plough 1 5 1 1 - - 1 - 9 Bristol-Myers Squibb 1 1 1 1 1 2 1 1 9 Eli Lilly - 1 1 2 2 1 1 - 8 Wyeth 4 - - 1 - 1 - 1 7 AstraZeneca - 1 2 3 - - 1 - 7 Industry wide total 33 32 26 35 38 28 29 22 The last Sanofi-Aventis NME was actually a new biologic, the meningococcal vaccine Menactra, launched in 2005. This year is not looking much better, with only one NME with a chance of US approval, Aquilda for hyponatraemia, which was filed last year. Sales in 2012 are seen at an underwhelming $161m. Next year, however, things start to look up, with a potential seven US NME approvals on the cards, including Multaq for atrial fibrillation and Aflibercept (VEGF Trap) for ovarian cancer. Unfortunately the second most significant pipeline project, Multaq, is also viewed as high risk, because regulators have already asked for further data once before. Consensus for sales in 2012 currently sits at $624m. Saredutant was also slated for 2009 US approval, the most important in sales potential terms, of that year’s cohort. The drug is a neurokinin-2 antagonist. Most neurokinin antagonists on the market are anti-emetics, although several have been tested in the field of depression, with limited success. Merck & Co’s Emend, a neurokinin-1 antagonist, is on the market for emesis, but the group abandoned research in depression after phase III trials failed to meet efficacy endpoints. The table below shows that Sanofi-Aventis has been particularly active in the field of neurokinin's, an investment that does not seem to have paid off. The company desparately needs 2009 to be the bumper year it promises to be, and it cannot afford many more set backs. Development Phase for Generic Product Company Pharmacological Class Depression Name Phase III Saredutant saredutant Sanofi-Aventis Neurokinin-2 antagonist Phase II Rezonic casopitant GlaxoSmithKline Neurokinin-1 antagonist Mitsubishi Tanabe TA-5538 casopitant Neurokinin-1 antagonist Pharma Phase I 823296 orvepitant GlaxoSmithKline Neurokinin-1 antagonist Neurokinin-1 antagonist 424887 - GlaxoSmithKline & SSRI Neurokinin-2 & neurokinin- SSR 241586 - Sanofi-Aventis 3 antagonist Pre-clinical SAR 10279 - Sanofi-Aventis Neurokinin-2 antagonist SAR 102779 - Sanofi-Aventis Neurokinin-2 antagonist Abandoned - Phase III Emend aprepitant Merck & Co Neurokinin-1 antagonist Abandoned - Phase II AV608 - Novartis Neurokinin-1 antagonist R673 (NK-1) befetupitant Roche Neurokinin-1 antagonist Osanetant osanetant Sanofi-Aventis Neurokinin-3 antagonist TAK-637 - Takeda Neurokinin-1 antagonist TAP TAK-637 - Pharmaceutical Neurokinin-1 antagonist Products 597599 vestipitant GlaxoSmithKline Neurokinin-1 antagonist CP-122,721 - Pfizer Neurokinin-1 antagonist CJ-17,493 - Pfizer Neurokinin-1 antagonist Abandoned - Phase I SR 144190 - Sanofi-Aventis Neurokinin-2 antagonist SSR 146977 - Sanofi-Aventis Neurokinin-3 antagonist Abandoned - Unclassified ZD4974 - AstraZeneca Neurokinin-1 antagonist 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..