Sanofi-aventis CEO Chris Viehbacher suggested that if the FDA ultimately approves its experimental anti-arrhythmia drug Multaq (dronedarone), the treatment could become a “bestseller” for the company, Bloomberg reported Tuesday.

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An FDA briefing document released earlier this week indicated that the drug should be approved for patients with atrial fibrillation, but with the restriction that sanofi-aventis should not be permitted to claim the drug reduces the risk of death. Agency reviewers said the evidence was not clear regarding such a claim. Viehbacher indicated that “there is clearly an unmet medical need, and there clearly is a benefit…We need to explain this and make sure the advisory committee is comfortable.”

Commenting on the upcoming advisory meeting, analyst Stuart MacDonnell of Citigroup remarked that recent Multaq studies provide a “good basis” for FDA approval of the drug, which he estimates could generate peak yearly sales of 1.5 billion euros ($1.88 billion), if approved. In addition, ABN Amro analyst Michael Leacock said that “a positive outcome would at least give investors a little more confidence that the innovation in sanofi-aventis’ pipeline can be delivered to the marketplace.”

Source: FirstWord

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Some pharmaceutical industry experts are predicting that sanofi-aventis CEO Chris Viehbacher may announce restructuring plans Wednesday, when the company reports quarterly financial results. Plans may involve reducing expenses by up to 1 billion euros ($1.3 billion), which could include job cuts, and acquiring smaller biotechnology companies in an effort to bolster the company’s pipeline, according to analysts. Jerome Forneris of Banque Martin Maurel suggested that “the challenge Viehbacher faces is a big one…He needs to shake things up, motivate his troops, lift their morale, and lead the company back to growth.”

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However, ABN Amro analyst Michael Leacock indicated that Viehbacher, who took over as CEO in December, may not disclose targets so soon. “It’s about the 18 billion euros ($23.3 billion) in operating costs he has to deal with…How can he reduce that operating cost effectively and efficiently? He doesn’t yet know the vehicle he’s got, so it will be kind of hard to set a destination.”

Earlier this month, Viehbacher reportedly told employees that the company is seeking to add to its pipeline of experimental medicines through acquisitions and is also preparing to diversify business operations.

Source: FirstWord

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Sanofi-aventis reported Thursday that an FDA advisory panel will review the company’s experimental atrial fibrillation drug Multaq (dronedarone) on March 18. The compound was granted priority review status by the US regulator in August, with a decision expected around January.

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Commenting on the news, Deutsche Bank analysts stated that “this is a further delay to the product and in our view reflects the agency’s uncertainty around the drug’s profile.” However, ABN AMRO analyst Michael Leacock remarked that “it clearly is a delay, but given that it has increasingly become common practice by the FDA to delay reviews, whether standard or priority, it is not a surprise.” Leacock, who anticipates peak sales of Multaq to be 720 million euros ($927 million) in 2012, added: “We don’t read anything material in it and we don’t change our forecasts.”

Earlier this month, the drugmaker reported that findings from a post-hoc analysis of data from the ATHENA study demonstrated that compared with placebo, Multaq significantly reduced the incidence and duration of hospitalisations among patients with atrial fibrillation/atrial flutter.

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After a busy summer of mergers and acquisitions, Sarah Wachter asks where Big Pharma is going and why?

This may be a bad year for M&A overall, with global activity down 30% in the first half, but Big Pharma is bucking the trend big-time: pharma deals were up almost 48% by mid-August compared to the same period last year, $121.5bn and counting, according to analysts Dealogic, and seven of the 10 largest transactions were announced in July alone. Read the full story

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