If Sanofi-Aventis manages to persuade Genzyme Corp to sell, at least the takeover will get the go-ahead from competition regulators in Europe.
The French drugmaker has revealed that the European Commission has cleared its proposed acquisition of Genzyme unconditionally under the continent's merger control rules. Sanofi said it welcomes this decision, "which is a requisite step in satisfaction of the condition to the tender offer relating to antitrust approvals".
Concluding that the deal would not "significantly impede effective competition in the European Economic Area or any substantial part of it", the Commission added that the proposed transaction "would not lead to significant combined market shares in the product categories where the parties' activities overlap". In addition, it says the deal does not raise concerns in the area of multiple sclerosis, "where both parties are developing treatments", and "in all cases there will remain a sufficient number of other credible competitors".
Of course, the proposed takeover may still not go through and one of the sticking points has been the potential value being put on Genzyme's leukaemia drug Campath (alemtuzumab) as a potential treatment for MS. Sanofi's offer of $18.50 billion, or $69 per share, has been repeatedly rejected by Genzyme but the firms are now talking about a contingent value right, which could see the former pay more depending on the success of alemtuzumab in MS.
Deal with UCSF
Back to concrete deals, and Sanofi has signed two collaborations with the University of California, San Francisco (UCSF). The first "promotes innovative research in pharmacological science", the Paris-headquartered firm stated, in areas such as oncology, aging, diabetes and inflammation. The second is a cancer partnership that will focus on accelerating "the progression of research through the clinical proof of concept stage".
Sanofi will fund up to five grants a year, with additional cash being available for students or fellows to intern at the company and it will also finance an annual research forum that will bring the two partners together "to share knowledge and perspectives on relevant scientific matters" and to review progress of particular projects. Chief executive Chris Viehbacher said the dea emphasises the firm's commitment to establish strong relationships and collaborations "with the best innovators in the world".
No cancer link to Lantus
Finally, Sanofi has also been boosted by the news of the US Food and Drug Administration's ongoing safety review into a potential link between its diabetes drug Lantus (insulin glargine).
The agency began its analysis In July 2009 following the publication of four observational studies, three of which suggested an increased risk of cancer associated with the use of Lantus. The FDA has determined that the evidence presented in the studies is inconclusive, due to limitations in how the studies were designed and carried out and in the data available for analysis.
The regulator has also reviewed results from a five-year trial which compared Lantus to neutral protamine hagedorn (NPH) insulin and the results did not show an increased risk of cancer in subjects treated with Sanofi's drug. However, the study was not specifically designed to evaluate cancer outcomes.
The FDA noted that Sanofi has amended an ongoing trial, ORIGIN, to adjudicate all cases of cancer occurring during the study. ORIGIN is designed to determine if treatment with Lantus to reduce fasting plasma glucose to 95 mg/dL or less would reduce the incidence of cardiovascular events in patients with pre-diabetes or early diabetes versus standard care; an interim review by an independent data monitoring committee did not show evidence of a signal for increased cancer risk and results are expected at the end of 2011.
The agency concluded by noting that Sanofi plans to conduct three epidemiological studies to further evaluate cancer risk associated with Lantus. Those results are due by the end of June.
