Sanofi suffers multiple sclerosis setback


French pharmaceutical Sanofi has run into trouble after the US Food and Drug Administration (FDA) rejected its multiple sclerosis drug Lemtrada (alemtuzumab). The agency said that its rejection of alemtuzumab was the result of poor Phase III clinical trial design and side effects that outweigh the potential benefits.

When Sanofi bought Genzyme for more than $20 billion (£12 billion) in February 2011, additional milestone payments were agreed, depending on the success of alemtuzumab. The monoclonal antibody was approved to treat multiple sclerosis in the EU in September 2013, leading to expectations that the FDA would follow suit in the US.

Without the US market, Lemtrada is very unlikely to meet sales targets, and consequently Sanofi’s share price fell by 1.1%. Furthermore, one US law firm is launching a class action on behalf of investors, claiming the French company made misleading statements about the prospects for alemtuzumab.

In a press release, a spokesperson for Genzyme stated that they strongly disagree with the conclusions and plan to appeal against the FDA’s decision.


Related Content

High hopes

3 February 2015 Feature

news image

Cannabinoids are finally coming out of the shadows and onto the shelves of pharmacies around the globe. Rachel Brazil reports

2012 pharma industry roundup

3 January 2013 Business

news image

What were the bigger stories? And how did the industry fare overall?

Most Read

Schott's glass

29 April 2015 Classic Kit

news image

Life through a lens

First pictures of hydrogen bonds unveiled

26 September 2013 Research

news image

Observation of intermolecular interactions in quinolines could help to settle the nature of this kind of bonding

Most Commented

Science for life: a manual for better living

1 May 2015 Review

news image

Looking beyond the hype

An unfortunate oversight

27 April 2015 Critical Point

news image

The US Toxic Substances Control Act is in dire need of reform. That demands compromises, says Mark Peplow