Sanofi hit hard by Lemtrada rejection
pharmafile | January 2, 2014 | News story | Medical Communications, Research and Development, Sales and Marketing | Aubagio, FDA, Genzyme, Lemtrada, MS, Sanofi
The FDA has asked for more information about Sanofi’s multiple sclerosis treatment Lemtrada, delaying its entrance into the world’s biggest pharma market.
The regulator has rejected Lemtrada (alemtuzumab) on the grounds that the drug had not been able to show that its benefits outweighed its ‘serious adverse effects’. Lemtrada is designed to treat relapsing remitting multiple sclerosis, the most common form of the disease.
In its complete response letter, the FDA also told Sanofi that it must carry out further clinical trials using different designs and methods prior to approval.
Sanofi’s subsidiary Genzyme first developed the drug, which became part of the French company in 2011 after a $20.1 billion acquisition deal.
Genzyme’s president and chief executive David Meeker said: “We are extremely disappointed with the outcome of the review and the implications for patients in the US suffering with multiple sclerosis who remain in need of alternative therapies to manage a devastating disease.”
He went on: “We strongly believe that the clinical development programme, which was designed to demonstrate how Lemtrada compares against an active comparator as opposed to placebo, provides robust evidence of efficacy and a favourable benefit-risk profile.
“This evidence was also the basis for the approvals of Lemtrada by other regulatory agencies around the world.” He added that both firms will be appealing the decision.
Milestone payments
What makes this a an even more bitter pill to swallow for Sanofi is that the purchase of Genzyme hinged on the approval and success of Lemtrada, which is expected by analysts to generate annual sales of around $700 million by 2018.
Sanofi worked out a complex deal in 2011 that involved making payments to shareholders based on sales and regulatory targets being met by the drug.
But it now does not believe that the expected milestone of a US approval of Lemtrada by 31 March will be met, meaning these payments will in all likelihood not be paid out.
“Genzyme’s takeover was about catching up in biologics, having a greater footprint in the United States, and also largely for Lemtrada,” said Eric Le Berrigaud, an analyst at Bryan Garnier & Co.
“This is unquestionably a setback, as without a U.S. market such a product doesn’t have the same potential.”
Lemtrada is currently approved in the European Union, Canada, and Australia, but the biggest sales drive will come from the US.
There are already a number of successful MS treatments for the disease, including Teva’s Copaxone, Biogen’s Avonex, and new oral treatments in the guise of Novartis’s Gilenya (fingolimod), which are expected to overtake older injectable forms of the treatment in the near future.
Sanofi also has an oral treatment, Aubagio, developed by Genzyme and which has already been approved in the US and Europe. Analysts on average expect Aubagio sales to reach $854 million by 2018.
Ben Adams
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