Sanofi criticised for multiple sclerosis manoeuvres
pharmafile | November 2, 2012 | News story | Sales and Marketing | Cancer, Lemtrada, MS, Sanofi
Sanofi is facing a backlash as it prepares its new MS treatment for the market.
Lemtrada (alemtuzumab) has produced very encouraging results in Phase III trials, showing it to be superior to current standard of care Rebif, producing a reduced relapse rate and slowing the rate of progressive disability.
The drug is currently being reviewed by the FDA and EMA, and could be on the market in early 2013. But Sanofi is facing criticism for withdrawing the drug in an existing indication in cancer, where it is well known as Campath.
Critics say once re-launched as Lemtrada, Sanofi will demand a high price for alemtuzumab, which could mean many patients will be denied access to the treatment.
The latest Phase III data for the drug is published in the Lancet, but the journal’s own editorial warns about possible pricing and access problems.
“There is concern that with a licence for multiple sclerosis, the cost of alemtuzumab could rise and might become too expensive for many patients and health systems,” the editorial states.
It concludes: “Finding promising treatments such as alemtuzumab is important. But so is keeping alemtuzumab accessible and affordable if its early success in these trials proves to be of enduring value.”
Campath was withdrawn from markets in September in order to prevent off-label use as an MS drug, a move that has caused protest from some doctors.
Doug Brown, head of Biomedical Research at UK charity MS Society told Reuters: “We urge Genzyme to price the treatment responsibly so that if it’s licensed, it’s deemed cost effective on the NHS.”
Three neurologists have already written to the health secretary to protest at the withdrawal of Campath. Professors Neil Scolding of the University of Bristol, Neil Robertson of the University Hospital of Wales and John Zajicek of the University of Plymouth, say Genzyme’s decision has “serious implications for vulnerable UK patients with MS”, and say those already taking the drug off-label could see their condition deteriorate as they wait for the drug to be re-launched as Lemtrada.
Sanofi could find itself embroiled in a controversy similar to the one surrounding Novartis’ Lucentis (ranibizumab). The ophthalmology treatment is virtually identical to Roche’s Avastin (bevacuzimab) as a molecule, but carries a far higher price tag. This has led many clinicians to use Avastin off-label, and even leading to numerous government-funded trials to assess the relative safety and efficacy of the drugs.
At least one company – Swiss firm BioXpress – is known to be developing a biosimilar version of alemtuzumab. The company could launch a rival product to Lemtrada, but may have to conduct extensive trials of its own to gain a licence for use in MS.
Andrew McConaghie
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