LONDON (Reuters) - Sanofi’s hopes in the multiple sclerosis market received a double boost on Friday as the European regulator backed an injectable treatment and adopted a more positive stance toward a pill for the neurodegenerative disease.
The European Medicines Agency said it was recommending Lemtrada, Sanofi’s biggest MS drug hope, for relapsing-remitting MS, ending a quarter-century development saga for the injectable treatment.
The European regulator also reversed an earlier decision not to give pill-administered Aubagio a “new active substance” (NAS) designation because it is very similar to a much older drug.
Without this designation, Aubagio, which received the regulator’s green light in March, could have faced generic copies in Europe in as little as three years - the time required for brief clinical studies of generics and to review applications for approval.
The news sent the stock over 1 percent higher. Sanofi’s shares, which have risen around 13 percent since the start of 2013, were trading 0.8 percent higher at 80.65 euros at 1225 GMT, outperforming Paris’ CAC40 bluechip index, down 0.7 percent.
EMA decisions are usually endorsed by the European Commission within a couple of months.
The U.S. Food and Drug Administration is expected to rule on Lemtrada in late 2013. The regulator recently extended its review timeline by three months but did not request any further clinical data on the drug, Sanofi said in a statement.
Lemtrada, also known as alemtuzumab, has been studied in multiple sclerosis since the early 1990s but its progress to market as a treatment for the disease has been halting and the drug has changed hands many times.
Lemtrada was approved back in 2001, under the different name Campath, as a treatment for B-cell chronic lymphocytic leukemia (B-CLL), although sales for this condition never took off.
It then went back into testing for MS, amid hopes that its ability to knock out immune system cells called lymphocytes would prove effective in a disease that is caused by abnormal immune attacks on the protective sheath surrounding nerve cells.
Still, industry analysts predict the drug will not be the first choice in a market where competition has exploded with new products, including oral treatments like Novartis’s Gilenya.
Instead, it may be kept for patients with more advanced MS, occupying a similar position to Biogen Idec’s Tysabri.
The current consensus for annual Lemtrada sales is $650 million by 2017, according to forecasts compiled by Thomson Reuters Pharma - a number that could rise following the EU recommendation.
For Sanofi, Lemtrada represents a second win in the MS field, following approval of Aubagio in the United States last year.
Aubagio reported sales of 20 million euros ($26 million) in the first quarter of 2013.
Separately, Sanofi got a regulatory boost in Japan on Friday when it won approval from the government there for diabetes treatment Lyxumia.
($1 = 0.7691 euros)
Reporting by Rosalba O'Brien and Caroline Copley; Writing by Elena Berton and Ben Hirschler; Editing by Christian Plumb