Sanofi won backing from a European advisory panel for its first multiple sclerosis therapy, the tablet Aubagio, a step forward in the French drugmaker's plan to grab a slice of the $14 billion MS business.
Aubagio, a once-daily pill, was recommended for treatment of relapsing forms of the debilitating disease by the European Medicines Agency's Committee for Medicinal Products for Human Use, the London-based agency said today.
The committee decided that the medicine's key ingredient, known as teriflunomide, couldn't be considered as a new active substance, the EMA said.
The decision not to grant new active substance status to Aubagio "isn't likely to have much of an impact", Vincent Meunier, an analyst at Exane BNP Paribas in Paris, who has a buy recommendation on the stock, said.
"The one risk is that a company decides to work on a generic version of the medicine, but Aubagio isn't a huge product for Sanofi."
Sanofi won US backing to sell the tablet in September.
The company has been building up an MS business since its 2011 purchase of the US biotech company Genzyme, which gave it access to Lemtrada, another experimental treatment for the nerve-damaging illness.
Sanofi needs new medicines to help offset revenue losses from generic competition to best-sellers including the blood thinner Plavix.
Aubagio is meant to treat relapsing-remitting MS, the most common form of the illness.
"We are very disappointed by the CHMP opinion regarding new active substance designation," David Meeker, chief executive of Sanofi's Genzyme unit. "This decision could have a detrimental impact on future scientific innovation in MS."
Sanofi said it's planning to ask the EMA to re-examine the designation.
The European Commission usually follows the panel's recommendation.
MS affects more than 2.1 million people worldwide, according to the National Multiple Sclerosis Society.
Patients with relapse remitting MS get attacks that degrade their neurological function, followed by periods of recovery.
Patients probably will use Aubagio in the earlier phases of the disease, while Lemtrada is more likely to be used at a more advanced stage, neurologists say.
Aubagio and Lemtrada will have to make inroads in a market flooded by new products, such as Novartis's pill Gilenya. Biogen Idec's BG-12, also an oral treatment, is awaiting a decision from US regulators this month.
The European panel recommended its approval today.
Mr Meunier estimates Aubagio will garner about €300 million in annual sales by 2016.
Aubagio will be an important treatment option for many MS patients because of its "very well characterised" safety profile, Michael Panzara, Genzyme's therapeutic area head for MS and immune diseases, said last September in an interview.
The market for MS drugs will grow to $19.6 billion annually by 2022 from $13.8 billion at present, Ravi Mehrotra and other Credit Suisse analysts predicted in an October research note. – Bloomberg
