Sanofi (SAN) 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 in a phone interview today. “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 U.S. backing to sell the tablet in September. The Paris-based company has been building up an MS business since its 2011 purchase of the U.S. biotech company Genzyme Corp., 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, the president and chief executive officer of Sanofi’s Genzyme unit in Cambridge, Massachusetts, said in a statement. “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 RRMS get attacks that degrade their neurological function, followed by periods of recovery.
Lemtrada is administered through infusions for five consecutive days when treatment begins and for another three days 12 months later. 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 AG (NOVN)’s pill Gilenya. Biogen Idec Inc. (BIIB:US)’s BG-12, also an oral treatment, is awaiting a decision from U.S. regulators this month. The European panel recommended its approval today.
Aubagio is a less compelling product than BG-12, Meunier said. He estimates Aubagio will garner about 300 million euros ($389 million) in annual sales by 2016.
“It’s not a great medicine,” he said.
Aubagio will be an important treatment option for many MS patients because of its “very well characterized” safety profile, Michael Panzara, Genzyme’s therapeutic area head for MS and immune diseases, said in an interview in September.
Multiple sclerosis is caused by an abnormal immune response that attacks the protective covering that surrounds nerve cells in the brain and spinal cord. The assault stops nerve cells from sending signals, sapping patients’ energy, blurring their vision and slowly robbing them of mobility, balance and coordination.
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 Oct. 8 note.
The EMA today also confirmed the CHMP’s refusal to back Sanofi and Isis Pharmaceuticals Inc. (ISIS:US)’s Kynamro, a drug to treat patients with a rare disorder that causes run-away levels of the fat-like substance cholesterol. Sanofi had requested a re- examination of the CHMP’s initial negative opinion in December.
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