Genzyme, a Cambridge-based unit of the French drugmaker Sanofi SA, said that it has moved closer to getting approvals to marketing two multiple sclerosis drugs in Europe.
The drugs are Lemtrada, a treatment for adult patients with relapsing multiple sclerosis, and Aubagio, also an MS treatment.
In a press release, Genzyme said that the Committee for Medicinal Products for Human Use, or CHMP, has issued a positive opinion on the approvals of Lemtrada and Aubagio. In deciding on whether to grant marketing approval for a drug candidate, regulators on the European Commission often follows the recommendations of the CHMP panel.
As a result of the CHMP’s positive opinions, Genzyme said it expects Lemtrada and Aubagio to get European marketing approvals “in the coming months.”
Genzyme has long been known as a maker of treatments for rare diseases. With the support of Sanofi --- Sanofi bought Genzyme for $20.1 billion in 2010 --- Genzyme is looking to enter the lucrative, and broader, market for multiple sclerosis drugs. The market for such drugs has been estimated at about $13 billion a year worldwide.
Genzyme has also been seeking approval to market Lemtrada in the US. Last August, Genzyme suffered a setback when the FDA asked it to change the way it presents clinical data and resubmit an application it filed about a year ago for approval of Lemtrada. The FDA has since agreed to review the Lemtrada application, and Genzyme said it expects the FDA to make a decision on Lemtrada “in late 2013.”
Projected revenue from Lemtrada, which will compete with several other MS drugs already being sold, became a major sticking point in 2010 when executives negotiated Sanofi’s takeover of Genzyme. Ultimately, the parties agreed to award Genzyme stockholders a tradeable security, called a contingent value right. Holders of the contingent value right will receive payments based on the attainment of regulatory approval and sales milestones for Lemtrada.
Aubagio received US approval from the Food and Drug Administration last September. Aubagio has also received market approvals from regulators in Australia and Argentina, a Genzyme spokesman said.