Sanofi Aims to Add Second-Generation Lemtrada to Pipeline

Sanofi plans to develop a new version of the experimental therapy Lemtrada as the French drugmaker seeks to expand the multiple sclerosis business it’s built since the purchase of Genzyme Corp.

“We have a next-generation Lemtrada,” David Meeker, the chief executive officer of Sanofi’s Genzyme unit, said in an interview yesterday in Lyon, France, at the annual conference of the European Committee for Treatment and Research of Multiple Sclerosis. “It’s getting ready to enter the clinic.” He declined to be more specific.

Lemtrada, also known as alemtuzumab, is a so-called monoclonal antibody administered to patients through infusions in two cycles annually. Late-stage clinical trials showed the drug slowed the progression of disability though it also led to infections and an autoimmune thyroid-related side effect in some patients.

Adding a new version of Lemtrada, a drug it gained in buying Genzyme last year, would help Paris-based Sanofi build the MS business. Last month, Sanofi won U.S. backing to sell the pill Aubagio, its first MS therapy. The company is counting on new drugs to help offset revenue losses from generic competition to best-sellers including the blood thinner Plavix.

The next-generation Lemtrada “won’t be a me-too,” Michael Panzara, Genzyme’s therapeutic area head for MS, immune diseases and neurology, said in a separate interview in Lyon today. With a new version, the company aims to preserve or enhance the drug’s effectiveness and improve safety, he said.

‘Actively Looking’

The new version of Lemtrada also may be tested for other immune diseases, Panzara said. Genzyme has other MS compounds in development and is also “actively looking outside” the company for new therapies, he added.

Sanofi is “on track” to soon file Lemtrada for approval in the U.S., Panzara said. The Food and Drug Administration refused to accept the initial application, and Sanofi said Aug. 27 it would resubmit the request in a new format. Lemtrada loses patent protection in the U.S. in 2017.

Sanofi gained experience in multiple sclerosis by selling Teva Pharmaceutical Industries Ltd.’s Copaxone in past years, an agreement that is now terminated. The Copaxone sales teams, which were outside the U.S., have been switched to Genzyme, Meeker said. In the U.S., Genzyme recently added about 200 people in areas such as sales, marketing and reimbursement teams, Bill Sibold, Genzyme’s head of MS, said in an interview.

Aubagio’s introduction in the U.S. “is going as expected,” Sibold said. “We are very pleased with the results. So far we’ve had very favorable reception from the community.”

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Aubagio is an oral therapy. Lemtrada is administered through infusions for five consecutive days when they begin the treatment 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.

Sanofi has “a portfolio to offer, and in my opinion they can offer it for the whole spectrum of MS patients, therefore they are interesting,” Heinz Wiendl, director of the neurology department at the University of Muenster in Germany, said in an interview. Aubagio and Lemtrada “may not become blockbusters, but they will gain their space in MS.” Wiendl has received consulting fees and grants from Sanofi, Biogen Idec Inc. and other drugmakers.

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 forecast in an Oct. 8 note.

Gilenya, BG-12

Aubagio and Lemtrada will have to make inroads in a market flooded by new products, such as Novartis AG’s pill Gilenya and Biogen’s BG-12, which is awaiting a decision from U.S. regulators this year.

“We will compete fine with BG-12,” Meeker said. Aubagio also will be “competing well” with older, injectable therapies such as Merck KGaA’s Rebif, he said. Results from a late-stage Aubagio trial, dubbed TOWER, were presented at ECTRIMS today.

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.

Sanofi Chief Executive Officer Chris Viehbacher spent $20.1 billion to buy Cambridge, Massachusetts-based Genzyme. After the purchase, he folded Aubagio, Sanofi’s own MS therapy, into Genzyme to build an MS franchise.

This year’s ECTRIMS conference “is the first time we are under one banner,” Sibold said. “Before there was a Sanofi booth and a Genzyme one. When you walk in the display area, we are as prominent as any other company. We are a player now.”

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