Biotech Values

[DewDiligence]

SNY’s Aubagio Fails Superiority to Rebif in Phase-3 Study

[Unlike the prior phase-3 study called TESMO, in which Aubagi easily bested a placebo (#msg-55641299]), the TENERE study reported here had the harder task of beating Rebif, and Aubagio couldn’t do it. This is a big setback for the Aubagio program, IMO. Although SNY has already submitted an NDA (disclosed today) and plans to submit an MAA in 1Q12, the commercial prospects for Aubagio would seem to be bleak.

SNY’s own PR on the TENERE study is at http://finance.yahoo.com/news/Genzyme-Reports-Top-line-bw-2255827539.html?x=0 .]

http://www.bloomberg.com/news/2011-12-20/sanofi-s-experimental-ms-drug-doesn-t-beat-rebif-in-patient-test.html

›By Albertina Torsoli - Dec 20, 2011 5:12 AM ET

Sanofi (SNY), France’s biggest drugmaker, said its experimental pill Aubagio for the treatment of multiple sclerosis failed to beat an older injected therapy at preventing relapses or keeping patients on treatment.

Aubagio, whose chemical name is teriflunomide, showed no statistical superiority to Merck KGaA’s medicine Rebif, Paris- based Sanofi said in an e-mailed statement today. The late-stage trial, dubbed Tenere, showed Aubagio was safe and well tolerated, Sanofi said.

Chief Executive Officer Chris Viehbacher has been building up the company’s multiple sclerosis business since this year’s $20.1 billion purchase of U.S. biotechnology company Genzyme Corp. (GENZ), which gave it access to another experimental MS treatment called Lemtrada. While Aubagio is an oral therapy, Lemtrada is a so-called monoclonal antibody that is injected into patients.

Sanofi is facing competition in the race to introduce MS drugs. Novartis AG (NOVN)’s Gilenya, the first oral drug for the disease, was approved last year and Israel’s Teva Pharmaceutical Industries Ltd. (TEVA) is developing a competing pill, laquinimod. Biogen Idec Inc. (BIIB), the world’s largest maker of medicines to treat MS, said Oct. 26 that its lead experimental medicine, the pill BG-12, was safe and reduced the risk of relapse in a second late-stage trial.

Limited Potential

“Aubagio has the advantage of being an oral treatment, but its potential will be limited by more efficacious drugs,” Eric Le Berrigaud, an analyst at Bryan, Garnier & Co. in Paris, said in e-mailed comments before the trial results were published. “If there weren’t other medicines like Gilenya, BG-12 and even Lemtrada, it would be a great product.”

Le Berrigaud estimates Aubagio may garner 500 million euros ($650 million) in annual sales by 2019, if it is approved.

Multiple sclerosis, which is believed to affect more than 2.1 million people worldwide, is an incurable disease that destroys the nerves and robs patients of their ability to control their movements. Many patients have trouble staying on current therapies because they’re difficult to use or cause side effects, according to the National Multiple Sclerosis Society.

Tenere Trial

The Tenere trial is the second completed study of five planned for Aubagio in MS, Sanofi said. The study, part of the last of three phases of human testing needed for regulatory approval, included 324 patients. The participants were divided into three groups: those who took a 7-milligram dose of Aubagio once a day, those who took 14 milligrams of the drug, and those who took Rebif. The groups were studied for 48 weeks.

Almost half of the patients receiving the lower dose of Aubagio either had a relapse or stopped taking the drug, compared with 37.8 percent at the higher dose and 42.3 percent for Rebif patients, Sanofi said. Annual relapse rates weren’t distinguishable between those taking Rebif and those taking the higher dose of Aubagio, and was higher in the low-dose group, the company said.

Most of the side effects seen in patients taking Aubagio were mild, and included diarrhea, hair thinning and back pain, Sanofi said. Those side effects occurred more frequently in the Aubagio groups than among those taking Rebif, the company said. The most common side effects in the Rebif patients were headache and flu-like symptoms, according to the statement.

A previous Aubagio trial, dubbed TEMSO, showed the drug reduced relapses by 31 percent compared with a placebo [#msg-55641299] and also lowered the risk of disability progression by 30 percent, Sanofi said on Oct. 15, 2010.

Earlier Phases

People suffering from MS probably will use Aubagio in the earlier phases of the disease, while Lemtrada will probably be taken as the disease progresses, Genzyme CEO David Meeker said in a Nov. 14 interview.

“BG-12 and Gilenya will prove tough competitors with respect to oral therapies,” ]no kidding] Peter Verdult and other analysts at Morgan Stanley in London wrote in a Nov. 2 note to clients.

Sanofi’s application for U.S. approval of Aubagio was accepted by the Food and Drug Administration in October, the company said today. The drugmaker said it plans to seek approval in the European Union in the first quarter next year.‹