Biotech Values

[DewDiligence]

Sanofi’s Teriflunomide Cuts MS Relapse Rate by 31%

[SNY reported the success of the TESMO phase-3 study in Aug 2010 (#msg-53886032) but said nothing else until now. At the ECTRIMS conference, SNY reported that both the high and low doses of Teriflunomide met the primary endpoint of relapse rate relative to placebo (HR=0.69, p<0.0005). The high dose, but not the low dose, met the secondary endpoint of time to disease progression (HR=0.70, p=0.02 for the high dose; HR=0.76, p=0.08 for the low dose.)

As an oral drug, Teriflunomide appears to be a serious competitor to Gilenya. Teriflunomide is also being tested in: a phase-3 trial called TOWER that is similar to TESMO, slated to finish in Oct 2011; a phase-3 trial called TENERE where the comparator is Rebif, slated to finish in Oct 2011; and a phase-3 trial called TOPIC in CIS, slated to finish in 2015.]

http://www.reuters.com/article/idCNLDE69D0X120101015

›Oct 15, 2010 3:20am EDT
By Caroline Jacobs

PARIS, Oct 15 (Reuters) - Sanofi-Aventis, locked in a battle to buy U.S. biotech Genzyme, said its multiple sclerosis candidate drug teriflunomide significantly cut relapses in patients who took the once-daily oral treatment.

The outcome of the final phase clinical trial showed that two different doses of the drug cut the annualised relapse rate of the chronic disease by 31 percent against placebo and that patients tolerated both doses well, the French drugmaker said on Friday.

Sanofi's two-year trial data follows those of Genzyme, a rare disease specialist, showing in five-year clinical results that its MS experimental drug alemtuzumab or Campath continued to show strong efficacy with no new or worsening side effects.

Sanofi's so-called TEMSO trial also demonstrated that the risk of progression in disability fell 30 percent in patients who were given 14 mg of teriflunomide and was down 24 percent for those on half the dose.

Teriflunomide had no major safety concerns, according to Sanofi, which cited diarrhea and nausea in patients on the higher dose as well as alanine transferase increases that were mainly mild.

The study involved 1,088 patients who were either on 7 mg or 14 mg doses of teriflunomide or on a placebo.

"We are very pleased with the successful results of the TEMSO study which are an important step forward in multiple sclerosis clinical research," Sanofi's head of research Marc Cluzel said in a statement.

Relapsing MS, the most common form of the neurological disease, happens when new symptoms appear and old ones worsen. Symptoms include partial or complete loss of vision, tingling or pain or weakness in one or more limbs.

Sanofi hopes to buy Genzyme and add rare disease as a new area to grow its business as it faces a loss in sales due to patent expiries on several of its top-selling drugs.

The battle between Sanofi and Genzyme, which turned down the French drugmaker's hostile $18.5 billion cash offer, is also being fought on the MS front.

Sanofi has said its offer assumes Campath performs in line with Wall Street projections, citing seven brokerages whose median peak annual sales for the drug are $700 million.

But Genzyme believes the drug could be the most effective available, if approved, and grab a substantial share of a market it estimates could be worth some $13 billion by the end of 2010.

Swiss drugmaker Novartis became the first to bring an oral multiple sclerosis drug to the market when it won U.S. approval in September for Gilenya.

Some investors believe sales at rivals like Biogen Idec could be hit as their treatments involve less convenient infusions or injections.

Sanofi announced its Phase III trial results on teriflunomide at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) congress, in Gothenburg, Sweden.

The TEMSO trial is part of a wider development programme of the drug [see comments in the prologue of this post].‹