Genzyme has submitted a marketing authorisation application to the EMA for its convenient oral teriflunomide for the treatment of relapsing forms of multiple sclerosis (MS).

The application is based on data from two pivotal Phase III studies. An additional three trials are also in progress making the treatment one of the longest in investigational MS therapy history.

Bill Sibold, Senior Vice President, Head of Multiple Sclerosis, Genzyme, says the application moves teriflunomide “one step to closer” to offering patients a new treatment option.

A similar application to market the medication in the US is currently under review by the FDA.

Teriflunomide is being studied in a large clinical programme that is expected to include more than 5,000 participants from more than 30 different countries. Five efficacy trials are now either completed or underway making it one of the largest and broadest of any MS agent under development.

“As an oral therapy with a promising clinical profile, teriflunomide is extremely well positioned to provide an alternative therapeutic option to patients who are currently taking injectable therapies,” said Bill Sibold. “Those injectable therapies make up approximately 80 percent of the MS market today.”

Sales increased more than 10% at Sanofi in the third quarter to €8.7 billion, despite the loss of €471 million due to generic competition compared to the same period a year ago.

Total sales grew 10.1% along with an 11% increase in growth platforms after strong performances in its diabetes, vaccines and consumer health divisions.

Christopher A. Viehbacher, Sanofi CEO, says the return to growth in sales and earnings is an “important milestone as the company progressively puts the patent cliff behind it”.

Growth platforms and Genzyme accounted for 68.5% of total sales after the recently acquired business recorded sales up 6.9% to €768 million.

Pharmaceutical net sales were up a tenth to €6.9 billion and helped year-to-date net sales rise 5.5% to €20 billion, despite generic competition to Lovenox, Ambien CR and Taxotere in the US and Plavix (pictured) and Taxotere in the EU plus the impact of US healthcare reform and EU austerity measures.

Its diabetes division was driven by a strong US and Emerging Markets performance which resulted in a 12.4% increase in sales after Lantus recorded growth of 14.6% and 23.4%, in respective markets. Growth in Sanofi’s vaccine division also increased 16.7% after a solid demand for seasonal flu medication in the US.

The Sanofi Group now expects 2011 business net income to be between 2%-5% lower than last year’s total. “We continue to make strong progress in R&D with the submission of five new products and also in the tight control of our costs,” said Mr Viehbacher.

It was reported this week that Sanofi is set to overtake Pfizer as the world’s biggest pharmaceutical company by 2016.

Submissions have been recently filed for Lyxumia (lixisenatide) in the EU, Aubagio (teriflunomide) and Zaltrap (aflibercept) in the US; Visamerin/Mulsevo (semuloparin) in the US and EU; plus Kynamro (mipomersen) in the EU.

The company released its Q3 performance on the day it announced it was cutting jobs in its US R&D and sales divisions.