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.”

Biopharmaceutical company Genzyme, part of Sanofi, has appointed William ‘Bill’ Sibold as Head of Multiple Sclerosis and Rogério Vivaldi as Head of Rare Diseases.

These two businesses make up Genzyme’s core focus following its integration with Sanofi.

David Meeker, Genzyme’s President and CEO, commented: “These appointments are a critical step in launching the new Genzyme. Bill and Rogério are dynamic leaders with the experience, energy, vision and commitment to patients needed to move us forward.”

Bill Sibold has worked in the biopharmaceutical industry for two decades, primarily in commercial roles – including responsibility for the MS drugs Avonex and Tysabri. In eight years at Biogen Idec he rose to become Senior Vice President of US Commercial. He joins Genzyme from Avanir Pharmaceuticals, where he was the Chief Commercial Officer.

“Our goal is to build a world-leading multiple sclerosis franchise,” said Meeker. “Bill’s substantial commercial experience and his deep knowledge of the MS field will be critical to the launch of Lemtrada and Aubagio, two investigational therapies with the potential to transform the lives of people living with MS.”

Rogério Vivaldi joined Genzyme in 1997; his roles have included President of the company’s Renal and Endocrinology Business and President of Genzyme Latin America. As a doctor, he became a recognised expert on the rare Gaucher disease and its treatment.

“Rogério’s experience as a physician treating Gaucher patients in Brazil and his subsequent work in building our rare disease business in Latin America will provide both continuity and an energising new beginning for our global rare disease business,” noted Meeker.

Based in Massachusetts, US, Genzyme specialises in biopharmaceutical therapies for rare and debilitating diseases. As part of Sanofi, it benefits from the commercial reach of a leading global pharmaceutical company.