BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Research Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
   

Sanofi (France) (SAN.PA)'s Genzyme Corporation (GENZ)'s Once-Daily, Oral Aubagio Approved in Australia to Treat MS


11/26/2012 7:01:53 AM

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company, (EURONEXT: SAN and NYSE: SNY) announced today that the Australian Therapeutic Goods Administration (TGA) has approved AUBAGIO® (teriflunomide) 14 mg as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). The TGA approval will enable health professionals to prescribe AUBAGIO 14 mg in Australia, which is now the second country to gain marketing authorization for the treatment, following FDA approval in September.

“We are very pleased with the TGA approval of AUBAGIO that makes available a new option for healthcare professionals, and people living with MS in Australia who may benefit from this once-daily, oral treatment,” said Bill Sibold, Head of Multiple Sclerosis, Genzyme. “The availability of AUBAGIO in the U.S. and subsequent registration in Australia not only demonstrates our continued progress, it also reflects our commitment to deliver differentiated treatments and provide access for patients globally.”

The TGA’s approval of AUBAGIO was based on safety and efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. The ongoing AUBAGIO clinical development program, involving more than 5,000 patients in 36 countries including Australia, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years.

“For some people living with MS, the additional burden of injectable therapies administered daily to weekly can sometimes be a struggle,” said Associate Professor John King, Senior Neurologist, Royal Melbourne Hospital, who participated in the clinical trials for AUBAGIO. “It is exciting to see a new oral treatment that has been shown to both reduce relapses and slow the progression of disability. This is an encouraging development for the MS community.”

AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for AUBAGIO is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).

“We welcome the advent of a new oral treatment option for MS patients in Australia,” said Professor Bill Carroll, Chairman of MS Research Australia. “It is important for people with MS and their clinicians to have access to a range of well-tolerated and convenient therapies that may reduce the impact of the disease on their lives and suit their lifestyle.”

AUBAGIO is marketed in the U.S. and now Australia. Marketing applications for AUBAGIO are under review by the European Medicines Agency (EMA) and other regulatory authorities.

About Genzyme, a Sanofi Company

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (SAN) and in New York (SNY).

Genzyme® is a registered trademark. All rights reserved.

AUBAGIO® is a registered trademark. All rights reserved.

Contact:

Genzyme Media Relations

Erin Walsh, +1-617-768-6881

Mobile: +1-617-945-3628

erin.walsh@genzyme.com

or

Sanofi Investor Relations

Kristen Galfetti, +1-908-981-5560

ir@sanofi.com

or

Sanofi Australia Media Relations

Patricia Waghorn, +61 (0) 2-8666-2726

patricia.waghorn@sanofi.com



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES
 

//-->