Genzyme’s Once-Daily, Oral AUBAGIO® Approved in Australia for Treatment of
Relapsing Multiple Sclerosis
CAMBRIDGE, Mass. -- November 21, 2012
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
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
“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
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
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
(EURONEXT: SAN) and in New York (NYSE: SNY).
Genzyme^® is a registered trademark. All rights reserved.
AUBAGIO^® is a registered trademark. All rights reserved.
Genzyme Media Relations
Erin Walsh, +1-617-768-6881
Sanofi Investor Relations
Kristen Galfetti, +1-908-981-5560
Sanofi Australia Media Relations
Patricia Waghorn, +61 (0) 2-8666-2726
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