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05 August 2013

Genpharm and Genzyme Aubagio ® agreement for the MENA region

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Genpharm and Genzyme, A Sanofi Company have agreed on a multiyear partnership to register and launch Aubagio® in the MENA region for the treatment of relapsing forms of Multiple Sclerosis (MS).

The MENA region have seen an increase in the number of MS cases in recent years due to several factors including improved and earlier diagnosis as well as better accessibility to MS treatments.

AUBAGIO® (Teriflunomide) is an FDA approved once-daily oral tablet developed by Genzyme, A Sanofi Company for relapsing forms of Multiple Sclerosis (MS).

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery periods may be incomplete, leading to progressive decline.

AUBAGIO® is a disease-modifying therapy (DMT) that offers an effective alternative for patients suffering from Relapsing Multiple sclerosis (RMS)

AUBAGIO® was extensively tested in several clinical trials and has one of the most robust clinical development programs. The FDA approved after reviewing data from the trials covering more than 1,000 patients in a 2-year study. When compared to placebo, AUBAGIO® 14mg showed a significant improvement in the 3 measures of MS activity:

  • Relapse Rate
  • Disability progression
  • MRI brain lesions

Aubagio® is the only marketed oral DMT to be studied successfully in Clinical Isolated Syndrome (CIS).

For further information on Aubagio please read the product information leaflet: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202992s000lbl.pdf

Aubagio® has received positive opinion by the European Medicinal Agency (EMA) and is awaiting European Union approval.

 http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002514/WC500144913.pdf

For further information related to Aubagio and its availability in your country of residence, please contact us at info@genpharmservices.com or call us at +971 4  4227010

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