GlaxoSmithKline and Human Genome Sciences receive European authorisation for Benlysta r (belimumab).

European authorisation of Benlysta represents a significant milestone and we are excited to offer physicians an additional treatment option for treating patients appropriate with this chronic disease ”, said Dr. Tony Hoss, senior Vice President, European Medical Affairs for GSK.

GSK and we have committed ourselves to Benlysta available in countries around the world ”, said H. Thosmas Watkins, President and Chief Executive Officer of HGS. We are especially proud to have brought forward this medication in Europe, where several important academic research centres have been key in its clinical development ”.

Technical specifications specifies the groups of patients who have not been studied with belimumab, including serious active CNS lupus and lupus nephritis active serious. Therefore, the use of belimumab is not recommended for the treatment of these situations. Belimumab should be used cautiously in co-administration with other targeting B cells or cyclophosphamide treatment, given that it has not been studied in combination with these treatments.

Benlysta (belimumab)

The Food and Drug Administration (FDA) of the United States authorized belimumab on March 9, 2011. GSK and HGS have announced the approval by Health Canada on July 12. There have been applications for authorisation, currently in process of review, Australia, Switzerland, Russia, Brazil, Israel, Singapore, Philippines, Taiwan and Colombia.

Belimumab fact sheet includes detailed recommendations for their use and shall be published in the European public assessment report (EPAR)

collaboration of GSK and HGS

HGS and GSK belimumab being developed within the framework of an agreement for joint development and comarketing this medicine signed in 2006. Under this arrangement, HGS has the responsibility to develop studies in phase III of belimumab with the help of GSK. Companies will share equally the costs of development of the phase III and IV, sales and marketing costs and benefits of any product marketed within the framework of the present agreement.

Benlysta is a registered trademark owned by Human Genome Sciences, Inc., used under license by the Group of companies GlaxoSmithKline.

GlaxoSmithKIine (GSK), one of the leading global research-based pharmaceutical and health care, aims to improve the quality of life of people, making it possible that people have more vitality, feel better and live more time.

GSK Biopharm R & D are investigating new approaches to take advantage of the therapeutic potential of drugs biolis for the benefit of patients with autoimmune diseases.

Human Genome Sciences aims to provide new drugs to people who are fighting against serious diseases.

HGS, Human Genome Sciences and Benlysta are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are property of their respective owners.

Referencia:

(i) GlaxoSmithKline and Human Genome Sciences. Technical data for Benlysta ® 2011