GlaxoSmithKline receives new approval for Rotarix and significant new indication for Lamictal® (lamotrigine) in Japan

Issued: London UK

• GSK’s rotavirus vaccine approved for use in babies for the prevention of rotavirus gastroenteritis
• Lamotrigine becomes the first treatment to be approved in Japan for adult bipolar disorder

GlaxoSmithKline (GSK) today announced that its rotavirus vaccine has received approval in Japan from the Ministry of Health, Labour and Welfare (MHLW) for use in infants to prevent gastroenteritis caused by rotavirus. Rotarix^TM is the first vaccine against rotavirus to be approved in Japan, and the third GSK vaccine to gain approval in Japan following the licences received for Cervarix^® in 2009 and Arepanrix^TM in 2010. It is expected to be available in Japan towards the end of the year, following the completion of national testing.

GSK also today gained approval for a significant new indication in Japan for Lamictal^® (lamotrigine) Tablets 25mg and 100mg for the prevention of depressive episodes in adult patients with bipolar disorder. Lamotrigine is the first treatment in Japan to be classified for bipolar disorder. It is currently licensed in Japan as an adjunctive therapy for epileptic seizures in patients inadequately controlled by other antiepileptic drugs. It will be available for the new indication immediately.

Philippe Fauchet, President of GlaxoSmithKline Japan, commented: “.These two approvals demonstrate the clear progress GSK is making in bringing more products that offer real value to patients in Japan. In total, we have now received 24 new product approvals, including eight new chemical entities, since 2009. We are particularly pleased to contribute to preventative healthcare with the approval of our rotavirus vaccineand we hope this will help to reduce the significant burden of this disease in Japan. In addition, with the new indication for lamotrigine, we now have the first approved treatment for bipolar disorder available in Japan to help prevent depressive episodes in adults with bipolar disorder”

Notes

Rotarix^TM is an oral vaccine for the prevention of gastroenteritis caused by rotavirus. It is given as a two-dose schedule to babies from the age of 6 weeks and can be completed by 10 weeks of age. It is currently approved in over 120 countries worldwide.

In Japan, approximately 1 in every 15 children will require hospitalization due to rotavirus-related diarrhoea by their fifth year of life.ⁱⁱGrowing evidence suggests that the introduction of rotavirus vaccines substantially reduce severe diarrhoea in young children. In Brazil hospitalisations due to rotavirus gastroenteritis decreased by almost 60% just one year after the introduction of universal mass vaccination.ⁱ

In April 2009, the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) recommended that rotavirus vaccination be included in all national immunisation programmes. Based on this decision, the WHO awarded global prequalification to Rotarix^TM. Since its first launch in 2007 100 million doses have been delivered which means that around 50 million children across the world have been vaccinated against rotavirus.

Lamictal^®(lamotrigine) was approved in Japan in October 2008 as adjunctive therapy for seizures in patients inadequately controlled (partial seizures, generalized seizures, tonic-clonic seizures, seizures associated with Lennox-Gastaut syndrome) by other antiepileptic drugs.

Lamotrigineis recommended by international guidelines as maintenance therapy for patients with bipolar disorder.^iii-ix Lamotrigine is currently approved in more than 110 countries for indications related to epilepsy and in more than 80 countries for indications related to bipolar disorder.

It is now also approved for the prevention of depressive episodes in adults aged 18 years and over with bipolar disorder.

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References

i.       Safadi M et al. Hospital-based surveillance to evaluate the impact of rotavirus vaccination in Brazil. Poster presentation at ESPID.  (accessed 9 May 2011)

ii.      J Infect Dis. 2005 Sep 1;192 Suppl 1:S106-10.

iii.     Am J Psychiatry 159:4, April 2002 Supplement

iv.     National Institute for Health and Clinical Excellence (NICE). 2006. Available (Accessed 1 July 2011).

v.      Yatham LN, et al. Bipolar Disord 2006;8:721–739.

vi.     Grunze H, et al. World J Biol Psychiatry 2002;3:115–124.

vii.    Scottish Intercollegiate Guidelines Network (SIGN). 2005. Available (Accessed 1 July 2011).

viii.   Calabrese JR, et al. J Clin Psychiatry 2004;65:569–579.

ix.     Suppes T, et al. J Clin Psychiatry 2005;66:870–886.

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Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2010.