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GlaxoSmithKline submits European marketing authorisation application for Pazopanib in advanced kidney cancer

Issued: Wednesday 4 March 2009, London, UK and Philadelphia, PA

GlaxoSmithKline (GSK) today announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for pazopanib as an oral therapy for patients with advanced and/or metastatic renal cell carcinoma (RCC).

RCC is the most common type of kidney cancer.[1]  The incidence of RCC is rising throughout the world[2] with 208,000 new cases diagnosed annually, and over 100,000 deaths.[3] More than 10 percent of new cases are diagnosed in Western Europe.[4]

Pazopanib is an investigational, oral, angiogenesis inhibitor which targets key proteins responsible for tumour growth and survival.[5]

The MAA submission is based on positive results from a randomised, double-blind, placebo-controlled Phase III study of pazopanib in treatment-naïve and cytokine-pre-treated patients with advanced RCC. The primary endpoint was progression-free survival. Secondary endpoints included overall survival, response rate and safety.[6]  From previously published studies the most common side-effects associated with pazopanib treatment include diarrhoea, hypertension, hair colour change, nausea, anorexia and vomiting. The complete results from the Phase III study will be presented at an upcoming medical conference. 

In December 2008, GSK also completed the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for pazopanib as an oral therapy for patients with advanced RCC. The filing is currently under regulatory review.

“If approved, pazopanib will offer physicians and patients a new therapeutic option for advanced kidney cancer and demonstrate our ongoing commitment to the development of innovative and personalised treatments for patients with cancer.” said Paolo Paoletti, Senior Vice President, R&D Oncology Unit.

“The MAA submission of pazopanib marks our fifth major submission since the formation of the R&D Oncology Unit in September 2008.  Previous submissions included FDA filings for pazopanib and ofatumumab, and MAA submissions for ofatumumab and eltrombopag,” said Moncef Slaoui, Chairman, Research and Development. “These submissions underscore the value of a dedicated Oncology R&D Unit in capturing the many synergies that exist between discovery and development in oncology and in delivering more products of value.”

About Pazopanib

Pazopanib is an investigational, oral, once-daily angiogenesis inhibitor targeting VEGFR, PDGFR and c-kit.5 VEGF and PDGF are growth factors critical to the development and growth of blood vessels[7],[8] – a process known as angiogenesis.[9] Angiogenesis plays a pivotal role in the growth and spread of several tumour types, with VEGF and PDGF overexpression linked to multiple cancers.8,9

Within a broad clinical program across multiple tumour types, there are three Phase III studies currently underway.  Pazopanib is also being evaluated as a monotherapy,in combination with targeted therapies and in combination with cytotoxic chemotherapy.More than 2,000 patients have been treated to date in clinical trials.

For further details please visit www.clinicaltrials.gov.

GSK in Oncology

GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK’s revolutionary ‘bench to bedside’ approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes collaborations with more than 160 cancer centres. GSK is closing in on cancer from all sides with a new generation of patient focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

To access the latest GSK Oncology media materials, visit www.gskcancermedia.com

Enquiries:

UK Media enquiries:

Philip Thomson

(020) 8047 5502

David Outhwaite

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Stephen Rea

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US Media enquiries:

Nancy Pekarek

(919) 483 2839

Mary Anne Rhyne

(919) 483 2839

Kevin Colgan

(919) 483 2839

Sarah Alspach

(215) 751 7709

European Analyst/Investor enquiries:

David Mawdsley

(020) 8047 5564

Sally Ferguson

(020) 8047 5543

Gary Davies

(020) 8047 5503

US Analyst/ Investor enquiries:

Tom Curry

(215) 751 5419

Jen Hill

(215) 751 7002

Cautionary statement regarding forward-looking statements
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 2007.

References [1] American Cancer Society. “What is Kidney Cancer (Renal Cell Carcinoma)?” http://www.cancer.org /docroot/CRI/content/ CRI_2_2_1X_What_is_kidney_cancer_22.asp?sitearea=.  Accessed December 9, 2008.[2]     Murai M and Oya M. Renal cell carcinoma: etiology, incidence and epidemiology. Curr. Opin. Urol. 2004;14, 229-233.[3]     Parkin M, Bray F et al.  Global Cancer Statistics.  CA Cancer J Clin. 2005;55:74-108.[4]     International Agency for Research on Cancer.  GLOBOCAN Report, 2002.  http://www-dep.iarc.fr/. Accessed March 2, 2009.[5]     Sonpavde G and Hutson T. Pazopanib: A Novel Multitargeted Tyrosine Kinase Inhibitor. Curr Oncol Rep. 2007;Mar9(2):115-9.[6]     ClinicalTrials.gov. “GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma.” http://www.clinicaltrials.gov/ct2/show/ NCT00334282?term= pazopanib&cond=renal&rank=3. Accessed December 17, 2008.[7]     Ferrara, N. Vascular Endothelial Growth Factor as a Target for AntiCancer Therapy. Oncologist. 2004; 9 (Suppl 1):2-10.[8]     Heldin, H., and Westermark, B. Mechanism of Action and In Vivo Role of Platelet Derived Growth Factor. Phys Rev. 1999; 79(4):1283-1301[9]     The Angiogenesis Foundation. “Understanding angiogenesis.”  http://www.angio.org/ understanding/understanding.html. Accessed December 12, 2008.