GlaxoSmithKline announces Swiss approval of Duodart®

• The first fixed dose combination medicine for benign prostatic hyperplasia

Issued: London UK

GlaxoSmithKline (GSK) announced today that the Swiss regulatory authority, Swissmedic, has granted approval for Duodart^®, a fixed dose combination (FDC) of dutasteride (0.5mg) and tamsulosin (0.4mg). Dutasteride and tamsulosin FDC is indicated for the treatment of men with moderate-to-severe symptoms of Benign Prostatic Hyperplasia (BPH) and reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate-to-severe symptoms of BPH¹.

“This positive decision by Swissmedic is a significant milestone for Duodart, as it is the first approval in Europe. We look forward to subsequent approvals and launches across Europe during 2010.” said Eddie Gray, President Pharmaceuticals Europe, GSK.

The regulatory submission for dutasteride and tamsulosin FDC was based on data from the CombAT study* ².

CombAT showed that combination therapy with dutasteride and tamsulosin offers patients with moderate-to-severe symptoms of BPH

• Significantly superior and sustained symptom improvement compared with the most frequently prescribed medication, the a-blocker tamsulosin
• Symptom improvement that starts as rapidly as tamsulosin monotherapy** and is sustained over four years
• A significant reduction in the risk of BPH complications – AUR and BPH related surgery vs. tamsulosin by 66% (p<0.001)and by="" 20% vs.="" dutasteride (p="NS)monotherapy" at four="">
• Significantly superior at reducing the relative risk of BPH clinical progression compared to both monotherapies

* (Bioequivalence has been demonstrated between the fixed dose combination and the free combination.)

** Tamsulosin is not indicated to reduce the risk of AUR or BPH-related surgery.

The combination therapy was generally well-tolerated and most reported drug-related adverse events were as anticipated from the known safety profiles of the two drugs, with erectile dysfunction and retrograde ejaculation as the most commonly reported drug-related adverse events. However, the incidence of cardiac failure observed was higher in the combination arm (0.9%) than in the tamsulosin arm (0.6%) and the dutasteride arm (0.2%). There was no difference in overall cardiovascular events across treatment groups.

The 4 Year Combination therapy with Avodart^® and Tamsulosin (CombAT) study was a multinational randomised study of 4,844 men at increased risk of BPH progression, which investigated whether combination treatment with the 5a-reductase inhibitor (5ARI), dutasteride (0.5mg), and an a-blocker, tamsulosin (0.4mg), was more effective than either monotherapy in improving symptoms and clinical outcomes in men with moderate-to-severe symptomatic BPH².

About BPH:

BPH is a very common condition. The histological prevalence in the general male population is estimated to be over 50% of men aged 51-60 years, and increases to 90% in those aged 81-90³.

The prevalence in Europe of moderate-to-severe symptoms of BPH in men ranges from 14% to 30%⁴.

For men who have moderate BPH many experience the bothersome symptoms which impact their quality of life, including interrupted sleep due to nocturia, limitations on daily activities due to a frequent and urgent need to urinate, adverse impact on close relationships, anxiety, and fear of surgery ^5,6,7.

BPH is a progressive disease⁸ and can lead to serious complications like AUR and BPH related surgery⁹. BPH has a significant social and economic burden ^10,11,12.

Notes to Editors:

Duodart^® is a registered trade mark of the GlaxoSmithKline group of companies.

Avodart^® is a registered trademark of the GlaxoSmithKline group of companies.

Duodart ^® has not received regulatory approval in any other market. Registration dossiers have been submitted to the FDA in the United States and the German regulatory authority which is acting as the lead Reference Member State in the Europe, as part of the European Commission’s decentralised procedure.

1. Duodart Summary of Product Characteristics (Switzerland).

2. Roehrborn CG, Siami P, Barkin J,et al.The Effects of Combination Therapy with Dutasteride and Tamsulosin on Clinical Outcomes in Men with Symptomatic Benign Prostatic Hyperplasia: 4-Year Results from the CombAT Study. Eur. Urol. 2010; 5 7:123-131.

3. Roehrborn CG et al. The Benign Prostatic Hyperplasia Registry and Patient Survey: study design, methods and patient baseline characteristics BJU Int 2007; 100: 813–9.

4. Madersbacher S et al. EAU 2004 Guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction (BPH guidelines). Eur. Urol. (2004); 46: 547-554.

5. Emberton M et al. Benign prostatic hyperplasia as a progressive disease: a guide to the risk factors and options for medical management. Int. J. Clin. Pract. 2008; 62: 18-26.

6. Garraway W et al. Impact of previously unrecognized benign prostatic hyperplasia on the daily activities of middle- aged and elderly men. British Journal of General Practice 1003, 318-321.

7. Mitropoulos D et al. Symptomatic Benign Prostate Hyperplasia: Impact on Partners’ Quality of Life Eur. Urol. 41(2002) 240-245.

8. Crawford ED et al. Baseline Factors as Predictors of Clinical Progression of Benign Prostatic Hyperplasia in Men Treated with Placebo. Journal of Urology 2006; 175, 1422-14.

9. Roehrborn CG. Acute Urinary Retention: Risks and Management. Med Reviews 2005; 7:31–41.

10. Fenter TC, Naslund MJ, Shah MB, et al. The Cost of Treating the 10 Most Prevalent Diseases in Men 50 Years of Age or Older Am J Manag Care 2006.

11. Black L, Naslund MJ, Gilbert TD, et al. An Examination of Treatment Patterns and Costs of Care Among Patients With Benign Prostatic Hyperplasia Am J Manag Care 2006;12:S99-S110.

12. McVary KT. BPH: Epidemiology and Co-morbidities. Am J of Managed Care 2006; 12 (5): 122-128.

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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 2009.