PHILADELPHIA, PA, USA (Press Release) - June 19, 2008 - GlaxoSmithKline (NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Avodart(dutasteride) in combination with tamsulosin for the treatment of symptomatic enlarged prostate, a disease that affects half of all men over 50 years old.¹ The new indication reflects emerging research showing the combination of the two medicines treats the symptoms of enlarged prostate more effectively than either medicine alone.

“The combination of Avodart and tamsulosin at diagnosis allows doctors to simultaneously treat the patient’s prostate on two fronts by reducing prostate size and rapidly improving symptoms,” said Steven A. Kaplan, M.D., from Weill Cornell Medical College of Cornell University in New York City.

Common symptoms of enlarged prostate include nocturia, frequent and urgent urination, incomplete emptying, starting and stopping, and weak stream. If left untreated, enlarged prostate can lead to hospitalization for the inability to urinate or prostate surgery.²

Avodart already had been approved by the FDA for the treatment of enlarged prostate to improve urinary symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of prostate-related surgery.³ Tamsulosin, an alpha-blocker, already had been indicated for the treatment of the signs and symptoms of enlarged prostate.⁷

The FDA approval was based on two-year results of the CombAT (Combination of Avodart and Tamsulosin) study, one of the largest clinical trials to date of men with enlarged prostate.² The CombAT study is the first long-term assessment of the combination of Avodart and an alpha-blocker.² Study results were first presented in September 2007 at the 29th annual meeting of the Société Internationale d'Urologie in Paris. The study was published in the February issue of the Journal of Urology.

The CombAT study results showed that combination therapy with Avodart and tamsulosin was superior to both monotherapies at Month 12 and continued to Month 24.² The primary endpoint was the change in International Prostate Symptom Score (IPSS)^[1] from baseline at Month 24 for combination therapy compared to each medication alone. The most common adverse reactions reported in subjects receiving combination therapy were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness.³

Data from the remaining 2 years of the CombAT study will provide further information on the pattern of symptoms and long-term outcomes associated with combination therapy vs. Avodart and tamsulosin monotherapies.

About CombAT
CombAT is a multicenter, randomized, double-blind and parallel-group study. Men [aged ≥50 years with a prostate volume (PV) ≥30 cc, serum prostate-specific antigen (PSA) level 1.5-10 ng/mL, Qmax >5 and ≤15 mL/sec with a minimum voided volume ≥125 mL and International Prostate Symptom Score (IPSS) ≥12] with moderate-to-severe enlarged prostate symptoms received placebo for four weeks and were then randomized to receive Avodart 0.5 mg/day and tamsulosin 0.4 mg/day (n=1610), Avodart 0.5 mg/day (n=1623), or tamsulosin 0.4 mg/day (n=1611).²

About Avodart
Avodart, the first and only dual 5ARI for the treatment of enlarged prostate, inhibits both the type I and type II isoenzymes responsible for the conversion of testosterone into dihydrotestosterone (DHT). DHT is the primary male hormone responsible for the enlargement of the prostate. Avodart suppresses DHT by 93 percent at 2 years. Avodart is indicated for the treatment of symptomatic enlarged prostate in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of prostate-related surgery. Avodart is now indicated in combination with the alpha blocker tamsulosin for the treatment of symptomatic enlarged prostate. While some men have fewer problems and symptoms after three months of treatment with Avodart, a treatment period of at least six months is usually necessary to see if Avodart will improve symptoms.

Only a healthcare provider can tell if symptoms are from an enlarged prostate and not a more serious condition such as prostate cancer. Men should see their doctors for regular exams. Children and women who are or may become pregnant should not take Avodart. Women who are or may become pregnant should not handle Avodart. Men treated with Avodart should not donate blood until at least six months after their final dose.

Caution should be used in patients with liver disease. Possible side effects include sexual side effects and breast tenderness and/or swelling. These side effects occur infrequently. For full prescribing information, see www.avodart.com.

About Enlarged Prostate
Enlarged prostate is a prevalent and progressive disease that affects 50 percent of men over 50 years of age and over 90 percent of men older than age 80.¹ An enlarged prostate causes changes in urinary habits because of its location around the urethra. Over time, the prostate can continue to grow and urinary symptoms may worsen as the bladder loses the ability to empty itself. Left untreated, in severe cases, an enlarged prostate can lead to serious long-term problems including acute urinary retention (AUR) and the need for prostate-related surgery, and in rare cases even kidney or bladder damage.⁶

About GlaxoSmithKline
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. Company information line: 1-888-825-5249. Website address: www.gsk.com

References:

1. Presti JC Jr. Neoplasms of the prostate gland. In: Tanagho EA, McAninch JW, eds. Smith’s General Urology 15th ed. New York, NY: Lange Medical Books/McGraw-Hill Professions Division: 2000:399-421.
   
2. Roehrborn C, Siami P, Barkin J, et al. The Effects of Dutasteride, Tamsulosin and Combination Therapy on Lower Urinary Tract Symptoms in Men with Benign Prostatic Hyperplasia and Prostatic Enlargement: 2-Year Results from the CombAT Study. J Urol 2008 Feb; 179: 616-621.
   
3. Avodart Prescribing Information
   
4. McConnell J, Roehrborn C, Bautista O, et al. The Long-Term Effect of Doxazosin, Finasteride, and Combination Therapy on the Clinical Progression of Benign Prostatic Hyperplasia. N Engl J Med 2003 Dec; 349(25):2387-2398.
   
5. Barry MJ, Fowler FJ Jr, O'Leary MP, et al. The American Urological Association symptom index for benign prostatic hyperplasia. J Urol 1992 Nov; 148(5):1549-57. Accessed on January 7, 2008
   
6. National Institute for Diabetes and Digestive and Kidney Disease (NIDDK). Prostate Enlargement: Benign Prostatic Hyperplasia. Accessed on June 6, 2008.
   
7. Flomax PI

[1] The International Prostate Symptom Score (IPSS) is a symptom index for enlarged prostate that was developed and validated by a multidisciplinary measurement committee of the American Urological Association (AUA). The symptom index includes questions covering frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency.⁵

GlaxoSmithKline

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