GlaxoSmithKline: Combo Drug Set to Become Blockbuster

08 Jul 2010 • by Natalie Aster
GlaxoSmithKline's Jalyn is approved in the US for the treatment of benign prostatic hyperplasia.

The FDA has approved GlaxoSmithKline's combination drug Jalyn for the treatment of symptomatic benign prostatic hyperplasia in men with enlarged prostate. Although the drug will face various challenges, Jalyn will drive GlaxoSmithKline to become the leading company in this market.

GlaxoSmithKline has received US marketing authorization for Jalyn (tamsulosin and dutasteride) to treat benign prostatic hyperplasia (BPH). This follows EU approval in March 2010, where it is marketed as Duodart. The FDA's decision was based on positive data from the extensive CombAT trial, which demonstrated that Falyn is more effective in relieving symptoms than tamsulosin on its own. As Datamonitor had previously predicted, the drug is expected to be launched in the second half of 2010.

BPH is a non-cancerous enlargement of the prostate affecting over 15 million men over the age of 50 years in the seven major markets (US, Japan, France, Germany, Italy, Spain, UK). Clinical BPH occurs when patients develop bothersome lower urinary tract symptoms, such as painful and frequent urination, and constriction of urine flow causing urinary retention. Symptoms increase almost linearly with age and with the aging population and the increase in life expectancy this condition is an interesting opportunity for pharmaceutical companies.

In 2009, the BPH market was valued at $4 billion across the seven major markets displaying strong growth from 2005. Performance was driven by strong sales for the gold standard of symptomatic treatment Flomax (tamsulosin, Merck & Co). GlaxoSmithKline entered this lucrative market in 2003 with Avodart (dutasteride), the second disease modifying drug on the market, which quickly became a leading brand with global BPH-specific sales in excess of $830m in 2009, up 18% on the previous year.

Jalyn is the first fixed dose combination to be approved for BPH. By combining the current gold standard therapies tamsulosin and dutasteride in one capsule, Jalyn will become a popular first-line treatment providing both acute symptom relief and long term reduction in prostate volume.

GlaxoSmithKline will, however, need to overcome one or two hurdles through this process. The possible accumulation of side effects could hinder uptake but given the expiry of Flomax's patent in the US in 2009, the main challenge for GlaxoSmithKline will be ensure the reimbursement of the new drug. The company will have to price its product carefully to appease payers. Nonetheless, Datamonitor expects sales for Jalyn to offset generic erosion and the product will become the market leader by 2018 with sales in excess of $1.1 billion across the seven major markets.

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