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Astellas gets first OK for prostate drug Vesomni

Approved in the Netherlands to treat men with lower urinary tract symptoms

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Astellas' new combination product for enlarged prostate problems in men has been approved in the Netherlands, its first market, under the Vesomni brand name.

Vesomni (formerly known as EC905) is a once-daily, fixed-dose combination of the antimuscarinic solifenacin and alpha blocker tamsulosin, which are both established treatments for men with benign prostatic hyperplasia (BPH).

Approval in the Netherlands as a treatment for lower urinary tract symptoms (LUTS) in men with BPH who are not responding to current therapy kicks off the mutual recognition process for EU-wide registration of the new product.

LUTS includes symptoms such as urgency and increased frequency of urination, and voiding difficulties like hesitancy and intermittency, and affect up to 60 per cent of older men in developed countries.

The Dutch approval is based on the results of the phase III NEPTUNE study, which found that Vesomni improved LUTS in men aged over 45 with both voiding and storage symptoms, performing better than both placebo and tamsulosin monotherapy

Urology is a core product franchise for Astellas, with its standalone Harnal (tamsulosin) product for BPH and overactive bladder (OAB) therapy Vesicare (solifenacin) bringing in sales of 67bn yen and 87bn yen respectively in fiscal 2011.

Harnal is starting to decline thanks to generic competition in Japan and Europe and is predicted to fall to around 53bn yen in fiscal 2013, so the Vesomni line extension will help Astellas support the BPH franchise in the coming years.

The company has already added to its OAB franchise with the approval of Myrbetriq/Betanis (mirabegron) in Japan in 2011 and the US last year, and has said in the past it wants to expand sales across its urology franchise to $2bn in fiscal 2014.

23rd May 2013

From: Sales

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