Novartis Pharma AG announced the start of a collaboration between Novartis Pharma GmbH and Bayer Vital AG for the commercialisation and distribution of Emselex (darifenacin hydrobromide) 7.5 mg and 15 mg in Germany. Emselex, a new once-daily M3 selective receptor antagonist (M3 SRA) recently received marketing approval from the European Commission in 25 European member states as well as Norway and Iceland for the treatment of overactive bladder (OAB), a company release said.

"Bayer Vital has significant expertise of the German urology market, so collaborating with them helps to ensure that Emselex will reach physicians quickly and ultimately benefit patients who suffer from overactive bladder," said Kurt Graves, chief marketing officer of Novartis Pharma AG. "Emselex is a new effective drug for the treatment of OAB that is selective for the M3 receptors in the bladder, with proven efficacy, good tolerability and with a well established central nervous system and cardiovascular safety profile."

Under the terms of the collaboration, Novartis remains the owner of the EU marketing authorization for darifenacin, while Bayer Vital gains exclusive commercialisation rights for Emselex in Germany.

Emselex is a once-daily M3 selective receptor antagonist (M3 SRA) oral treatment that works by selectively inhibiting the M3 receptor, the primary mediator of detrusor contraction, while sparing the M1 and M2 receptors that are located in various body organs, including the brain and heart. Emselex has been shown to effectively reduce the number of weekly incontinence episodes by up to 77 per cent versus placebo.1 Additional clinical trials comparing Emselex with placebo showed Emselex does not impair cognitive function and has a cardiovascular safety profile similar to placebo.

To date, 98 clinical trials with Emselex have been completed involving more than 10,500 subjects and patients, of whom 7,146 were treated with darifenacin. Across a range of pivotal endpoints, Emselex has been shown to significantly improve all other key symptoms of OAB, including the number of times patients had to visit the bathroom each day, bladder capacity, frequency of urgency, severity of urgency and the number of incontinence episodes leading to a change in clothing or pads.

Emselex 7.5mg and 15mg was granted approval by the European Commission for the treatment of overactive bladder (OAB) in all 25 European member states as well as Norway and Iceland on October 27, 2004. Novartis is able to market Emselex throughout these countries. This product is known as Enablex in the US. The US Food and Drug Administration issued an approvable letter in October 2003 for the approval of Enablex in the US, and discussions with the FDA are progressing according to schedule.