"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, 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 marketing authorization for darifenacin, while Bayer Vital gains exclusive commercialization rights for EMSELEX in Germany.
About EMSELEX
EMSELEX is a once-daily M3 selective receptive antagonist (M3 SRA) oral treatment that works by selectively inhibiting the M3 receptor, the primary mediator of detrusor contraction, whilst 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% versus placebo.1 Additional clinical trials comparing EMSELEX with placebo showed that 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.2
EMSELEX® (darifenacin hydrobromide),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 27th October 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.
About OAB
Symptoms of overactive bladder include urinary urgency (a sudden and compelling desire to pass urine, which is difficult to defer) with, or without, urge incontinence (involuntary leakage accompanied by urgency), usually with urinary frequency (voiding the bladder too often), and nocturia (waking at night one or more times to void the bladder).
Disclaimer
This release contains certain forward-looking statements that can be identified by the use of forward-looking terminology, such as "will reach", or similar expressions, or by express or implied discussions regarding potential additional marketing approvals or future sales of EMSELEX. Such forward looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause the actual results with EMSELEX to be materially different from any future results, performance, or achievements expressed or implied by such statements. There can be no guarantee that EMSELEX will receive any additional marketing approvals in any other countries, or that it will reach any particular sales levels. Any such results can be affected by, among other things, uncertainties relating to clinical trials, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection, competition in general, government, industry, and general public pricing pressures, as well as factors discussed in the Company's Form 20-F filed with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
References
1. Chapple C. Darifenacin is effective in improving the major symptoms of overactive bladder: A pooled analysis of phase III studies. Eur Urol Suppl 2004;3(2):A512
2. Haab F et al. Darifenacin, an M3 Selective Receptor Antagonist, is an Effective and Well-Tolerated Once-Daily Treatment for Overactive Bladder. European Urology. 2004; 45: 420-429.
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