Diseases and Products | MN-246 (Urinary Incontinence)

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Disease Overview:

Urinary incontinence occurs when normal regulation of bladder function is lost. According to the American Foundation for Urologic Disease, urinary incontinence occurs more frequently in women than in men. According to the National Kidney and Urologic Disease Information Clearinghouse, the number of patients in the United States suffering from urinary incontinence was over 13,000,000 in 2005. In addition, according to the National Overactive Bladder Evaluation Program, over 33,000,000 patients in the United States suffered from overactive bladder in 2005.

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Market Overview:

The market for drugs to treat urinary incontinence is expected to grow substantially as more patients seek treatment and as newer drugs are introduced to the market. According to Datamonitor, the global market for urinary incontinence is projected to grow to $4.0 billion in 2010. The current marketplace is dominated by anti-cholinergic drugs that are modestly effective and produce treatment-limiting side effects such as dry mouth. According to Med Ad News, sales of the market leader, Pfizer Inc.’s Detrol®, were approximately $1.1 billion in 2006.

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MN-246 for the Treatment of Urinary Incontinence:

MN-246 is a novel, orally bioavailable β3-adrenergic receptor agonist under development for the treatment of urinary incontinence. MN-246 represents a new approach to treating urinary incontinence and may have advantages over existing therapies, including improvements in efficacy through increases in bladder volume with decreases in involuntary bladder contractions and the absence of anti-cholinergic effects such as dry mouth.

In preclinical studies, MN-246 exhibited a high degree of selectivity in isolated tissue preparations for the β3-adrenergic receptor subtype relative to the β1- and β2-adrenergic receptor subtypes. The β3-adrenergic receptor is abundant in the bladder wall, whereas β1-adrenergic receptors are found in the heart, small intestine, and adipose tissue and β2-adrenergic receptors predominate in the uterus, blood vessels, diaphragm, and bronchioles. A selective agonist for the β3-adrenergic receptor should relax bladder smooth muscle, allowing it to hold more urine, while exerting minimal effects on the heart and cardiovascular system where β1- and β2- adrenergic receptors predominate.

We initiated a double-blind, randomized, placebo-controlled, single escalating dose Phase I clinical trial of MN-246 for the treatment of urinary incontinence in the first quarter of 2006. This clinical trial, which involved healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of MN-246, was completed in the fourth quarter of 2006. We also conducted a Phase I food effects study in healthy volunteers, which was completed in the first quarter of 2007. MN-246 was tolerated in both clinical trials.

We will limit our development efforts on MN-246 to those activities necessary to maximize MN-246’s value while pursuing a variety of initiatives to monetize this product candidate.

 

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