Healthcare Industry News:  trospium chloride 

Biopharmaceuticals Urology

 News Release - August 13, 2007

Esprit Pharma Secures Marketing Rights to SANCTURA(R) XR Creating a New Benchmark for Tolerability in the Treatment of Overactive Bladder

EAST BRUNSWICK, N.J.--(HSMN NewsFeed)--Esprit Pharma, Inc. announced today that it has exercised its option to acquire the marketing rights of the recently approved SANCTURAŽ XR (trospium chloride extended release capsules). Today, Esprit Pharma paid the milestone due upon approval by the U.S. Food and Drug Administration (FDA) to its development and co-promotion partner, Indevus Pharmaceuticals, Inc., securing Esprit rights to market SANCTURA XR in the United States and its territories. Indevus announced on Monday, August 6, that SANCTURA XR had been approved by the FDA.

SANCTURA XR is indicated for the once-daily treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

SANCTURA XR, the once-daily formulation of SANCTURAŽ, is a unique quaternary ammonium compound in a class of anticholinergic compounds known as muscarinic receptor antagonists.

OAB is a medical condition whose symptoms include urinary frequency, urgency, and urge urinary incontinence, the accidental loss of urine that occurs after the strong, sudden urge to urinate. OAB is estimated to affect approximately 33 million Americans and represents a significant clinical problem with potential medical, hygienic, and social consequences. When untreated, this condition can lead to disability, dependence, and isolation from the community. It is most prevalent among the elderly and strikes women twice as frequently as men. A major barrier to the successful treatment of this condition is the high discontinuation rate due to intolerable side effects. Dry mouth is cited as the primary reason for why patients stop taking their medication.

"The introduction of SANCTURA XR will provide overactive bladder patients an efficacious treatment combined with excellent tolerability," said David R. Staskin, M.D., Director, Section of Voiding Dysfunction, New York Presbyterian Hospital and associate professor of urology and obstetrics and gynecology at Weill-Cornell Medical College and a lead investigator of the Phase III clinical study. "The efficacy of the prior formulation is preserved as well as the lack of metabolic drug-drug interactions, while the dry mouth rate is half of the prior formulation. SANCTURA XR offers physicians a unique quaternary amine as a once-daily treatment option for patients whose quality of life is significantly affected by bladder control issues."

John T. Spitznagel, chairman and chief executive officer of Esprit Pharma, stated, "The approval of SANCTURA XR sets a new benchmark in the treatment of overactive bladder, further strengthens our flagship brand, and reinforces our commitment to patients who suffer from overactive bladder and the clinicians who treat them. We are extremely excited about bringing this best in class compound to market in the near future."

Esprit is responsible for the marketing and sales of SANCTURA XR and Indevus is a sales co-promotion partner for the product through 2008.

Prescribing Information

Complete prescribing information for SANCTURA XR is available from the Company upon request.

About Esprit Pharma

Esprit Pharma is a niche oriented, forward thinking pharmaceutical company committed to improving patient outcomes and well-being within the urology and women's health care fields. Led by a highly experienced management team, Esprit focuses on serving the unique needs of these physician specialties by selectively acquiring and maximizing the potential of approved and late-stage development medicines and providing support through internal expertise and a dedication to medical education. Esprit is a privately held company with investment support from several leading healthcare venture capital and private equity firms. For additional information visit the Company's Internet site at www.espritpharma.com.


Source: Esprit Pharma

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