Somnus Therapeutics Completes Phase I Study Of Sleep Maintenance Drug

Main Category: Sleep / Sleep Disorders / Insomnia
Also Included In: Clinical Trials / Drug Trials
Article Date: 15 Dec 2008 - 4:00 PDT

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Somnus Therapeutics, Inc., a private specialty pharmaceutical company developing a controlled-release sleep-maintenance therapy, and SkyePharma PLC (LSE:SKP) today announced the completion of the first Phase I study of SKP-1041. Under the terms of the licensing agreement between SkyePharma and Somnus, a US$1 million milestone payment is now payable to SkyePharma.

SKP-1041 is a new formulation of zaleplon, a non-benzodiazepine hypnotic agent, which utilizes SkyePharma's proprietary Geoclock™ technology for controlled release. The formulation is designed to treat people who have difficulty maintaining sleep but not with sleep onset and is intended to prevent middle-of-the-night awakening while avoiding next-day hangover effects.

In June 2007, Somnus entered into an exclusive agreement with SkyePharma for the worldwide development and commercialization of SKP-1041. Under the agreement, SkyePharma will formulate and manufacture the product and Somnus will develop and commercialize it. The agreement includes a milestone payment of one million US dollars (US$1,000,000) to SkyePharma upon the successful completion of the first Phase I clinical study.

"We are delighted with the successful completion of the Phase I study for SKP-1041 by Somnus," said Dr. Ken Cunningham, CEO of SkyePharma. "Both companies are confident that the Geoclock™ version of zaleplon has the potential to provide major benefits through controlled release; to help provide a good night's rest, as well as validating our formulation and controlled-release technologies. We believe SKP-1041 could generate significant sales in the large but poorly served sleep maintenance market, where there is a clear need for a product which allows deep sleep early and maintains sleep through the night, with no cognitive impairment or daytime drowsiness."

"We are very impressed with SkyePharma's Geoclock™ technology, which provides the reliable release capability that leverages zaleplon's attributes for sleep maintenance with bedtime dosing," said Gary Cupit, CEO of Somnus. "We are equally pleased with the company's flexibility as a partner at all levels, which also facilitated the swift achievement of this important milestone. The success of our virtual business model relies on strong partner relationships such as this one with SkyePharma and the one with our contract research organization. Such relationships are essential to accelerating product development and reducing costs."

The Phase I study was a single-center, double-blind, placebo-controlled crossover study with an open-label positive control arm to investigate the pharmacokinetic and pharmacodynamic profile of single oral doses of alternative zaleplon prototypes in 19 healthy subjects aged between 20-50 years.

About SkyePharma PLC

Using its proprietary drug delivery technologies, SkyePharma develops new formulations of existing products to provide a clinical advantage and life-cycle extension. The Company has twelve approved products in the areas of oral, inhalation and topical delivery. The Group's products are marketed throughout the world by leading pharmaceutical companies. For more information, visit http://www.skyepharma.com.

About Somnus Therapeutics, Inc.

Somnus was founded in the summer of 2007 by Care Capital, a life sciences venture capital firm based in Princeton, New Jersey, with Gary Cupit. By leveraging a small team of experienced managers with a scientific advisory board, clinical research organizations and other outsourced services, Somnus can focus on accelerated clinical development of therapeutics for CNS markets. For more information please visit the Somnus web site at http://www.somnusthera.com.

Somnus Therapeutics, Inc.

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