11th Dec 2008 10:00
SkyePharma Announces Successful Completion
of Phase I Study for Sleep Maintenance Product (SKP-1041)
LONDON, UK, 11 December 2008 -- SkyePharma PLC (LSE: SKP) and its partner, Somnus Therapeutics, Inc., today announce the successful completion of the first Phase I trial of their controlled release sleep maintenance product, SKP-1041. Under the terms of the 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 utilises SkyePharma's proprietary Geoclock™ technology for controlled release. The formulation is designed to treat people who have difficulty maintaining sleep but not sleep onset, and is intended to prevent middle-of-the-night awakening while avoiding daytime drowsiness.
In June 2007, SkyePharma entered into an exclusive agreement with Somnus 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 also calls for Somnus to pay SkyePharma a milestone payment of US$1 million upon the successful completion of the first Phase I clinical study.
The Phase I study was a single centre, double-blind, placebo controlled cross-over study with an open label positive control arm to investigate the pharmacokinetic and pharmacodynamic profile of single oral doses of alternative zaleplon prototypes in healthy young subjects involving 19 subjects aged between 20 and 50 years.
Dr. Ken Cunningham, CEO of SkyePharma said, "We believe SKP-1041 could generate very significant sales growth for SkyePharma. The sleep maintenance market is large but poorly served and there is a clear need for a product which through controlled release allows early deep sleep and maintains sleep through the night, with no cognitive impairment or daytime drowsiness. The successful completion of this Phase I study for SKP-1041 further validates our confidence in the potential of our Geoclock™ technology, with the first approval of a Geoclock™ product (Lodotra™) expected shortly in the EU."
"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, chief executive officer of Somnus. "We are pleased to be working with SkyePharma, which has been an excellent partner at all levels and has facilitated the swift achievement of this important milestone."
For further information please contact:
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SkyePharma PLC
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Ken Cunningham
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+44 20 7491 1777
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During office hours
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Peter Grant
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Financial Dynamics (UK Enquiries)
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David Yates
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+44 20 7831 3113
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Outside office hours
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Jonathan Birt
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Somnus Therapeutics, Inc.
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Gary C. Cupit CEO
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(908) 901-0300
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Martin Associates (for media)
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Ellen M Martin
Kureczka
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(510) 832-2044
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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 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 www.somnusthera.com.
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