LONDON, UK, 22 November 2010 - SkyePharma PLC (LSE: SKP) today announces that enrolment for two Phase III studies to assess efficacy and safety of Flutiform™ has commenced in Japan.
The two Phase III trials will provide clinical data to support the regulatory process in Japan. One of the trials is a multicentre, comparative study designed to confirm the efficacy and safety of Flutiform™ compared with monotherapy, and the second is a long-term study to confirm the safety and efficacy of Flutiform™.
Under the agreement with Kyorin for Japan, development and approval milestones worth several million pounds are payable to SkyePharma and there is a high mid single digit percentage royalty on net sales. The development costs associated with obtaining approval for the Japanese market will largely be met by Kyorin, which is responsible for clinical studies and regulatory submissions.
The Group continues to make preparations for a potential launch of Flutiform™ in Europe in 2011. The Marketing Authorisation Application was submitted to the MHRA in March 2010. Mundipharma has the rights to market the product in Europe.
Dr Axel Müller, Chief Executive Officer, said: “We are pleased to report continued progress, ahead of schedule, with the development programme for Flutiform™ in Japan. We look forward to working with our partner, Kyorin, as we move a step closer towards commercialising Flutiform™ in this important and growing market.”
For further information please contact:
Axel Müller, Chief Executive Officer +44 207 491 1777
Peter Grant, Chief Financial Officer
Jonathan Birt /Sue Quigley +44 207 831 3113
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Group 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.
Flutiform™ HFA-MDI is a fixed-dose combination of fluticasone and formoterol in a metered dose inhaler (“MDI”). The product incorporates the most commonly prescribed inhaled anti-inflammatory corticosteroid (fluticasone propionate) and a fast onset long-acting beta-agonist (formoterol fumarate) in combination with an environmentally-friendly aerosol propellant hydrofluoroalkane (“HFA”) and is being developed for asthma.
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