SOURCE: SkyePharma PLC

January 03, 2008 03:45 ET

SkyePharma PLC - Regulatory Approval

London, UK--(Marketwire - January 3, 2008) -

                            SkyePharma PLC

               U.S. FDA Approves New Sular Formulation

LONDON, UK, and Atlanta, USA, 3 January 2008 -- SkyePharma PLC (LSE: SKP) and Sciele Pharma, Inc (NASDAQ: SCRX) announce that the U.S. Food and Drug Administration (FDA) has approved all four dosage strengths of the new Sular® formulation. Sular® is a calcium channel blocking agent for the treatment of high blood pressure. The new Sular formulation utilizes SkyePharma's patented GEOMATRIX™technology, which provides a lower dose of Sular® for each of its current doses. The expected launch for the new Sular® formulation is during the first quarter of 2008.

SkyePharma will receive US$2 million (GBP1 million) upon the approval and also low mid single digit royalties on net sales of new Sular®. SkyePharma will also be manufacturing the new Sular® formulation at our Lyon manufacturing facility.

Dr Ken Cunningham, COO of SkyePharma said: "This new Sular® formulation is a further example of the versatility of the GEOMATRIX™technology and will provide an additional revenue stream for SkyePharma."

For further information please contact:

SkyePharma PLC                Frank Condella             +44 20 7491 1777
                              Ken Cunningham
                              Peter Grant

Financial Dynamics 
 (UK Enquiries)               David Yates                +44 20 7831 3113
                              Deborah Scott

Trout Group (US Enquiries)    Christine Labaree           +1 617 583 1308
                              Seth Lewis

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 Company has eleven 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

About Sciele Pharma, Inc.

Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/ Metabolic, Women's Health and Pediatrics. The Company's Cardiovascular/Metabolic products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit/hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Speed of Execution, Simplicity, and Teamwork.

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