LONDON, UK, 20 May, 2008 – SkyePharma PLC (LSE: SKP) today announces the presentation of its Phase III, long-term, open label safety study evaluating Flutiform™ for the treatment of asthma in adolescent and adult patients. The scientific poster will be shown today, during the American Thoracic Society (“ATS”) Meeting in Toronto, Canada.
The ATS meeting is one of the largest gatherings of Pulmonary and Critical Care clinicians and researchers in the world. Last year’s conference in San Francisco was attended by over 16,000 people from 90 countries. The conference provides information on the latest and most significant developments in clinical practice, research (clinical, basic and translational), health advocacy and education.
As announced in November 2007, the study (SKY2028-3-003) involved 472 patients, who were assigned to treatment with Flutiform™, either 100/10µg or 250/10µg twice daily, for 6 or 12 months. The author of the poster, Dr. Ekkehard Beck, stated “Study results suggest that long term treatment with Flutiform™ 100/10µg and Flutiform™ 250/10µg will be a safe therapy for patients with persistent asthma.”
The results of this trial will form part of the US New Drug Application (“NDA”) for Flutiform™. As announced on 30 April 2008, a top line analysis of key results of the first Phase III efficacy study (SKY2028-3-002) demonstrated statistically significant differences in favour of Flutiform™ compared with both fluticasone and formoterol taken alone at the level of improvement in FEV1 (forced expiratory volume in the first second), the primary endpoints measured. It has also been announced that: the last patient visits for the two remaining core Phase III efficacy studies, SKY2028-3-004 and SKY2028-3-001, have taken place and results are expected in the summer; the additional efficacy study, SKY2028-3-005, required for the NDA, has commenced recruitment; and the overall development programme remains on schedule for the NDA to be filed with the FDA in the USA in Q1, 2009.
Frank Condella, CEO of SkyePharma, said: “We are pleased that this poster will be presented today at the ATS, which includes additional data from the Phase III, long-term, open label safety study evaluating Flutiform™ for the treatment of asthma in adolescent and adult patients. The results from our Phase III work continue to be encouraging.”
Background information on study SKY2028-3-003 (presented at ATS 2008 on poster board A40, on 20 May, from 10.45am – 12.15 pm Toronto time)
SkyePharma performed a long term, open-label safety study with Flutiform™ in 472 adult and adolescent patients with asthma. Eligible patients had FEV1 of =40 =85% of predicted normal values.
This long-term safety study demonstrated that the drug was effective and well tolerated in these study patients.
87.5% of the patients completed the study. Seven patients withdrew due to an adverse event, 8 patients withdrew due to an asthma exacerbation and 6 patients withdrew due to lack of efficacy. The study population had a mean FEV1 predicted of 73% and a mean bronchodilator reversibility response of 28%. The overall mean change in FEV1 from baseline to the final visit was +389 +/- 466 mL, p<0.001 in both groups.
37% of patients had treatment emergent adverse events (“TEAEs”), of which 19.9% of were mild and 13.3% were moderate in severity. The most common adverse events were nasopharyngitis, pharyngitis and respiratory tract infection. Ten patients had serious TEAEs, which included 12 events, 4 of which were related to the respiratory system.
For further information please contact: SkyePharma PLC Frank Condella +44 20 7491 1777 During office hours Ken Cunningham
Peter Grant
Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113 Outside office hours 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 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 Flutiform™ Flutiform™ HFA-MDI is being developed as a fixed-dose combination of formoterol and fluticasone in a metered dose inhaler (‘MDI’) for the treatment of asthma. The product incorporates a long-acting beta-agonist (formoterol fumarate) with anti-inflammatory corticosteroid (fluticasone propionate) in combination with an environmentally-friendly aerosol propellant hydrofluoroalkane (“HFA”) and is being developed for asthma. Flutiform™ is aimed at the market for combination steroid and long-acting beta-agonist inhalers which is forecast to be approximately US$10 billion worldwide by 2010.
