SkyePharma reaches distribution agreement on asthma and COPD drug
SkyePharma has entered into an agreement with Mundipharma International for the development, marketing and distribution of Flutiform, its novel combination product for asthma and chronic obstructive pulmonary disease (COPD).
SkyePharma has entered into an agreement with Mundipharma International for the development, marketing and distribution of Flutiform, its novel combination product for asthma and chronic obstructive pulmonary disease (COPD).
Mundipharma will have exclusive rights to market Flutiform in Europe and other territories outside North, Central and South America, with an option to negotiate for exclusive rights in Japan. Mundipharma is a privately-owned pharmaceutical company that is already SkyePharma's licensee for its oncology drug DepoCyte, in Europe and certain other markets.
SkyePharma's chief executive, Frank Condella, said: 'We expect to reach the market with Flutiform in 2009, by which time the European market for combination treatments for asthma and COPD is expected to exceed US$3 billion.'
SkyePharma will receive royalties on sales by Mundipharma, with the royalty rate in double digits and escalating on attainment of various sales targets. SkyePharma is currently conducting the clinical trials required for US approval of Flutiform in adult asthma. Mundipharma will have access to data from these trials, which will be used as the basis for obtaining European approval of Flutiform.
Mundipharma will also conduct, at its own expense, an additional clinical study needed for regulatory approval in Europe.
Flutiform consists of a unique fixed-dose combination of the long-acting bronchodilator formoterol with the inhaled steroid fluticasone in a proprietary metered-dose aerosol inhaler with a dose counter.