SkyePharma PLC (Nasdaq: SKYE) has entered into an agreement with Mundipharma International Corporation Limited (Mundipharma) for the European (and other international markets) development, marketing and distribution of Flutiform™, its novel combination product for asthma and chronic obstructive pulmonary disease (COPD).
Mundipharma, a privately-owned pharmaceutical company, 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 has already been licensed by SkyePharma for its oncology drug DepoCyt®, in Europe and certain other markets.
Under the terms of agreement:
SkyePharma has received an upfront payment of euro 15 million ($19 million) on signature and will receive additional milestone payments of up to a further euro 70 million ($90 million) on attainment of various development and revenue targets.
SkyePharma will receive royalties on sales by Mundipharma, with the royalty rate in double digits and escalating on attainment of various sales targets.
In addition SkyePharma and Mundipharma's associate company, Mundipharma Medical Company, will be entering into a manufacturing and supply agreement under which SkyePharma will supply commercial goods and samples to Mundipharma Medical Company at cost plus an applicable margin.
Flutiform™, consisting 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, is currently under clinical trials required for US approval in adult asthma.
The data from these trials will also be accessible to Mundipharma, which will be used as the basis for obtaining European approval of Flutiform™.
Find more details of the agreement at SkyePharma PLC.
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