SkyePharma, Kos sign deal for marketing, distribution of asthma drug Flutiform in United States

By E. Janene Geiss

Philadelphia, May 8 - SkyePharma plc said Monday that it has entered into an agreement with Kos Pharmaceuticals, Inc. to jointly develop Flutiform, SkyePharma's novel combination product for asthma and chronic obstructive pulmonary disease, or COPD.

Kos said it will have exclusive rights to market Flutiform in the United States and a right of first negotiation in Canada, according to a company news release.

SkyePharma said it could receive up to $165 million in milestone payments on achievement of all regulatory and revenue targets, of which $25 million has been paid upfront. SkyePharma will also receive royalties from Kos sales.

The United States represents the largest market opportunity for Flutiform, officials said.

SkyePharma said remains in negotiations with potential partners for Europe and other markets around the world.

Kos also is active in the respiratory market with its recently acquired inhaled steroid product, Azmacort.

Kos said it plans to increase its sales force of 750 members concentrated on the cardiovascular and respiratory markets, expecting to have more than 1,000 representatives by the time Flutiform is launched.

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.

The product is taken twice a day. SkyePharma's proprietary formulation technology, designed to stabilize the active components and thereby ensure a reproducible dose even after prolonged storage, provides patent protection for Flutiform to 2019.

Flutiform is in phase 3 development for the indication of asthma in adults and adolescents and is expected to be submitted for approval by the FDA in the second half of 2007, reaching the market in 2009.

London-based SkyePharma develops pharmaceutical products benefiting from world-leading drug delivery technologies that provide easier-to-use and more effective drug formulations.

Kos is a Cranbury, N.J., fully integrated, specialty pharmaceutical company engaged in developing, commercializing, manufacturing and marketing proprietary prescription products for the treatment of chronic diseases.

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