Kos Life Sciences, a subsidiary of Kos Pharmaceuticals, and Jagotec AG, a subsidiary of SkyePharma PLC have signed an exclusive agreement for the marketing and distribution in the United States of SkyePharma's product, Flutiform.

Flutiform is a formoterol and fluticasone fixed dose combination in a HydroFluoroAlkane metered dose inhaler. According to the release, the strategic partnership includes an upfront licensing payment of $25 million. If all regulatory and sales milestones are met, SkyePharma could receive up to an additional $140 million in payments, plus mid-teens sales royalties.

"We are very pleased with SkyePharma's clinical development of Flutiform for the asthma indication and are excited about this commercial opportunity in a very large and expanding market segment," commented Adrian Adams, president and CEO of Kos Pharmaceuticals. "This strategic partnership should broaden our presence in the respiratory area, and provides a high potential partner product for Azmacort, our inhaled corticosteroid therapy," he continued.

SkyePharma's chief executive, Frank Condella, said: "We are delighted to announce this partnership with Kos for our major pipeline product Flutiform. Kos has a tremendous track record of successful marketing with its cholesterol product, Niaspan. Over the past 5 years, sales of Niaspan have increased at a compound annual growth rate of over 50%, helping Kos to become the fastest growing pharmaceutical company in the United States, and the sixth fastest growing of all US companies in 2005. Kos is also active in the respiratory market with its recently acquired inhaled steroid product, Azmacort."

SkyePharma will retain the commercial rights to Flutiform outside the US and Canada and continues to be responsible for Flutiform's Phase III clinical trials and regulatory approval in the United States. SkyePharma will also be responsible for the supply of the product. Kos' responsibilities include the commercialization of Flutiform, the potential clinical development of COPD and paediatric asthma indications and all phase IIIb and phase IV studies

SkyePharma's product Flutiform consists of a unique fixed-dose combination of the long-acting bronchodilator formoterol with the inhaled steroid fluticasone in a proprietary non-CFC metered-dose aerosol inhaler with a dose counter. Formoterol provides 12 hours of bronchodilation and has a rapid onset of action (1-3 minutes).

Kos Pharmaceuticals currently markets Niaspan and Advicor for the treatment of cholesterol disorders, Azmacort for the treatment of asthma, Cardizem LA for the treatment of hypertension and angina, and Teveten and Teveten HCT for the treatment of hypertension.