NicOx and TOPIGEN sign agreement for NCX 1020 in COPD and other respiratory diseases

31-Oct-2005

NicOx S.A. and TOPIGEN Pharmaceuticals Inc. announced they have signed a license and development agreement for NicOx' phase 2a compound, NCX 1020, in Chronic Obstructive Pulmonary Disease (COPD) and other respiratory disorders. NicOx has granted TOPIGEN rights to NCX 1020 in North America, in return for a EUR2 million upfront payment and up to EUR52.9 million in milestones and commercial success fees, in addition to a share in future revenues. NCX 1020 is a novel, proprietary, nitric oxide-donating derivative of budesonide, which is a widely prescribed inhaled corticosteroid for the treatment of respiratory diseases.

Under the terms of the agreement, TOPIGEN acquires the development and commercialization rights to NCX 1020 in North America with an option to obtain rights to the rest-of-world from NicOx at a later date. TOPIGEN will manage and fund all further development activities, through to product registration, supervised by a joint management committee and NicOx will receive an undisclosed royalty on TOPIGEN's net sales in North America. Should TOPIGEN exercise the option for rest-of-world rights, NicOx will receive payment of an option-exercise fee and additional milestones. The total potential payments of EUR54.9 million include those related to the rest-of-world option and those subject to the achievement of development and commercial objectives. In the event that TOPIGEN enters into a development and commercialization agreement for NCX 1020 with a third party, NicOx will receive a share of all resulting TOPIGEN revenue, including potential license fees, milestone payments and royalties.

NicOx has already conducted certain clinical and preclinical studies on NCX 1020, including some in models of COPD (Pulmonary Pharmacology and Therapeutics 17 (2004) 219-232). These studies suggested that NCX 1020 is more effective than budesonide alone in protecting against bronchoconstriction and in inhibiting the infiltration and subsequent activation of neutrophils in the lungs (neutrophils are immune cells implicated in COPD pathology). Using its proprietary discovery capabilities, TOPIGEN recently confirmed and built on these results by demonstrating that NCX 1020 inhibited the release of other mediators involved in COPD, where budesonide had no effect. NicOx completed a phase 1 study and a randomized, double-blinded, placebo controlled phase 2a study in asthmatic subjects. These results indicated that the drug was well tolerated, with a trend in activity and promising pharmacokinetic profile in asthma patients.

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