NicOx S.A. and Topigen Pharmaceuticals Inc. have signed a license and development agreement for NicOx' phase 2a compound, NCX 1020, in Chronic Obstructive Pulmonary Disease (COPD) and other respiratory disorders.

According to a company release, NicOx has granted Topigen rights to NCX 1020 in North America, in return for a €2 million upfront payment and up to €52.9 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.

Paul Wotton , president and CEO, Topigen, stated, "NCX 1020 is an excellent drug candidate for the treatment of COPD. It represents an exciting new class of nitric oxide-donating therapeutics targeted at inflammation in lung disorders. In our own laboratory, we have shown that the product has unique pharmacologic properties, which target specific markers of COPD. We are pleased to be collaborating with NicOx, the leader in the discovery and development of novel drugs using nitric oxide technology."

The release further states that under the terms of the agreement, Topigen acquires the development and commercialisation rights to NCX 1020 in North America with an option to obtain rights to the rest-of-world from NicOx at a later date.

Michele Garufi, chairman and CEO of NicOx, commented, "Topigen's commitment to the respiratory area and strong expertise will help maximise the value of this promising product and we support the decision to focus on the poorly served COPD patient population, where there is a greater opportunity to demonstrate clinical benefit. This is another important advance in our strategy of partnering with leading biopharmaceutical companies outside our key therapeutic domains."

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).

COPD represents the fourth-leading cause of death in the United States and is projected to become the third-leading cause of death by 2020. Current treatments improve quality of life and provide symptomatic relief in some patients. However, there are no drugs available that can slow the progressive decline in lung function, which is characteristic of the disease. Therefore, there is a pressing need for more effective therapies, which can target the underlying inflammatory processes responsible for COPD lung damage

NicOx S.A. is an emerging pharmaceutical company involved in the research and development of nitric oxide-donating drugs with superior efficacy and safety profiles in the inflammation, pain and cardiovascular therapeutic areas.