October 27, 2005 03:00 ET

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

Sophia-Antipolis cedex -- (MARKET WIRE) -- October 27, 2005 -- October 27, 2005

NicOx S.A. (Eurolist: NICOX) and TOPIGEN Pharmaceuticals Inc. today 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 E2 million upfront payment and up to E52.9 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.

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.

Paul Wotton PhD., President and CEO of TOPIGEN, commented: "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."

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 E54.9 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.

Michele Garufi, Chairman and CEO of NicOx, commented: "TOPIGEN's commitment to the respiratory area and strong expertise will help maximize 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). 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.

Chronic Obstructive Pulmonary Disease (COPD):

COPD is most prevalent in the elderly population and its main cause is believed to be smoking, although genetic and environmental factors, such as air pollution, are also thought to play a role. Initial symptoms include sho rtness of breath, reduced capacity for physical activity and a serious and persistent cough, with additional complications such as heart problems, muscle wasting and weight loss occurring in later stages of the disease. The decline in respiratory function which these patients experience is thought to result from chronic inflammation of the lungs and bronchi (large airways). Bronchoconstriction, together with the production of abnormal quantities of sputum, frequently blocks the airways and destruction of the alveoli (the microscopic air sacs in the lungs) often leads to a reduced efficiency of gas exchange. COPD is typically treated with inhaled corticosteroids, beta 2-adrenergic agonists and muscarinic antagonists, but unfortunately irreversible damage has typically occurred by the time symptoms appear. COPD can be divided into two main disease types, chronic bronchitis and emphysema, with one rarely occurring without some degree of the other.

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

NicOx seeks to commercialize its products through partnerships and co -development agreements where it maintains future marketing rights for specialist products.

NicOx S.A. (Bloomberg: COX:FP, Reuters: NCOX.LN), headquartered in Sophia-Antipolis, France, is a public company listed on the Eurolist of Euronext Paris (segment: Next Economy).


TOPIGEN is a privately held biopharmaceutical company developing several new classes of drugs for respiratory disorders based upon its proprietary platform technology using novel, DNA/RNA chemistry. These drugs are uniquely focused on inhibiting multiple inflammatory pathways at the cellular site of inflammation using a single drug product. By topically targeting multiple affected airway receptors with its drugs, the Company expects to improve outcomes for many patients with respiratory diseases. This pioneering approach has shown promising preclinical and clinical results in inhibiting the underlying inflammation associated with many pulmonary conditions such as asthma, COPD and allergic rhinitis. TOPIGEN is headquartered in Montreal, Canada.

The elements included in this communication may contain forward looking statements subject to certain risks and uncertainties. Actual results of the company may differ materially from those indicated in the forward-looking statements because of different risks factors described in the company's document de reference.


NicOx: Karl Hanks

Manager of Corporate Relations and Market Analysis

Tel +33 (0)497 15 22 03

Investors in the United States

Burns McClellan: Lisa Burns / Laura Siino

Tel +1 212 213 0006

Financial Dynamics:

Jonathan Birt

Tel +1 212 850 56 34 / Julia Phillips

Tel +44 (0)20 7831 3113

TOPIGEN: G. John Mohr

Corporate Contact

Tel (514) 868-0077,

Media Contact - LaVoie Group: Donna LaVoie, / Bryan Murphy

Tel (781) 596-0200

NicOx S.A.,

2455 route des Dolines, Espace Gaïa II, BP313, 06906 Sophia Antipolis cedex, France.

Tel. +33 (0)4 9238 7020 - Fax +33 (0)4 9238 7030

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