NicOx and Ferrer expand collaboration in dermatology

Published:

NicOx and Ferrer expand collaboration in dermatology

September 15, 2005. Sophia Antipolis, France. www.nicox.com

NicOx S.A. (Eurolist: NICOX) today announced that it has expanded its existing collaboration with Grupo Ferrer Internacional, S.A., for the research, development and marketing of nitric oxide-donating corticosteroids in dermatology. Under the amended agreement, NicOx is eligible to receive additional milestone payments, commercial success fees and royalties, beyond those outlined in the original agreement, in return for granting Ferrer an option on the U.S. development and marketing rights to any products that result from this collaboration.

Topical corticosteroids have been the mainstay for treating a range of common skin disorders since the first use of hydrocortisone in the 1950s (see NOTE 1). Ferrer and NicOx have decided to focus on applying nitric oxide-donating technology to more modern, potent corticosteroids, following the positive clinical results obtained for the prototype compound NCX 1022 (see press release dated April 29, 2004). This decision is based on the medical need for high-potency products with improved side effect profiles.

Antonio Guglietta, Vice President of Research and Development at Ferrer, commented: "Topical corticosteroids are associated with side effects, such as thinning of the skin, which can be permanent and disfiguring in some cases. Newer synthetic compounds have a dramatically increased activity but this has been accompanied by a corresponding increase in side effects. These can require doctors to frequently review patients, use a lower potency cream than is needed for the particular skin disorder under treatment and limit the duration of therapy.

We are very pleased to be expanding this important collaboration with NicOx and believe it has the potential to fulfill the important medical need for synthetic corticosteroids with improved risk-benefit ratios."

The licensing and co-development agreement between NicOx and Ferrer was signed in April 2004. Under the newly amended agreement, NicOx has granted Ferrer an option on the U.S. development and marketing rights, to any products resulting from the collaboration, which it may exercise following the commencement of phase II studies. In return, NicOx is eligible for additional milestone payments, commercial success fees and royalties beyond those foreseen in the original contract. In the case that Ferrer decides to sublicense U.S. rights, NicOx would receive 50% of all payments received by Ferrer from the sub-licensee, including milestone payments, success fees and royalties. Under the amended agreement, Ferrer has marketing rights for the European Union (including EFTA), Latin America, French-speaking Africa (including Morocco and Algeria) and Egypt in addition to the option on U.S. rights. NicOx retains all rights for Asia and has the right to co-market products directly in the European Union and EFTA.

NicOx is responsible for compound synthesis and NicOx and Ferrer are jointly coordinating the currently ongoing preclinical testing of new development candidates. Ferrer will then manage and fund all development through to registration. All research and development activities will be overseen by a joint development committee.

The local skin problems, or skin atrophy, caused by topical corticosteroids have been linked to their ability to reduce dermal blood flow, which can be visualized as a blanching of the skin. Clinical results for NCX 1022 (a nitric oxide-donating derivative of hydrocortisone) revealed no skin blanching, in contrast to reference products, which suggests that the compound has a reduced propensity to cause skin atrophy.

Michele Garufi, Chairman and CEO of NicOx, commented: "We are extremely pleased to be expanding our collaboration with Ferrer. Ferrer represents the perfect partner for this project due to its established sales and marketing presence in dermatology and strong commitment to research and development. This collaboration seeks to address the drawbacks of commonly used products and we believe it represents a significant commercial opportunity. We look forward to its successful progress."

NOTE 1: Topical corticosteroids are used in a range of skin disorders that affect millions of people each year. The severity of these conditions can vary widely and in the worst cases they can be painful, increase the risk of infection and cause social isolation due to appearance. These disorders appear to run in families and often involve an allergic or immune reaction and follow a disease course involving flare-ups and remissions.

- Atopic Dermatitis is commonly referred to as eczema and symptoms typically begin during infancy. Symptoms include rashes and dry, itchy skin.

- Psoriasis is a disease in which skin cells reproduce faster than they are lost from the surface of the skin, due to an immune reaction. There are many different forms of the disease and the most common is plaque psoriasis, which is characterized by raised, thickened patches of red skin covered with silvery, white scales.

- Seborrheic Dermatitis commonly affects the areas of the body where sebaceous glands are most prominent, such as the scalp, forehead and eyebrows. The disease can vary from mild dandruff to dense scales and its development has been associated with yeast infections. The disease peaks in infancy and middle age and is more common in men than in women.

- Contact dermatitis occurs in response to physical contact with an irritant or allergen and normally appears as fluid-filled bumps or blisters at the area of contact.

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.

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).

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.

CONTACTS:

NicOx:

Karl Hanks

Manager of Corporate Relations and Market Analysis

Tel +33 (0)497 15 22 03

hanks@nicox.com

www.nicox.com

Investors in the United States - Burns McClellan: Lisa Burns

lburns@burnsmc.com / Laura Siino

lsiino@burnsmc.com

Tel +1 212 213 0006

Financial Dynamics: Jonathan Birt