March 02, 2006 01:16 ET

NicOx compound demonstrates excellent preclinical results in Pfizer glaucoma collaboration

Sophia Antipolis Cedex -- (MARKET WIRE) -- March 2, 2006 -- March 2, 2006. Sophia Antipolis, France.

NicOx S.A. (Eurolist: NICOX) today announced that it has achieved very promising pre-clinical results in its collaboration with Pfizer Inc. (NYSE: PFE), which is focused on the development of more effective treatments for glaucoma using NicOx' proprietary nitric oxide-donating technology. The NicOx compound proved to be significantly more effective than the reference drug in a validated in vivo model of abnormally high intraocular pressure (IOP, pressure within the eye) and was superior to the reference drug in two other validated models. NicOx also announced today that it has signed a major new agreement which grants Pfizer exclusive rights to use its technology across the entire field of ophthalmology (see separate press release).

It is estimated that over 3 million people in the United States suffer from glaucoma and 120,000 are believed to have lost their vision as a result of the disease (see NOTE 1). Current drug therapy is focused on reducing IOP, which is believed to cause progressive vision impairment. The degree of IOP reduction is believed to be li nked to prognosis. However, despite recent advances in glaucoma treatment, research shows that around 10% of patients who receive proper care still experience vision loss, demonstrating the strong necessity for improved drugs.

Ennio Ongini, Vice President of Research at NicOx, commented: "We find the preclinical results produced by the joint Pfizer-NicOx team extremely interesting, as they indicate that nitric oxide-donation can significantly improve the control of intraocular pressure. This is important, as research suggests that the greater the pressure reduction you achieve, the slower a patient's disease will progress towards vision loss and blindness."

In the first in vivo model, raised IOP was induced transiently, followed by treatment with either vehicle, the NicOx compound, or the reference drug. Mean peak IOP occurred between 60 and 90 minutes and the NicOx compound demonstrated a significantly lower IOP profile in terms of an under the curve analysis (p < 0.05), compared to the reference drug and vehicle.

In a second in vivo disease model, the NicOx compound achieved a maximum mean decrease in IOP of 12.8 mmHg at 4 hours post dose and was superior to the reference drug. The NicOx compound was also significantly better than vehicle at all time points in this model (p < 0.05). In a third in vivo model, the NicOx compound achieved a maximum mean decrease of 9.2 mmHg 2 hours after the first dose, which was significantly better than vehicle (p < 0.05 for hours 1 to 6) and superior to the reference drug.

Michele Garufi, Chairman and CEO of NicOx, added: "We are very encouraged by the strong preclinical results of our compound for the treatment of glaucoma and look forward to working with Pfizer to advance its development into the clinic. These results are a testimony to the potential of our nitric oxide-donating technology to be developed in a wide variety of therapeutic areas."

There is experimental evidence that nitric oxide may play a role in controlling IOP through specific mechanisms, including relaxation of the ciliary muscles and other structures which allow fluid to drain from the eye.

In November 2005, NicOx announced that Pfizer selected a development candidate and exercised its option to acquire an exclusive worldwide license to the proprietary compounds covered by this current agreement, which was originally signed in August 2004. To date, NicOx has received EUR 4 million from Pfizer in connection with this agreement and stands to receive an additional EUR 33 million, plus royalties, if the collaborati on results in the successful commercial development of a product. These sums would be in addition to the upfront payments, research funding, potential milestones and royalties due under the major new agreement with Pfizer that was announced by NicOx today (see separate press release).

NOTE 1: Glaucoma is a group of eye diseases which can lead to the loss of peripheral vision and eventually total blindness. Glaucoma is frequently linked to abnormally high pressure in the eye (IOP), due to blockage or malfunction of the eye's drainage system. Abnormally high IOP does not cause any symptoms itself, however it can lead to vision loss. People over the age of 60 are at an increased risk of developing glaucoma, as are people of African-American and Asian decent. The disease has also been associated with severe nearsightedness, diabetes and previous eye injury. Drug therapy is used to reduce IOP and therefore prevent further vision loss, typically through increasing the drainage of intraocular fluid by relaxing certain muscles in the eye. Surgery is used in more severe cases, either through creating small scars in the muscles which control fluid outflow with a laser, or by using conventional cutting techniques to create a drainage hole.

NicOx (Bloomberg: COX:FP, Reuters: NCOX.LN) is a product-driven biopharmaceutical company dedicated to the development of nitric oxide-donating drugs to meet unmet medical needs. NicOx is targeting the therapeutic areas of inflammatory and cardio-metabolic diseases.

Resources are focused on two lead compounds, HCT 3012, in phase 3 development for the treatment of osteoarthritis, and NCX 4016, in phase 2 for Peripheral Arterial Obstructive Disease (PAOD). NicOx has strategic partnerships with some of the world's leading pharmaceutical companies, including Pfizer Inc. and Merck and Co., Inc.

NicOx S.A. is headquartered in Sophia-Antipolis, France, and 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.


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 Bi rt - Tel +1 212 850 56 34 - / Julia Phillips - Tel +44 (0)20 7831 3113 -

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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