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NicOx Announces Initiation of First Phase 1 Study of Investigational Nitric Oxide-Donating Agent in Hypertensive Patients by Merck & Co., Inc.

SOPHIA ANTIPOLIS, France, May 13 /PRNewswire-FirstCall/ -- NicOx S.A. (Eurolist: COX) today announced that Merck & Co., Inc. has initiated the first in a series of planned clinical studies, in mild to moderate hypertensive patients, under the companies' collaborative agreement to develop new nitric oxide-donating antihypertensive agents using NicOx' proprietary technology. Three drug candidates have now been selected from the companies' joint research program, of which two have completed initial dose ranging studies in healthy volunteers under the exploratory clinical study paradigm with encouraging results.

Merck plans to conduct a number of clinical studies in hypertensive patients involving single and multiple ascending dosing, prior to the selection of a compound to be advanced into phase 2. The most advanced candidate is now being evaluated in the first of these studies, which is a single ascending dose trial in mild to moderate hypertensive patients. The main objectives of this study are to assess the efficacy, safety, tolerability and pharmacokinetics of single ascending doses of this candidate. Subsequent studies will assess multiple ascending doses.

"The initiation of this series of clinical studies in hypertensive patients is a very important step towards delivering a new treatment paradigm for hypertension, where the medical need remains significant," commented Jacques Djian M.D., NicOx' Cardiometabolic Area Leader. "We believe these drug candidates have considerable potential as improved antihypertensive agents based on their nitric oxide-donating properties and we hope they will deliver a major advance in antihypertensive treatment for patients worldwide."

In July 2007, NicOx announced the initiation of the first in a series of studies in healthy volunteers for the selected candidates (see press release of July 16, 2007). Merck is responsible for funding and performing the development of these compounds going forward.

To date, NicOx has received euro 19.2 million from Merck under this agreement. NicOx also stands to receive potential additional milestone payments of euro 269 million and industry standard royalties on the sales of products which result from the agreement. Furthermore, NicOx has the option to co-promote resulting products, on a fee-for-detail basis, to specialist physicians in the United States and certain major European countries.

"We are delighted that less than one year after the first drug candidate entered human testing, we now have three drug candidates identified and that the first of these has started patient dosing," said Michele Garufi, Chairman and CEO of NicOx. "We look forward to continued rapid progress in our collaboration with Merck and to the future introduction of a new anti-hypertensive class on the market."

NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven biopharmaceutical company dedicated to the development and future commercialization of investigational drugs for unmet medical needs. NicOx is applying its proprietary nitric oxide-donating technology to develop an internal portfolio of NCEs in the therapeutic areas of inflammatory and cardio-metabolic disease.

Resources are focused on the development of naproxcinod, a proprietary NCE and the first compound in the Cyclooxygenase Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents, which is in phase 3 clinical studies for the treatment of the signs and symptoms of osteoarthritis, with final phase 3 results anticipated in 2008.

Beyond naproxcinod, NicOx has a pipeline containing multiple nitric oxide-donating NCEs, which are in development internally and with partners, including Pfizer Inc and Merck & Co., Inc., for the treatment of prevalent and underserved diseases, such as atherosclerosis, hypertension, glaucoma and Chronic Obstructive Pulmonary Disease (COPD).

NicOx S.A. is headquartered in France and is listed on the Euronext Paris Stock Exchange (Compartment B: Mid Caps).

This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated in the forward-looking statements.

For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of NicOx S.A. to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Document de Reference filed with the AMF, which is available on the AMF website ( or on NicOx S.A.'s website (

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