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NicOx S.A. and Merck & Co., Inc. sign major exclusive worldwide agreement in antihypertensive field

21 Mar 2006

Announced a major new agreement to collaborate on the development of new antihypertensive drugs using NicOx’ proprietary nitric oxide-donating technology.

SOPHIA ANTIPOLIS, France and WHITEHOUSE STATION, NJ, USA | Mar 21, 2006 | NicOx S.A. (Eurolist: NICOX) and Merck & Co.,

Inc., today announced that they have signed a major new agreement to collaborate on the development of new antihypertensive drugs using NicOx’ proprietary nitric oxide-donating technology. This agreement follows the successful completion of the companies’ research collaboration, which has generated promising results.

Under the terms of the agreement, NicOx will receive an upfront payment of €9.2 million (US$ 11.2 million) and is eligible for potential further milestone payments of €279 million (US$ 340.2 million). NicOx has the option to co-promote on a fee for detail basis products that result from the agreement to specialist physicians, such as cardiologists, in the United States and certain major European countries. In addition, Merck will pay NicOx industry standard royalties on the sales of all products resulting from the collaboration.

The agreement covers nitric oxide-donating derivatives of several major classes of antihypertensive agents for the treatment of high blood pressure, complications of hypertension, and other cardiovascular and related disorders. Merck has the exclusive right to develop and commercialize antihypertensives that use NicOx’ nitric oxide-donating technology for the treatment of systemic hypertension.

NicOx will continue to be involved in the new research program, which will be focused on identifying lead candidates for development, while Merck will fund and manage all further pre-clinical and clinical development activities following selection of lead compounds.
“We are very pleased to be entering into this new collaboration with NicOx, which aims to address one of the world’s leading health problems,” said Anthony Ford-Hutchinson, Ph.D, Executive Vice President, Research Medicine, Merck Research Laboratories. “We believe NicOx’ innovative NO-donating technology has the potential to lead to the development of new and improved antihypertensive medicines. With this new agreement, we are building on our excellent existing relationship with NicOx to combine NicOx’ research skills with Merck’s industry-leading development and marketing capabilities in this area, with our joint goal of advancing patient care.” “We are delighted to be entering into this new agreement with Merck, which demonstrates the importance of our research in the cardiovascular area,” said Michele Garufi, Chairman and CEO of NicOx. “The option to co-promote resulting products alongside Merck, which has long held one of the leading cardiovascular franchises in the industry is central to NicOx’ strategy. We intend to leverage this opportunity to support our transformation into a fully integrated biopharmaceutical company.”

The signature of this major new agreement follows the successful completion of NicOx’ previous research collaboration with Merck, which has generated promising results showing that nitric oxide donation can improve the efficacy of antihypertensive agents in in vivo models. Results demonstrated that a prototype NO-donating antihypertensive compound was superior at lowering blood pressure than its widely used parent reference drug in established models of hypertension. Early findings from an additional antihypertensive class are promising and Merck and NicOx will now be concentrating on identifying candidates for development.
“We believe nitric oxide donation offers the potential for delivering antihypertensive agents with improved efficacy,” added Ennio Ongini, Vice President of Research at NicOx. “The results obtained in our joint research collaboration with Merck validate the concept that nitric oxide donation enhances antihypertensive activity. We look forward to seeing this important program enter the clinic as soon as possible, following the signature of this new agreement with Merck.”

Clinical outcome studies have long demonstrated that uncontrolled high blood pressure significantly increases the risk of heart failure, heart attack, stroke and kidney failure. Despite this compelling evidence, treatment remains inadequate, with fewer than half of patients on antihypertensive therapy estimated to have their blood pressure under control. Patients often need a combination of two or more drugs to reach blood pressure goals, highlighting the continued need for more effective therapies.

Experimental evidence suggests that endothelial nitric oxide, released from the lining of blood vessels, plays an important role in controlling blood pressure. Furthermore, the action of nitric oxide also appears to interplay with the reninangiotensin system and the balance of these two signaling systems appears to be important in the control of vascular tone and kidney function.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

About NicOx
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 herapeutic 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).

SOURCE: NicOx S.A.

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