BioWorld International Correspondent

PARIS - NicOx SA received a second milestone of €5 million (US$6.8 million) from Merck & Co. Inc. under the collaboration agreement the two companies signed in March 2006 to develop new antihypertensive drugs using the French company's proprietary nitric oxide-donating technology.

The milestone was triggered by the initiation of the first in a series of planned clinical trials of an initial development candidate selected by the two companies in January this year, which triggered an initial €5 million milestone payment to NicOx, of Sophia-Antipolis, France. At the same time, Merck, of Whitehouse Station, NJ, embarked on good laboratory practice (GLP) compliant toxicology studies before submitting an exploratory IND for the compound to the FDA.

The primary objective of the first trial is to assess the safety, tolerability and pharmacokinetics of single oral doses, in order to select the dose and dosing regimens for further clinical studies. Merck is responsible for developing the compound through to its commercialization and will shoulder all future costs.

"We are delighted that Merck has initiated clinical studies and hope this compound will deliver a major advance in antihypertensive treatment," said Jacques Djian, NicOx' cardiometabolic area leader. "There is evidence that endothelial nitric oxide plays an important role in the regulation of blood pressure, and we believe that this drug candidate could satisfy the clear unmet medical need in the hypertensive market, where more than 40 percent of treated patients do not achieve blood pressure goals, even with the use of existing therapies."

Under its agreement with Merck, which covers NO-donating derivatives of several major classes of antihypertensive agents for the treatment of high blood pressure, complications of hypertension and other cardiovascular disorders, NicOx stands to receive milestone payments totaling €279 million (US$384 million), in addition to an up-front payment of €9.2 million, as well as industry-standard royalties on the sales of all products resulting from the collaboration.

The agreement grants Merck the exclusive right to develop and commercialize antihypertensives that use NicOx' NO-donating technology for the treatment of systemic hypertension. For its part, NicOx has the option to co-promote products that result from the agreement to specialist physicians in the U.S. and certain major European countries on a fee-for-detail basis.