NicOx receives EUR 5 million milestone from Merck & Co., Inc.
17 Jul 2007 -
NicOx S.A. announced that Merck & Co., Inc. has initiated the first in a series of planned clinical trials for the first selected drug candidate from the companies' major collaborative agreement to develop new nitric oxide -donating antihypertensive agents using NicOx' proprietary technology. The initiation of this clinical trial follows the review of an exploratory Investigational New Drug (IND) submission for this drug candidate by the US Food and Drug Administration (FDA) and results in a EUR 5 million milestone payment from Merck & Co., Inc. to NicOx.
The first trial in the clinical program for this candidate is a phase 1, dose-escalating study in healthy volunteers. The primary objective of this trial is to assess the safety, tolerability and pharmacokinetics of single oral doses, in order to select the dose and dosing regimen for further clinical studies. Merck is responsible for funding and performing the development of this compound going forward. The initiation of this clinical development program follows the announcement in January 2007 of the companies' selection of the first development candidate and that Merck had started the Good Laboratory Practice (GLP) compliant toxicology studies needed to submit an exploratory IND for this compound (see NOTE). Including the EUR 5 million milestone payment announced today, NicOx will have received EUR 19.2 million from Merck under their current agreement, of which EUR 10 million will have been received since the beginning of 2007. NicOx also stands to receive a potential additional EUR 269 million in milestone payments and Merck will pay NicOx industry standard royalties on the sales of products that result from the agreement. Furthermore, NicOx has the option to co -promote products that result from the agreement, on a fee-for-detail basis, to specialist physicians in the United States and certain major European countries.
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