NicOx S.A. announced it has achieved the first milestone in its agreement with Merck & Co., Inc. in the anti-hypertensive field, resulting in a €5 million milestone payment to NicOx. The milestone was linked to the initiation of Good Laboratory Practice (GLP) toxicology studies on the first development candidate that was recently selected by the two companies. This milestone represents an important step towards the future initiation of clinical development on this compound.
Michele Garufi, chairman and CEO of NicOx, declared: "We are very pleased by the rapid selection of the first development candidate with Merck and are eager to move this antihypertensive compound into clinical development. The selection and advancement of this compound is a testament to the excellent joint research conducted by NicOx and Merck and once again highlights the potential of our nitric oxide-donating technology to generate safe and effective new product candidates for human health."
NicOx and Merck have been working together in a major collaboration since March 2006, which is focused on the development and commercialization of new antihypertensive drugs using NicOx' proprietary nitric oxide-donating technology for the treatment of high blood pressure, complications of hypertension and other cardiovascular and related disorders. NicOx and Merck have selected the first nitric oxide-donating compound as a candidate for development. The companies have now entered a new stage of the collaboration by initiating Good Laboratory Practice (GLP) compliant toxicology studies, which are expected to provide data needed for the submission of an Investigational New Drug (IND) procedure with the US Food and Drug Administration (FDA). Merck is responsible for the funding and performance of the development of this compound going forward.
Under the terms of the agreement, Merck has the exclusive right to develop and commercialize antihypertensive compounds using NicOx' proprietary nitric oxide-donating technology for the treatment of systemic hypertension. 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. In addition, Merck will pay NicOx industry standard royalt ies on the sales of all products that result from the agreement. To date NicOx has received €14.2 million from Merck in connection with this agreement, including the €5 million milestone payment announced, and stands to receive €274 million in further potential milestone payments.