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 €5 million milestone payment from Merck & Co., Inc. to NicOx.
"We believe this candidate has considerable potential as an improved antihypertensive agent, based on its nitric oxide-donating properties," said Jacques Djian MD., 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 per cent of treated patients do not achieve blood pressure goals, even with the use of existing therapies. We are delighted that Merck has initiated clinical studies and hope this compound will deliver a major advance in antihypertensive treatment for patients worldwide."
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 programme 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.
Including the €5 million milestone payment announced today, NicOx will have received €19.2 million from Merck under their current agreement, of which €10 million will have been received since the beginning of 2007. NicOx also stands to receive a potential additional €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.
"NicOx and Merck have been successful in advancing this first compound into the clinic only sixteen months after the signature of our major agreement", said Michele Garufi, Chairman and CEO of NicOx. "We feel confident that the drug candidate resulting from this agreement with Merck, where we have a co-promotion option to specialist physicians in selected markets, together with our lead compound naproxcinod, will represent a solid and attractive basis to transform NicOx into an integrated pharmaceutical company ."
NicOx is a product-driven biopharmaceutical company dedicated to the development of nitric oxide-donating drugs to meet unmet medical needs. NicOx is targeting the therapeutic areas of inflammation and cardio-metabolic disease. Resources are focused on two lead compounds, naproxcinod (formerly HCT 3012); in phase 3 development for the treatment of signs and symptoms of osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes.