The antihypertensive market is expected to exceed $50bn (€41bn) by 2014 across the seven major markets, with novel treatments and the market-leading Angiotensin Receptor Blocker (ARBs) delivering much of the drive.
Under the terms of the agreement, NicOx will receive an upfront payment of €9.2m and is eligible for potential further milestone payments of €279m
NicOx has the option to co-promote on a fee for detail basis products that result from the agreement to physicians, in the US and certain European countries.
In addition, >Merck will pay NicOx industry standard royalties on the sales of all products resulting from the collaboration.
The trigger of this new agreement follows the completion of NicOx' previous research collaboration with Merck, which showed 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.
"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."
Additional terms of the agreement will see Merck exclusively develop and commercialise 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 believe NicOx' innovative NO-donating technology has the potential to lead to the development of new and improved antihypertensive medicines," said Anthony Ford-Hutchinson, Vice President, Research Medicine, Merck Research Laboratories.
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.
"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 ARBs are now the most prescribed class of antihypertensives, as aggressive marketing and premium pricing enables manufacturers to deliver strong growth in a highly genericised market.
Post-2009, however, the value of the ARB class is set to flatten on the back of generic erosion and indication expansion for the ARBs as a class.
Merck's foray into this competitivie market is with one eye on Novartis' SPP100 (aliskiren), which looks set to become the first innovative treatment for hypertension in over a decade.