SOPHIA ANTIPOLIS, France, March 28 /PRNewswire-FirstCall/ -- NicOx S.A. (Eurolist: COX) today announced that Pfizer Inc has initiated the first in a series of planned clinical trials for PF-03187207, a new experimental medicine for the treatment of glaucoma. The initiation of this clinical trial follows the granting of an Investigational New Drug (IND) approval for PF-03187207 by the United States Food and Drug Administration (FDA), which results in a euro 1 million milestone payment from Pfizer to NicOx.
PF-03187207 is the lead development compound generated under the August 2004 collaboration agreement between Pfizer and NicOx, which is focused on the research and development of nitric oxide-donating prostaglandin F2-alpha analogs for the treatment of glaucoma. PF-03187207 is expected to have an increased capacity to reduce high Intraocular Pressure (IOP, pressure within the eye), based on the well-known activities of nitric oxide. The development of abnormally high IOP, due to blockage or malfunction of systems controlling the amount of fluid in the eye, is believed to be one of the principal causes of glaucoma (see NOTE 1).
In November 2005, PF-03187207 was selected as the lead candidate for development, from a series of nitric oxide-donating prostaglandin F2-alpha analog compounds synthesized by NicOx. During February 2007, Pfizer submitted an Investigational New Drug (IND) application to the FDA (see NOTE 2) and administration of study drug to humans in the first clinical study has now been initiated, following the granting of this IND. This clinical study will test the safety and tolerability of the compound and may provide a first indication of efficacy.
Including the euro 1 million milestone payment announced today, NicOx will have received euro 5 million from Pfizer to date in connection with the 2004 agreement and stands to receive an additional euro 32 million, plus royalties, if the collaboration results in the successful commercial development of a product. These sums are in addition to the research funding and potential milestones and royalties due under the second major agreement, signed in March 2006, which granted Pfizer exclusive rights to use NicOx' proprietary technology across the entire field of ophthalmology.
Damian Marron, Vice-President of Corporate Development at NicOx, declared: "We are very pleased with the rapid progress that has been achieved with Pfizer, which proves the quality of our collaboration and the ability of NicOx' technology to generate robust drug candidates. The granting of the IND and the immediate initiation of the clinical program are key steps in the development of this important drug candidate, which represents a potential leading treatment for glaucoma."
NOTE 1: Glaucoma is a group of eye diseases which can lead to the loss of peripheral vision and eventually total blindness. It is estimated that over 3 million people in the United States suffer from glaucoma and 120,000 are believed to have lost their vision as a result of the disease. The disease is frequently linked to abnormally high pressure in the eye (IOP), due to blockage or malfunction of the eye's drainage systems. Abnormally high IOP does not cause any symptoms itself, however it can lead to vision loss. Drug therapy is used to reduce IOP and therefore prevent further vision loss, typically through increasing the drainage of intraocular fluid by relaxing certain muscles in the eye. Surgery is used in more severe cases, either through creating small scars in the muscles which control fluid outflow with a laser, or by using conventional cutting techniques to create a drainage hole.
NOTE 2: An Investigational New Drug (IND) application is a request for authorization from the FDA to administer an investigational drug or biological product to humans. Once an IND has been submitted, the sponsor (usually the company developing or holding a license to the compound) must wait 30 calendar days before initiating clinical trials. During this time, the FDA has an opportunity to review the IND for potential safety issues, to ensure that subjects will not be subjected to unreasonable risk.
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) 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 pain and inflammation and cardio-metabolic disease. Resources are focused on two lead compounds, naproxcinod (formerly HCT 3012), in phase 3 development for the treatment of osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes.
NicOx has strategic partnerships with some of the world's leading pharmaceutical companies, including Pfizer Inc and Merck and Co., Inc.
NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a public company listed on the Eurolist of Euronext(TM) Paris (segment: Next Economy).
The elements included in this communication may contain forward-looking statements subject to certain risks and uncertainties. Actual results of the company may differ materially from those indicated in the forward-looking statements because of different risks factors described in the company's document de reference.
NicOx S.A.CONTACT: NicOx: Karl Hanks, Manager of Corporate Relations and MarketAnalysis, +33(0)497-24-5342, hanks@nicox.com; Investors in the UnitedStates: Lisa Burns, lburns@burnsmc.com, or Laura Siino, lsiino@burnsmc.com,+1-212-213-0006, both of Burns McClellan; or Media: Jonathan Birt,+1-212-850-5634, jbirt@fd-us.com, or Julia Phillips, +44(0)20-7831-3113,julia.phillips@fd.com, both of FD, all for NicOx S.A.
Web site: http://www.nicox.com/
