BioWorld International Correspondent

PARIS - NicOx SA and Pfizer Inc. have signed an extension to their March 2006 collaboration agreement that grants New York-based Pfizer the exclusive right to apply NicOx' proprietary nitric oxide-donating technology to drug discovery research in the field of ophthalmology.

The one-year extension of the agreement's research phase provides for NicOx, of Sophia-Antipolis, France, to receive a further €3 million (US$4.4 million) in research funding in March and extends Pfizer's option to license resulting compounds until May 2009.

Under the terms of the original agreement, Pfizer paid NicOx an up-front license fee of €5 million and made a €15 million equity investment in the company in 2006. It also paid NicOx €6 million in research funding in the form of two annual payments of €3 million in 2006 and 2007.

Altogether, NicOx could receive total potential milestone payments in excess of €300 million under the agreement, of which €102 million would arise from the successful full development and launch of the first compound.

Meanwhile, Pfizer initiated a dose-ranging Phase II clinical trial in Japan of PF-03187207, a drug candidate developed by NicOx for the treatment of glaucoma. The product currently is undergoing a Phase II proof-of-concept trial in the U.S.

The Japanese study will compare the safety and efficacy of PF-03187207 in relation to Xalatan (latanoprost), a drug marketed by Pfizer that is the world leader for the treatment of glaucoma, with sales worth some $1.5 billion in 2006.

PF-03187207 is the lead compound selected for development by Pfizer under the collaboration agreement it signed with NicOx in August 2004, which covered the research and development of nitric oxide-donating prostaglandin F2-alpha analogs for the treatment of glaucoma.

The trial initiated in the U.S. in March 2007 was designed to compare the safety and efficacy of PF-03187207 with Xalatan, with a particular emphasis on its ability to lower intraocular pressure (IOP), and the Japanese trial is similar in design. The primary endpoint is the reduction in IOP at day 28, compared to baseline. Secondary endpoints will include safety assessments and the IOP on days 14 and 28, as well as the proportion of patients attaining target IOP or less at each of the study visits.

According to NicOx, PF-03187207 has the potential to be more effective in reducing high IOP than drugs currently on the market. 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.

"We believe the initiation of this separate Japanese study for PF-03187207 highlights Pfizer's determination to rapidly advance this clinical program toward coordinated regulatory filing in the world's major pharmaceutical markets," said Maarten Beekman, vice president of clinical development at NicOx.

"Preclinical results have suggested that NicOx' technology has the potential to deliver improved treatments for glaucoma, and we look forward to the results of the ongoing proof-of-concept Phase II study of PF-03187207 in the United States," he added.

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