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NicOx's glaucoma product begins clinical trials

NicOx has initiated the first in a series of planned clinical trials for a new experimental medicine for the treatment of glaucoma in conjunction with co-development partner Pfizer

French biopharmaceutical company, NicOx, has initiated the first in a series of planned clinical trials for PF-03187207, a new experimental medicine for the treatment of glaucoma in conjunction with co-development partner, Pfizer.

The initiation of the clinical trial follows the granting of an Investigational New Drug (IND) approval for PF03187207 by the FDA, which has resulted in a EUR 1m 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 has been examining nitric oxide-donating prostaglandin F2-alpha analogues for the treatment of glaucoma.

In November 2005, PF-03187207 was selected as the lead candidate for development, from a series of nitric oxide-donating prostaglandin F2-alpha analogue compounds synthesised by NicOx.

Pfizer submitted an Investigational New Drug (IND) application to the FDA in February 2007. The present study will test the safety and tolerability of the compound and demonstrate possible efficacy.

NicOx has received EUR 5m (GBP 3.4m), including the most recent payment, from Pfizer to date and could receive an extra EUR 32m (GBP 21.7m) plus royalties, if the collaboration produces a viable product. The sums do not include 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.

Pfizer held a symposium at the Sixth International Glaucoma Symposium on 29 March, held in Athens, Greece, entitled: "Shielding the optic nerve: reflections on glaucoma risk reduction".

The symposium offered practical guidance of clinical management and insights into how glaucoma specialists approach the challenge of preventing or delaying vision loss in patients at risk for, or diagnosed with, the disease.

The evaluation of risk of glaucoma onset was presented as an essential part of the clinical decision-making process when a patient presents with ocular hypertension. The development of a model for the calculation of the risk of disease onset based on baseline predictive factors was described as a "crucial step in the evolution of glaucoma management".

The pipeline for glaucoma comprises two therapeutic groups: antihypertensives in late-stage clinical trials and neuroprotective agents in preclinical development. According to Frost & Sullivan analysts, the market for glaucoma therapies in the US alone was worth USD 1.5bn in 2004 and has been forecast to increase to around USD 2.8bn (EUR 2.1bn/ GBP 1.4bn) by 2011.

4th April 2007

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