Monday, French biotechnology firm NicOx S.A. (COX.PA) said that a phase II Japanese study of glaucoma drug PF-03187207 did not meet its primary end point of reduction in intraocular pressure at day 28. The company also revealed that Pfizer Inc. (PFE), its partner in the development of the investigational glaucoma drug, has decided not to launch an Asian phase 3 program for PF-03187207, after reviewing the results of the Japanese study.
According to NicOx, in the phase II Japanese study, the two highest doses of PF-03187207 showed an improvement in intraocular pressure over Pfizer Inc.'s (PFE) Xalatan 0.005% of up to 11%. Abnormally raised intraocular pressure is one of the principal symptoms of glaucoma. The phase II study enrolled 112 Japanese patients with primary open-angle glaucoma or ocular hypertension.
In 2007, Xalatan raked in $1.6 billion in global sales. According to U.S. health care data provider IMS Health, sales of Xalatan in Japan totaled $250 million last year.
NiCox stated that PF-03187207 appeared to be safe and well tolerated, with only mild adverse events in the mid-stage study.
In May, the results of the U.S. study of PF-03187207, which enrolled 215 patients, showed that the highest dose of the investigational drug showed a 12% improvement over Xalatan 0.005% at day 28, but failed to attain statistical significance. Following the results of the U.S. study, Pfizer decided not to launch a phase 3 program for PF-03187207 outside of Asia.
In both the Japanese and U.S. studies, PF-03187207 showed a 20% greater reduction in intraocular pressure at 20 hours post-dose compared to Xalatan 0.005%, which reached statistical significance in the U.S. study. The results suggest that PF-03187207 has a more sustained intraocular pressure lowering effect, said NicOx.
NicOx and Pfizer are currently in discussions regarding the rights to PF-03187207, to allow its potential continued development and commercialization. Pfizer and NicOx jointly develop PF-03187207 under an August 2004 agreement. The two companies are currently concentrating on diabetic retinopathy. Diabetic retinopathy is retina damage due to diabetes, which can result in blindness.
PFE closed Friday's trade at $19.75.
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