Pfizer decides not to launch phase III trials for glaucoma drug

New York-Pfizer officials have decided not to launch global phase III trials of NicOx’s PF-03187207 glaucoma drug but plan to continue collaborating with the French company.

A phase II study of the drug in the United States compared the safety and efficacy of various doses of the nitric oxide-donating prostaglandin analog with another prostaglandin analog, latanoprost 0.005% (Xalatan, Pfizer), in patients with primary open-angle glaucoma and ocular hypertension. The higher doses of PF-03187207 demonstrated a clinically significant reduction in diurnal IOP from baseline, according to NicOx, and the highest dose showed consistently more IOP lowering than latanoprost at all study visits and at all individual time points.

On the primary endpoint at 28 days, however, PF-03187207 showed a 12% improvement over latanoprost, which did not reach statistical significance. A statistically significant advantage over latanoprost was observed on several secondary endpoints, however, according to NicOx.

“While the study did not meet its primary clinical endpoint and our criteria for launching a global phase III program for this compound, we remain committed to our joint research program with NicOx, where the follow-up compounds to PF-03187207 have produced encouraging results,” said David Eveleth, vice president, ophthalmology development, Pfizer.

Per the companies’ 2006 collaboration agreement, Pfizer has an option to obtain exclusive worldwide licensing rights to nitric oxide-donating prostaglandin analogs developed through May 2009. The successful development and launch of these compounds would result in milestone payments and industry-standard royalties on sales to NicOx.

“Although Pfizer has decided that PF-03187207 does not meet its specific requirements for the U.S. and European markets, we believe this phase II study demonstrates a clear commercial potential for PF-03187207, and we are exploring possible strategies with Pfizer to unlock this value,” said Michele Garufi, chairman and chief executive officer of NicOx. “Moreover, the promising results from our joint research program make us confident that a follow-up candidate will be selected by Pfizer with the potential for further improvement over existing treatments.”

Pfizer is conducting a phase II study of PF-03187207 in Japan and may continue the development of the drug for potential registration in Asia, including Japan, depending on the results of this study, which are expected in the third quarter of this year. The two companies also are in discussions regarding the rest-of-world rights to the compound. Asia currently accounts for 20% of sales of latanoprost.