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NicOx Reports Results for the First Three Quarters of 2008
Date:10/22/2008

zer's decision not to launch a

phase 3 program.

Eric Castaldi, Chief Financial Officer at NicOx, said: "During the third quarter of 2008 we have achieved considerable success in the development of naproxcinod, while keeping the necessary control on expenses. We are very encouraged by the positive top-line results from the 302 phase 3 study, which comfortably met its efficacy endpoints and supported naproxcinod's non-detrimental effect on blood pressure, as well as by the good long term safety data observed in the 301 extension study.

We have also significantly advanced our pre-launch activities for naproxcinod, through the signature of an agreement for the manufacture of naproxcinod capsules for future commercialization, and are confident that the New Drug Application will be filed in mid 2009 as planned. We remain focused on the finalization of the clinical program for naproxcinod and look forward to the results of the 303 phase 3 study and the 111 and 112 Ambulatory Blood Pressure Monitoring studies in the coming months. As anticipated, our cash balance at the end of the third quarter is EUR124.8 million, which will enable us to fully finance the remaining clinical trials for naproxcinod and continue to advance the development of the other compounds in our portfolio."

Financial summary of the first nine months of 2008:

Revenues were EUR2.9 million for the nine months ended September 30, 2008, compared to EUR18.4 million during the same period in 2007. These revenues were due to the allocation of payments received from Pfizer Inc and Merck & Co., Inc. following the agreements signed with the two companies in the fields of ophthalmology and hypertension, respectively.

For the first nine months of 2008, operating expenses were EUR60.4 million, compared to EUR39.0 million for the corresponding period of 2007. As expected, the majority of these expenses were due to research and development costs related to naproxcinod, NicOx'
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