NicOx Reports First Quarter 2008 Financial Results
May 14 2008 - 6:00AM
PR Newswire (US)
SOPHIA ANTIPOLIS, France, May 14 /PRNewswire-FirstCall/ -- NicOx
S.A. (Eurolist: COX) today reported financial results for the first
three months of 2008. On March 31, 2008, the Company had cash, cash
equivalents and financial instruments of euro 153.7 million,
compared to euro 201.2 million on March 31, 2007. Revenues were
euro 1.4 million in the first quarter of 2008, compared to euro 8.7
million for the corresponding period of 2007. The higher revenues
achieved in Q1 2007 were principally due to two milestone payments
from Merck & Co., Inc. and Pfizer Inc which were fully
recognized during that period. Operating expenses were euro 17.5
million in the first quarter of 2008, compared to euro 10.1 million
in the first quarter of 2007. This increase in operating expenses
was mainly due to the ongoing phase 3 clinical studies for
naproxcinod, NicOx' lead investigational drug and the first
compound in the CINOD class, for the treatment of the signs and
symptoms of osteoarthritis. In the first quarter of 2008, NicOx
recorded a net loss of euro 13 million. This compares to a net
profit of euro 1.8 million for the first quarter of 2007. Key
operational highlights - first quarter 2008 -- NicOx initiated two
large Ambulatory Blood Pressure Monitoring (ABPM) studies for
naproxcinod in hypertensive patients with osteoarthritis. These two
large clinical pharmacology studies in the United States will
assess the blood pressure profile of naproxcinod in comparison to
ibuprofen and naproxen, using the Ambulatory Blood Pressure
Monitoring (ABPM) technique. These two trials are 12 and 16 weeks
in duration and together are expected to recruit around 420
osteoarthritis patients with controlled hypertension. Results of
both studies are projected in the fourth quarter of 2008 -- Pfizer
Inc signed an extension of its March 2006 ophthalmology research
agreement with NicOx. This agreement grants Pfizer the exclusive
right to apply NicOx' proprietary nitric oxide-donating technology
to drug discovery research across the field of ophthalmology. The
most advanced project under this agreement is focused on nitric
oxide-donating prostaglandin analogs for the treatment of glaucoma
and has produced encouraging results for various compounds in a
validated in vivo model of abnormally high intraocular pressure
(IOP), compared to a commonly used reference drug -- The Company
continued to take the necessary steps to ensure the successful
commercialization of naproxcinod and signed an agreement for the
commercial manufacture of naproxcinod drug substance with the fine
chemical company Archimica. The aim of this agreement is to ensure
that commercial supplies of an appropriate scale will be available
to ensure the successful launch of naproxcinod -- In January, NicOx
announced that Pfizer initiated phase 2 clinical development for
PF-03187207 in Japan. PF-03187207 is an investigational nitric
oxide-donating prostaglandin analog for the treatment of glaucoma.
This dose ranging phase 2 study will recruit 120 patients and is
expected to report results in the third quarter of 2008 -- In May,
following the end of the first quarter, NicOx announced the results
of a U.S. phase 2 trial for PF-03187207. This dose ranging study
conducted by Pfizer Inc, compared the safety and efficacy of
PF-03187207 to Xalatan(R) (latanoprost) in patients with primary
open angle glaucoma and ocular hypertension. On the primary
endpoint, PF-03187207 showed a 12% improvement over Xalatan(R)
0.005%, which did not reach statistical significance, although a
statistically significant advantage over Xalatan(R) 0.005% was
observed on a number of secondary endpoints (p