July 28, 2008. Sophia Antipolis,
France. www.nicox.com
NicOx S.A. (Euronext Paris: COX) today reported its financial results for
the six months ended June 30, 2008.
Key highlights for the first six months of 2008:
- Completion of patient enrollment in the third naproxcinod pivotal phase 3
study (303)
- Post hoc analysis of Office Blood Pressure Measurements (OBPM) from the
naproxcinod 301 phase 3 study presented at EULAR, showing a statistically
significant difference between naproxcinod and naproxen in 3 out of 4
comparisons
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- Initiation of two large Ambulatory Blood Pressure Monitoring (ABPM)
studies for naproxcinod in hypertensive patients with osteoarthritis, which
aim to provide complimentary data on naproxcinod’s blood pressure profile.
These studies have subsequently completed patient enrollment in July
- Agreement signed with Archimica Inc. for commercial manufacture of
naproxcinod drug substance
- Initiation of first clinical trial by Merck & Co., Inc. for an
investigational nitric oxide-donating agent in hypertensive volunteers
- Extension of the research agreement with Pfizer Inc, which covers NicOx’
proprietary technology in ophthalmology
- Announcement of the results of a U.S. phase 2 study for the nitric oxide-
donating prostaglandin analog PF - 03187207 and the decision by Pfizer not
to launch a global phase 3 development program for this compound
Michele Garufi, Chairman and CEO of NicOx, commented: “We remain focused on
finalizing our planned NDA submission for naproxcinod with the US FDA in
mid 2009. We are on track to achieve this important milestone with our two
ongoing phase 3 studies nearing completion. Our confidence in our lead
product has led us to sign an agreement with Archimica for the supply of
naproxcinod drug substance for our future commercial needs. Additionally,
we are proud of the relationships we have built with our pharmaceutical
partners, with Pfizer extending our ophthalmology research collaboration
and Merck initiating the first clinical trial in hypertensive volunteers in
the first half of this year. We believe NicOx is in a strong position to
face the future and we look forward to confirming the efficacy and blood
pressure profile of naproxcinod during the second half of 2008.”
Revenues for the first half of 2008 were EUR 2.2 million, compared to EUR
11.2 million during the same period in 2007. These revenues were due to
payments received from NicOx’ partnered programs with Merck & Co., Inc. in
the antihypertensive field and Pfizer Inc in ophthalmology.
For the first six months of 2008, operating expenses were EUR 40.6 million,
compared to EUR 23.7 million for the same period in 2007. The majority of
these expenses relate to the phase 3 and the overall clinical development
of naproxcinod, NicOx’ lead drug candidate, which is a unique, first in
class, Cyclooxygenase-Inhibiting Nitric Oxide Donator (CINOD) in
development for the treatment of the signs and symptoms of osteoarthritis.
The Company recorded a net loss of EUR 33.1 million for the first six
months of 2008, compared to a net loss of EUR 6.6 million for the same
period in 2007. On June 30, 2008, NicOx had cash, cash equivalents and
current and non-current financial instruments of EUR 141.6 million,
compared to EUR 195.2 million on June 30, 2007.
Review of the first six months of 2008:
Naproxcinod phase 3 studies near completion ahead of projected New Drug
Application (NDA) filing in mid 2009
NicOx’ plan for the regulatory filing of naproxcinod consists of three
pivotal phase 3 trials (the 301, 302 and 303 studies). Each of these
studies has been designed to compare the efficacy of naproxcinod to placebo
on three standard co-primary endpoints after 13 weeks.
Positive efficacy and blood pressure results from the 301 study, which was
conducted in patients with osteoarthritis of the knee, were presented at
the American College of Rheumatology (ACR) in November 2007. An additional
analysis of the Office Blood Pressure Measurements (OBPMs) from the 301
study was presented in June 2008 at the European League Against Rheumatism
(EULAR) and showed a statistically significant difference (p < 0.05, for 3
out of 4 comparisons) between naproxcinod and naproxen in terms of the mean
change from baseline in systolic and diastolic blood pressure at week 13.
Patient enrollment in the 302 study was successfully completed in December
2007 and 26-week efficacy and safety results are expected in the third
quarter of 2008.
NicOx announced in May 2008 the completion of enrollment in the third
pivotal phase 3 naproxcinod trial (the 303 study) in 810 patients with
osteoarthritis of the hip. The objective of this study is to assess
naproxcinod's efficacy in relieving the signs and symptoms of
osteoarthritis of the hip and provide additional safety data, including
further information on naproxcinod's blood pressure profile, as assessed by
OBPM, in comparison to naproxen. Results from this study are expected in
the fourth quarter of 2008.