NicOx Signs Agreement With DSM for the Commercial Manufacture of Naproxcinod Drug Substance
02 Dezembro 2008 - 10:30AM
PR Newswire (US)
SOPHIA ANTIPOLIS, France, December 2 /PRNewswire-FirstCall/ --
NicOx S.A. (NYSE Euronext Paris: COX) today announced it has signed
an agreement with DSM for the commercial manufacture and supply of
naproxcinod drug substance (or API, active pharmaceutical
ingredient). Naproxcinod is NicOx' lead investigational product and
the first compound in the Cyclooxygenase-Inhibiting Nitric
Oxide-Donating (CINOD) class of anti-inflammatory agents, which
recently achieved positive results in the third pivotal phase 3
study in osteoarthritis patients. Under the terms of the agreement,
DSM will supply naproxcinod API for commercial purposes from its
fine chemicals production site in Linz, Austria. DSM is one of the
world's leading independent suppliers to the pharmaceutical
industry, with some 40% of today's top-selling medicines in the
world containing ingredients developed and produced by DSM. This
follows the signature of an agreement with Capsugel in September
2008 for the commercial manufacture of naproxcinod oral capsules,
which is widely recognized as the world leader in capsule
manufacturing. Staffan Stromberg, Vice President of Technical
Development and Operations at NicOx, commented: "The latest
positive results observed in the 111 and 303 studies support our
confidence in naproxcinod's blockbuster potential. We are therefore
very pleased to have signed these contracts with global leaders in
high capacity API and capsule production. We project these
agreements should cover the high sales forecasts for the initial
years of naproxcinod's commercialization that have been suggested
by our market research." The agreement with DSM aims to secure
commercial supplies of an appropriate scale to support the
successful launch of naproxcinod. As per the agreement, NicOx
envisages the first deliveries of significant quantities of
commercial material being made from the fourth quarter of 2009
onwards. Following this agreement with DSM and the importance of
cost control in the current economic environment, NicOx has ended
its present API supply agreement with Archimica. At the point of
termination, Archimica had met all contract milestones and was in
full compliance with the other terms of the contract. Luca
Mantovani, President & Business Unit Director at DSM Pharma
Chemicals, declared: "We are happy to consolidate our relationship
with NicOx through this agreement. Naproxcinod is an exciting
compound and being part of its pre-launch and future
commercialization plans is an interesting opportunity for DSM." On
November 24, NicOx announced that the third pivotal phase 3 study
for naproxcinod in osteoarthritis of the hip had met all three
co-primary efficacy endpoints. Following the positive results from
the 301 and 302 studies in osteoarthritis of the knee, 303
represents the third pivotal phase 3 study for naproxcinod to
achieve p