SOPHIA ANTIPOLIS, France, September 23 NicOxS.A. (Euronext Paris: COX) today announced it has signed an exclusiveagreement with Capsugel, the leading producer of two-piece capsules, for thecommercial manufacturing and global supply of naproxcinod capsules.Naproxcinod is NicOx' lead investigational product and the first compound inthe Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class ofanti-inflammatory agents. The aim of this agreement is to ensure sufficientsupplies of naproxcinod capsules to underpin its successful commerciallaunch. The filing of a New Drug Application (NDA) for naproxcinod with theU.S. Food and Drug Administration (FDA) is projected for mid-2009.
The agreement with Capsugel follows the signature of an agreement for thecommercial manufacture and supply of naproxcinod active pharmaceuticalingredient (API) with Archimica in March 2008. NicOx recently announced theresults of the second pivotal phase 3 study for naproxcinod in patients withosteoarthritis of the knee (the 302 study, see NicOx press release ofSeptember 15th, 2008). This study met all three of its co-primary efficacyendpoints and supported naproxcinod's non-detrimental effect on bloodpressure.
Staffan Stromberg, Vice President of Technical Development and Operationsat NicOx, said: "We are very happy to have concluded this agreement withCapsugel, which is recognized as the world leader in capsule manufacturing.We believe Capsugel's flexibility and production capacity is well adapted toNicOx' launch preparations for naproxcinod. This agreement is also the resultof the excellent collaboration between the two companies, in which Capsugel'stechnology has been used in the production of naproxcinod clinical trialsupplies."
Under the terms of this exclusive agreement, Capsugel will be responsiblefor the formulation and encapsulation of naproxcinod API, using its patentedLEMS(TM) technology (Liquid Encapsulation Microspray Sealing). Themanufacturing will be performed at one of Capsugel's plants in France. A 2001study showed that 66% of patients prefer to take drugs as capsules, comparedto 22% who prefer tablets(1).
NicOx chose Capsugel as an exclusive supplier following a long-standing,fruitful collaboration, where Capsugel has been responsible for themanufacturing of naproxcinod capsules for clinical studies. Capsugel produced160 billion capsules in 2007, giving it a 50% share of the capsule market.Its experience, expertise and capabilities make Capsugel the choice partnerfor the high-quality and efficient manufacture of naproxcinod capsules.Capsugel can bring to NicOx its expertise both in formulation andencapsulation due to its leading edge capsule manufacturing technology andformulation development capabilities.
"We are very pleased to continue our collaboration with NicOx throughthis agreement," commented Keith Hutchison, Vice President of Research andDevelopment at Capsugel. "Naproxcinod is a new therapeutic approachaddressing a huge market need and we believe this agreement represents anexciting opportunity for Capsugel. We are looking forward to leveraging ourexpertise to ensure substantial supplies of naproxcinod capsules and to bethus part of the expected success for this novel compound."
NicOx is developing naproxcinod in phase 3 clinical studies, which aredesigned to demonstrate that it is safe, well tolerated and effective fortreating the signs and symptoms of osteoarthritis, in addition to having nodetrimental effect on blood pressure, in contrast to traditionalNon-Steroidal Anti-Inflammatory Drugs (NSAIDs) and COX-2 inhibitors. Theresults of the third phase 3 trial for naproxcinod (the 303 study) areexpected by the end of the year.
Capsugel is a division of Pfizer Inc. With a diverse product line,including hard gelatin, softgel, non-animal, and fish gelatin capsules,Capsugel is at the fo