SOPHIA ANTIPOLIS, France, Oct. 15 /PRNewswire/ -- NicOx S.A. (Eurolist: COX) today announced the opening of its United States headquarters in Warren, New Jersey, where the Company will base its Commercial Affairs and U.S. Clinical Operations departments. Mr. Sanjiv Sharma, who was appointed last April as Vice President of Commercial Affairs (see press release April 30, 2007), will head the U.S. office (see NOTE). In addition to commercial activities, U.S. Clinical Operations will be based in this office, led by Joan Sutphen, who joined NicOx in February 2007 as Director of U.S. Clinical Operations.
“As NicOx transitions from a pure research and development organization to a fully integrated commercial company, we recognized the need to open NicOx’ U.S. headquarters. As we move closer to our anticipated New Drug Application filing for naproxcinod, we will need to build our sales and marketing infrastructure,” stated Damian Marron, Vice President of Corporate Development at NicOx. “Over the past few months, Sanjiv has built an excellent U.S.-based team, which has begun to develop commercial strategies for our product portfolio. In addition, Sanjiv’s team will provide indispensable support to our management team, particularly relating to new in-licensing and acquisitions opportunities.”
NicOx has made additional appointments to the Commercial Affairs team, all of whom have considerable marketing, market research, and business analysis experience. The NicOx’ U.S. clinical team will establish a permanent clinical presence in the U.S. where the majority of NicOx’ clinical trials are planned and conducted and will help to implement NicOx’ U.S. clinical strategy and provide strong support and management of the Clinical Research Organizations (CRO) working for the Company. The 6,000 square feet facility will accommodate additional hires in the coming months, as the Company prepares for the filing of a New Drug Application (NDA) for naproxcinod, NicOx’ first in class COX- inhibiting Nitric Oxide Donator (CINOD) for the treatment of the signs and symptoms of osteoarthritis.
Sanjiv Sharma, Vice President Commercial Affairs at NicOx, said, “We selected Warren because many leading global pharmaceutical firms, biotech companies, universities, and hospitals are located in New Jersey, making this a highly attractive location as we build the skills and infrastructure we need in the U.S. Furthermore, we are in close proximity to the global headquarters of Pfizer Inc and Merck & Co., Inc., our collaborators in ophthalmology and hypertension, as well as the contract research organizations which are assisting with naproxcinod’s pivotal studies.”
Naproxcinod, NicOx’ lead investigational product, is in phase 3 clinical development for the treatment of the signs and symptoms of osteoarthritis. Results from the first pivotal phase 3 study (the 301 study), announced last October (see press release of October 27, 2006), showed naproxcinod had superior efficacy compared to placebo and patients experienced a sustained reduction in blood pressure compared to baseline and the existing anti- inflammatory agent, naproxen. The two remaining pivotal phase 3 studies for naproxcinod (the 302 and 303 studies) currently are ongoing. NicOx is expected to report results in mid-2008 and anticipates filing a NDA for naproxcinod in the U.S. during the first quarter of 2009.
NOTE:
NicOx Inc: 15 Independence Blvd, Warren Township, New Jersey, U.S.
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven biopharmaceutical company dedicated to the development of nitric oxide- donating drugs to meet unmet medical needs. NicOx is targeting the therapeutic areas of inflammation and cardio-metabolic disease. Resources are focused on two lead compounds, naproxcinod (formerly HCT 3012); in phase 3 development for the treatment of signs and symptoms of osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes.
NicOx has strategic partnerships with some of the world’s leading pharmaceutical companies, including Pfizer Inc. and Merck & Co., Inc.
NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a public company listed on the Eurolist of Euronext(TM) Paris (segment: Next Economy).
The elements included in this communication may contain forward-looking statements subject to certain risks and uncertainties. Actual results of the company may differ materially from those indicated in the forward-looking statements because of different risks factors described in the company’s document de reference.
CONTACT: Karl Hanks, Manager of Corporate Relations and Market Analysis,
NicOx S.A., +33(0)4-97-24-53-42, hanks@nicox.com; or Investors in the
United States, Lisa Burns, lburns@burnsmc.com, or Juliane Snowden,
jsnowden@burnsmc.com, both of Burns McClellan; Media in the United States,
Jonathan Birt of FD, +1-212-850-5634, jbirt@fd-us.com; or Media in Europe,
Valerie Auffray, +44(0)207-282-2979, valerie.auffray@citigatedr.co.uk, or
David Dible, +44(0)207-282-2949, david.dible@citigatedr.co.uk, both of
Citigate Dewe Rogerson, all for NicOx S.A.
Web site: http://www.nicox.com/
