As it gets ready to prepare a filing with regulators across the Atlantic for its osteoarthritis drug naproxcinod, French biotechnology firm NicOx has opened its US headquarters in Warren, New Jersey.
Explaining the move, Damian Marron, vice president of corporate development, said that “as NicOx transitions from a pure R&D organisation to a fully-integrated commercial company”, it recognised the need to open a base in the USA. The decision has been prompted by the progress of naproxcinod, the firm’s’ lead investigational product which has shown promising efficacy data in Phase III trials and “as we move closer to our anticipated New Drug Application filing…we will need to build our sales and marketing infrastructure,” he added.
The results from two remaining Phase III studies for naproxcinod should be reported in mid-2008 and the NDA filing is planned for the first quarter of 2009.
NiCox says that over the past few months it has built up a strong commercial team in the USA and it is also looking to establish “a permanent clinical presence” in the USA, where the majority of its trials are planned and conducted, which will “provide strong support and management” of the clinical research organisations working for the company on naproxcinod. Sanjiv Sharma, vice president of commercial affairs, said that Warren was selected because of the number of pharmaceutical firms, biotechnology 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 USA”.
He added that the firm is now “in close proximity to the global headquarters of Pfizer and Merck & Co, our collaborators in ophthalmology and hypertension". The deal with the latter, which could be worth up to 286 million euros, saw NicOx license rights to a series of blood pressure-lowering drugs, while the Pfizer partnership, valued at $385 million, uses the French group’s nitric oxide-donating technology for a drug which is being developed to treat the eye disease glaucoma.