BioWorld International Correspondent
PARIS - NicOx SA is seeking to raise about €130 million (US$168.4 million) in a capital increase which involves the offer of new ordinary shares with existing shareholders having preferential subscription rights. The subscription price will be announced Jan. 29.
NicOx, of Sophia Antipolis, France, said the additional funds would enable it to speed up the development of its drug candidates, especially its lead compound, naproxcinod, which is in Phase III clinical trials for the treatment of the signs and symptoms of osteoarthritis.
The holders of preferential subscription rights would be able to sell all or part of those rights if they decide not to subscribe, or to subscribe for only some of the new shares to which they are entitled. Shareholders also would be entitled to subscribe for additional new shares on a reducible basis.
The preferential subscription rights will be allocated Jan. 30 for shareholders who are registered as owning shares at the close of trading Jan. 29. The subscription period will be open from Jan. 30 to Feb. 5 inclusive. During that time, the preferential subscription rights will be listed and negotiable on the Eurolist market of the Euronext Paris stock exchange. The offer is open to the public in France only.
The capital increase is being underwritten by a syndicate of banks led by Merrill Lynch International and UBS Investment Bank as joint global coordinators and joint bookrunners and including Lazard-Natixis and Piper Jaffray as joint lead managers.
The final details of the offering, including the number of new shares to be issued and the subscription price at which existing shareholders will be able to subscribe for them, will be announced on Jan. 29. The settlement, delivery and listing of the new shares are scheduled for Feb. 16. New shares will be fungible with existing shares listed on the Eurolist market of Euronext Paris.
According to company Chairman and CEO Michele Garufi, "the funds from this offering will help maximize the value of naproxcinod, our lead development compound, by financing the completion of the regulatory Phase III clinical trials, together with the initial pre-marketing to support the launch of the compound."
Naproxcinod is the first of NicOx' CINOD (COX-inhibiting nitric oxide-donating) class of anti-inflammatory agents. Unlike existing nonsteroidal anti-inflammatory drugs (NSAIDs), naproxcinod appears to have no detrimental effect on blood pressure. Last October NicOx announced the results of the first Phase III trial of naproxcinod, which showed superiority to placebo on all three co-primary efficacy endpoints and a sustained reduction in blood pressure versus baseline and naproxen.
The additional funds will enable NicOx to complete the regulatory clinical development of naproxcinod. Two further pivotal Phase III trials are due to be initiated in the first half of 2007, in line with the company's objective of filing an initial marketing authorization application for naproxcinod in the United States in the first quarter of 2009.
In addition, NicOx plans to initiate two new Phase II trials of NCX 4016, its nitric oxide-donating derivative of aspirin, in type 2 diabetes during the first half of 2007. NicOx is developing NCX 4016 for the treatment of insulin resistance and said it has a potentially improved safety profile and a different mechanism of action relative to existing drugs.
NicOx receives €5 million milestone from Merck
Shortly before launching its rights issue, NicOx announced that it had received an initial milestone payment of €5 million from Merck & Co., Inc., of Whitehouse Station, N.J., with which it is collaborating in the development of new antihypertensive drugs.
The milestone was linked to the initiation of good laboratory practice (GLP) toxicology studies on the first development candidate that was recently selected by the two companies. NicOx said this represents an important step for moving the compound into clinical development.
It was less than a year ago, in March 2006, that NicOx and Merck signed a collaboration agreement covering the development and commercialization of antihypertensive drugs using NicOx' proprietary nitric oxide-donating technology for the treatment of high blood pressure, hypertension and other cardiovascular disorders.
Under the agreement, NicOx has received €14.2 million from Merck to date, including the latest milestone payment, and stands to receive a further €274 million in potential milestones. In addition, Merck will pay NicOx royalties on the sales of all products that result from the collaboration.