BioWorld International Correspondent

NiCox SA completed the second leg of a two-part fundraising effort that has yielded gross proceeds of about €100 million (US$143.2 million), by raising €69.9 million in a discounted rights offering. The rights issue comprised 20,042,031 new shares, priced at €3.49 per share. The company's closing share price immediately before the Nov. 25 launch of the offer was €7.05, although it subsequently dropped well below that level. The stock closed Monday at €5.54.

NiCox, of Sophia Antipolis, France, had raised €30 million via a private placement in November, which was priced at €7.50 per share. That included a €20 million investment from the Strategic Investment Fund (Fonds Strategique d'Investissement; FSI), a fund created by the French government last year to back innovative, high-potential French companies. Including the rights offering, in which it invested a further €3.7 million, the FSI will have a 5.17 percent stake in the company.

NiCox is now flush with cash, having reported €66.8 million at the end of the third quarter. "We shall end the year with around €150 million. That will leave us in a very comfortable position to negotiate a partnership and to prepare for the launch of naproxcinod," CEO Michele Garufi told BioWorld International.

The funding should take the company to profitability. "This is our last financing as an R&D company," he said. However, he is not ruling out additional investment, to fund acquisitions, for example. "It would be better to have more than one compound to sell, and that's what I'm looking for."

The coming year will be a pivotal one for the company. Naproxcinod, in development for treating signs and symptoms associated with osteoarthritis, is currently under review at the FDA, with a PDUFA date of July 24, 2010. The company filed a marketing authorization application in Europe Monday.

The product is the first in a new drug class, which NiCox calls the cyclooxygenase inhibiting nitric oxide donators. It comprises a modified form of the nonspecific cyclooxygenase inhibitor naproxen, which has a nitric-oxide-donating moiety.

It offers, the company said, a favorable blood pressure profile vs. alternative nonsteroidal anti-inflammatory drugs. "It will be key to our discussion with the FDA," Garufi said. "Of course we want to see how this will be reflected in the label."

Naproxcinod is as yet unpartnered, but it is unlikely, Garufi said, that the company will enter a global deal for the compound. It aims to participate in the commercialization of the molecule in the U.S., but it is unlikely to do so in Europe, because of the fragmentation of the market and the poor reimbursement available for a product like naproxcinod. "It's a much more risky strategy. That's the reason why I'm focused on the U.S.," he said.

The company already has a marketing team based at its U.S. headquarters in Warren, N.J., and pre-commercialization activities are under way. The establishment of a sales team will come later. "We will do it only once we are sure naproxcinod will be registered and we have clear visibility on the launch date," Garufi said.

Published  December 23, 2009