BioWorld International Correspondent
PARIS - AstraZeneca plc informed NicOx SA on Monday that it had decided to terminate its drug development collaboration with the French company, and the following day NicOx said it had reacquired full rights to the family of COX-inhibiting nitric oxide-donating drugs (CINODs) it is developing as anti-inflammatory and analgesic compounds.
Those drugs include its two lead products, AZD 3582 and AZD 4717, the first of which completed a Phase II trial earlier this year. It was the outcome of that trial that led London-based AstraZeneca to terminate development of the product rather than advance it into Phase III trials.
NicOx CEO Michele Garufi, who had opined in June that there was "an 80 percent chance" of AstraZeneca continuing the collaboration, responded defiantly to the British company's decision to the contrary. "Although surprised by the strategic decision of AstraZeneca to discontinue the program on CINODs, we remain fully convinced of the potential of this class and we are confident of attracting new partners for these compounds and for the other projects in our pipeline," he said.
Investors seem more skeptical, however, since NicOx's share price plunged by 26.4 percent to €3.90 Tuesday, having already fallen 8.3 percent to €5.30 the day before.
According to NicOx, "AstraZeneca deemed that the results on AZD 3582 did not fulfill their strategic commercial criteria for further investment," although the British company made no formal announcement of its decision. AstraZeneca was developing AZD 3582 for the treatment of acute and chronic nociceptive pain, as well as other NicOx CINODs, under agreements signed with the French company in 1998 and 2002.
NicOx, of Sophia Antipolis, still says the phase I and II trials of AZD 3582 demonstrated "very good safety and efficacy endpoints . . . and confirmed the additional benefits from nitric oxide donation," although a statement issued by the two companies in February indicated that the drug "did not reach its primary endpoint with respect to gastrointestinal ulcers." After undertaking its own review of the results, however, NicOx came to the conclusion that AZD 3582 had been active against ulcers but that the trial did not yield a statistically significant result in that respect.
NicOx is now talking to other pharmaceutical companies with a view to concluding a fresh co-development agreement for its CINODs, maintaining that it has acquired a large volume of positive data from the Phase II trial of AZD 3582, which involved more than 3,000 patients.