BioWorld International Correspondent
PARIS - The share price of NicOx SA on the Nouveau Marché in Paris plummeted by more than 83 percent last week after AstraZeneca plc issued a statement in the names of both companies announcing that the recently completed Phase II trial of a drug candidate they are developing did not attain its primary therapeutic objective.
On Monday, NicOx, of Sophia-Antipolis, asked the French stock market watchdog, the Commission des Opérations de Bourse (COB), to investigate transactions in its stock during the weeks preceding the release of that statement.
Four days earlier, on Thursday, the French company had issued a formal request to London-based AstraZeneca for the full data file on the Phase II trial of AZD 3582, a COX-inhibiting, nitric oxide-donating drug (CINOD) the companies are developing for acute and chronic nociceptive pain.
NicOx said it was surprised by the way AstraZeneca issued a statement in both their names on Feb. 18 announcing that the trial "did not reach its primary endpoint with respect to gastrointestinal ulcers." The statement did acknowledge, however, that "the majority of the secondary objectives, including protection against gastrointestinal damage . . . were achieved, and overall AZD 3582 was well tolerated." It also said AstraZeneca "remains committed to the completion of the ongoing AZD 3582 Phase II development program."
Under agreements signed in 1998 and 2002, AstraZeneca has exclusive worldwide rights to develop, manufacture and sell certain CINODs developed by NicOx, the most advanced one being AZD 3582. The British company initiated a multicenter Phase II trial of AZD 3582 in January 2001, and on its completion provided NicOx with a summary and partial data. But NicOx now said it wants its specialists to assess the full data.
Sylvain Goyon, the manager of corporate relations at NicOx, told BioWorld International that AstraZeneca had put out its statement before the French company had seen the data. He insisted that not only had all the secondary endpoints been met but that the drug had been active against ulcers as well, albeit not to a statistically significant extent.
He maintained that NicOx was more "surprised" at AstraZeneca's "strange behavior" than unhappy with the trial results, and stressed that it was not only financial considerations that were at stake but also "the credibility of the company and its technology."
The stock market seems to share that view and to have reached its own judgment. While NicOx's share price had declined during the preceding few weeks and months, like many of the world's stocks, the plunge that followed the publication of the Feb. 18 statement was of a very different nature. From €9.80 on Feb. 17, NicOx' stock tumbled to €5.22 on Feb. 19 and €1.70 on Feb. 20.