NeoPharm To Meet FDA Over Neomark

NeoPharm has said it expects to meet with the US Food and DrugAdministration by mid-January to discuss how to proceed with its New Drug Application for Neomark (broxuridine), a prognostic indicator for breast cancer cell proliferation. Shares in NeoPharm fell 38 cents on the day of the announcement (Friday December 19), and then a further $2.40 on the Monday to reach $4.

The drug was not recommended for approval by the FDA's Oncologic Drugs Advisory Committee at its meeting on December 19. NeoPharm chief executive William Govier said that the company was "extremely disappointed in, and surprised by, the committee's decision." He believes that the problem lies with the fact that this is the first time that the ODAC has had to review a prognostic agent, and there are as yet no clear guidelines for development and registration of these agents.

Clinical trials of broxuridine in this setting were conducted under the sponsorship of the US National Cancer Institute, and NeoPharm has access to a database involving over 5,000 patients who have received the drug for prognostic applications. Mr Govier said this database could be drawn upon to provide data which should answer the panel's concerns.