Axcan receives non-approval letter for Helicide
MONT SAINT-HILAIRE, CANADA, August 13, 2002 -- Axcan Pharma announced that the U.S Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) submitted for Helicide in the eradication of Helicobacter pylori, is not approvable at this time.
No safety or efficacy issues were raised. However, FDA inspection-related issues remain outstanding at one of the five manufacturing sites involved in the production of Helcide.
"We intend to work closely with the FDA and supplier to promptly resolve all outstanding issues. In fact, much of that work has already taken place," commented Léon F. Gosselin, President and CEO of Axcan. "We expect to respond to the three issues raised by the FDA by October 31, 2002, and anticipate the review period to be six months.
"Approval for Helicide is still anticipated to occur in fiscal 2003 with a commercial launch in early fiscal 2004. We remain comfortable with analysts' estimates for revenues and earnings for both fiscal 2002 and 2003," he concluded.
Axcan conducted a Phase III North American trial on 277 patients and confirmed that Helicide has the potential to be used as a first-line therapy for the eradication of Helicobacter pylori, the main cause of duodenal ulcers. Data has shown that Helicide is effective in eradicating both metronidazole sensitive and resistant strains of Helicobacter pylori.
Posted: August 2002