Axcan Pharma Inc., a leading specialty pharmaceutical company, reported that it has received approval from the Therapeutic Products Directorate of Health Canada for Helicide, a patented single capsule triple therapy, for the eradication of Helicobacter pylori which is a bacterium now recognized as being the main cause of gastric and duodenal ulcers. Each Helicide capsule contains the equivalent of 40 mg of bismuth biskalcitrate (bismuth), 125 mg of metronidazole and 125 mg of tetracycline hydrochloride (tetracycline), and is administered in combination with a proton pump inhibitor.
“We are very pleased with this approval since our studies confirmed that Helicide is not only as effective as the most widely prescribed therapeutic regimen for the eradication of Helicobacter pylori, but it can be administered successfully in patients who are resistant to existing therapies,” indicated Dr. François Martin, Axcan's senior vice president, Scientific Affairs. “ Axcan has indeed been able to demonstrate that Helicide is highly effective in eradicating metronidazole-resistant strains of Helicobacter pylori whereas the omeprazole, amoxycillin and clarithromycin (“OAC”) combination, the most widely prescribed therapeutic regimen for Helicobacter pylori eradication, is not as effective against clarithromycin-resistant strains of Helicobacter pylori. As a consequence, Helicide, unlike clarithromycin-based therapies, may be successfully administered not only to patients who are infected by metronidazole-resistant strains but also to those who are resistant to clarithromycin-resistant Helicobacter pylori strains,” Dr. Martin added.
The commercial launch plans of Helicide for the Canadian market will be announced at a later date. Axcan expects to receive approval for the U.S. market in 2003. The entire North American market for pre-packaged Helicobacter pylori eradication regimens is valued at more than U.S. $100 million annually.
Helicobacter pylori is now recognized as the primary cause of gastric and duodenal ulcers, which affect at least 10 per cent of the North American population at some point. Existing ulcer treatment regimens lead to high recurrence rates. Gastric and duodenal ulcers respectively recur in approximately 40 per cent and 80 per cent of patients within a year if they receive short-term treatment with acid suppression therapy, but without Helicobacter pylori eradication.
Helicobacter pylori infects half of the world population, including at least 25 per cent of the North American population. The presence of this bacterium in the stomach of patients can be diagnosed by several methods, some of which require tissue specimens and culture. Other, less invasive tests include C13 or C14urea tests (Breath Tests). Once a diagnosis of Helicobacter pylori infection has been established, current treatment consensus suggests that eradication therapy be prescribed for all patients with a history of peptic ulcer disease, since the eradication of Helicobacter pylori reduces the rate of ulcer recurrence. Studies have shown that the recurrence rate of peptic ulcer after one year is only 2 per cent in patients in whom the organism has been eradicated.
The Phase III North American trials conducted on 275 patients compared Axcan's Helicide regimen (3 single-triple capsules given 4-times a day, plus omeprazole 20 mg twice a day) to the widely used OAC combination. On a per-protocol basis (results in full accordance with the protocol established for the study), the eradication rates observed were 92 per cent for the group treated with Helicide versus 87 per cent for the group treated with OAC. On an intent-to-treat basis (results including all data associated with the correct or incorrect use of the drug), the eradication rates were 88 per cent and 83 per cent, for Helicide and OAC, respectively.
In addition, although in all study patients at baseline, 40 per cent had a metronidazole-resistant strain, and 11 per cent had a clarithromycin-resistant strain, metronidazole resistance was overcome and Helicobacter pylori eradication was achieved in 86 per cent of metronidazole-resistant patients treated with Helicide on a per-protocol basis, and in 80 per cent on an intent-to-treat basis. On the other hand, only 23 per cent of clarithromycin-resistant patients were successfully treated with OAC on a per-protocol basis and 21 per cent on an intent-to-treat basis. These results confirm that Helicide is statistically and clinically comparable to OAC and that Helicide has the potential to be used as a first-line therapy for the eradication of Helicobacter pylori.