Helicobacter pylori is an important factor in peptic ulceration.The presence of this bacterium is associated with gastritis, as well as gastric and duodenal ulcers. Axcan Pharma has developed a bismuth-based single capsule triple therapy product consisting of metronidazole, tetracycline and bismuth subcitrate for the eradication of H. pylori. The composition (Helicide™) has completed a phase III investigation in North America. The phase III trial was being conducted in 62 centres in the US and Canada and it compared Helicide™ (in combination with a PPI) with a combination of omeprazole, clarithromycin and amoxicillin (OAC). The Helicide™ regimen was at least as effective as OAC in eradicating H. pylori. The potential advantage of Helicide™ is that it could eliminate the need to take multiple drugs. The single capsule overcomes an important compliance problem for patients who have to take multiple drugs at different times of the day. The treatment is very cost effective. Phase III trials are being conducted in Europe and Australia investigating the use of Helicide™ in the eradication of H. pylori.
In October 2001, Axcan filed an NDA with the US FDA for a single capsule containing bismuth subcitrate 40mg/metronidazole 125mg/tetracycline 125mg, and also filed a new drug submission with Health Canada. However, in August 2002, Axcan received a non-approvable letter from the FDA for Helicide™ in the eradication of H. pylori. 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 Helicide™. Axcan will respond to the three issues raised by the FDA by the end of October 2002. A commercial launch for Helicide™ is expected early in 2004.
Axcan Pharma has acquired full ownership of the H. pylori single capsule patent having purchased Pirri's (Gephar SA) interest in the patent. Axcan Pharma has also signed a letter of intent with Vianex. According to the terms of the agreement, Vianex acquires the distribution rights for Greece to Axcan's single capsule bismuth-based triple therapy for the eradication of H. pylori.
Axcan has entered into a worldwide (except Australia and New Zealand) licensing agreement for a series of patents covering triple and quadruple therapies for H. pylori eradication. This agreement was signed with Exomed Australia Pty Ltd, Gastro Services Pty Ltd and Ostapat Pty Ltd, all of which are Australian companies and co-owners of the patents. The transaction included a cash payment of approximately $ US 136 000 and royalties to be paid as a percentage of sales, once the product is launced. Axcan Pharma had granted IL-Yang of Korea an option to its Helicide™ for H. pylori eradication for Korea and China, but it appears that this was not taken up.
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