Pharmaceutical majors unite in Japan to combat H. pylori

On August 31, nine pharmaceutical companies operating in Japan (Kyowa Hakko Kirin, Takeda Pharmaceutical, AstraZeneca, Mitsubishi Tanabe Pharma, Eisai, Astellas Pharma, Abbott Japan, Shionogi and Taisho Pharmaceutical) announced that they had jointly submitted an application to Japan’s Ministry of Health, Labor and Welfare (MHLW) for the approval of a therapy aimed at the elimination of Helicobacter pylori (H. pylori) infection, note analysts at industry expert GlobalData.

H. pylori is a bacterium found in the gastric mucous layer or adhering to the epithelial lining of the stomach. Half of the world’s population is estimated to be infected with H. pylori, with infection rates in some Asian countries reaching as high as 70%. Barry Marshall was awarded the Nobel Prize for Medicine in 2005 for discovering that infection with H. pylori can cause chronic active gastritis, which can trigger an inflammatory response leading to gastric and duodenal ulcers, and eventually stomach cancer. The exact causes that trigger disease progression and the reasons for symptomatic differences within the infected patient populations have not yet been determined despite ongoing research. However, the correlation between H. pylori infection and the increased likelihood of gastric cancer after infection has been scientifically proven. For example, a study in Japan found that 99.3% of 3,161 gastric cancer patients, between the years of 1996 and 2010, tested positive for H. pylori infection.

High rate of H. pylori in Japan

Japan has one of the highest incidences of stomach cancer in the world, due in part to its National Health Insurance system only approving H. pylori therapy after the diagnosis of cancer or ulcerative pathology. On the contrary, in the USA, H. pylori-specific gastritis is treated to prevent disease progression towards gastric cancer. Currently, the prescribed regimen in the USA comprises a proton pump inhibitor (PPI) together with amoxicillin hydrate and clarithromycin, to reduce acid production and increase bacterial clearance respectively. However, as with most infectious disease, the widespread use of clarithromycin has resulted in resistant bacteria, especially in Japan. In these cases of clarithromycin resistance or allergy, metronidazole is substituted as the second antibiotic.