Japanese drugmakers Shionogi and Nippon Kayaku have been granted approval for Cetrotide, an agent for preventing premature ovulation, from the country's Ministry of Health, Labor and Welfare, the companies announced. Cetrotide (cetrorelix acetate), which was developed by German company AEterna Zentaris, is currently available in 92 countries worldwide.
"Cetrotide has a well-established safety profile with over 250,000 women treated worldwide," noted Jurgen Engel, executive vice president of global research and development and COO at AEterna Zentaris. "The approval of Cetrotide in Japan, coupled with our focused development strategy for this product, further validates our world class development capabilities."
According to the agreement, Nippon Kayaku will import the agent from the German
company and manufacture it, and Shionogi will market the drug in Japan. The
drug is currently in late-stage clinical development for the treatment of benign
prostate hyperplasia and endometriosis.