Japan is estimated to be the second largest pharmaceutical market with recorded sales in 2008 of $76.6 billion which represents 10% of world pharmaceutical sales. Even so, there are instances where, although marketed in the West, many drugs have still not been approved in Japan (so called “drug lag”).
Though, as a result of the harmonization of the international pharmaceutical regulation in recent years, international collaborative studies have been conducted and the number of “drug lag” cases decreases with each year there are still cases in which the development of a drug marketed in the West is delayed due to a number of background environmental factors unique to the Japanese market. The “drug lag” problem has been officially recognized by Japanese regulators, who together with pharmaceutical companies are currently addressing the issue.
By being present both in Japan and the UK, Sosei established a wide network within the pharmaceutical industry, and is focusing on the search of products with high potential value. Sosei’s in-licensing strategy is based on securing development and commercialization rights to potential products that are in the late stage of development or already marketed in the West, but still have not been introduced to Japan. Through its wide network and know-how, Sosei aims to develop novel medicines to address unmet medical needs.
Based on this strategy. Sosei in-licensed, developed and obtained approval for NorLevo® (emergency contraceptive) in Japan. NorLevo® was first approved in Europe (France) in 1999 and has since been approved in some 50 countries worldwide and listed as an essential drug by WHO, but has not been approved in Japan until now. Sosei in-licensed the rights for NorLevo® for Japan and Australia from Laboratoire HRA Pharma (France) in 2001. After successful development, Sosei was granted an approval by the Japan Ministry of Health, Labour and Welfare in February 2011.
