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.
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 pipeline product SOH-075 for emergency contraception was developed by Laboratoires HRA Pharma as NorLevo® and the exclusive distribution rights for Japan, Australia were licensed to Sosei in April 2001. It is already approved in more than 60 major EU/Asian countries. Sosei submitted the New Drug Application (NDA) to Ministry of Health, Labour and Welfare (MHLW) in Japan in September 2009.
