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The ability to secure these compounds and move them quickly towards
commercialization has been assisted by the changes within the Japanese
regulatory and approval process. Since 1998 product approvals have
been granted for applications filed with overseas clinical trial data
together with a bridging study. This has enabled pharmaceutical companies
to avoid the total duplication of trials with Japanese patients only.
Sosei will continue to seek additional compounds that are already
at Phase III or marketed outside of Japan for use in the Japanese
market.
Sosei priority pipeline product SOH-075 (Norlevo®) for emergency contraception has been in-licensed from Laboratoires HRA Pharma and is now in the final Phase III stage of development.
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