Tokyo, Japan – 16 December 2005: Sosei Co. Ltd ("Sosei" - 4565, Tokyo Stock Exchange MOTHERS index), a leading Japanese biopharmaceutical company, today announces a business update, including a portfolio review, following the acquisition of Arakis Limited on August 30 2005. This acquisition represented a major step towards Sosei's strategic vision of becoming a global top ten biopharmaceutical company.
Results of Portfolio Review
At acquisition, the combined companies had a joint pipeline of sixteen product opportunities at various stages of both research and development. These have subsequently been prioritised in order to focus resource on a robust, regulatory Development Pipeline, comprising ten of the original projects and the new nomination, SD726, referred to above.
The six programmes not prioritised into the full regulatory Development Pipeline are being further reviewed in the light of the many Product Discovery assets the newly combined group has available to it.
Key Updates from the Development Pipeline
Eligard – is a long acting formulation of the LHRH agonist leuprorelin. Sosei submitted its application for the regulatory approval of Eligard as a generic product in February 2005 to the Japanese Ministry of Health, Labour and Welfare (MHLW) following discussions with them. The Japanese Pharmaceuticals and Medical Devices Agency (J-PMDA: Extra-departmental organisation of the MHLW) is reviewing the application and further discussions are ongoing as to the classification of the regulatory application for Eligard since they have a difference in perspective as outlined below:
Reasons for Revision:
Following the portfolio review outlined above, we consider:
1) the possibility of acquiring Marketing Authorisation of Eligard during the current period has been reduced and thus we reduce the forecasted milestone from Sales and reduce its research cost.
2) the likelihood of out-licensing SOU-001 during the current period has been significantly reduced and therefore the receipt of a forecasted initial payment has now been removed from the latest forecast.