PRA Health Sciences, Inc. and Takeda Pharmaceutical Company Limited announced that they have agreed to a new partnership to expand their global relationship initially disclosed in September 2016 to include Japan.
Takeda and PRA will establish a joint venture, each holding 50% of the share respectively, to provide clinical trial delivery and pharmacovigilance services as a strategic partner of Takeda in Japan. Takeda also will transfer all of the shares of Takeda Pharmaceutical Data Services (TDS), a wholly-owned subsidiary of Takeda, to PRA. This partnership is another step in Takeda’s transformation of its global research and development organization by providing access to a more flexible operational capability to support development, as well as further globalizing Takeda Development Center Japan, based in Osaka.
In alignment with Takeda's global R&D strategy, the newly established joint venture will leverage its internal resources and expertise to manage an entire portfolio of studies for Takeda, across Phases I-IV, and provide pharmacovigilance and other operational services for both development and marketed product portfolios in close alignment with Takeda Development Center Japan.
“This agreement expands our innovative approach, first announced in September of last year, to now include Japan, our home country, and accelerates our ability to deliver medicines to patients,” said Andy Plump, M.D., Ph.D., Director, Chief Medical and Scientific Officer at Takeda. “This joint venture and transfer of TDS will establish a flexible operating model leveraging expertise from both Takeda and PRA, as we focus clinical development to deliver innovative, highly-differentiated products to patients.”
“These transactions reflect our growing partnership allowing us to gain access to a highly talented Japanese team of clinical development professionals,” said PRA Chief Executive Officer Colin Shannon. “As our collaborative efforts continue, we remain steadfast in our mutual desire to improve the lives of the patients we serve.”
Takeda initially will establish a new, wholly-owned subsidiary in the first quarter of 2017, which will become a part of Takeda Development Center Japan. This new subsidiary is expected to result in the transfer of approximately 140 Takeda employees continuing to support drug development and marketed products in Japan. Upon closing of the joint venture, expected to occur in the second quarter of 2017, the new subsidiary will be jointly owned by Takeda and PRA.
Takeda will transfer to PRA all of the shares of TDS in the second quarter of 2017, with approximately 60 employees supporting Takeda Development Center Japan.
There is no revision to Takeda's financial forecast of FY2016 due to the partnership. Additional details regarding the transfer and structure of the joint venture will be announced as soon as they are determined.