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Agreements

Date: 2017-04-07

Type of information: Services contract

Compound:

Company: Takeda Pharmaceutical (Japan) PRA Health Sciences (USA - NC)

Therapeutic area:

Type agreement: services contract

Action mechanism:

Disease:

Details:

  • • On September 13, 2016, PRA Health Sciences and Takeda Pharmaceutical announced that the companies have entered into a new partnership agreement under which PRA Health Sciences (PRA) will serve as Takeda’s primary strategic partner to deliver on the company’s pipeline and marketed products clinical development and post-approval needs. This partnership provides a flexible operating model that combines operational expertise, transferred from Takeda to PRA, with PRA’s wide range of global capabilities. This model is aimed to improve operating efficiencies, drive globalization and reduce fixed infrastructure costs. This flexible approach aims to facilitate the development of new medicines by focusing resources, teams and activities where needed. The partnership will enable PRA to utilize its internal resources and expertise to manage an entire pipeline of studies for Takeda, across Phases I-IV and provide Regulatory, Pharmacovigilance and other operational services for both development and marketed product portfolios. The transformation is expected to result in approximately 300 Takeda employees supporting drug development and marketed products to be given the opportunity to transition to PRA in the United States and Europe, subject to appropriate information and consultation with works councils, unions, and employee representatives. Discussion regarding Japan employees is ongoing between Takeda and PRA.
 

Financial terms:

  • • On April 7, 2017, Takeda Pharmaceutical announced that it has entered into an agreement for absorption-type company split with its wholly-owned subsidiary which was established in March 2017 and intends to enter into another agreement for joint venture with Pharm Research Associates (UK) Ltd, a subsidiary of PRA Health Sciences aiming for transferring a part of Takeda Development Center Japan businesses to PRA. Takeda and PRA announced the expansion of their partnership to Japan on February 15, 2017. Takeda is in the process of implementing the steps to accelerate R&D transformation by refocusing on oncology, gastroenterology and central nervous system, plus vaccines, and concentrating R&D activities in Japan and the U.S.  As a part of this initiative, the company entered into a global partnership agreement with PRA in August 2016, followed by an agreement to expand their global partnership in February 2017 to include Japan.
  • Subsequent to the company split, a half of the issued shares in NewCo will be transferred to PRA(UK). Through this transaction, NewCo will become a joint venture between Takeda and PRA(UK), and then its name will become “Takeda-PRA Development Center KK”, which is scheduled to be effective as of June 1, 2017. • On February 15, 2017, PRA Health Sciences and Takeda Pharmaceutical 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.
  • 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.

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