Agreement Supports Accelerated, More Efficient Clinical Trial Strategy and Operations
Osaka, Japan, September 13, 2016, and Raleigh, N.C., September 12, 2016 – PRA Health Sciences, Inc. (NASDAQ: PRAH) and Takeda Pharmaceutical Company Limited (TSE: 4502) announced today 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 is a fundamental part of Takeda’s R&D transformation and represents a truly innovative approach to clinical development, unprecedented in our industry,” said Andy Plump, M.D., Ph.D., Director, Chief Medical and Scientific Officer at Takeda. “PRA has a reputation for providing tailored sourcing solutions. We believe PRA will be an ideal partner as we focus, deliver and advance our current and future pipeline.”
The innovative 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 will facilitate the development of new medicines by focusing resources, teams and activities where needed, an important requirement for an industry-leading, highly agile R&D organization focused on meeting patient needs.
“This partnership is an exciting opportunity for PRA and represents a significant milestone and transformational business opportunity for us,” said PRA Chief Executive Officer Colin Shannon. “This is the first time that a pharmaceutical company and a clinical research organization (CRO) have come together to create such a comprehensive business and operational strategy. This partnership model redefines collaboration and is the first of its kind in the CRO industry.”
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.
About PRA Health Sciences
PRA is one of the world's leading global contract research organizations, by revenue, providing outsourced clinical development services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes approximately 70 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East, and approximately 12,000 employees worldwide. Since 2000, PRA has performed approximately 3,300 clinical trials worldwide and has worked on more than 100 marketed drugs across several therapeutic areas. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 60 drugs. To learn more about PRA, please visit www.prahs.com.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.