Takeda and PRA Health Sciences Announce Transformational Clinical Development and Marketed Product Partnership
September 12 2016 - 9:00AM
Business Wire
Agreement Supports Accelerated, More
Efficient Clinical Trial Strategy and Operations
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.
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“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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160912005204/en/
For PRA Health Sciences:Christine
Rogers+1- 919.786.8463rogerschristine@prahs.comorFor Takeda Pharmaceutical Company Limited:Tsuyoshi
Tada – JapanTsuyoshi.tada@takeda.com+81 332 782 417orJulia
Ellwanger – U.S.A.julia.ellwanger@takeda.com+1.224.554.7681
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