Catalent Provides Sunesis Pharmaceuticals with Key Phase 3 Clinical Trial Support for Vosaroxin
Somerset, NJ, August 24, 2010 — Catalent Pharma Solutions and Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) entered into a clinical supply services agreement to support Sunesis’ pivotal Phase 3 VALOR trial of vosaroxin in first relapse or primary refractory acute myeloid leukemia (AML). Catalent will provide expertise in labeling and kitting of the clinical trial materials to be used in Sunesis’ multinational trial, and will provide supply chain support to clinical sites. As part of Catalent’s development and clinical services segment, the clinical packaging and logistics will be handled in Catalent’s Philadelphia, PA and Schorndorf, Germany facilities.
Catalent Pharma Solutions provides a comprehensive, full-service and vertically integrated operation for clinical trials materials preparation in support of Phase I through Phase IV studies, covering virtually all dosage forms. Our clinical supply services are cGMP compliant and include established clinical trial material and material management SOPs with QA oversight.
Catalent’s clinical supply services segment is one of the most respected packaging networks for pharmaceuticals in the clinical trial phase of development. Catalent’s team of experts has years of experience and is able to adapt quickly to customer needs, providing innovative, customized solutions. With facilities in the United States, the United Kingdom and Germany, joined by uniform systems and machinery, Catalent’s capacity provides the ability to meet customer distribution needs, ultimately reducing turnaround time.
"As we continue to make important strides towards ensuring that the pivotal Phase 3 VALOR trial is a well-executed study and work diligently on its timely launch, a key to our progress is our clinical supply partnership with Catalent Pharma Solutions," said Daniel Swisher, Sunesis' Chief Executive Officer.
“We are pleased to work with Sunesis in providing global clinical supply services support for vosaroxin and the VALOR trial, and we are confident that Catalent’s integrated global solution will help Sunesis advance this important compound,” said Frank Lis, Catalent’s Vice President and General Manager, Clinical Supply Services.
To learn more about Catalent’s Development and Clinical Services, visit our website at www.catalent.com/development .
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,000 people at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion in annual revenue. For more information, visit www.catalent.com .