PPD plans to spin off its compound partnering business from its core CRO business. The spin-off will result in two capitalized, highly focused, independent public companies, according to a PPD statement.

The CRO business will continue to operate under the PPD name and will be focused solely on its drug discovery and development services. The compound partnering business will focus on developing and commercializing its drug candidates and to access external capital, if needed, without any constraints associated with operating in combination with the CRO business.

Additionally, PPD has entered into an agreement to acquire Excel PharmaStudies, Inc., one of the largest CROs in China, providing PPD additional capacity and expertise in this market. The acquisition adds to PPD’s Phase II–IV clinical, data management, biostatistics, regulatory and quality assurance services. Excel will operate as a wholly owned subsidiary of PPD.

Excel’s 300 employees will join PPD, and Mark Engel, co-founder, will work exclusively with PPD as a strategic consultant. The acquisition, subject to various closing conditions, is expected to close in 4Q09.

Also, PPD has been awarded a contract by the FDA to evaluate the agency’s Center for Drug Evaluation and Research (CDER) post-market spontaneous adverse event surveillance system. The company will evaluate the value of the spontaneous adverse event reports to support safety-related regulatory actions and report its findings to the FDA and the public.

The award of $2.7 million for the first year is part of a two-year project of FDA’s Initiative for Maximizing the Benefit of Passive Adverse Event Collection throughout a Product’s Life Cycle (IMPACT). The FDA will use these findings to develop an implementation strategy for ensuring optimal use of the system as part of its pharmacovigilance efforts to protect public health.