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.
PPD 3Q09
3Q Revenue: $341.1 million (-13%)
3Q Earnings: $37.7 million (-25%)
YTD Revenues: $1.1 billion (-11%)
YTD Earnings: $140.3 million (flat)
Comments: Development segment revenue for the quarter was $315.8 million (-12%), and income from operations was $52.2 million (-25%). Discovery sciences segment revenue for the quarter was $1.1 million (-68%). Discovery sciences segment loss from operations was $5.3 million, compared to income of $0.6 million in 3Q08, due to an increase in R&D expenses from the company’s dermatology business, which it acquired in 2Q09. Revenue in the quarter included a $3.0 million milestone payment from Takeda Pharmaceutical Co., triggered by the submission of a new drug application for alogliptin in Japan.
AstraZeneca withdrew its regulatory submissions Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the FDA and the EMEA. The applications were submitted in June 2009.
The decision was based on updated analysis that demonstrated no overall survival advantage when vandetanib was added to chemotherapy, as well as preliminary feedback from regulatory agencies that the current package with progression-free survival (PFS) as the primary endpoint might not be sufficient for approval.
The company will complete its ongoing Phase III trial program to assess Zactima’s efficacy in different clinical settings.
Morphotek, Inc. has entered into a license agreement with
Centocor Ortho Biotech for the development and commercialization of an antibody targeting solid tumors. Financial terms were not disclosed.
Morphotek has been granted an exclusive worldwide license for the development, manufacture and sale of the antibody. Preclinical studies conducted by Centocor have shown that the relevant antigen is over-expressed in many solid tumors.
"We are delighted to conclude this license agreement with Centocor Ortho Biotech as we are committed to bringing healthcare solutions to cancer patients, especially for areas of unmet medical need," said Philip Sass, Ph.D., chief operating officer of Morphotek. "Morphotek is well positioned to apply its technologies, knowledge and expertise in monoclonal antibody development for the development and commercialization of this antibody. The preclinical data package for this antibody have shown anti-cancer effects and we look forward to validating these in human trials."
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