Contract research news in brief
pharmafile | March 27, 2012 | News story | Research and Development |Â Â AMRI, Cetero, Kforce, Particle Sciences and QED Clinical Services, inVentiv HealthÂ
Cetero files for bankruptcy after FDA admonishments, AMRI shutters Hungarian facility and inVentiv Health buys Kforce; also updates from Particle Sciences and QED Clinical Services.
US-based contract research organisation Cetero Research has filed for bankruptcy eight months after the FDA issued a warning letter to the company for falsification and manipulation of data, maintaining incomplete records and faking documents. The violations have led to various pharmaceutical clients having to redo bioanalytical studies carried out by Cetero between April 2005 and June 2010. Cetero’s bankruptcy filing says that the FDA action caused its liquidity to become ‘severely constrained’, and it is now sitting on liabilities of $248 million and assets of between $1 million and $10 million. The company will obtain a $15 million credit line to help finance a restructuring and sale of assets.
Albany Molecular Research Inc (AMRI) says it will shut down its chemistry R&D operations in Budapest, Hungary, by the end of this month with the loss of around 100 jobs. The CRO opened the unit in 2009 as part of an expansion programme in Europe that centred on the provision of parallel synthesis and medicinal chemistry services. AMRI is in the midst of a restructuring exercise aimed at reducing its costs. It posted a loss of $24 million last year on revenues down 4% to a little under $47 million.
Healthcare consultancy inVentiv Health has agreed to buy Kforce Clinical Research (KCR) from parent company Kforce Inc for $50 million in cash. KCR will be combined with inVentiv’s existing functional service provider and staffing businesses within its clinical operations, adding in capacity for site management and monitoring, clinical project and programme management, clinical programming and data management, biostatistical analysis and reporting, pharmacovigilance, medical writing, regulatory affairs, and quality assurance and training. inVentiv said it expects annual revenues for KCR of around $70 million, based on a previously announced contract loss and anticipated future business.
US drug development services company Particle Sciences Inc has teamed up with Pernix Therapeutics to develop a topical dermatology product for the paediatric market based on “a more convenient, and improved vehicle”, according to PSI chief executive Mark Mitchnick. The CRO says it is applying advanced drug delivery and formulation technologies to an ‘established paediatric product category’ in the project.
QED Clinical Services has created an Indian subsidiary based in Ahmedabad – QED Clinical Services India Private Limited – to expand its clinical capacity and international reach. In addition to conducting trials in India, QED India will act as a hub for the UK-based CRO’s Asia Pacific operations for control and oversight of its local partners across the region. The unit will be headed by country head and director of operations, Ali Saijad Bohra.
Phil Taylor
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