It was bound to happen. As Cetero Research navigates bankruptcy proceedings, some drugmakers are bristling over the value of past work that the contract research organization conducted or how previous contracts will be honored. For instance, Kythera Biopharmaceuticals wants to be repaid at least $245,600 over complaints that Cetero botched development work (read this).
And both Par Pharmaceutical and Perrigo have filed papers indicating they want to ensure they receive credit for work due before any deals are struck with a prospective buyer. In court documents, Perrigo writes that applications are pending with the FDA, which may require reformatting, reanalysis or other work to ensure its drugs are good to go, but the generic drugmaker is concerned about how this obligation will be fulfilled (see here and here).
Cetero, you may recall, filed for bankruptcy protection two months ago after the FDA issued an alert last year to drugmakers to reevaluate studies between April 2005 and June 2010 over concerns about falsified data and manipulated samples (read here). More recently, the agency disclosed more information about trials that will require re-analysis or independent audits (see this). Approximately 100 tests will be re-dosed and about 120 will require paper audits, April Johnson, vp of business relationship management at Cetero recently told us.
The FDA alert put a strain on Cetero finances because lenders viewed its problems as a breach of “applicable health laws and regulations” that amounted to a default on its loans. If you turn to page 51 of this document, nearly two dozen drugmakers are listed. However, the drugmakers whose trials must undergo reanalyses or audits has not been disclosed. To what extent the concerns and objections will make it more difficult for a speedy resolution is unclear. Bankruptcy negotiations are, as one can imagine, complicated affairs.
Hat tip to Outsourcing Pharma