As it settles its differences with the FDA and embarks on finding new ownership, Cetero Research is being pursued by a California biotech that wants almost $250,000 from the troubled CRO, alleging a breach of contract.
Kythera Biopharmaceuticals filed an objection in U.S. Bankruptcy Court in Delaware, where Cetero filed its bankruptcy protection suit in March. Four years ago, Kythera entered an agreement with Cetero for the CRO to conduct clinical services in the development and testing of the biotech's ATX-101 drug for reducing chin fat. At some point, as Outsourcing-Pharma notes, Cetero used the wrong isomer during work stipulated under the contract's second addendum, forcing it into a third one. That resulted in Kythera expending "significant internal resources and delaying its ATX-101 development program…"
"In other words, had [Cetero] performed under the Second Addendum (i.e. had they not breached the agreement), the services rendered under the Third Addendum would not have been necessary and Kythera would not have been forced to incur an additional $247,597," Kythera's lawyers allege in the objection filing.
Kythera's claims could put another wrench in the Cetero's quest to transfer its ownership, something that has already been delayed after unsecured creditors successfully argued that they didn't have enough time to submit takeover bids. And Kythera isn't the only party speaking out: Generics manufacturers such as Perrigo ($PRGO) and Par Pharmaceutical ($PRX) have also filed objections in the suit, Outsourcing-Pharma says.
FierceCRO's phone calls to Cetero seeking comment were not returned. A spokeswoman for Kythera declined to comment while legal proceedings were in process.
- read more from Outsourcing-Pharma
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