Cetero is re-doing studies for Teva, Actavis, Ranbaxy and other generic firms to satisfy FDA concerns about its data, court documents show.
As part of its bankruptcy case Cetero has posted a list of clients it is re-doing work for to fix its data integrity dispute with the US Food and Drug Administration (FDA). The list shows 21 contracts, more than one-third of which are with Israeli generics giant Teva.
In February Teva played down its exposure. “In any pipeline there are issues, whether it’s with Cetero or some other. But we feel pretty good about escitalopram being our largest launch this year. I’m not too concerned about Cetero on escitalopram”, William Marth, CEO of Teva Americas, said.
Teva began selling escitalopram, an antidepressant marketed in the US by Forest Laboratories, last month and has a 180-day period of exclusivity. The Cetero filing shows it has eight rework contracts for unnamed projects though.
At the moment Teva now has the most rework contracts with Cetero but it is possible others are more exposed. Last month April Johnson, vice president, business relationship management at Cetero, told Outsourcing-Pharma work had begun on 20 of the 100 studies the FDA wants re-doing.
This is consistent with the list, which features 21 rework contracts , and suggests Cetero is yet to sign deals for the bulk of the work. The list shows Actavis, Ranbaxy, and CorePharma are among the firms with rework contracts. Some other big generic players claim to have avoided the need to do rework.
“The biostudy at question now falls outside of the range of concerns that the FDA has about Cetero. So there is no issue regarding the biostudy that was performed at Cetero”, Paul Bisaro, CEO of Watson, said in February when discussing work Cetero performed on its lidocaine generic.
Big biopharma business
As Cetero has previously said, the rework contracts focus on Phase I tests of generic drugs to show equivalence with reference products. However, other sections of the document show the list of all contracts at Cetero reads like a Who’s Who of big biopharma businesses.
Johnson & Johnson has five contracts with Cetero, plus its subsidiary McNeil Consumer Healthcare has another five deals with the CRO (contract research organisation). Other big firms with multiple ties to Cetero include GlaxoSmithKline with six contracts and Eli Lilly with four deals.
Cetero posted the contract list to show the amount it plans to pay to fix any defaults. None of Cetero’s clients are due to receive cash but some of its suppliers are. Most notably Siemens Healthcare Diagnostics is due almost $70,000 (€50,000) for a lab equipment service deal.