Bristol-Myers Squibb and partner withdraw application

Bristol-Myers Squibb and its partner ImClone Systems have announced the withdrawal of a submission regarding Erbitux.

The partnership said the decision to temporarily cancel the biologics licence application for the drug was based upon a “chemistry manufacturing and controls matter”.

Bristol-Myers Squibb noted the request would eventually be resubmitted.

The company added the withdrawal would not have any impact on the currently marketed version of Erbitux, “including the safety and efficacy of the product for approved indications”.

Last month, it was announced Bristol-Myers Squibb and Exelixis had entered a deal to develop two cancer programmes.

The deal will see the progression of studies on XL184 and XL281, which will be directed by a joint committee.

Under the terms of the collaboration, Exelixis received a payment of $195 million (142.3 million pounds) for commercialisation and development rights from its partner.

The company will receive additional licence payments of $45 million over this year.