Impax does deal with Shire over Adderall XR and Carbatrol

UK-based specialty pharmaceutical company Shire plc has settled with Impax Laboratories in the US, over the latter's Abbreviated New Drug Application and attempt to market generic versions of Adderall XR (mixed amphetamine salts) for the treatment of Attention Deficit Hyperactivity Disorder.

The litigation to be shelved involved patent infringement lawsuits covering Shire's US patents Nos 6,322,819, 6,605,300 and 6,913,768. As part of the settlement, Impax has confirmed that its proposed generic products infringe Shire's '819, '300 and '768 Patents and that the three patents are valid and enforceable.

Impax will be permitted to market generic versions of Adderall XR in the US no later than January 1, 2010 and will pay Shire a royalty from those sales. In certain situations, such as the launch of another generic version of Adderall XR, Impax may be permitted to enter the market as Shire's authorised generic. No payments to Impax are involved in the settlement.

Impax has also agreed a deal to promote Shire's Carbatrol (carbamazepine) for the treatment of epilepsy in the US. Shire will pay Impax to promote the drug to neurologists using a specialty field sales force of 66 representatives. Promotion will continue for three years beginning on or about July 2006. Impax will have incentives under a gain share arrangement.

Matthew Emmens, Shire ceo said: 'We are very pleased to have resolved the lawsuits against Impax. The settlement terms are consistent with our beliefs that Shire's patents are valid and enforceable.We look forward to working together with Impax to resume promotion and growth of Carbatrol.'

Shire also confirmed that discussions with Barr Laboratories, in connection with Barr to market a generic Adderall XR, are continuing. The Court continued the final pre-trial conference to March 10, 2006. No trial date has been set.

The agreements will be submitted to the US Federal Trade Commission for its review as required by law.