Shire, Impax settle pending Adderall litigation, sign agreement for Carbatrol

By Lisa Kerner

Erie, Pa., Jan. 19 - Shire plc and Impax Laboratories, Inc. said they have settled all pending litigation in connection with Impax's Abbreviated New Drug Application and its attempt to market generic versions of Shire's Adderall XR (mixed amphetamine salts) for the treatment of attention deficit hyperactivity disorder.

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, according to a company news release.

Impax will be permitted to market generic versions of Adderall XR in the United States no later than Jan. 1, 2010 and will pay Shire a royalty from those sales.

Impax may be permitted to enter the market as Shire's authorized generic in certain situations, such as the launch of another generic version of Adderall XR.

According to NDCHealth, U.S. gross sales of Adderall XR tablets were about $912 million in the 12 months ended Nov. 30, 2005.

No payments to Impax are involved in the settlement agreement.

"This agreement is a win-win for both companies as we are now able to resolve the uncertainty of the outcome of litigation and prevent the suit from becoming an even more costly and time consuming dispute," Impax president Larry Hsu said in the release.

In a separate agreement, Impax will promote Carbatrol (carbamazepine extended release capsules), Shire's product for the treatment of epilepsy, beginning around July 2006.

The general agreement calls for Impax to receive about $40 million over three years in exchange for providing physicians with product details and related information. Impax is entitled to certain incentive payments based on prescription growth.

Other terms of the agreement are confidential and were not disclosed.

"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," Matthew Emmens, Shire chief executive officer, said in the release.

Shire is a specialty pharmaceutical company, based in Basingstoke, England, focused on central nervous system, gastrointestinal, general products, and human genetic therapies.

Impax Laboratories, Inc. is a technology based specialty pharmaceutical company based in Hayward, Calif.

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