Barr and its Duramed subsidiary settle Adderall litigation with Shire, sign additional agreements

By Lisa Kerner

Charlotte, N.C., Aug. 15 - Barr Pharmaceuticals, Inc. said its subsidiary, Duramed Pharmaceuticals Inc., and Shire plc signed a product acquisition agreement for Adderall (immediate-release mixed amphetamine salts) tablets and a product development agreement for six proprietary products.

Under the product acquisition agreement, Duramed will pay Shire $63 million to purchase Adderall tablets.

The product development agreement allows Shire to obtain regulatory approval for Duramed's Seasonique extended-cycle oral contraceptive product and to market it in certain territories.

In addition, Shire has certain rights to five additional products in development based on Duramed's transvaginal ring technology.

For its part, Shire will pay Duramed an initial $25 million payment for incurred development expenses, and reimbursement for development expenses going forward of up to $140 million over an eight-year period. Duramed and Shire will retain marketing rights to the products in different countries.

Barr Laboratories, another Barr subsidiary, signed a settlement and license agreement allowing it to launch a generic version of Adderall XR more than nine years earlier than the last-to-expire Shire patent listed in Food and Drug Administration's Orange Book.

The agreement calls for Barr to pay Shire a royalty equal to a portion of profits generated from the sales of generic Adderall XR during Barr's period of generic marketing exclusivity.

Shire's settlement with Impax Laboratories allows Impax to market a generic version of Adderall XR 181 days following Barr's launch.

"We believe the agreements announced today provide an equitable resolution to our Adderall XR patent litigation that creates a significant benefit for consumers, as well as the company's shareholders," Barr chairman and chief executive officer Bruce L. Downey said in the release.

As part of the settlement, Barr admits that Shire's patents are valid and enforceable and that Barr's generic product infringes one of the Shire patents, according to a company news release.

"We are very pleased to have reached this settlement on terms that are consistent with our beliefs that Shire's patents are valid and enforceable and infringed by would-be generic competitors," Shire chief executive officer Matthew Emmens said in the release.

"We are also excited about the opportunity of a new development and licensing agreement in the specialty area of women's health, particularly in Europe."

Adderall is indicated for the treatment of attention deficit hyperactivity disorder.

Barr develops generic and proprietary pharmaceuticals and is located in Woodcliff Lake, N.J.

Shire is a pharmaceutical company based in Basingstoke, England.

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