Shire And Barr Settle All Pending Litigation Concerning ADDERALL XR And Enter Into Development And License Agreement

Basingstoke, UK and Philadelphia, US - Shire plc announces that it has settled all pending litigation with Barr Laboratories, Inc. ("Barr"), a subsidiary of Barr Pharmaceuticals, Inc. in connection with Barr's Abbreviated New Drug Application ("ANDA") and its attempt to market generic versions of Shire's ADDERALL XR (extended-release mixed amphetamine salts) for the treatment of Attention Deficit Hyperactivity Disorder ("ADHD").

Barr will not be permitted to market a generic version of ADDERALL XR in the United States until April 1, 2009, except for certain limited circumstances, such as the launch of another party's generic version of ADDERALL XR. As announced earlier this year, Shire's settlement with Impax Laboratories allows Impax to market a generic version of ADDERALL XR 181 days following Barr's launch. No payments to Barr are involved in the settlement agreement.

The litigations, all pending in the United States District Court for the Southern District of New York, are directed to Barr's infringement of Shire's U.S. Patent Nos. 6,322,819 ("the '819 Patent"), 6,605,300 ("the '300 Patent") and 6,913,768 ("the '768 Patent") and Barr's desire to market generic versions of ADDERALL XR prior to the expiration of Shire's patents. As part of the settlement, Barr entered into consent judgments and agreed to permanent injunctions confirming the validity and enforceability of Shire's '819, '300 and '768 Patents. Barr has also admitted that any generic product made under its ANDA would infringe the '768 patent.

Shire and Duramed Pharmaceuticals, Inc. ("Duramed"), a subsidiary of Barr Pharmaceuticals, Inc., have also entered into an agreement related to Duramed's transvaginal ring technology that will be applied to at least five women's health products, as well as a license to Duramed's currently marketed oral contraceptive, Seasonique (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg). Under this agreement, Shire will make an initial payment of $25 million to Duramed for previously incurred product development expenses, and will reimburse Duramed for development expenses incurred going forward up to a maximum of $140 million over eight years. Shire will have the exclusive rights to market these products in the five major European markets of the UK, Germany, France, Italy and Spain and other areas, excluding North America and to the subsequent sales they will generate on a royalty-free basis.

Duramed has also agreed to purchase Shire's ADDERALL (immediate-release mixed amphetamine sales) product for $63 million. This transaction is subject to reporting under the United States Hart-Scott-Rodino Act.

Matthew Emmens, Shire Chief Executive Officer stated: "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. 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."

The agreements will be submitted to the United States Federal Trade Commission as required by law and become effective upon the Courts' signing of consent judgments for all of the litigations.

SOURCE: Shire PLC