Shire expands its gastrointestinal portfolio through in-licensing Celiac disease Phase 2 product from Alba Therapeutics Corporation

Worldwide rights for all potential uses, excluding U.S. and Japan



BASINGSTOKE, UK and PHILADELPHIA, PA, USA | December 14, 2007 |
– Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, today announces that it has acquired the worldwide rights, excluding the U.S. and Japan, to AT-1001 from Alba Therapeutics Corporation (Alba). AT-1001 is Alba’s lead inhibitor of barrier dysfunction in various gastrointestinal disorders that is currently in Phase 2 development for the treatment of Celiac disease. Shire has acquired rights to all uses for AT-1001, which may also be studied for the treatment of Crohn’s disease and other indications.

Matthew Emmens, Chief Executive Officer, commented: "The licensing of AT-1001 from Alba is a natural fit to our growing portfolio of gastrointestinal products. This product will be marketed to specialist physicians and we would expect to use our existing European sales force that is currently establishing relationships and expertise in the GI area through the marketing of MEZAVANT XL."

Financial terms of the license are geared to the successful development and commercialization of the product. Shire will pay Alba an upfront license fee of $25 million and further development and sales-based milestones totalling to a maximum of $300.5MM should the product reach blockbuster status. Shire will also pay royalties on net sales of the product, with tiered, single or double digit royalty rates.

Alba and Shire will form a joint development committee to monitor R&D activities of AT-1001. Alba will fund all development until AT-1001 has completed Proof of Concept, which is expected to be in the first half of 2009, after which Shire and Alba will share equally development costs under a joint development plan.

About Celiac disease:

Celiac disease is a T-cell mediated auto-immune disease that occurs in genetically susceptible individuals and is characterized by small intestinal inflammation triggered by gluten. There are no currently marketed pharmaceutical products for this disorder and the current treatment for Celiac is complete elimination of gluten from the diet.

Celiac disease is largely under-diagnosed although recent advances in diagnostics have improved diagnosis dramatically. After screening, it is thought that the incidence is approximately 1%¹ in the western world.

About AT-1001:

AT1001 is a novel peptide that inhibits intestinal paracellular permeability by inhibiting stimulus-induced cytoskeletal rearrangement in epithelial cells that leads to the disassembly of tight junctions. It is currently under investigation in a multi-centre, double blind, placebo controlled Phase 2 dose ranging study to evaluate its safety, tolerability and efficacy in 140 Celiac subjects during gluten challenge.

SHIRE PLC

Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company’s website: www.shire.com.

Rewers, Gastroenterology vol128, 2005

 

SOURCE: SHIRE

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