BASINGSTOKE, England and PHILADELPHIA, December 14 /PRNewswire-FirstCall/-- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialtybiopharmaceutical company, today announces that it has acquired the worldwiderights, excluding the U.S. and Japan, to AT-1001 from Alba TherapeuticsCorporation (Alba). AT-1001 is Alba's lead inhibitor of barrier dysfunctionin various gastrointestinal disorders that is currently in Phase 2development for the treatment of Celiac disease. Shire has acquired rights toall uses for AT-1001, which may also be studied for the treatment of Crohn'sdisease and other indications.
Matthew Emmens, Chief Executive Officer, commented: "The licensing ofAT-1001 from Alba is a natural fit to our growing portfolio ofgastrointestinal products. This product will be marketed to specialistphysicians and we would expect to use our existing European sales force thatis currently establishing relationships and expertise in the GI area throughthe marketing of MEZAVANT XL."
Financial terms of the license are geared to the successful developmentand commercialization of the product. Shire will pay Alba an upfront licensefee of $25 million and further development and sales-based milestonestotalling to a maximum of $300.5M should the product reach blockbusterstatus. Shire will also pay royalties on net sales of the product, withtiered, single or double digit royalty rates.
Alba and Shire will form a joint development committee to monitor R&Dactivities of AT-1001. Alba will fund all development until AT-1001 hascompleted Proof of Concept, which is expected to be in the first half of2009, after which Shire and Alba will share equally development costs under ajoint development plan.
About Celiac disease:
Celiac disease is a T-cell mediated auto-immune disease that occurs ingenetically susceptible individuals and is characterized by small intestinalinflammation triggered by gluten. There are no currently marketedpharmaceutical products for this disorder and the current treatment forCeliac is complete elimination of gluten from the diet.
Celiac disease is largely under-diagnosed although recent advances indiagnostics have improved diagnosis dramatically. After screening, it isthought that the incidence is approximately 1% (1) in the western world.
AT1001 is a novel peptide that inhibits intestinal paracellularpermeability by inhibiting stimulus-induced cytoskeletal rearrangement inepithelial cells that leads to the disassembly of tight junctions. It iscurrently under investigation in a multi-centre, double blind, placebocontrolled Phase 2 dose ranging study to evaluate its safety, tolerabilityand efficacy in 140 Celiac subjects during gluten challenge.
Notes to Editors
Shire's strategic goal is to become the leading specialtybiopharmaceutical company that focuses on meeting the needs of the specialistphysician. Shire focuses its business on attention deficit and hyperactivitydisorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) andrenal diseases. The structure is sufficiently flexible to allow Shire totarget new therapeutic areas to the extent opportunities arise throughacquisitions. Shire's in-licensing, merger and acquisition efforts arefocused on products in niche markets with strong intellectual propertyprotection either in the US or Europe. Shire believes that a carefullyselected portfolio of products with strategically aligned and relativelysmall-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website:http://www.shire.com.
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