Healthcare Industry News: guanfacine
News Release - December 14, 2007
Shire Expands its Gastrointestinal Portfolio Through In-Licensing Celiac Disease Phase 2 Product From Alba Therapeutics CorporationWorldwide Rights for All Potential Uses, Excluding U.S. and Japan
No Other Existing Therapeutic Treatment for Celiac Disease
BASINGSTOKE, England and PHILADELPHIA, December 14 (HSMN NewsFeed) -- 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.
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 $300.5M 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.
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.
Notes to Editors
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: http://www.shire.com.
"Safe Harbor" Statement Under The Private Securities Litigation Reform Act of 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research; product development including, but not limited to, the successful development of JUVISTAŽ (Human TGFbeta3) and GA-GCB (velaglucerase alfa); manufacturing and commercialization including, but not limited to, the launch and establishment in the market of VYVANSE(TM)(lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder ("ADHD")); the impact of competitive products including, but not limited to, the impact of those on Shire's ADHD franchise; patents including, but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval including, but not limited to, the expected product approval date of INTUNIV(TM) (guanfacine extended release) (ADHD); Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2006.
(1) Source: Rewers, Gastroenterology vol128, 2005
Source: Shire plc
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