Shire has hit the licensing trail again by linking up with the USA’s Alba Therapeutics Corp in a development deal for the latter’s experimental gastrointestinal disorder drug.

The UK-headquartered firm has acquired the worldwide rights, excluding the USA and Japan, to Alba’s AT-1001, which is currently in Phase II trials as a treatment for celiac disease. Celiac is characterised by small intestinal inflammation triggered by gluten and there are no marketed drugs for the disorder; the current treatment is complete elimination of gluten from the diet.

Shire has also acquired rights to all uses for AT-1001, which may also be studied for the treatment of Crohn’s disease and other indications such as ulcerative colitis. Cashwise, Alba will receive an upfront fee of $25 million and further development and sales-based milestones of up to $300.5 million “should the product reach blockbuster status”. Shire will also pay out royalties on net sales of the product.

Alba and Shire will form a joint development committee to monitor R&D activities of AT-1001 and the former will fund all development until the compound has completed proof of concept, which is expected to be in the first half of 2009. Thereafter, the firms will share equally development costs.

Shire chief executive Matthew Emmens said the licensing of AT-1001 “is a natural fit to our growing portfolio of gastrointestinal products”. He added that it 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 its new ulcerative colitis drug Lialda/Mezavant XL (mesalazine).

His counterpart at Alba, Blake Paterson, said that the combination of his firm’s barrier function technology and autoimmune disease capabilities with Shire's “proven track record in GI drug development and
commercialization” should be a winning one.