Healthcare Industry News:  mesalamine 

Biopharmaceuticals Licensing Gastroenterology

 News Release - December 14, 2007

Alba Therapeutics Corporation and Shire plc Enter Into $325 Million ex-US, ex-Japan Licensing Agreement to Develop and Commercialize AT-1001

BALTIMORE, Dec. 14 (HSMN NewsFeed) -- Alba Therapeutics Corporation announced today that it has entered into a strategic collaboration with Shire plc (LSE: SHP, Nasdaq: SHPGY, TSX: SHQ), to jointly develop AT-1001, Alba's lead inhibitor of barrier dysfunction in various gastrointestinal ("GI") disorders. Shire will receive rights to commercialize all forms of AT-1001 outside of the United States and Japan. Alba will retain all rights to commercialize AT-1001 in the United States and Japan.

Under the terms of the collaboration, Alba will receive an initial, non- refundable licensing payment of US$ 25 million. Joint development costs toward global approval of AT-1001 will be shared 50/50 after the completion of two Phase 2 studies for Celiac disease. Alba is eligible to receive over US$ 80 million if certain clinical, regulatory and launch milestones are met for certain GI indications. Additional milestone payments totaling over US$ 40 million per indication will also be payable to Alba if the Collaboration is expanded beyond GI indications. Alba is also eligible to receive up to US$ 220 million in sales-based milestones, as well as tiered royalties. Not including royalties and cost sharing, the deal is valued at over US$ 325 million if all milestones are achieved.

Dr. Blake M. Paterson, Alba's President & CEO said:

"We are pleased to enter into this partnership with Shire, which leverages the unique experience and expertise of both companies in developing therapies for GI disorders. The combination of Alba's barrier function technology and autoimmune development capabilities with Shire's proven track record in GI drug development and commercialization will greatly enhance our efforts to bring these novel therapies to patients."

Matthew Emmens, Shire's CEO said:

"Alba's products have the potential to be an excellent addition to our current gastrointestinal business. This technology should provide significant benefit to patients with serious autoimmune and inflammatory conditions."

Alba will lead worldwide development operations through the end of Phase 2 clinical trials in Celiac disease. The companies will share responsibility for Phase 3 clinical trial execution and for the pursuit of additional indications such as Crohn's disease. This will leverage Shire's regulatory and clinical experience, as well as its commercial infrastructure.

Michael Yasick, Shire's Senior Vice President and Gastrointestinal Global Business Unit Leader added:

"We are excited about this opportunity for Shire to expand its GI franchise beyond mesalamine-related products such as Lialda(TM) / MEZAVANT XL®. We look forward to working closely with Alba on the development of these new therapies."

Dr. Paterson also noted that, "this partnership is another step in Alba's evolution as a biopharmaceutical company and provides a significant validation of our barrier function technology platform, specifically applied to gastrointestinal disease. The partnership will also enhance our ability to provide solutions for other inflammatory and immune related diseases, both acute and chronic."

About AT-1001

AT-1001 is an inhibitor of barrier dysfunction that has been shown to block intestinal permeability and the genesis of some autoimmune diseases, both through the reduction of antigen presentation to the body's immune system and the inhibition of cytokine production. AT-1001 is orally formulated and is currently in Phase 2 studies for Celiac disease, a gastrointestinal autoimmune disease. INDs for oral AT-1001 in beta cell preservation (Type 1 Diabetes) and Crohn's disease have also been filed and cleared FDA review.

About Alba

Alba Therapeutics Corporation is a privately held, clinical-stage biopharmaceutical company based in Baltimore, Maryland. Alba is dedicated to development and commercialization of disease modifying therapeutics to treat autoimmune and inflammatory disease, drug delivery agents and mucosal vaccine adjuvants by exploiting its technology to regulate the assembly and disassembly of tight junction proteins in cells throughout the body.


Source: Alba Therapeutics

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