AbbVie Inc. and Alvine Pharmaceuticals, Inc. announced that they have entered into a global collaboration to develop a novel oral treatment for patients with celiac disease, currently in Phase 2 development. This collaboration builds on AbbVie's expertise and leadership in the field of gastroenterology with its on-market products to treat Crohn's disease, ulcerative colitis, and diseases associated with exocrine pancreatic insufficiency. ALV003 is an investigational oral therapy composed of two recombinant, gluten specific enzymes (a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP)), that degrade gluten in-vitro and in human clinical testing, and may reduce the symptoms and intestinal injury associated with celiac disease in patients attempting to adhere to a gluten-free diet. Data from a Phase 2a study reported at Digestive Disease Week (DDW) 2012, showed reduction of intestinal inflammation in patients exposed to gluten and treated with ALV003 compared to patients treated with placebo. Under the terms of the agreement, AbbVie will make an initial upfront payment of $70 million for an exclusive option to either acquire the assets relating to ALV003, or the equity of the company. Alvine will maintain responsibility for Phase 2 clinical development, and upon successful completion of the approximately 500 patient Phase 2b study, AbbVie may exercise its option for the agreed upon additional consideration. Alvine will also be entitled to receive a milestone payment upon AbbVie's initiation of Phase 3 development.

Alvine Pharmaceuticals, Inc. Presents at BIO-Europe 2012, Nov-12-2012 . Venue: CCH Congress Center Hamburg, Am Dammtor / Marseiller Str, 20355 Hamburg, Germany.

Alvine Pharmaceuticals, Inc. announced that its lead candidate, ALV003, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of patients with celiac disease. Alvine is currently conducting phase 2 clinical trials with ALV003. Under the FDA Modernization Act of 1997, the Fast Track program was designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA during clinical development and for the possibility of priority review, which can reduce the time required for FDA review of a New Drug Application. About ALV003: ALV003 is an orally administered mixture of two recombinant gluten-specific proteases, a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP). ALV003 targets gluten and degrades it into small fragments, which, in vitro, diminishes its immunogenicity. ALV003 is being developed as a potential treatment for celiac disease patients in conjunction with a gluten-free diet and is currently in phase 2 clinical development.