AbbVie and Alvine Pharmaceuticals, a leader in celiac disease therapeutics development, announced in a May 14, 2013 press release that they have entered into a global collaboration to develop a novel oral treatment for patients with celiac disease, currently in Phase 2 development.
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. The therapy may reduce the symptoms and intestinal injury associated with celiac disease in patients attempting to adhere to a gluten-free diet.
"Celiac disease is an area with significant unmet medical need," said Scott Brun, M.D., vice-president, pharmaceutical development, AbbVie, in the release. "Patients who currently are unable to completely avoid gluten in their diets could potentially benefit from this promising investigational treatment. AbbVie has significant experience within immunology and gastroenterology and the exclusive option to acquire this asset complements AbbVie's broad mid-stage pipeline."
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.