Alvine Pharmaceuticals Inc., a private, clinical-stage, specialty biopharmaceutical company located in San Carlos, CA, announced that AbbVie Inc. (ABBV) and Alvine Pharmaceuticals have entered into a global collaboration to develop a novel oral treatment for patients with celiac disease, currently in Phase 2 development.
Alvine said that the 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.
Alvine stated that ALV003 has the potential to be the first therapy to treat celiac disease.
As per the terms of the deal, 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 said it will also be entitled to receive a milestone payment upon AbbVie's initiation of Phase 3 development. In collaboration with AbbVie Biotech Ventures Inc., a subsidiary of AbbVie dedicated to making early investments in emerging biotech and pharmaceutical companies, AbbVie was an early investor in Alvine Pharmaceuticals.
Celiac disease is the most common autoimmune disease, affecting approximately 6 million people in the U.S. and E.U. Celiac disease is an acquired autoimmune disorder that develops in genetically susceptible individuals after exposure to dietary gluten, the protein found in wheat, rye and barley that humans cannot fully digest. Celiac disease is a systemic illness that can affect many organ systems, causing chronic gastrointestinal symptoms, such as nausea, diarrhea, and constipation, and can potentially cause serious medical consequences, including malabsorption, osteoporosis, anemia, infections and malignancies.
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