Alvine Pharmaceuticals Obtains Patents for Celiac Disease Therapies

Business Wire, Feb 21, 2008

SAN CARLOS, Calif. -- Alvine Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of autoimmune and gastrointestinal diseases, today announced that the United States Patent and Trademark Office has issued two key patents, 7,320,788 and 7,303,871, covering gluten detoxification with proline specific prolyl endopeptidases (PEPs) and with mixtures of a PEP and a glutamine specific protease. Alvine has an exclusive worldwide license to these patents under an agreement with Stanford University. Both patents provide important protection for ALV003, Alvine's lead product currently in clinical development for use in the treatment of celiac disease.

"Alvine is delighted that these two patents have issued," said Dr. Abhay Joshi, Alvine's President and Chief Executive Officer. "Alvine and others have shown PEPs to be efficient at degrading gluten. With these patents and our recently announced initiation of clinical trials of ALV003 (a combination of a PEP and a glutamine specific protease), we believe Alvine is well positioned to capitalize on the potential use of proteases as therapeutic agents to treat celiac disease. ALV003 is more efficient at degrading gluten than either a PEP or a glutamine specific protease alone."

About ALV003

ALV003 is an orally administered combination of two proteases engineered to digest gluten. It targets the glutamine and proline residues that are common in gluten. ALV003 consists of a glutamine specific cysteine protease (EP-B2) and a proline specific prolyl endopeptidase (PEP). The proposed mechanism of action of ALV003 is to digest gluten into non-immunotoxic fragments.

About Celiac Disease

Celiac disease is the most common hereditary autoimmune disease with prevalence as high as 1% in the U.S. and E.U. Celiac disease is triggered by the ingestion of gluten in genetically susceptible individuals. Gluten is a protein found naturally in wheat, rye, and barley, and is one of the most common food additives in the human diet. Patients with celiac disease mount an immune response to gluten and gluten fragments, resulting in systemic immune mediated damage in the gut and other organs. Gluten ingestion can be associated with symptoms such as nausea, diarrhea, constipation and rash. Complications of celiac disease can include osteoporosis, anemia, dermatitis, weight loss, diabetes, central nervous system conditions, other autoimmune diseases and malignancies. There are currently no approved pharmaceutical therapies for celiac disease. The only available treatment for individuals diagnosed with celiac disease is a life-long adherence to a strict gluten-free diet which is difficult to follow. There is a high unmet medical need for celiac disease therapies.

About Alvine

Alvine Pharmaceuticals, Inc. is a privately held biopharmaceutical company dedicated to developing and commercializing therapeutics for autoimmune/gastrointestinal diseases. Alvine's lead product candidate, ALV003, is a combination protease engineered to digest gluten. It is being developed to treat patients with celiac disease. For additional information about the company, please visit www.alvinepharma.com.