April 20, 2014 2:55 PM ET

Biotechnology

Company Overview of Alvine Pharmaceuticals, Inc.

Company Overview

Alvine Pharmaceuticals, Inc., a biopharmaceutical company, engages in developing and commercializing therapeutics for autoimmune/gastrointestinal diseases. It offers ALV003, a pipeline lead drug candidate for celiac disease; Transglutaminase 2 (TG2), a multifunctional protein with enzymatic, cell signaling, and cell adhesion activities to the pathogenesis of a variety of diseases, including celiac disease; and neurological disorders, including Huntington’s Disease, type 2 diabetes, liver cirrhosis and fibrosis, renal scarring, vascular remodeling, and cancers; and HLA-DQ2 blockers, a class II heterodimer of HLA (human leukocyte antigen). The company was incorporated in 2005 and is based in S...

740 Shoreway Road

Suite B

San Carlos, CA 94070

United States

Founded in 2005

Phone:

650-632-1645

Fax:

650-637-3396

Key Executives for Alvine Pharmaceuticals, Inc.

Chief Executive Office
Scientific Founder and Director
Age: 48
Senior Director of Finance
Chief Business Officer and Senior Vice President
Chief Medical Officer and Senior Vice President of Development
Age: 56
Compensation as of Fiscal Year 2013.

Alvine Pharmaceuticals, Inc. Key Developments

Alvine Pharmaceuticals, Inc. Doses First Patient in Phase 2b Trial for ALV003 in Celiac Disease

Alvine Pharmaceuticals, Inc. announced that the first randomized study patient was dosed in the CeliAction Study(TM), a phase 2b study of its lead clinical candidate, ALV003, which is in development for the treatment of patients with celiac disease. ALV003 is an orally administered mixture of two gluten-specific proteases shown in vitro to degrade gluten, the primary immunologic trigger for celiac disease. The CeliAction Study(TM), a phase 2b, randomized, double-blind, placebo-controlled, dose-ranging clinical study will evaluate the safety and efficacy of ALV003 at different dose levels administered over a twelve-week period in approximately 500 patients in the United States, Canada and Europe. The study is currently enrolling diagnosed celiac disease patients who are symptomatic despite attempting to follow a gluten-free diet. The study will evaluate the safety and efficacy of ALV003 administered over a twelve-week period; patients must remain on a gluten-free diet during the study. The primary efficacy endpoint for the study is the change in small intestinal mucosal morphology as measured by the change in villus height to crypt depth ratio (Vh:Cd) from baseline and week 12 assessments. Secondary endpoints are the changes in density in intestinal intraepithelial lymphocytes and celiac disease-specific symptoms during the study.

AbbVie Inc. and Alvine Pharmaceuticals, Inc. to Collaborate on Investigational Oral Therapy for Celiac Disease

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

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

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