关键词：AbbVie,Alvine,ALV003,乳糜泻,麸质过敏症

2013年5月15日讯 /生物谷BIOON/ --AbbVie与Alvine制药今天宣布，双方已达成了一项全球性合作，开发一种新型的口服药物ALV003，用于乳糜泻（celiac disease）的治疗，好医师网，该药有望成为首个乳糜泻治疗药物。

目前该药处于IIa期临床开发。此次合作，是基于AbbVie在肠胃病学领域的专业知识和领导地位，目前AbbVie已上市的产品，包括克罗恩病（Crohn's disease）、溃疡性结肠炎、胰腺外分泌功能不全相关疾病等治疗药物。

ALV003是一种实验性口服药物，由2种重组的蛋白酶：谷蛋白特异性酶（半胱氨酸蛋白酶EPB2，cysteine protease ，EP-B2）和脯氨酰内肽酶（prolyl endopeptidase，PEP）组成。在体外及人体临床试验中，ALV003能够降解谷蛋白（gluten），并可能减轻试图坚持无麸质饮食（gluten-free diet）乳糜泻患者的症状及肠道损伤。IIa期临床数据表明，，在暴露于gluten后，与安慰剂组相比，ALV003治疗组表现出较少的肠道炎症。

根据协议条款，AbbVie将支付一笔7000万美元的预付款，获得收购ALV003相关资产或Alvine公司股权（equity）的独家选择权。Alvine将继续负责IIb期临床开发。在AbbVie启动III期临床试验时，将支付一笔里程碑款项。

乳糜泻（coeliac disease），又称乳糜腹泻、麸质过敏症，是一种最常见的具有遗传性、发生于小肠的自身免疫性疾病，是机体对谷蛋白（gluten）的一种反应，这种谷蛋白存在于黑麦、大麦、小麦及数百种这类谷物制成的食物中。机体免疫系统对谷蛋白发生反应，导致肠道损伤。（生物谷bioon.com）

英文原文：AbbVie and Alvine to Collaborate on Investigational Oral Therapy for Celiac Disease

AbbVie secures exclusive option to acquire global rights to ALV003

ALV003 has the potential to be the first therapy to treat celiac disease

North Chicago, Ill. and San Carlos, Calif., May 14, 2013 – AbbVie (NYSE: ABBV) and Alvine Pharmaceuticals, a leader in celiac disease therapeutics development, announced today 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.

“Celiac disease is an area with significant unmet medical need,” said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. “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.”

“A collaboration between Alvine and AbbVie combines our respective strengths and expertise in the development of what could become the first therapeutic option for this major unmet medical need,” said Abhay Joshi, Ph.D., president and chief executive officer, Alvine. “We are pleased to have an industry leader in gastroenterology as a collaborator, whose considerable global development reach can be focused on getting this novel therapy to more patients.”

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. 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.

About Celiac Disease

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. Currently there is no approved therapy for celiac disease and the only option for patients is to attempt to follow a strict, life-long gluten-free diet.

About Alvine Pharmaceuticals

Alvine Pharmaceuticals, Inc. is a private, clinical-stage, specialty biopharmaceutical company located in San Carlos, CA, focused on the development of biologics targeting autoimmune and inflammatory diseases, including celiac disease. Alvine is focusing clinical development efforts on ALV003, an investigational drug in Phase 2 trials that could potentially be the first approved therapeutic treatment for patients with celiac disease.

(责任编辑：lili.zhao)

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