NORTH CHICAGO, Ill. and SAN CARLOS, Calif., May 14, 2013 /PRNewswire via COMTEX/ — AbbVie 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. For additional information about the company, please visit http://www.alvinepharma.com.
AbbVie Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” in our 2012 Annual Report on Form 10-K/A, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie employs approximately 21,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
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Mamie Y. Lara
June 21, 2013 at 3:57 amWhat I don’t understand is since I have celiac disease (very severely, for almost 4 years) and am 23 weeks pregnant with baby girl #1 and am almost 28 years old, how is continuing to breast feed my child GLUTEN-FREE breast milk going to prevent her from getting celiac disease? I understand the introduction of gluten being slow, and continuing to breast feed, but how is it supposed to “prevent” her from getting celiac disease? If she’s supposed to have it (because of my wonderful, celiac disease-filled genes) she’ll get it. Maybe I’m over-thinking this being a first-time mom, but I just don’t think that anything is going to prevent my daughter from inheriting my disease… although, according to this study, it might just postpone the inevitable.
Paula
June 21, 2013 at 10:27 amThanks for your comment. Yes, as you’ve said, at least one study showed the strategy of combination of breastfeeding and introduction of small amounts of gluten at age 4 months may prevent the onset of celiac in some at-risk children. Here is the study: http://pediatrics.aappublications.org/content/early/2013/02/13/peds.2012-1015.full.pdf+html Of course breastfeeding has many benefits for a child, but would just introducing gluten at 4 months (rather than 6 months), without breastfeeding have produced the same result, I’m unsure. I do believe there have been studies showing breastfeeding may provide some protection. If I find the study, I will post.
Isabel Q. Maynard
May 26, 2013 at 12:13 amThe U.S. Food and Drug Administration has granted Fast Track designation to ALV003, which means it may be approved more quickly than average, and has a decent chance of becoming the first pharmaceutical treatment on the market for celiac disease.