April 3, 2012
Tokyo, Japan and Gothenburg, Sweden, April 3, 2012- Ajinomoto Pharmaceuticals Co., Ltd. (President, Tomoyasu Toyoda; Headquarters, Chuo-ku, Tokyo; “Ajinomoto Pharmaceuticals” and Albireo AB (Gothenburg, Sweden; “Albireo”) today announced that they have signed an agreement providing Ajinomoto Pharmaceuticals exclusive rights to develop and commercialize elobixibat (Development code: A3309) in Japan, South Korea, Thailand, Indonesia, Vietnam and Taiwan. Under the agreement, Ajinomoto Pharmaceuticals will pay a significant upfront fee, milestones and tiered double-digit royalties to Albireo in consideration of the rights. Elobixibat is a first-in-class investigational drug in development for chronic constipation and irritable bowel syndrome with constipation (IBS-C).
Mr. Tomoyasu Toyoda, President & CEO of Ajinomoto Pharmaceuticals Co., Ltd. said “It is our great pleasure that we have this opportunity to develop and commercialize elobixibat. We will work together with Albireo to file the NDA and launch the product as quickly as possible. We believe that elobixibat will certainly contribute to the treatment of patients suffering from chronic constipation and IBS with constipation and increase patient quality of life. Elobixibat will be the starting point of the growing collaborative relationship between Albireo and Ajinomoto Pharmaceuticals in the gastrointestinal area.
Dr. David Chiswell, Chairman of Albireo said “We are excited to enter into this agreement and look forward to collaborate with Ajinomoto Pharmaceuticals to bring elobixibat to patients in Japan and Asia. Ajinomoto Pharmaceuticals, having gastrointestinal diseases as one of their key strategic areas, is a perfect fit for Albireo and elobixibat in this territory”.
Elobixibat is an orally available therapeutic alternative with a novel physiological mechanism of action. Elobixibat is acting locally in the gut with minimal systemic exposure and modulates the enterohepatic circulation of bile acids by inhibiting the Ileal Bile Acid Transporter (IBAT) thereby increasing colonic fluid secretion and motility. Phase II clinical trials with elobixibat in patients with chronic constipation conducted in USA and Europe have demonstrated clinically meaningful, statistically significant and dose-dependent improvement on key constipation and IBS-C symptoms such as bowel movement frequency, straining, stool consistency and bloating.
The prevalence of severe chronic constipation and IBS-C is high and patients are not satisfied with current available treatments. Elobixibat has the potential to become a safe and effective treatment alternative for this group of patients and increase patient quality of life.
Ajinomoto Pharmaceuticals offers various treatments for lower gastrointestinal tract diseases. Among the IBD treatments, oral alpha-4 integrin antagonist, (Development Code: AJM300), once-daily 5-ASA granules (Development code: AJG501) and a budesonide rectal foam are under development. A novel oral bowel cleansing agent (Development code: AJG522) is under NDA. Ajinomoto Pharmaceuticals is committed to contributing to diagnosis and treatment of patients through research and development and the activities to increase public awareness about diseases in the gastrointestinal area and aims to be a dedicated and focused GI specialty pharmaceutical company trustable and reliable for patients and medical practitioners.
Albireo AB is a Swedish biotechnology company focused on the development of novel therapeutic alternatives in the gastrointestinal area. The management team has a broad experience in drug development, in particular in the GI area and has an extensive network in the international scientific and clinical communities. In addition to elobixibat, Albireo has a pipeline of drug candidates in earlier stages of development in areas such as IBD and liver diseases. Albireo was created as a spin-out of AstraZeneca in 2008, financed by a syndicate of leading healthcare investors, led by Phase4 ventures, and joined by TPG Biotech, TVM Capital and Scottish Widows Partnership.
Chronic constipation (CC) is among the most common diseases, throughout the world, affecting approximately 15% of the general population particularly women and the elderly population. Patients with CC often experience hard and lumpy stools, straining during defecation and a sensation of incomplete evacuation, as well as discomfort and bloating. CC adversely affects a person´s quality of life and is associated with significant health care expenditure. Studies show that approximately 50% of individuals with CC are not satisfied with available treatments underscoring the unmet medical need in this area.
IBS-C is a disease characterized by a combination of abdominal pain and constipation. Throughout the world, about 10%–20% of adults have symptoms consistent with IBS, and most studies find a female predominance. IBS symptoms come and go over time, often overlap with other functional disorders, impair quality of life, and result in high health care costs. There is a high rate of dissatisfaction with available therapies.