Saint-Prex, Switzerland, Gothenburg, Sweden, July 3, 2012 – Ferring Pharmaceuticals (Ferring) and Albireo AB (Albireo) announced today that they have signed a license agreement under which Ferring has rights to develop and commercialise elobixibat, a first-in-class compound for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). The agreement gives Ferring rights to market the product globally with the exception of Japan and a small number of Asian markets. In consideration of the rights, Ferring will pay Albireo a significant upfront licensing fee, milestones and tiered double-digit royalties. Ferring will also be responsible for development costs in its territory.
The agreement is one of the biggest investments made by Ferring for licensing rights of a product. Ferring is a recognized leader in Inflammatory Bowel Disease (IBD) including ulcerative colitis and Crohn’s disease, and aims to become a global player in the broader gastroenterology field. Ferring believes that the novel therapy elobixibat, which is targeting a currently under-served, but large patient population, will significantly strengthen its gastroenterology portfolio. Elobixibat is due to enter Phase III trials for the CIC indication and Phase IIB trials for the IBS-C indication shortly.
“Elobixibat perfectly complements our gastroenterology portfolio, which includes PENTASA® for IBD and PICOPREP® for bowel cleansing. We also have several promising products in our pipeline within gastroenterology,” commented Michel Pettigrew, President of the Executive Board and COO at Ferring. “What is more, it fits well with our company philosophy of ‘People Come First’ – in particular the patient, as it addresses a problem that affects from 15% up to almost a third of the population but that has seen little progress in treatment options over the years.”
Dr. Jan Mattsson, Executive Director of the Board and COO of Albireo said “We are excited to enter into this agreement and look forward to collaborating with Ferring to bring this novel therapy to patients around the world suffering from CIC or IBS-C. Ferring has a long and strong track record in gastroenterology and we believe will be an ideal partner for Albireo and elobixibat in this territory.”
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Elobixibat is a first-in-class compound with a novel physiological mechanism of action. It acts locally in the gut with minimal systemic exposure and modulates the enterohepatic circulation of bile acids by a partial inhibition of the Ileal Bile Acid Transporter (IBAT). This increases colonic fluid secretion and motility. Phase II clinical trials with elobixibat in patients with CIC 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 CIC 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.
About chronic idiopathic constipation and IBS-C
Chronic constipation (CIC) is among the most common diseases throughout the world, affecting approximately 15% of the general population particularly women and the elderly population. Patients with CIC often experience hard and lumpy stools, straining during defecation and a sensation of incomplete evacuation, as well as discomfort and bloating. CIC adversely affects a person´s quality of life and is associated with significant health care expenditure. Studies show that approximately 50 % of individuals with CIC 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.
About Ferring Pharmaceuticals
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology and endocrinology. Ferring has its own operating subsidiaries in more than 50 countries and markets its products in more than 90 countries. To learn more about Ferring or our products please visit www.ferring.com.
About Ferring’s Gastroenterology Products
Ferring’s product, PENTASA® (mesalazine), is used for the treatment and long-term management of inflammatory bowel diseases, such as ulcerative colitis and Crohn’s disease (approved indications vary by country). PENTASA® is available orally as tablets and granules (sachets), and in topical formulations (suppositories and enemas). Ferring markets PENTASA® worldwide, excluding the U.S. (in the U.S., Shire US, Inc. uses the PENTASA® name under a trademark license from Ferring) and in Japan where Kyorin distributes PENTASA®.
PICOPREP® (sodium picosulfate 10mg, magnesium oxide 3.5mg, citric acid 12g), a dual action laxative medication, is used to cleanse a patient’s bowels prior to endoscopy, surgery and radiological procedures. This product is sold in some countries under the trademarks PICO-SALAX® or PICOLAX®.
Albireo is a Swedish biotechnology company focused on the development of novel therapeutic alternatives in the gastrointestinal area. In addition to elobixibat, Albireo has a pipeline of drug candidates in earlier stages of development in areas such as IBD and liver diseases. 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. 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.