Allergan has announced that the European Commission has completed the transfer of the Marketing Authorisation for CONSTELLA® (linaclotide), a treatment for irritable bowel syndrome with constipation (IBS-C), from Almirall S.A. to Allergan Pharmaceuticals International Ltd.
Allergan Pharmaceuticals International Ltd is now the legal license holder for CONSTELLA® within the 28 countries of the European Union, assuming responsibilities for the development, pharmacovigilance and commercialisation of the product. CONSTELLA® has a European Marketing Authorisation for the symptomatic treatment of moderate-to-severe IBS-C in adults and is the only pharmaceutical product specifically licensed to treat the multiple symptoms of IBS-C across the EU.1 It is also the first targeted therapy for IBS-C that is included in the UK National Institute of Clinical Excellence’s guidelines on diagnosis and management of IBS.2
“The transfer of license for CONSTELLA® in the European Union heralds a major step on our journey to becoming a leading partner for gastroenterology physicians by bringing innovative gastrointestinal therapies to patient communities with significant unmet needs,” said Paul Navarre, President of International Brands at Allergan. “CONSTELLA® adds an important flagship product for our International GI team, and positions us strongly to leverage mid-to-late stage GI pipeline programmes.”
Estimates indicate that between 10–15% of the European population suffers from irritable bowel syndrome (IBS).3 One-third of patients with IBS are thought to have IBS-C and suffer from abdominal pain, bloating and constipation.4
In 2015, Allergan Pharmaceuticals International Ltd acquired rights to CONSTELLA® in over 40 countries around the world including the European Union, Switzerland, Turkey and the Commonwealth of Independent States from Almirall S.A. The transfer of Marketing Authorisation for CONSTELLA® to Allergan Pharmaceuticals International Ltd in Switzerland has not yet been granted.
The company will begin to transition product packaging and promotional materials from Almirall S.A. to Allergan Pharmaceuticals International Ltd, which will be phased over the next few months.
- European Medicines Agency: European public assessment reports. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d125&searchTab=&alreadyLoaded=true&isNewQuery=true&status=Authorised&status=Withdrawn&status=Suspended&status=Refused&keyword=Enter+keywords&searchType=name&taxonomyPath=Diseases.Digestive+System+Diseases.Gastrointestinal+Diseases.Intestinal+Diseases.Colonic+Diseases.Colonic+Diseases%2C+Functional&treeNumber=¤tCategory=Irritable+Bowel+Syndrome&searchGenericType=generics. Last accessed February 2016.
- National Institute for Health and Care Excellence. Irritable bowel syndrome in adults: diagnosis and management of irritable bowel syndrome in primary Care (February 2015). Available at http://www.nice.org.uk/guidance/cg61. Last accessed March 2016.
- Müller-Lissner S et al. Epidemiological Aspects of Irritable bowel syndrome in Europe and North America. Digestion 2001;64:200–4.
- Spiller R et al. Guidelines on the irritable bowel syndrome: mechanisms and practical management. Gut 2007;56:1770–98.