Tillotts Pharma Successfully Completes DCP1 for Colpermin™ in Europe
RHEINFELDEN, Switzerland, Nov. 29 2017 – Tillotts Pharma AG (“Tillotts”), part of the Japanese Zeria Group, today announced that the German Federal Institute for Drugs and Medical Devices (BfArM) has closed the decentralised authorisation procedure (DCP) for Colpermin™ (peppermint oil), an over-the-counter2 (OTC) antispasmodic already marketed in Switzerland. Under this procedure, Colpermin was simultaneously authorised in a number of Member States3 of the European Union (EU). Tillotts is currently looking for an appropriate partner to take over the marketing rights for Colpermin as soon as possible.
“Obtaining the marketing authorisation for eighteen European States for Colpermin is the result of the hard work of our employees and our dedication to GI-health.” said Thomas A. Tóth von Kiskér, CEO at Tillotts. “We are extremely pleased with our growth in 2017 and will continue our strategy to partner with companies involved in diseases of the digestive system. At Tillotts, we value the benefits of joining forces and we strive to improve disease management for people with gastrointestinal diseases through partnerships and collaborations.”
Colpermin is an antispasmodic with delayed release indicated for the symptomatic treatment of painful bowel cramps and bloating in irritable bowel syndrome (IBS), a chronic condition of the digestive system.
IBS is the most commonly diagnosed gastrointestinal condition4. In 1991, IBS was listed second as a cause of absence from work, only behind the common cold5. More recent data suggest that this gap is even decreasing: not only a high economic impact but also a substantial decrease in patients’ quality of life could be observed6. An estimated 10–20%7 of people in the general population experience symptoms of IBS, although only about 15% of affected people actually seek medical help8. IBS causes abdominal pain and altered bowel habits7. The main complaints are either frequent, watery bowel movements (diarrhoea) or not frequent enough bowel movements (constipation). In some patients these symptoms may switch between diarrhoea and constipation7. Although the condition cannot be cured, treatments are available to alleviate symptoms.
For more information, contact Federica Ricatto, Senior Communications Manager:
Phone: +41 61 935 2749
The press release is available in German here
Tillotts Pharma AG, part of the Japanese Zeria Group, is a fast-growing specialty pharma company with approximately 300 employees in Switzerland and abroad. Tillotts is dedicated to the development, in/out-licensing and commercialisation of innovative pharmaceutical products for the digestive system. Tillotts successfully markets its own products for the treatment of IBD as well as in-licensed products, in over 65 countries through its affiliates within Europe and a network of gastroenterology-focused partners throughout the world. GI-health is our passionTM. All trademarks used or mentioned here are protected by law. © Copyright Tillotts Pharma AG. All rights reserved.
Zeria Pharmaceutical Co., Ltd., founded in 1955, based in Tokyo, Japan, focuses on R&D, manufacturing and sales of prescription drugs as well as OTC products. The company is listed on the First Section of Tokyo Stock Exchange (Stock code: 4559). Zeria holds a leading position within the gastroenterology field in Japan and operates internationally through a number of subsidiaries. For more information about Zeria please visit www.zeria.co.jp
Notes and References
- Decentralised authorisation procedure
- Colpermin is a prescription drug in Spain and Sweden.
- The rights to Colpermin, including the rights to the trademark, are owned by Tillotts in various countries except for the following: United Kingdom and Ireland.
- Brandt LJ et al. An evidence-based systematic review on the management of irritable bowel syndrome. Am J Gastroenterol. 2009;104, Suppl 1;S1-S35
- Schuster MM. Diagnostic evaluation of the irritable bowel syndrome. Gastroenterol Clin North Am. 1991;20(2):269-78
- Canavan C et al. Review article: the economic impact of the irritable bowel syndrome. Aliment Pharmacol Ther. 2014 Nov;40(9):1023-34
- Longstreth GF et al. Functional bowel disorders. Gastroenterol. 2006;130:1480-91
- Hungin APS et al. The prevalence, patterns and impact of irritable bowel syndrome: an international survey of 40 000 subjects. Aliment Pharmacol Ther. 2003;17:643-50
ColperminTM pack shot
Source: Tillotts Pharma AG. Download high resolution photo here.