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2019.01.22

Tillotts Pharma AG announces launch of ASACOLTM 1600 mg (mesalazine)* for ulcerative colitis

RHEINFELDEN, Switzerland, 22 January 2019 – Tillotts Pharma AG (“Tillotts”), part of the Japanese Zeria Group, announces the launch of ASACOL™ 1600 mg (mesalazine) in Denmark, Iceland, the Netherlands* and Norway. ASACOL™ 1600 mg is the first 1600 mg mesalazine tablet for the treatment of mild to moderate ulcerative colitis (UC).

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A clinical study1 showed that once-daily ASACOL™ 1600 mg (mesalazine) is effective for the induction and maintenance treatment of mild to moderate UC with 22.4% of the enrolled patients in clinical and endoscopic remission at week 8 when treated with a 3.2 g/day regimen (2 tablets, once-daily). Data from the open label extension study showed that the extended treatment with 1.6 g/day (1 tablet, once-daily) is effective for the maintenance of clinical remission. At week 38, 70% of the patients, in remission after induction, maintained remission.

“The development of ASACOL™ 1600 mg was made possible due to the incorporation of the new OPTICORE™ technology. This launch represents many years of dedicated work and the successful collaboration with important industry partners and research institutes. It is the culmination of one of the programs in our pipeline, a pipeline that is global and innovative and will offer new partnership opportunities as Tillotts expands into the biotechnology world,” said Johannes Spleiss, Chief Scientific Officer at Tillotts. “Clinical data1 confirm the efficacy and safety profile of ASACOL™ 1600 mg once-daily for the treatment of mild to moderate UC,” added Robert Hofmann, MD, PhD, Medical Director at Tillotts. “We trust that the once-daily dose regime with only one to three tablets will improve adherence and quality of life in patients with UC.”

UC is an inflammatory bowel disease that involves chronic inflammation of the lining of the large bowel. UC only affects the colon and rectum and causes inflammation and ulceration of the large intestine. Symptoms vary, but often include blood in the stool and diarrhoea. UC is a chronic debilitating disease that may lead to life-threatening complications. Low adherence to medication in UC is associated with an increased risk of relapse2,3, a low quality of life4 and high healthcare costs5.

About ASACOL™ 1600

ASACOL™ 1600 mg (mesalazine)* is a medicine for the treatment of the inflamed lining of the large bowel (colonic and rectal mucosa). Important information on ASACOL™ 1600 mg and its use can be found in the public assessment report (PAR) and/or in the summary of product characteristics (SmPC) publically available on the website of the Swedish Medical Product Agency§.

Reporting of Side Effects: At Tillotts Pharma, we continuously monitor the safety of our products by collecting information regarding side effects associated with their use. Any side effects or safety concerns may be reported by completing our online form in the section “Product Safety” on www.tillotts.com.

About OPTICORE™

OPTICORE™ stands for OPTImized COlonic RElease. OPTICORE™ is a new, advanced enteric coating designed to ensure targeted release of the active ingredient in the gut irrespective of the gut pH variability.6,7 OPTICORE™ has been developed based on the PhloralTM technology. To learn more about OPTICORE™, watch the video animation: https://youtu.be/uAksSOD-0E8. 

For more information, contact Federica Ricatto, Senior Communications Manager, Medical Affairs:

Phone: +41 61 935 2749 | Email: Federica.Ricatto@tillotts.com

About Tillotts

Tillotts Pharma AG, part of the Japanese Zeria Group, is a fast-growing specialty pharma company with more than 300 employees in Switzerland and abroad. Tillotts is engaged in advancing care and is committed to making a difference for the millions of people worldwide who suffer from GI-diseases.

All trademarks used or mentioned here are protected by law. © Copyright Tillotts Pharma AG. All rights reserved.

About Zeria

Zeria Pharmaceutical Co., Ltd., founded in 1955, based in Tokyo, Japan, operates internationally through a number of subsidiaries in the Ethical Pharmaceuticals and Consumer Healthcare businesses. Zeria is dedicated to research and development of pharmaceutical products and is specialised in the gastroenterology field, among others. The company is listed on the First Section of Tokyo Stock Exchange (Stock code: 4559).

References

  1. D’Haens G.R., et al., Randomised non-inferiority trial: 1600 mg versus 400 mg tablets of mesalazine for the treatment of mild-to-moderate ulcerative colitis. Aliment Pharmacol Ther. 2017; 46(3):292–302.
  2. Kane S., et al., Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis. Am J Med. 2003; 114:39-43.
  3. Khan N., et al., Long-term oral mesalazine adherence and the risk of disease flare in ulcerative colitis: nationwide 10-year retrospective cohort from the veterans affairs healthcare system. Aliment Pharmacol Ther. 2012; 36(8):755-64.
  4. Kane S.V., Systematic review: adherence issues in the treatment of ulcerative colitis. Aliment Pharmacol Ther. 2006; 23(5):577-85.
  5. Kane S., et al., Compliance with 5-ASA products is associated with decreased medical costs. Am J Gastroenterol 2006; 101(Suppl): p. 436.
  6. Varum F.O., et al., Poster presented at AAPS National Biotechnology Conference 2016; [Poster number 02W0200].
  7. Ibekwe V.C., et al., A new concept in colonic drug targeting: a combined pH-responsive and bacterially-triggered drug delivery technology. Aliment Pharmacol Ther. 2008; 28(7):911-6.

* In the Netherlands ASACOL™ 1600 mg (mesalazine) is available as YALDIGO™.
§ Sweden is the reference member state for the Decentralised Procedure (DCP).

Photos

ASACOL™ 1600mg pack shot (30 and 60 tablets).
Source: Tillotts Pharma AG. Download high resolution photo.

 

OPTICORE™ logo.
Source: Tillotts Pharma AG. Download high resolution photo.