SBA Member, 22.01.2019
Tillotts Pharma AG (“Tillotts”), part of the Japanese Zeria Group, announces the launch of ASACOLTM 1600 mg (mesalazine) in Denmark, Iceland, the Netherlands and Norway. ASACOLTM 1600 mg is the first 1600 mg mesalazine tablet for the treatment of mild to moderate ulcerative colitis (UC).
A clinical study1 showed that once-daily ASACOLTM 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 ASACOLTM 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 ASACOLTM 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 life4and high healthcare costs5.
- 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.
- Kane S., et al., Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis. Am J Med. 2003; 114:39-43.
- 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.
- Kane S.V., Systematic review: adherence issues in the treatment of ulcerative colitis. Aliment Pharmacol Ther. 2006; 23(5):577-85.
- Kane S., et al., Compliance with 5-ASA products is associated with decreased medical costs. Am J Gastroenterol 2006; 101(Suppl): p. 436.
- Varum F.O., et al., Poster presented at AAPS National Biotechnology Conference 2016; [Poster number 02W0200].
- 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.