Once-a-day colitis drug could take on the leaders
pharmafile | November 7, 2006 | News story | Sales and Marketing |Â Â Â
Shire is hoping its new, one-a-day treatment approach for ulcerative colitis (UC) will give the market leaders a run for their money.
A slow-release dose of the company's ulcerative colitis treatment MMX mesalazine could be more efficient than existing products because patients only have to take it once a day.
Ulcerative colitis is a disease of the large bowel and rectum when the lining of the bowel becomes inflamed, and it is estimated that as many as 2.2 million people in Europe suffer from inflammatory bowel disease – a condition which includes UC.
Current 5-aminosalicylate (5-ASA) treatments for UC including brand leader Procter & Gamble's Asacol need to be taken two or three times a day. This can lead to patients not keeping to the treatment regime, resulting in a loss of the drug's effectiveness. Shire is targeting this problem with its once-daily tablet, currently under review by the EU.
The company presented new evidence of its daily mesalazine dose at the United European Gastroenterology Week congress, which showed that a one-a-day oral treatment for mild-to-moderate UC is effective in inducing remission of the disease.
Combined data from two randomised, placebo-controlled phase III studies of 517 patients with UC showed that at eight weeks, around one third receiving 2.4g once a day or 4.8g once a day of MMX mesalazine achieved remission.
The slow-release formula was effective in both inducing remission in patients who had been switched from another established 5-ASA and in patients who were newly diagnosed, or who had not received a 5-ASA in the previous five days.
The recent survey by the Crohn's and Colitis Foundation of America showed that 65% of patients were poorly compliant with their current therapy of a twice or three times daily pill regime, citing the burden of pills and the inconvenience associated with taking the medication.
Stefan Schreiber, professor of medicine and gastroenterology and head of the Institute for Clinical Molecular Biology at Christian-Albrecht's University, Keil, Germany, said: "These studies show that MMX mesalazine is effective for the reduction of remission of active, mild to moderate UC."
Prof Schreiber, one of the study investigators, added: MMX mesalazine also has the added convenience of once daily dosing, which may improve patient compliance.
Development of the once-daily formulation was made possible by new technology that combines a gastro-resistant polymer film to delay the release of the drug until it reaches the ileum. It also ensures prolonged and consistent release of the active drug throughout the entire colon.
Shires development coincides with the news that Teva has signed a deal with Schering-Plough UK to co-promote its UC and Crohn's disease treatment Mesren to challenge the leading brand in Mesren's class, Procter & Gamble's Asacol.
Mesren and Asacol share the same active ingredient mesalazine and deliver a virtually identical release profile, but Mesren will be marketed at a much lower price.
