Shire seeks approval for its ulcerative colitis drug in Europe
European Regulatory Agencies of SPD476, an ulcerative colitis drug
which uses Cosmo's cutting-edge MMX multi matrix system, promising
to give the company the upper hand in the $1.6 (€1.34) billion
mesalanine market through its easy and effective delivery.
Although mesalanine (5-aminosalicylic acid) is an existing and well-known treatment for the condition, if approved SPD476 would offer a once-daily oral mesalanine treatment for active mild to moderate ulcerative colitis, eliminating the need for repeated daily administrations.
Shire already filed for approval in the US last December and an application with Health Canada is also pending.
The most common adverse events reported in SPD476 Phase III studies were flatulence, nausea or headaches, which the company says were not dose related and occurred in less than 3 per cent of patients receiving SPD476.
"We expect it will be about a year before the drug hits the European market, and we are obviously a little ahead in the regulatory process stateside," Jessica Mann, head of Shire's corporarate communications told In-Pharmatechnologist.com.
"Procter is currently dominating the scene with Asacol, but we believe SPD476's added benefits will help us capture more of that market."
As of 2003, mesalamine-based Asacol had a 60 per cent share of ulcerative colitis drug market.
The drug is coated with a pH-sensitive acrylic polymer which delays release of mesalamine until the tablet reaches an environment of pH 7 or above, thus dissolving in parts of the colon with low systemic absorption.
With SPD476 on the other hand, the programmed release is achieved through an array of lipophilic, amphiphilic and hydrophilic coat matrices that offer delayed and extended action.
Its MMX technology uses a proprietary system for targeting the release of high concentrations of mesalamine throughout the length of the colon, with the potential to reduce the burden for ulcerative colitis patients of having to take large numbers of tablets.
"The European submissions for SPD476 represent the achievement of another important milestone for Shire," Shire's chief executive Matthew Emmens said in a statement.
"Currently there is no once-daily oral treatment for ulcerative colitis so we look forward to offering patients the efficacy and convenience of SPD476."
Shire already markets mesalamine as Pentasa in the US and Colazide in the UK and same parts of Europe, but patients are required to take multiple tablets a day and this is also the case with Asacol.
In 2004, Pentasa held a 17.6 per cent share of the US mesalamine market and Colazide a 6 per cent share of the UK market.
Now Shire has its eyes on a bigger chunk of the market with SPD476, which it licensed from drug developer Giuliani to develop and commercialise it in the North America, Europe (excluding Italy) and the Pacific Rim.
Giuliani retains the development and commercialisation rights to SPD476 inItaly.
Ulcerative colitis is a chronic, relapsing type of inflammatory bowel disease in which part, or all, of the large intestine becomes inflamed and often ulcerated.
Patients experience intermittent attacks separated by periods of remission, and can suffer from diarrhoea, bleeding and abdominal pain.
Because no non-surgical cure for ulcerative colitis has been found, treatment of the disease usually consists of long-term pharmacotherapy directed at controlling the symptoms of the disease.
About 30 per cent of people with ulcerative colitis eventually undergo surgery, typically after 15 to 25 years of disease.
