Shire to get European approval for its ulcerative colitis drug

By Emilie Reymond

- Last updated on GMT

Related tags: Ulcerative colitis

Pharma company Shire has agreed with European regulators on
labelling information for its ulcerative colitis drug Mezavant, a
further step in the firm's ambition to capture more of the $1.6bn
(€1.2bn) mesalazine market through its easy and effective delivery
system.

The UK-based company said Mezavant should gain approval across Europe in the first quarter of 2007 enabling Shire to make a phased launch of the drug next year.

"It is the timescale we were expecting and the rest of the process is now pretty much straightforward,"​ Jessica Mann, Shire's spokesperson told In-PharmaTechnologist.com.

"We now expect to roll this out in Europe from the first quarter of next year on a country-by-country basis."

Although mesalazine is currently used for the condition, if approved, Mezavant would offer a once-daily oral mesalazine treatment for active mild to moderate ulcerative colitis, avoiding the need for repeated daily administrations.

Shire already filed for approval in the US in December last year and the Food and Drug Administration (FDA) is expected to give the thumbs up on 21 January 2007.

The Shire spokesperson said that currently dominating the ulcerative colitis drug market is Asacol developed by Procter. The drug is coated with a PH-sensitive acrylic polymer which delays the release of mesalasine until the tablet reaches an environment of pH 7 or above, then dissolving in parts of the colon with low systemic absorption.

However, with Shire's new drug, which uses Cosmo's cutting-edge MMX multi matrix system, the programmed release is achieved through an array of lipophilic, amphiphilic and hydrophilic coat matrices that allow delayed and extended action.

MMX mesalazine is a novel, high-strength oral formulation of the 5-aminosalicylate (5-ASA) mesalazine.

The MMX technology uses a proprietary system to target the release of high concentrations of mesalasine throughout the length of the colon, reducing the burden for patients of having to take large numbers of tablets.

"The advantages of Mezavant are that it targets the area in the intestine in most need of treatment and it needs to be taken only once a day,"​ said Mann.

Shire already markets mesalasine as Pentasa in the US and Colazide in the UK and Europe, but patients are required to take multiple tablets a day.

The spokersperson wouldn't comment on any specific figures, but if approved, the new drug will allow Shire to obtain a bigger share of the market.

"We believe Mezavant is a very strong product and it will have a great appeal to both patients and physicians,"​ said Mann.

The new drug was in-licensed from drug developer Giuliani to develop and commercialise it in the US, Canada, Europe (excluding Italy) and the Pacific Rim.

Giuliani has developed Mezavant from proof of concept to Phase IIa and retains the development and commercialisation rights in Italy and in South and Central America.

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.

In 2005, over 450,000 patients were identified to be suffering with ulcerative colitis in Europe.

Because no non-surgical cure for the condition has been found, treatment 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 the disease.

Related topics: Ingredients, Delivery technologies

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