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Inflammatory Bowel Disease: New Treatments Won't Set Market Alight

Posted on: Wednesday, 28 February 2007, 18:34 CST

Inflammatory bowel disease (IBD), primarily constituted of ulcerative colitis and Crohn's disease, affects approximately 1.8 million people in the seven major markets. Datamonitor forecasts a growing market and the launch of six major brands in IBD indications in as many years. However, few appear to offer especially novel mechanisms of action.

Higher rates of IBD are generally seen in northern, industrialized countries and a growing body of data implicates a dysfunctional mucosal immune response to commensal bacteria in the development of IBD, especially Crohn's disease. Crohn's disease most commonly affects the lower part of the small intestine but can actually affect any area of the gastrointestinal (GI) tract from the mouth to the anus, while ulcerative colitis more commonly affects the colon and rectum.

The current management of IBD focuses on diet and nutritional therapy for mild disease sufferers and anti-inflammatory and corticosteroid therapies if the disease becomes more severe. A step-up treatment regime would then move to more potent corticosteroids then traditional immunosuppressant therapy followed by, or in combination with, a biologic therapy.

The last resort is surgery involving removal of diseased sections of the intestine. However, unlike ulcerative colitis, being a systemic disease of the gut Crohn's cannot be 'cured' with surgery and the disease can often re-occur. This fact increases the need for pharmacological therapies to treat the more severe Crohn's disease patients.

Biologics set to go head to head in Crohn's disease

In 2005, 40% of IBD sales were for biologics, including some off-label use, and the intestinal anti-inflammatories are estimated to create 50% of the total market sales. Eight years after the launch of Centocor and Schering-Plough's Remicade (infliximab) in Crohn's disease the next generation of anti-TNF's are poised for approval, and are predicted to increase the value of the market significantly.

However, this time gap has allowed some novel cytokine therapies to be developed and so the anti-TNF class will soon be under attack. In particular, Elan and Biogen Idec's resurrected Tysabri (natalizumab) will provide a promising candidate for patients failing anti-TNF, despite the potential side-effects. Gastroenterologists do not appear overly worried by the one in 1000 chance of life-threatening progressive multifocal leukoencephalopathy (PML) with Tysabri.

UCB's Cimzia (certolizumab) and Humira (adalimumab) target TNF and offer similar product profiles. Datamonitor predicts that both will initially be used after Remicade in the treatment algorithm, until sufficient physician and patient confidence is achieved. The battle between the two will depend on efficacy, convenience and cost. Humira's efficacy in all patient segments and it's wealth of safety data, added to the fact that it has already been used off-label could lead it to prevail over Cimzia's superior dosing regime.

The launch of these and other new biologic and traditional therapies is expected to significantly change the market over the next two years, increasing the estimated sales attributed to Crohn's disease to over $2 billion by 2008 in the seven major markets, three quarters of which is accounted for by the biologic therapies.

Biologics not forecast to excel

Remicade was approved for moderate to severe ulcerative colitis by the FDA in September 2005, which made it the first biologic therapy approved to treat ulcerative colitis, which as of March 2006 is also true in the EU. Because surgery can effectively be a cure, and ulcerative colitis patients respond better to 5-ASAs, an existing class of medication, Datamonitor predicts less success for biologics in this indication. However, Shire's Lialda (known as Mesavance in the EU), approved by the FDA for ulcerative colitis in January 2007, is forecast to have strong uptake, despite merely being a new formulation of the ubiquitous mesalazine molecule.

Lialda's once daily dosage regime is claimed to be a significant step forward for ulcerative colitis treatment over other oral mesalazine and mesalazine-prodrug formulations, which require three to four times daily dosing and six to 16 pills a day. However, clinical trials do suggest that Lialda twice-daily as the best option for existing 5-ASA patients to switch to, reducing this key advantage over existing therapies and tempering Datamonitor's predictions.

After the dearth of new therapies in this area for the better part of the last decade, a more competitive market is predicted, something that can only be good news for IBD suffers. On the surface, the launch of Lialda, Humira and Cimzia appear to be a significant step forward, but the fact is none of these treatments involve particularly novel mechanisms for IBD treatment. Physicians in need of new options must look to more controversial and early phase products.

Source: Datamonitor

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