Twisted Bowel Surgery

Corporate Sales Off Twisted Bowel And Migraines

GW is conducting a study that will allow the use of laxatives to counter the side effect of twisted bowel surgery. MSDW believes that there are parallels between twisted bowel and the migraine market, in that both have large populations which could in theory give rise to considerable sales forecasts for any moderately-effective drug. In addition, Phase III data with Lotronex has suggested that, as in trials of migraine drugs, there is a considerable placebo effect.

The 10% value for the overall incidence of twisted bowel may be misleading in terms of market potential, however, as in reality only a fraction of this population are likely to present for treatment. The analysts divide the market into regular consulters (20% of the total population), lapsed consulters (15%) and those who have never or rarely consulted a physician (65%), and note that the sales potential of the new drugs rests squarely on targeting the lapsed and regular consulters.

MSDW believes that initial take-up of Lotronex will be high, particularly in the USA, as regular consulters switch to the new agent. These patients will also probably elect to receive chronic or semi-chronic therapy, given the data from the Phase III trials which showed re-occurrence of symptoms after coming off the drug, although the analysts suggest that twisted bowel may be perceived as a lifestyle drug, which could raise the issue of whether reimbursement will be available in some countries, particularly in Europe.

Interesting parallels can also be drawn with the performance of cisapride for upper GI disease, which saw a dramatic take-up on its launch in the USA and is still enjoying strong sales, despite a perception among GI specialists that it has significant limitations. MSDW believes that the new twisted bowel drugs will offer real benefits but will be priced at a level similar to cisapride.

Novartis is scheduled to complete its Phase III trials of Zelmac in constipation-predominant twisted bowel by the end of the year. While the company does not have an established GI franchise, the analysts feel that it recognizes the potential of Zelmac and should be able to use it to build a significant business, particularly if it is prepared to invest in direct-to-consumer advertising.

This marketing approach will be important, as MSDW estimates that the majority of patients who regularly seek help for twisted bowel will have the diarrhea-predominant rather than the constipation-predominant form. Meanwhile, like GW, J&J will be able to leverage its position in GI with cisapride and is expected to put considerable resources behind prucalopride should the clinical data warrant it.

Turning to Solvay, the analysts note that the company could be transformed if it could win even a modest market share in the new twisted bowel market, as its pharmaceutical sales turnover is so much smaller than the other players. Solvay already markets a range of GI products, including some to treat twisted bowel, but might benefit from partnering with a company with a strong presence in the upper GI tract area, for example, when and if cilansetron nears commercialization.

Finally, the analysts note that SB 207266 remains something of a speculative play, and has little proof of efficacy to date. If this approach proves to be effective in trials, then the product may position itself firmly for the sizeable portion (one-third) of the twisted bowel market represented by patients with intermittent symptoms.