Johnson & Johnson/Janssen Biotech: Simponi edges closer to approval in ulcerative colitis market.
Janssen Biotech has filed for an additional indication for Simponi in the US and EU.
Expanding Simponi’s indication to include ulcerative colitis is a savvy move by Janssen Biotech. Its other brand Remicade retains a prominent position in the ulcerative colitis market, but it is under threat in the near term. With several pipeline candidates looking to capture market share, and key competitor Humira looming on the horizon, second-to-market entry in the US is hotly contested.
In line with Datamonitor’s predictions, Janssen Biotech has submitted follow-on tumor necrosis factor (TNF) inhibitor Simponi (golimumab) as a potential treatment for moderate to severe active ulcerative colitis (UC) in the US and EU. The regulatory filings are supported by data generated in Simponi’s Phase III PURSUIT program. While the positive data from the induction phase of the trial were presented at the 2012 Digestive Disease Week annual meeting, data from the maintenance phase are yet to be published.
Datamonitor expects that Simponi will gain approval for UC from both the FDA and EMA and estimates launch by Q2 2013. Based on the patients studied in PURSUIT, Simponi could be positioned in the TNF-inhibitor naive population. This would place it in direct competition with Janssen’s other biologic, Remicade (infliximab).
While the company’s exact strategy to position both treatments in the UC setting remains unclear, Datamonitor speculates that intravenous Remicade could be positioned for acute/hospital use, while subcutaneous Simponi would be used for maintenance treatment outside of the hospital setting, making the maintenance data even more key.
Simponi is in the race for second-to-market entry in the US. Although Abbott’s TNF inhibitor Humira (adalimumab) gained approval in the EU for UC in April 2012, its US approval has been delayed after a Complete Response Letter from the FDA. In addition, several pipeline candidates are also seeking to capture UC patient share from Remicade. These include oral candidate tofacitinib (Pfizer) and biologic vedolizumab (Takeda).
With increasing competition within the US and EU UC markets over the coming five years, Remicade’s dominant position is under threat. Evidently, Janssen Biotech appears focused on allowing Simponi to gain traction in the UC space prior to other pipeline drugs. Indeed, Datamonitor forecasts that the drug could accrue sales in this indication of $249m by 2019.