One of the European Commission’s stipulations for Takeda’s purchase of Shire was that it divest the biopharma’s inflammatory bowel disease candidate SHP647.
This is because it would largely chase the same patients as Takeda's already approved Entyvio, raising issues about diluting a competitive market.
This was back in 2018; today, however, the commission has “released Takeda from the obligation to divest the pipeline compound SHP647 and certain associated rights,” because the Japanese pharma couldn’t sell it off, and trials for the drug were largely stopped back in March due to the pandemic. The pharma will now simply cull the med.
“Takeda will no longer develop the SHP647 compound in any inflammatory bowel disease indication, including Ulcerative Colitis or Crohn’s Disease," it said in a statement. “The SHP647 clinical trial program will be discontinued in an orderly manner over the coming months.”
What happened? Well, Takeda says it “engaged in two formal and rigorous sale processes spanning 14-months to identify and engage with potential purchasers of SHP647,” but after it “engaged with more than 60 potential purchasers,” the “sale process was unsuccessful.”
This also comes as studies for the drug were disrupted by COVID-19. “New patient enrollment into the study protocols was already stopped in late March due to the risks associated with the COVID-19 pandemic,” Takeda explained in a statement. “The trials will be unblinded and not restarted.”
The drug was originally developed by Pfizer, which licensed it out to Shire back in 2016.
The monoclonal antibody targeting MAdCAM-1—which plays a key part in chronic gastrointestinal inflammation—had cleared phase 2 in both ulcerative colitis and Crohn’s and had won an FDA orphan drug designation in pediatric ulcerative colitis.
But, according to GlobalData projections released in late July, the candidate is expected to collect less than $100 million in 2023.