Takeda’s ulcerative colitis drug gets Phase III boost
pharmafile | February 22, 2012 | News story | Research and Development |
Takeda’s ulcerative colitis drug vedolizumab has succeeded in a late-stage trial.
The Phase III trial studied vedolizumab in 895 patients with moderately to severely active ulcerative colitis who have failed at least one conventional therapy, including TNF alpha antagonists.
Both phases of the GEMINI trial met their primary endpoints, providing statistically significant improvements in clinical response in the induction phase and clinical remission in the maintenance phase.
Tadataka Yamada, chief medical and scientific officer at Takeda, said: “We are very pleased with the outcomes of this pivotal trial, and the potential that vedolizumab holds for patients with this debilitating disease.
“We thank the patients and investigators for their engagement and participation in this clinical evaluation of vedolizumab.”
Vedolizumab was initially developed by Millennium Pharmaceuticals, which Takeda acquired in 2008 for nearly $9 billion.
The drug works by blocking a key inflammatory marker on white blood cells, preventing the migration of the cells into the intestinal wall.
Takeda’s drug is also undergoing late-stage studies for Crohn’s disease, and analysts have touted the treatment as future blockbuster.
If the drug is approved it will be entering into a market with a number of anti-TNF therapies, including Abbott’s blockbuster Humira and Janssen’s Remicade – but would be used after these therapies have failed.
Ulcerative colitis is a chronic, relapsing-remitting condition, caused by an overactive inflammatory response in the gastrointestinal tract.
Common symptoms include diarrhoea, rectal bleeding, incontinence, abdominal pain, fever, malaise and weight loss.
Analysts at Decision Resources say that the chronic, long-term use of TNF-alpha inhibitors for the condition will contribute to a modest increase in sales of maintenance therapies from $1.1 billion in 2009, to around $1.8 billion in 2019.
Decision Resources said this growth would be curbed by ongoing monitoring and cost containment costs, given the high price of biologics.
The modest growth of $800 million through to 2019 will be driven by the uptake of Humira, Janssen/Merck’s Simponi and vedolizumab in mature markets, it added.
Ben Adams
