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Takeda unlocks positive pivotal data on top drug prospect vedolizumab

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A few months after filing for approval in the U.S. and Europe, Takeda has finally rolled out a big portion of its late-stage data on vedolizumab, making a case that its new biologic has big market potential in treating ulcerative colitis and Crohn's disease, two of the most common types of inflammatory bowel disease.

More than a year ago Takeda released two brief statements on vedolizumab (MLN0002, plucked from Millennium's pipeline after its takeover), saying the drug produced a statistically significant rate of clinical remission for Crohn's disease and ulcerative colitis. But in the second Phase III CD trial the company had to concede that the drug failed a primary endpoint on enhanced response. No data were discussed. Takeda tapped it as one of 6 programs slated for approval in 2014, making it a key player in the big game to come up with fresh products to replace its market for Actos as generics arrived to knock down the price.

The data today reveals that the most pronounced effect was for ulcerative colitis, where investigators determined that 47.1% of treatment-resistant patients achieved a clinical response to vedolizumab compared with 25.5% of the placebo arm after 6 weeks of treatment. Only 31.4% of patients taking the antibody achieved a statistically significant improvement on a disease score for Crohn's disease compared to 25.7% of the placebo patients--not a significant difference--but 39% achieved remission after a year of therapy every 8 weeks compared to 21.6% of the placebo arm.

"Ulcerative colitis and Crohn's disease are different ends of the spectrum of inflammatory bowel disease. In ulcerative colitis the inflammation is much more superficial than in Crohn's disease, which has deeper transmural inflammation and even inflammation into the mesentery," the University of Chicago's Stephen Hanauer told MedPage Today.

This is an important drug for Takeda, which has been undergoing a shakeup as it tries to streamline in the wake of generic competition to Actos. Millennium officials have said they expect a restructuring to reduce its staff level by the end of this summer. And new products are essential for its longterm success.

Miles Sparrow, a gastroenterologist at the Alfred Hospital in Melbourne, Australia, tells Bloomberg that the drug could become a regular go-to drug for the 10% of patients each year who stop responding to standard treatments like Humira and Remicade.

"These are diseases of life time, a significant percentage of patients would have lost response," Sparrow told the business news service. "When these diseases are not treated or undertreated, the burden of the disease is very significant for patients. They really feel miserable versus when they are well their quality of life will be normal or nearly normal."

"These clinical studies suggest that vedolizumab may have the potential to maintain clinical remission in the appropriate patients," said Dr. Asit Parikh, vice president, general medicine, Takeda. "Takeda has a strong legacy of researching and treating GI disorders globally, and vedolizumab represents our focus on and commitment to patient communities."

- here's the press release
- read the story from MedPage Today
- see the Bloomberg report

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