Myovant adds relugolix data in uterine fibroids ahead of June PDUFA; Mubadala teams up with UK for $1B+ fund
As Myovant barrels toward its PDUFA date for relugolix in uterine fibroids, the biotech is beefing up its data package with new Phase III results.
A Phase III randomized withdrawal study met its primary endpoint and all secondary endpoints, Myovant and Pfizer announced Wednesday morning, evaluating a once-daily relugolix combo therapy with estradiol and norethindrone acetate. The FDA has marked June 1 down on the calendar for a regulatory decision.
Myovant enrolled 229 eligible women who had previously completed a long-term extension study, and sought to examine benefits of the experimental drug in continued treatment for up to two years. All of the patients took the treatment for a year before being randomized to continue the drug or to placebo for another year.
At Week 76, the primary endpoint measurement date, 78.4% of women in the continued treatment arm achieved the sustained responder rate compared to just 15.1% of those in placebo. That resulted in a stellar p-value of p<0.0001.
The combo therapy also hit all three secondary endpoints at the same p-value, which included measurements of sustained responder rate at two years, time to relapse of heavy menstrual bleeding, and amenorrhea rate.
The drug has already been approved as a monotherapy for advanced prostate cancer, dubbed Orgovyx, becoming the first once-a-day pill to treat the condition. It was priced at $2,300 per month, former CEO Lynn Seely told Endpoints News at the time. Orgovyx uses the same pathway to lower testosterone in men as it does to lower estrogen and progesterone in women.
UAE state fund teams up with UK for new investments
The UAE and the UK have teamed up on a new life sciences fund that plans to raise billions for the British biotech sector.
Abu Dhabi’s Mubadala, one of the country’s state-backed funds, is planning to spend £800 million over the first five years of the deal. The cash will be funded alongside £200 million from a British government program announced last year.
The Financial Times was the first to report the news Tuesday.
Clinching the deal with Mubadala was seen in the UK as a major win for Prime Minister Boris Johnson as he seeks to carve out new trade deals following Brexit. In addition to biotech, the agreement will help fund “energy transition and infrastructure” programs in both countries.
“This is a major win for the Office for Investment and shows how the UK is an investment destination of choice,” UK international trade secretary Liz Truss said in a statement. “From Liverpool and Edinburgh to Oxford and Nottingham, our world class life sciences clusters and innovative businesses will see the benefits of this partnership.”