Wonder drug regulates hormones in both men and women

Friday, 13 October 2017, 07:30:16 AM. If successful, a new drug from the biotech Myovant Sciences could treat two women’s health disorders, as well as prostate cancer. The drug, Relugolix, works to reduce estrogen in women and testoste…

If successful, a new drug from the biotech Myovant Sciences could treat two women’s health disorders, as well as prostate cancer.

The drug, Relugolix, works to reduce estrogen in women and testosterone in men. The hormones are factors in two painful conditions affecting women, uterine fibroids and endometriosis, and in prostate cancer.

Treating those conditions with a hormone-blocking medication is not completely new — AbbVie’s Lupron Depot, for example, already does it. But that drug has to be injected, has safety issues and is not supposed to be used in the long term, said Leerink Partners analyst Jason Gerberry. The uterine fibroids and endometriosis markets are “both large, but there are no effective, well tolerated oral therapies” for them, he said.

Myovant’s drug, which is taken orally once a day, has a different mechanism than Lupron Depot, which the company said allows it to work faster and better than competitors.

And when it comes to uterine fibroids and endometriosis, Relugolix also aims to curb side effects like hot flashes and bone loss by incorporating low-dose hormone replacement in the medication. (Lupron is taken with a separate add-back therapy.) In prostate cancer, the drug lacks that aspect and comes in a higher dose, working to suppress the testosterone that drives the disease.

Relugolix is currently in late-stage clinical trials, with results expected in 2019. The drug had positive results in a late-stage clinical trial for uterine fibroids done by Takeda Pharmaceutical and released in October; Takeda is releasing results from another late-stage trial in pain by the end of the year.

Myovant was formed last year by privately held Roivant Sciences and Takeda, which licensed Relugolix to the biotech.

Chief Executive Lynn Seely, a rare female CEO in biotech, told MarketWatch that her goal is to make the company a global leader in women’s health.

An endocrinologist who worked in academia early in her career, Seely led the development of prostate cancer drug Xtandi at Medivation (the drug is now owned by Pfizer). When she took Myovant public, Seely recalled speaking “to rooms and rooms of male investors.”

Uterine fibroids and endometriosis, which affect an estimated 7.5 million and 19 million U.S. women respectively, are “hugely common, but nobody is talking about them,” Seely told MarketWatch. In these disease areas, “the lack of development is shocking.”

The two are different diseases, but both typically affect pre-menopausal women and are driven by estrogen, Seely said.

In individuals with endometriosis, tissue that is supposed to grow inside the uterus grows elsewhere. When tissue sheds during the menstrual cycle, it is unable to exit the body, causing irritation and pain.

Uterine fibroids are growths in the uterus that can cause pain, heavy bleeding and bladder problems.

Besides Lupron Depot, the only other medications for the diseases are oral contraceptives and pain medications, but none work particularly well as a long-term option.

That may be changing. On Tuesday, Allergan said that the Food and Drug Administration is considering its drug for uterine fibroid-related bleeding, with an approval decision expected in the first half of 2018.

AbbVie submitted an application with the FDA last month for its drug with Neurocrine Biosciences that is intended to manage endometriosis with associated pain.

And the biotech ObsEva is also developing a treatment for uterine fibroids and endometriosis, though the medication may only be available at the end of 2021.

Though ObsEva’s OBE2109 is behind competitors, Leerink’s Gerberry said he’s hopeful that the drug will distinguish itself.

“While the competitive pipeline of treatments in development for [uterine fibroids/endometriosis] is deep, we believe OBE2109 may possess the best in class profile,” he said earlier this year.

But Seely said she’s confident in Relugolix, and that having options for women is “tremendous.”

To her, success means “women have the option to take our pill instead of undergoing invasive procedures” and dealing with painful symptoms, she said. “The goal is she feels well enough to go about her daily business.”

Myovant shares have surged 35.2 percent over the last three months, compared with a 5.2 percent rise in the S&P 500.

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    Article Wonder drug regulates hormones in both men and women compiled by nypost.com