Disease With $78 Billion Cost Draws Drugmakers to Women’s HealthBy
More than 170 million women have endometriosis globally
Bayer, AbbVie, ObsEva are exploring new treatment options
Drugmakers Bayer AG and AbbVie Inc., leaders in female health, are turning their sights to a little-known women’s disease that’s hard to diagnose and even harder to cure.
The condition, endometriosis, occurs when tissue that normally grows inside the womb spreads outside of it. The pain can be so unbearable that women can’t work, costing $78 billion a year in lost productivity and medical expenses in the U.S. alone, according to the World Endometriosis Research Foundation. The disease is also associated with half of infertility cases.
Bayer, the world’s biggest maker of contraceptives, and rival AbbVie see an opportunity as patients and doctors demand alternatives to decades-old medicines such as AbbVie’s Lupron and birth-control pills, which weren’t designed for endometriosis and in many cases are merely a stop-gap before surgery.
"There hasn’t been a lot of innovation because we don’t understand the disease well enough," said Hugh Taylor, chief of obstetrics and gynecology at Yale-New Haven Hospital and editor-in-chief of the journal Reproductive Sciences. “It’s frustrating.”
Bayer’s head of innovation, Kemal Malik, says the void is accidental rather than intentional.
“Half the world’s population are women, yet there aren’t many pharmaceutical companies that do research and development in diseases of women,” Malik said. “I don’t think the industry is crazy misogynist and doesn’t want to develop drugs for women. It’s more that the science, perhaps compared to other therapeutic areas, just wasn’t as good.”
With Bayer’s contraceptives providing solid if flat sales, the company is expanding into new areas of gynecology, targeting old foes with new treatments to boost its women’s health business. The German drugmaker is shifting away from synthetic hormones like Visanne, used in Europe to ease the pain associated with endometriosis.
“What the pre-clinical research is focused on is non-hormonal approaches,” said Joachim Marr, Bayer’s head of medical affairs for women’s health. “That’s where all the hope resides.”
Two of those therapies, which use hormones as a target but not as an ingredient, have moved into human testing. One is a pill that hinders production of estradiol, reducing inflammation. The other experimental medicine targets the process of making prolactin, a hormone found in higher concentrations in women with endometriosis.
Bayer is also developing compounds with the German biotech Evotec AG. The first one is entering human tests, adding a third early-stage drug to the two it already has. Evotec received the first milestone payment in the four-year-old partnership Thursday and the company said in a statement it aims to bring two more compounds in to human trials as part of the agreement. The financial details weren’t disclosed.
Other approaches are emerging to offer pain relief to some of the 176 million women affected by the disease globally. AbbVie’s experimental medicine elagolix is in late-stage testing and may be submitted for approval next year. Elagolix may be the first pill in a class of drugs that suppress the female hormones estrogen and progesterone, similar to Lupron, an injection that generated $826 million in sales last year. Elagolix would also be the first drug approved for endometriosis in the U.S. in more than 25 years, AbbVie said.
“The unmet medical need in endometriosis is significant,” Shao-Lee Lin, AbbVie’s vice president of global therapeutic areas and international development, said in a company presentation in June. “We really need something that is minimally invasive, but has a high degree of efficacy.”
Elagolix reduced menstrual pain and pelvic pain linked with endometriosis in a late-stage study, though side effects including hot flushes, headaches and nausea. The company, in partnership with Neurocrine Biosciences Inc., is also testing elagolix in uterine fibroids, growths that can appear during a woman’s child-bearing years. If successful, elagolix may generate more than $1 billion in annual sales in 2021 for North Chicago, Illinois-based AbbVie, according to data compiled by Bloomberg.
ObsEva SA, a closely held Swiss company, is using a similar approach. Its drug, licensed from Japan’s Kissei Pharmaceutical Co., would help prevent or postpone surgery, said Ernest Loumaye, ObsEva’s chief executive officer and a former gynecologist.
“The fact that AbbVie was pushing forward obviously contributed to our decision to work with Kissei on this class,” Loumaye said in an interview. “It will certainly contribute to make the condition much more silent.”
A lack of awareness means it can take up to seven years after symptoms start to diagnose endometriosis, usually with surgery. With celebrities such as actresses Daisy Ridley and Lena Dunham talking this spring about their experiences battling the disease, it may be that more women seek diagnosis and treatment sooner.
“It’s a sensitive topic that wasn’t talked about a lot, wasn’t something that you really could probably market very well in the old days,” Yale’s Taylor said. “Viagra changed that all for us, and now we can talk about these things.”