Bayer has been building up its women’s health drug pipeline by striking deals and on Tuesday the pharmaceutical giant unveiled its latest one: $425 million up front for KaNDy Therapeutics, a biotech whose experimental menopause drug is projected as a blockbuster seller.
KaNDy’s small molecule drug, NT-814, is in development as a treatment for common symptoms of menopause, such as night sweats and hot flashes. A Phase 3 clinical trial is expected to start next year.
Under the terms of the acquisition agreement, Stevenage, UK-based KaNDy could earn up to $450 million more in milestone payments as the drug approaches launch. Additional payments, described only as being in the triple digit millions, are tied to sales targets.
Current treatments for menopause include hormone therapy, such as Premarin, a Pfizer (NYSE: [[ticker:PFE]]) drug. In addition to treating menopausal symptoms, the Pfizer estrogen tablets are used to prevent osteoporosis. The former blockbuster drug accounted for $734 million in revenue last year, continuing a sales slide that the company attributes to growing generic competition. Premarin’s label carries a boxed warning flagging increased risks of endometrial cancer, cardiovascular problems, and dementia.
KaNDy is taking a non-hormonal approach with a drug designed to target two receptors, neurokinin 1 and 3. The company says these receptors modulate a group of estrogen-sensitive neurons in the brain’s hypothalamus. Estrogen levels decline in menopause, and in the hormone’s absence, these “KNDy neurons” become hyperactive. That activity disrupts the mechanisms the body uses to regulate temperature, the company says. KaNDy recently completed a Phase 2b dose-ranging study for NT-814, a once-daily pill.
With KaNDy, Bayer will be chasing Astellas Pharma, whose menopause drug candidate fezolinetant has already reached Phase 3 testing. That once-daily pill takes a similar approach to KaNDy’s compound, but instead of targeting two neurokinin receptors it hits solely neurokinin 3.
KaNDy launched in 2017 as a a spin-off from Stevenage-based NeRRe Therapeutics, which itself spun out of GlaxoSmithKline (NYSE: [[ticker:GSK]]) in 2012. Investors in KaNDy include Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed, and Longitude Capital.
Bayer’s KaNDy deal follows a partnership announced in January with Daré Bioscience, a San Diego company developing a hormone-free, vaginal contraceptive. The pharmaceutical giant paid an undisclosed amount up front to gain US rights to commercialize the lead Daré product candidate, which is still in clinical development. Before that, Bayer and Germany-based Evotec expanded an alliance focused on developing treatments for polycystic ovary syndrome, one of the more common causes of female intertility.
Bayer and KaNDy expect to complete the transaction in September.
Image: iStock/Andrei Stanescu
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