Ann Arbor Pharma Firm Gets $62M To Commercialize Drug For Ovarian Disease

ANN ARBOR — Millendo Therapeutics Inc., the Ann Arbor pharma firm, announced an exclusive license agreement with the pharmaceutical giant AstraZeneca for the worldwide development and commercialization rights to AZD4901, a product candidate for the treatment of polycystic ovary syndrome, the most common endocrine disease in women.

Millendo also said it has secured a $62 million Series B investment led by Chevy Chase, Md.-based New Enterprise Associates Inc.

Previously known as Atterocor, Millendo is focused on developing novel approaches for the treatment of orphan and specialty endocrine diseases.

“This acquisition of MLE4901 combined with the new funding and our current programs around ATR-101 puts us on a new trajectory to build a specialty pharmaceutical company focused on multiple disease-modifying treatments for endocrine disorders caused by hormone dysregulation,” said Millendo president and CEO Julia Owens.

Under the agreement, Millendo acquired global rights to develop and commercialize MLE4901. In exchange, AstraZeneca will receive an upfront payment and take an equity stake in Millendo, as well as development and commercial milestone payments. In addition, AstraZeneca is eligible to receive royalties on net product sales.

The financing was led by New Enterprise Associates and included new investors Roche Venture Fund, the venture arm of the Swiss drugmaker; Chicago-based Adams Street Partners; Altitude Life Science Ventures LLC of Seattle; Boston-based Longwood Fund, and Renaissance Venture Capital Fund of Ann Arbor. Also participating were current Millendo investors Frazier Healthcare Partners of Seattle, Osage University Partners of Bala Cynwyd, Pa., 5AM Ventures of Menlo Park, Calif., and the Regents of the University of Michigan under the MINTS (Michigan Investment in New Technology Startup) program.

In conjunction with the financing, Tracy Saxton of Roche Venture Fund will join Millendo’s board of directors and Carol Gallagher will represent New Enterprise Associates, shifting from her role as an independent board member.

“Endocrine diseases represent a tremendous unmet medical need as well as an opportunity to develop a company focused on tackling these diseases,” Gallagher said. “Millendo has assembled an exceptionally strong team of drug development experts in this field as well as a portfolio of drug candidates that will make an important impact on the lives of many patients.”

MLE4901 was developed on AstraZeneca’s Open Innovation platform, which allows for the clinical development of compounds that do not fall under AstraZeneca’s R&D core focus areas.

Polycystic ovary syndrome is the most common endocrine disease in women, affecting 5 to 15 percent of the female population. PCOS is caused by Gonadotropin Releasing Hormone (GnRH) hyperpulsatility, which leads to increased luteinizing hormone (LH) pulse frequency and downstream hormonal abnormalities including androgen excess. Clinical symptoms include androgen excess, menstrual dysfunction, metabolic syndrome, and infertility. Current treatments are used off-label and directed at managing symptoms. There are no approved therapies for PCOS on the market.

MLE4901 is a Neurokinin 3 receptor (NK3R) antagonist that acts to diminish GnRH hyperpulsatility and luteinizing hormone (LH) pulse frequency. In a Phase 2a clinical trial, significant reductions in LH and testosterone were observed in PCOS patients treated with MLE4901.

ATR-101 is a selective small molecule inhibitor of ACAT1, which reduces adrenal steroids and induces apoptosis (spontaneous cell death) of cells derived from the adrenal cortex. ATR-101 is currently in clinical development for the treatment of adrenocortical carcinoma, a rare cancer of the adrenal gland cortex, with additional development areas to include congenital adrenal hyperplasia, a genetic defect of cortisol synthesis, and endogenous Cushing’s syndrome, a condition resulting from chronic cortisol excess.

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