Standard endometriosis treatment includes anti-inflammatory drugs, then hormone therapy that circulates throughout the body. Forendo Pharma is developing a new approach that offers a potentially more targeted treatment. The company’s endometriosis drug is still experimental, but Merck spinout Organon sees enough promise to acquire the startup outright.
Organon announced Thursday that it will pay $75 million up front and assume about $9 million of Forendo’s debt. The Jersey City, New Jersey-based company has also agreed to development and regulatory milestone payments that could reach $270 million. If the endometriosis drug reaches the market, commercialization milestones could bring $600 million more. The Forendo acquisition agreement is Organon’s third women’s health deal since it spun out of Merck in June.
Endometriosis is a condition in which the uterine lining, called the endometrium, grows outside of the uterus and causes pain and fertility problems. Turku, Finland-based Forendo aims to treat endometriosis by interfering with the abnormal growth of endometrial cells. The company’s drug, FOR-6219, is a small molecule designed to target an enzyme called hydroxysteroid 17-beta dehydrogenase type 1 (HSD17B1). Doing so inhibits the conversion of the hormone estrone into a highly potent form of estradiol, another hormone that regulates the growth of endometriotic tissue.
Most endocrinology treatments focus on affecting hormones circulating throughout the body. According to Forendo, its drug is different than currently available treatments because of its local effect, working in the targeted tissues without affecting hormones circulating systemically. Forendo calls its approach “intracinology.” According to Organon and Forendo, the targeted effect of FOR-6219 means it could be studied as a long-term treatment for endometriosis. The drug is being readied for Phase 2 testing.
The Forendo pipeline also includes a drug candidate for polycystic ovarian syndrome, which is associated with metabolic disorders, hyperandrogenism, and infertility. The condition has no FDA-approved treatment. Forendo’s experimental drug, a targeted therapy designed to block the enzyme HSD17B5, is preclinical.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Organon is comprised of the former women’s health business and off-patent drugs of Merck. The pharmaceutical giant announced last year that it would place those drugs in a new business that would be spun out as a standalone, publicly traded company. The spinoff was completed in June. At that time, Organon closed its $215 million acquisition of Alydia Health, a startup that had commercialized a medical device for treating postpartum hemorrhage. In July, Organon licensed global rights to ebopiprant, a potential treatment for pre-term labor that is currently in mid-stage clinical development.
Organon expects to close the Forendo transaction next month. The deal was announced just prior to Organon’s release of its financial results for the third quarter, the company’s first full quarter as a standalone company. Of Organon’s total $1.6 billion in third quarter revenue, women’s health accounted for $381 million. Organon’s profit for the period was $323 million.
Photo by Flickr user Ed Uthman via a Creative Commons license
