Organon and Forendo Pharma have entered into a definitive agreement, under which Organon will acquire Forendo, a clinical-stage drug development company focused on novel treatments in women’s health.
Forendo’s lead clinical compound is an investigational, potentially first-in-class oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor in early clinical development for endometriosis, being evaluated for its potential effect on endometriotic lesions.
Endometriosis is a common and chronic condition that affects up to 1 in 10 women of reproductive age, causes abdominal pain and is associated with infertility.
“Organon is dedicated to delivering medically significant women’s healthcare interventions, prioritizing disease areas based on her unmet needs. Endometriosis is among our highest priority areas of focus,” said Kevin Ali, Organon’s Chief Executive Officer. “Our acquisition of Forendo further demonstrates our commitment to building a pipeline of impactful treatment options for women with unmet medical needs.”
Preclinical research suggests that Forendo’s lead investigational clinical compound, FOR-6219, inhibits the conversion of low potency estrone into highly potent estradiol in endometriotic lesions ex vivo.
Forendo says this investigational compound is different than currently available treatments because of its potential ability to act locally in the target tissues without impacting systemic hormone levels. This potentially selective activity allows for its evaluation as a long-term treatment option for endometriosis. There are currently no long-term treatment options for endometriosis approved. FOR-6219 is entering Phase 2 clinical development.
Forendo’s pipeline also includes a preclinical program targeting polycystic ovarian syndrome (PCOS), one of the most common women’s health conditions often associated with metabolic disorders, hyperandrogenism and infertility. As there are currently no approved therapies for PCOS, this represents another priority disease area for Organon.
Risto Lammintausta, CEO of Forendo, emphasized the importance of the transaction: “This is a great opportunity for Forendo to join forces with a larger organization capable of accelerating the development of our innovative product candidates through mid and late-stage trials and, once approved, make the resulting drugs available to patients suffering from endometriosis and PCOS worldwide. Based on the preclinical data, we believe our novel therapeutic mechanisms hold promise in therapeutic areas where patients currently have limited options.”
Consideration for the transaction includes a $75 million upfront payment, assumption of approximately $9 million of Forendo debt, payments upon the achievement of certain development and regulatory milestones of up to $270 million and commercial milestones payments of up to $600 million, which together could amount to total consideration of $954 million.
Completion of the transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in December 2021.
