A survey of dealmakers’ intentions in 2017 conducted by inVentiv Health highlighted women’s health indications as an area with a demand surplus, or a seller’s market. The potential for promising assets in this field was demonstrated in April this year, when Astellas Pharma announced its acquisition of the biotech company Ogeda for up to €800 million, including €500 million up front. The driver of the deal was the neurokinin 3 (NK3) receptor antagonist fezolinetant—a potential new treatment for various hormone-related conditions including menopausal hot flushes, for which it has shown efficacy in a phase 2 trial (Nat. Rev. Drug Discov.16, 377; 2017).
Investigational drugs with the same target have also been the focus of recent outlicensing and fundraising activity. Millendo Therapeutics is developing a NK3 receptor antagonist, MLE490 — which it gained in a deal with AstraZeneca in January 2016—for polycystic ovary syndrome and vasomotor symptoms. The phase 2 development of MLE4901 will be supported by a $62 million series B financing round that the company announced simultaneously. And NeRRe Therapeutics, a company that spun out of GlaxoSmithKline in 2012, is advancing NT‑814, a dual NK1,3 receptor antagonist, in phase 2 trials for vasomotor symptoms. The company raised £23 million in a series B financing round in January of this year.
Another hormone-related condition for which there has been dealmaking activity recently is endometriosis (Table 1), for which no new classes of drug have been approved by the US Food and Drug Administration in more than 25 years, despite the need for more effective treatments. However, new options are approaching the market. In May of this year, AbbVie reported promising phase 3 results in endometriosis for elagolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist that it gained through a $575 million deal with Neurocrine back in 2010. These results are anticipated to provide the basis for submission to regulatory agencies later this year, and elagolix is forecasted to become a blockbuster if it is approved, with sales of ~$1.3 billion in 2022, according to data from Clarivate Analytics.
Other recent deals also involve GnRH receptor antagonists, which make up around one third of the current pipeline for endometriosis and are being investigated for indications such as uterine fibroids as well. For example, in June 2016, Takeda and Roivant Sciences announced the formation of Myovant Sciences, which is investigating an oral GnRH receptor antagonist licensed from Takeda, relugolix, in phase 3 trials for endometriosis, uterine fibroids and prostate cancer.
Table 1: Selected endometriosis deals
Date |
Companies |
Deal summary |
July 2017 |
Evotec, Bayer |
Evotec extends its partnership with Bayer to develop therapies for endometriosis until 2018. The original partnership was signed in 2012 with the goal of identifying 3 potential candidates over a five year period. Evotec has received a milestone payment from Bayer after one of the programs reached phase 1 development. |
November 2016 |
BalOnco, Antev |
Antev to license BalOnco to develop an extendedrelease formulation of the GnRH antagonist teverelix for benign prostatic hyperplasia, prostate cancer and endometriosis. |
November 2016 |
MDNA Life Sciences, University of Oxford |
University of Oxford partners with molecular diagnosticfocused MDNA to develop a mitochondrial biomarker blood-based diagnostic test. The non-invasive test will be developed using MDNA’s Mitomic Technology platform. |
June 2016 |
Myovant Sciences, Takeda Pharmaceutical Company |
Myovant Sciences is formed by Roivant Sciences and Takeda, and will develop and commercialize the oral GnRH receptor antagonist relugolix for endometriosis, uterine fibroids and prostate cancer. |
November 2015 |
ObsEva, Kissei Pharmaceuticals |
ObsEva and Kissei Pharmaceutical announce a collaboration to develop and commercialize the oral GnRH antagonist KLH‑2109 (OBE2109) for endometriosis and other potential indications. |
September 2014 |
SRI International, Nobelpharma |
Japanese pharma Nobelpharma partners with nonprofit research institute SRI International to develop the selective estrogen-receptor modulator SR16234 for endometriosis. |
July 2014 |
University of Oxford, Bayer |
Bayer and the University of Oxford announce a multitarget collaboration to develop new therapeutic treatments for gynecological indications, including endometriosis and uterine fibroids. |
June 2010 |
Neurocrine Biosciences, AbbVie |
Neurocrine Biosciences partners with Abbvie to develop and commercialize the GnRH antagonist elagolix and other GnRH-targeted compounds. Under the agreement AbbVie paid $75 million up front (for worldwide exclusive rights to elagolix) and could potentially pay up to $500 million further in milestone payments. |
