January 22, 2020
Myovant Sciences Ltd. (MYOV) offers a new drug “pipeline in a pill”, asserts biotech expert Jay Silverman, contributing editor to Medical Technology Stock Letter.
Relugolix is a small molecule, gonadotropin-releasing hormone (GnRH) receptor antagonist, and an oral drug candidate for the treatment of uterine fibroids (UF), endometriosis, and advanced prostate cancer.
More than 2,150 study participants have received treatment with relugolix in successful Phase I, Phase II, and Phase III clinical trials. Myovant’s partner Takeda Pharamceutical (TAK) has obtained marketing authorization in Japan for Relumina (relugolix 40 mg tablets), while MYOV has retained ROW rights.
Several clinical and regulatory catalysts are due in 2020 that, in our view, will increase the NPV of relugolix, propel MYOV shares and also increase the company’s potential takeover value.
GnRH modulation has been validated in studies in prostate cancer, breast cancer, endometriosis, uterine fibroids, and additional indications where regulation pituitary hormones may play a role. There are already a series of GnRH agonists on the market, as well as a few antagonists.
With a broad clinical profile, in our view MYOV’s Relugolix could offer advantages over existing agonists and antagonists through an improved safety profile and more convenient dosing options.
Myovant will most likely be the second GnRH inhibitor to gain FDA approval, with an NDA submission for relugolix in uterine fibroids (UF) due by April 2020. Orlissa from AbbVie (ABBV) was approved in July 2018 for pain in endometriosis and the company submitted a NDA for in uterine fibroids in August 2019.
Uterine fibroids are extremely common among adult women. The standard of care treatment includes GnRH agonists, NSAIDS, and oral contraceptives and are not effective enough for a significant proportion of patients.
In many cases uterine fibroids can progress to require surgery, we see GnRH antagonists as having the potential to fulfill an important gap in the market. Given its competitive efficacy profile, we believe relugolix could help a number of patients with uterine fibroids.
Though AbbVie’s Orilissa entered the market in 2018, we believe Myovant will benefit from AbbVie’s powerful marketing to develop and educate the market for oral GnRH inhbitors. Myovant’s lead indication is uterine fibroids and is about 9-12 months behind Orilissa.
Meanwhile, in its first trial in prostate cancer, men receiving once-daily, oral relugolix achieved sustained testosterone suppression; the results support an NDA submission to FDA upcoming in Q2:20 and future regulatory submissions in Europe and Japan.
Orilissa is not currently in development for prostate cancer and is not being developed in a co-formulation with add-back therapy, which could give relugolix a commercial advantage in terms of convenience for patients.
The potential for patients to rapidly come on and off of oral relugolix therapy makes intermittent treatment a new option. Recent surveys of men with prostate cancer suggest a preference to a pill versus frequent injections.
As a novel pipeline in a pill with de-risked clinical data, ease of use and safety advantages over other GnRH inbitors/agonists, in our view relugolix is a next-generation blockbuster for endometrial disorders. As a wholly owned asset, we also believe MYOV is an attractive biotech takeover candidate. The stock is a buy under $17 with a target price of $25.