Myovant Sciences (MYOV) recently reported their earnings and the first peek at Orgovyx sales with their partner Pfizer (PFE), reports John McCamant, editor of The Medical Technology Stock Letter.
Myovant reported Q4 FY20 Orgovyx product revenue of $3.6 million in their first launch quarter. The company reported that a cumulative >2,000 patients have been prescribed Orgovyx through the end of April (estimated ~1,500 through the quarter) through specialty distribution channels, with 43% commercial coverage and 51% Medicare Part D coverage.
As coverage expansion continues, physician awareness of Orgovyx has also increased, nearing levels for primary competitor leuprolide.
While still in the early days of the launch, prescriptions are understandably skewed toward new patient starts and treatment-naive patients, but management also highlighted a 75% reorder rate from the current 800+ active treatment centers as a sign of sustainable growth before treatment-switching increases. In our view, the launch is rolling out nicely as Pfizer is an excellent partner.
Meanwhile, the EMA is currently reviewing relugolix in prostate cancer with a decision expected in CY2022. Recall that Pfizer has the option to acquire exclusive commercialization rights to relugolix in oncology ex-US, – Canada, and Takeda territories, and will make that decision by mid-2021.
Beyond prostate cancer, the women’s health indications for the relugolix combo remain on track with FDA PDUFA date of June 1st in uterine fibroids (UF) and an EMA decision due mid-year. A filing for endometriosis is expected to occur this quarter in the US and later this year in Europe.
We expect the FDA review of the relugolix combo in UF to meet its June 1 PDUFA with a quick turnaround to launch that same month if approved. The EMA decision on uterine fibroids is also still expected mid-year, with partner Gedeon Richter ready to launch upon approval.
For endometriosis, FDA/EMA filings are anticipated for this calendar year, respectively. The recently launched Phase 3 SERENE contraception study continues to enroll, with an estimated primary completion of December 2022.
While it is early days for Orgovyx launch in prostate cancer, in our view, the launch is rolling out nicely as Pfizer is an excellent partner.
With Pfizer’s option to acquire ex-U.S. cancer rights coming up mid-year, we expect Pfizer to take the option and eventually buy MYOV to acquire 100% of the economics across both cancer and the woman’s health indications.
