Knight Therapeutics Announces Relaunch of MYFEMBREE(TM) in Canada

Executive Summary

• Knight Therapeutics announced the relaunch of MYFEMBREE® in Canada, a first‑in‑class oral therapy for heavy menstrual bleeding due to uterine fibroids and moderate‑to‑severe endometriosis pain.
• The product was approved by Health Canada in September 2023, launched in February 2024, and generated approximately $2.9 M in Canadian sales in 2024.
• Knight expects the relaunch to leverage its existing commercial and medical infrastructure, tapping an estimated $45 M market for GnRH agonist/antagonist therapies in Canada growing at a ~8% CAGR.

Key Details

• Product: MYFEMBREE® (relugolix 40 mg / estradiol 1 mg / norethindrone acetate 0.5 mg) – oral fixed‑dose combination for uterine fibroids and endometriosis.
• Regulatory Status: Health Canada approval received September 2023; initial launch February 2024.
• Sales Performance (2024): Approx. $2.9 M in Canadian revenue (IQVIA data).
• Market Opportunity: Total GnRH agonist/antagonist sales for fibroids and endometriosis in Canada estimated at $45 M, with a 5‑year CAGR of 8%.
• Commercial Strategy: Relaunch will be supported by Knight’s existing commercial and medical teams, creating synergies across its women’s health portfolio.
• Licensing Background: In June 2024, Knight and Sumitomo Pharma America entered exclusive license and supply agreements for MYFEMBREE®, ORGOVYX® (relugolix), and vibegron in Canada, plus an asset purchase of the mature products.
• Executive Quote: “The relaunch of MYFEMBREE® provides physicians an effective treatment option… MYFEMBREE® strengthens our women’s health portfolio and benefits from the synergies of our existing commercial and medical infrastructure.” – Samira Sakhia, President & CEO.

Notable Quotes

• Samira Sakhia, President & CEO: “The relaunch of MYFEMBREE® provides physicians an effective treatment option for the management of uterine fibroids and endometriosis, conditions that continue to impact so many women.”

Materiality Assessment: Material – Positive (the relaunch signals a significant commercial milestone with measurable sales to date and a sizable addressable market).