Knight Therapeutics relaunches Myfembree in Canada

Executive Summary

• Knight Therapeutics announced the relaunch of Myfembree® (relugolix/estradiol/norethindrone acetate) in Canada.
• The product, approved by Health Canada in September 2023 and launched in February 2024, generated approximately $2.9 million in Canadian sales in 2024.
• The relaunch follows exclusive license and supply agreements with Sumitomo Pharma America Inc., and an asset purchase that gave Knight ownership of the product portfolio.

Key Details

• Product: Myfembree® – fixed‑dose combination tablet (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg).
• Indications: Treatment of heavy menstrual bleeding due to uterine fibroids and moderate‑to‑severe pain from endometriosis in premenopausal women.
• Regulatory Status: Approved by Health Canada (Sept 2023); commercial launch began Feb 2024.
• Commercial Agreements:
• Exclusive license and supply agreements with Sumitomo Pharma America Inc. (SMPA) for Myfembree, Orgovyx (relugolix), and vibegron in Canada.
• Asset purchase agreement whereby Knight acquired the mature product assets from SMPA affiliates.
• Market Context: IQVIA estimates total Canadian GnRH agonist/antagonist sales for endometriosis & uterine fibroids at $45 million (5‑year CAGR ≈ 8%).
• 2024 Sales Performance: Approximate Canadian sales of Myfembree in 2024 were $2.9 million.
• Strategic Rationale: Relauch leverages Knight’s existing commercial and medical infrastructure, strengthening its women’s health portfolio.

Notable Quotes

“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,” said Samira Sakhia, President & CEO of Knight.
“Myfembree strengthens our women's health portfolio and benefits from the synergies of our existing commercial and medical infrastructure.”