Business
Knight and TherapeuticsMD Announce Health Canada Approval of BIJUVA®
MONTREAL and BOCA RATON, Fla., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) (“Knight”) and TherapeuticsMD, Inc. (NASDAQ: TXMD)
About this update from Therapeuticsmd, Inc.
[{"type":"text","content":"MONTREAL and BOCA RATON, Fla., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) (“Knight”) and TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD”) announced today the approval of BIJUVA® (estradiol and progesterone) capsules by Health Canada. In Canada, BIJUVA is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause in women with an intact uterus. VMS are commonly known as hot flashes or flushes and night sweats. VMS affect 60% to 80% of women entering menopause.1\n BIJUVA is a once-daily combination of estradiol and progesterone in a single oral capsule that will be available in two strengths in Canada. The two hormones included in BIJUVA have the same structure as the hormones produced and circulating in the woman’s body. In the U.S., BIJUVA is marketed by TherapeuticsMD and is indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause. “We are pleased to be able to offer a new treatment for postmenopausal women to address challenging symptoms of hot flashes and night sweats with BIJUVA.” said Samira Sakhia, President and Chief Operating Officer of Knight. “The approval of BIJUVA by Health Canada is a significant accomplishment by Knight, adding to the earlier approval of IMVEXXY® in August 2020, that offers new treatment options to women in Canada,” said Robert Finizio, Chief Executive Officer of TherapeuticsMD. Knight and TherapeuticsMD signed a license agreement in July 2018 pursuant to which TherapeuticsMD granted Knight the exclusive Canadian commercialization rights to BIJUVA and IMVEXXY (estradiol vaginal inserts). Under the terms of the license agreement related to BIJUVA in Canada, Knight will pay TherapeuticsMD a milestone fee for the regulatory approval in Canada of BIJUVA, sales milestone fees based upon certain aggregate annual sales of BIJUVA in Canada, and royalties based on aggregate annual sales of BIJUVA in Canada. About BIJUVA BIJUVA was developed and approved in the U.S. for the treatment of moderate to severe VMS due to menopause in women with a uterus. It is a combination of 1 mg bio-identical estradiol and 100 mg bio-identical progesterone in a once-daily oral softgel capsule. In Canada, BIJUVA is available as a once-daily capsule in two strengths; 1 mg estradiol/100 mg progesterone...