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Imvexxy (estradiol vaginal inserts) is approved in the U.S. for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mayne Pharma
Deal Size: $225.7 million Upfront Cash: $140.0 million
Deal Type: Licensing Agreement January 03, 2023
Details:
Imvexxy (estradiol vaginal inserts) is approved in the U.S. for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Mayne Pharma
Deal Size: $225.7 million Upfront Cash: $140.0 million
Deal Type: Agreement December 04, 2022
Details:
TherapeuticsMD has three growing assets whose value has been enhanced by the recent approval of both Annovera’s (segesterone acetate) supplemental NDA and lower-dose Bijuva, as well as the increasing relevance of convenient and safe contraceptive options for women.
Lead Product(s): Segesterone Acetate,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Annovera
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Rubric Capital Management
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Financing August 01, 2022
Details:
The sNDA included minor revisions to Annovera (segesterone acetate) in vitro release testing specification that allowed for normal manufacturing variability, was approved by the FDA in August 2018 as the only long-lasting, reversible, procedure-free birth control.
Lead Product(s): Segesterone Acetate,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Annovera
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2022
Details:
TherapeuticsMD intends to use the net proceeds from the offering for commercialization of its three FDA-approved products, IMVEXXY® (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity).
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cantor
Deal Size: $110.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 11, 2021
Details:
TherapeuticsMD intends to use the net proceeds from the offering for commercialization of its three FDA-approved products which includes IMVEXXY®, BIJUVA® and ANNOVERA®, and for working capital and general corporate purposes.
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cantor Fitzgerald
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering November 10, 2020
Details:
BIJUVA is a once-daily combination of estradiol and progesterone in a single oral capsule that will be available in two strengths in Canada indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with an intact uterus.
Lead Product(s): Estradiol,Progesterone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Bijuva
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Knight Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
Details:
The agreement is aimed at expanding access to ANNOVERA® (segesterone acetate and ethinyl estradiol vaginal system), a first of its kind annual birth control ring. ANNOVERA is the first FDA-approved long-lasting birth control method that does not require a medical procedure.
Lead Product(s): Segesterone Acetate,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Annovera
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Nurx
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 15, 2020
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