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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:
As part of the agreement, Duchesnay will explore opportunities to register ANNOVERA with local regulatory agencies in these regions and will invest in the Population Council’s research activities to develop new innovative contraceptive products.
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: Population Council
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement November 30, 2020
Details:
This builds on a decades-long partnership between the two organizations to optimize the delivery of several vaginal products, including the Population Council’s proprietary progestin, Nestorone®, and MIV-150, and manufacturing lead formulations for toxicology.
Lead Product(s): Segesterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Nestorone
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Population Council
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 15, 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
Partner/Sponsor/Collaborator: TherapeuticsMD
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 15, 2020
Details:
The arrangement combines Afaxys' unique capabilities serving the United States public health contraception market with TherapeuticsMD’s commitment to supply ANNOVERA to the U.S public health system.
Lead Product(s): Segesterone Acetate,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: TherapeuticsMD
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 13, 2020
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