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Details:
The net proceeds will be used for the Twirla (levonorgestrel and ethinyl estradiol), the first and only combined hormonal once-weekly birth control patch delivering a low dose of estrogen.
Lead Product(s): Levonorgestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Twirla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $7.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 03, 2023
Details:
The agreement aims to expand patient access and streamline fulfillment for Twirla (levonorgestrel ethinyl estradiol) transdermal system, a once-weekly combined hormonal contraceptive (CHC) patch, indicated for use as a method of contraception by women.
Lead Product(s): Levonorgestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Twirla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: vitaCare Prescription Services
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 13, 2023
Details:
TWIRLA is a combination of levonorgestrel, a progestin, ethinyl estradiol and estrogen. It is a hormonal contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation.
Lead Product(s): Levonorgestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Twirla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2023
Details:
The combination will create one of the largest and fastest growing UK pharma companies and accelerated growth in current and future product portfolio, especially in healthcare (leading asset Akizza having gestodene/ethinylestradiol combination) in the UK and internationally.
Lead Product(s): Gestodene,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Akizza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aspire Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition October 03, 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 generic version of Taytulla®1 Capsules, Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg, has received approval by the United States Food & Drug Administration.
Lead Product(s): Norethisterone Acetate,Ethinyl Estradiol,Ferrous Fumarate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Norethindrone Acetate/Ethinyl Estradiol/Ferrous Fumarate-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 29, 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:
Approval of Twirla (levonorgestrel) was based on SECURE study, which demonstrated safety in a large diverse group of women in a clinical trial setting.
Lead Product(s): Levonorgestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Twirla
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 05, 2022
Details:
U.S.FDA has approved Abbreviated New Drug Application for Merzee (Slayback Pharma), an AB-rated generic equivalent of Taytulla® (Allergan), an estrogen/progestin combination oral contraceptive indicated for use by women to prevent pregnancy.
Lead Product(s): Norethisterone Acetate,Ethinyl Estradiol,Ferrous Fumarate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Merzee
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Lupin Ltd
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2022
Details:
Twirla (levonorgestrel and ethinyl estradiol) transdermal system is combined hormonal contraceptive patch, indicated for use as a method of contraception by women of reproductive potential with a body mass index < 30 kg/m2.
Lead Product(s): Levonorgestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Twirla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2022
Details:
This acquisition gives Organon full global ownership of Marvelon® and Mercilon® brands (except in South Korea) by reacquiring the rights to them in these markets. Marvelon and Mercilon are currently available by prescription in Vietnam.
Lead Product(s): Desogestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Marvelon
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Organon
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition February 16, 2022
Details:
This strategic agreement with Afaxys, a recognized leader in the public health system, will help ensure that Twirla is available, accessible and affordable to a much broader group of patients who can benefit from it.
Lead Product(s): Levonorgestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Twirla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Agile Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 10, 2022
Details:
Amneal Pharmaceuticals has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for 150 mcg/day Norelgestromin and 35 mcg/day Ethinyl Estradiol Transdermal System.
Lead Product(s): Norelgestromin,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Zafemy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2021
Details:
Evra is a transdermal contraceptive patch assets. The deal is complemented by a transitional business license agreement and series of other related agreements to run the business without interruption during the period required to transfer marketing authorizations to Richter.
Lead Product(s): Norelgestromin,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Evra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gedeon Richter
Deal Size: $263.5 million Upfront Cash: Undisclosed
Deal Type: Acquisition December 03, 2020
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:
Taytulla® is an estrogen/progestin combination oral contraceptive indicated for use by women to prevent pregnancy. Annual market sales for Taytulla® for the twelve month period ending August, 2020 were $157 million, according to IQVIA™.
Lead Product(s): Norethisterone Acetate,Ethinyl Estradiol,Ferrous Fumarate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Gemmily
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 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:
Mithra grants license to Zentiva for commercialization of its vaginal contraceptive ring in three key European markets.
Lead Product(s): Etonogestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myring
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Zentiva
Deal Size: $2.2 million Upfront Cash: Undisclosed
Deal Type: Agreement July 06, 2020
Details:
Under the terms of this agreement, Gynial will distribute Myring™ in Switzerland, where the Swiss contraceptive rings market is worth EUR 8 million per year.
Lead Product(s): Etonogestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gynial
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 05, 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
Details:
Under the terms of the agreement, Farmitalia will distribute Myring™ in Italy, which is the third largest worldwide vaginal contraceptive ring market in terms of sales value and volume, after the US & Germany.
Lead Product(s): Etonogestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Farmitalia
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 21, 2020
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