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Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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            Lead Product(s): Norelgestromin,Ethinyl Estradiol

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Zafemy

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 26, 2021

            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.

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            Lead Product(s): Estradiol

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy

            Highest Development Status: Approved Product 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, IMVEXXY® (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity).

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            Lead Product(s): Acetylsalicylic Acid

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 25, 2021

            Details:

            Contrary to previous findings, low-dose aspirin therapy before conception and during early pregnancy may increase pregnancy chances and live births among women who have experienced one or two prior miscarriages.

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            Lead Product(s): Hydroxyprogesterone Caproate

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Makena

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 14, 2020

            Details:

            FDA’s Notice of Opportunity for a Hearing regarding the Agency’s proposal to withdraw approval for Makena also referred to as 17-OHPC, to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

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            Lead Product(s): Norelgestromin,Ethinyl Estradiol

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Evra

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Gedeon Richter Plc.

            Deal Size: $263.5 million Upfront Cash: Undisclosed

            Deal Type: Acquisition December 03, 2020

            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.

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            Lead Product(s): Estradiol

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Cantor Fitzgerald

            Deal Size: $30.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering November 10, 2020

            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.

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            Lead Product(s): Norethindrone Acetate,Ethinyl Estradiol,Ferrous Fumarate

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Gemmily

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 09, 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™.

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            Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 08, 2020

            Details:

            Approved by the U.S. Food and Drug Administration (FDA) on May 22, 2020, Phexxi is a vaginal pH modulator designed to maintain vaginal pH within the normal range of 3.5 to 4.5 – an acidic environment that is inhospitable to sperm.

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            Lead Product(s): Bremelanotide

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Vyleesi

            Highest Development Status: Approved Product Type: Peptide

            Partner/Sponsor/Collaborator: AMAG Pharmaceuticals

            Deal Size: $16.3 million Upfront Cash: $12.0 million

            Deal Type: Divestment July 27, 2020

            Details:

            Under the terms of the termination agreement, all of AMAG’s rights and obligations to develop and commercialize Vyleesi under the license agreement will terminate, and full ownership of Vyleesi will transfer back to Palatin.