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Lead Product(s): Conjugated Estrogens
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Cenestin
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Avion Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership November 12, 2020
Details:
Avion Pharmaceuticals gets exclusive rights to relaunch Cenestin® in the USA. Cenestin® is the only plant-derived mixture of nine conjugated estrogens indicated for treatment of moderate to severe symptoms of vasomotor, and vulvar and vaginal atrophy due to menopause.
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Lead Product(s): Segesterone Acetate,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Annovera
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Population Council
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement November 30, 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.
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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): Menotropins
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Menopur
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 15, 2020
Details:
Abstract titled "Differential Ovarian Response to Gonadotropin Preparations Despite Similar Ovarian Reserve: MENOPUR in GnRH (Gonadotropin Releasing Hormone) Antagonist Single Embryo Transfer – High Responder (MEGASET-HR) Trial Analysis" will be presented at the conference.
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Lead Product(s): Levonorgestrel
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Mirena
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 October 14, 2020
Details:
This new submission will seek to extend the indication another year for up to seven years of pregnancy prevention based on results from a Phase 3 extension trial evaluating the efficacy and safety of Mirena.
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Lead Product(s): Estradiol,Progesterone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Bijuva
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: TherapeuticMD
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 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.
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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): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy
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 August 25, 2020
Details:
In Canada, IMVEXXY is approved for the treatment of postmenopausal moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA).
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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.
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