All Data
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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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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: TherapeuticMD
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 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.
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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 July 15, 2020
Details:
The final data analysis demonstrated a cumulative pregnancy rate of 13.7% over seven cycles of use in Phexxi group.
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Lead Product(s): Etonogestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myring
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Zentiva
Deal Size: $2.2 million Upfront Cash: Undisclosed
Deal Type: Agreement July 06, 2020
Details:
Mithra grants license to Zentiva for commercialization of its vaginal contraceptive ring in three key European markets.
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Lead Product(s): Undisclosed
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Approved Product Type: Undisclosed
Partner/Sponsor/Collaborator: Naari
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition June 10, 2020
Details:
The portfolio acquired comprises eight U.S. FDA approved ANDAs and two products pending approval. It includes generic products in female hormones which will be manufactured at Naari’s dedicated female hormone facility in India and commercialized over the next 24 months.
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Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
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 May 22, 2020
Details:
Data demonstrate high efficacy rates of more than 93% when Phexxi is used as directed, also underscore the sexual satisfaction and lubricating factors experienced by women in the AMPOWER trial.
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