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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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