Suanfarma Suanfarma

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[{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Pharmaceuticals Delays Recruitment In Donesta Phase III Clinical Programme","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mayne Pharma Submits New Drug Application for E4\/DRSP to the FDA","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra and Searchlight Pharma Announce Filing of New Drug Submission for Estelle\u00ae in Canada","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4\/DRSP in the US","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Mithra Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data Show NEXTSTELLIS\u00ae Has Selective Impact On Endocrine Markers Compared With Common Combined Oral Contraceptives","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Efficacy Data Reinforces NEXTSTELLIS\u00ae Benefits Across Patient Populations","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Mithra Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nextstellis\u00ae Receives FDA Marketing Exclusivity and Phase III Data Published","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Announces Positive Top-Line Results from Donesta\u00ae Phase 3 Studies in Menopausal Women","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase II","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase II"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"SEARCHLIGHT PHARMA INC","pharmaFlowCategory":"D","amount":"$18.7 million","upfrontCash":"Undisclosed","newsHeadline":"Mithra and Searchlight Pharma Announce Donesta\u00ae Licensing Agreement for Canada","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Fuji Pharma","pharmaFlowCategory":"D","amount":"$45.4 million","upfrontCash":"$29.0 million","newsHeadline":"Mithra Receives EUR 1.25 Million Milestone Payment from Fuji Pharma Under Estelle\u00ae Licensing Agreement","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"H.C. Wainwright & Co.","pharmaFlowCategory":"D","amount":"$70.1 million","upfrontCash":"Undisclosed","newsHeadline":"Mithra Prices Private Placement to Raise EUR 20 Million in Equity","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase II","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase II"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Fuji Pharma","pharmaFlowCategory":"D","amount":"$45.4 million","upfrontCash":"Undisclosed","newsHeadline":"Mithra to Receive EUR 2.5 Million Milestone Payment from Fuji Pharma under ESTELLE\u00ae Licensing Agreement","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"SEARCHLIGHT PHARMA INC","pharmaFlowCategory":"D","amount":"$17.9 million","upfrontCash":"Undisclosed","newsHeadline":"Mithra and Searchlight Pharma Sign DONESTA\u00ae Licensing Agreement for Canada","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Announces Completion of Recruitment in Pediatric Study of Estelle in Adolescent Patients","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Receives Guidance From the FDA for the DONESTA\u00ae NDA Marketing Authorization Filing in The United States","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Receives Positive DSMB Opinion on DONESTA\u00ae European Phase 3 Trial","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Completes Pediatric Study of ESTELLE\u00ae in Adolescent Patients","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"DONESTA\u00ae Safety Study for Menopause Completes Treatment Phase and Advances to Data Management & Reporting Phase","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"}]

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            Details:

            Donesta (estetrol) is a next generation orally administered Estetrol (E4)-based hormone therapy product, which is under phase 3 clinical development for the treatment of the symptoms of menopause.

            Lead Product(s): Estetrol

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

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 29, 2024

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            Estelle (estetrol monohydrate) is an estrogen receptor agonist small molecule drug candidate, which is currently being evaluated in combination with drospirenone for contraception for 12 to 17 years aged females.

            Lead Product(s): Estetrol,Drospirenone

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

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 20, 2023

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            Donesta (estetrol) is a next generation orally administered Estetrol (E4)-based hormone therapy product, which is under phase 3 clinical development for the treatment of the symptoms of menopause.

            Lead Product(s): Estetrol

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

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 18, 2023

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            Donesta (estetrol) is a hormone capsule formulation acting as an Estrogen receptor agonist, approved for the treatment of alleviating symptoms of menopause.

            Lead Product(s): Estetrol

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

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 30, 2023

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            Under the terms of the agreement, Searchlight will have sales and marketing rights for DONESTA® in Canada. DONESTA (estetrol) phase 3 clinical program, which demonstrated a meaningful reduction in the frequency and severity of vasomotor symptoms compared to placebo.

            Lead Product(s): Estetrol

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

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: SEARCHLIGHT PHARMA INC

            Deal Size: $17.9 million Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement October 26, 2023

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            Under the agreements, Fuji Pharma obtains the rights to commercialize and advance the develoopment of Estelle, Mithra’s oral contraceptive product candidate based on Estetrol, for the treatment of Japanese patients with dysmenorrhea or endometriosis, in Japan and ASEAN.

            Lead Product(s): Estetrol,Drospirenone

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

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Fuji Pharma

            Deal Size: $45.4 million Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement October 23, 2023

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            The proceeds will support the NDA filing of Donesta, a next generation Estetrol-based hormone therapy, and to support differentiation for treatment of menopause symptoms related to hair, skin and sexual desire, and for the development of Estetrol and Zoreline.

            Lead Product(s): Estetrol

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

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

            Deal Size: $70.1 million Upfront Cash: Undisclosed

            Deal Type: Private Placement August 24, 2023

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            Details:

            Under the agreements, Fuji Pharma obtains the rights to commercialize and advance the develoopment of Estelle, Mithra’s oral contraceptive product candidate based on Estetrol, for the treatment of Japanese patients with dysmenorrhea or endometriosis, in Japan and ASEAN.

            Lead Product(s): Estetrol,Drospirenone

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

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Fuji Pharma

            Deal Size: $45.4 million Upfront Cash: $29.0 million

            Deal Type: Licensing Agreement August 03, 2023

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            Details:

            Under the agreement, Searchlight will have the Canadian rights to Donesta, a next generation orally administered Estetrol (E4)-based hormone therapy product, for the treatment of the symptoms of menopause.

            Lead Product(s): Estetrol

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

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: SEARCHLIGHT PHARMA INC

            Deal Size: $18.7 million Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement July 31, 2023

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            Details:

            Estelle® is a novel patent protected combined oral contraceptive pill containing 3 mg drospirenone (DRSP) and 15 mg estetrol (E4). E4 is a naturally produced estrogen during pregnancy, which can now be made from a plant source.

            Lead Product(s): Estetrol,Drospirenone

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

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 10, 2023

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