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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":"Mithra Pharmaceuticals","sponsor":"Farmitalia ","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Mithra Signs LSA for Commercialization of Myring\u2122 in Italy, the Third Biggest Worldwide Market","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Gynial","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Mithra Pharmaceuticals and Gynial Sign Commercialization Agreement for Myring\u2122 in Switzerland","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"May 2020","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 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":"Mithra Pharmaceuticals","sponsor":"Spirig Healthcare","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Mithra Signs LSA for Commercialization of Tibelia\u00ae in Liechtenstein and Switzerland","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Approved","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Approved"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Zentiva","pharmaFlowCategory":"D","amount":"$2.2 million","upfrontCash":"Undisclosed","newsHeadline":"Mithra to Commercialize Myring In France, Poland And UK","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Mayne Pharma","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":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Mayne Pharma","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":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mithra CDMO","sponsor":"Mithra Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ExeVir and Mithra Announce Manufacturing Collaboration for Innovative Covid-19 Treatments","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"BELGIUM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"BCI Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"BCI Pharma Enters Into Strategic Partnership with Mithra to Identify Novel Therapy for Endometriosis and Cancer in Women","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Preclinical","country":"BELGIUM","productType":"Small molecule","productStatus":"Undisclosed","date":"December 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Preclinical"},{"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":"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":"BCI Pharma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Announces New Positive Preclinical Data from CSF-1R Inhibitor Program","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Preclinical","country":"BELGIUM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Preclinical"},{"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"}]

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            Details:

            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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            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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            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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            Colony-stimulating factor 1 receptor (CSF-1R) is a cell-surface tyrosine kinase receptor and a key regulator of macrophage biology and homeostasis andpromising therapeutic strategy for cancer treatment.

            Lead Product(s): Undisclosed

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

            Highest Development Status: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: BCI Pharma

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 15, 2023

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            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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            Donesta (Estetrol), a next generation estetrol (E4)-based hormone therapy product candidate, demonstrated a meaningful reduction in vasomotor symptoms from baseline and compared to placebo in Phase 3 pivotal “E4 Comfort” clinical trial for treatment of VMS in postmenopausal women.

            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: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 14, 2022

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            Mithra acquired a purchase option on the rights to two development programs in innovative CSF1R kinase inhibitors, led by BCI Pharma. Under the terms of the contract, Mithra has the possibility to buy the rights to a development program on inhibitors.

            Lead Product(s): Undisclosed

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

            Highest Development Status: Preclinical Product Type: Small molecule

            Recipient: BCI Pharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration December 16, 2021

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            XVR011 is a single domain-based anti-SARS-CoV-2 antibody (llama-derived VHH-Fc) optimized for stability, safety, broad neutralizing capability and excellent manufacturability.

            Lead Product(s): llama-derived VHH-Fc Antibody

            Therapeutic Area: Infections and Infectious Diseases Product Name: XVR011

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Recipient: Mithra Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration July 15, 2021

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            NEXTSTELLIS (drospirenone and estetrol tablets) indicated for use by females of reproductive potential to prevent pregnancy. Nextstellis® has been granted marketing exclusivity as a new chemical entity from the US Food and Drug Administration (FDA).

            Lead Product(s): Drospirenone,Estetrol

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

            Highest Development Status: Approved Product Type: Small molecule

            Recipient: Mayne Pharma

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 27, 2021

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            New data shows treatment with NEXTSTELLIS®,1 a novel, investigational combined oral contraceptive containing drospirenone and estetrol, resulted in less changes in endocrine markers, including lower increases in hormone binding globulins vs COCs based on ethinyl-estradiol.

            Lead Product(s): Drospirenone,Estetrol

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

            Highest Development Status: Approved Product Type: Small molecule

            Recipient: Mayne Pharma

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 06, 2021

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