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    [{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Fuji Pharma","pharmaFlowCategory":"D","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","country":"BELGIUM","productType":"Hormone","year":"2023","type":"Licensing Agreement","leadProduct":"Estetrol","moa":"||Progesterone receptor","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved FDF","graph3":"Mithra Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Gynecology\/Obstetrics","amount2New":0,"dosageForm":"Oral Tablet, Film Coated","sponsorNew":"Mithra Pharmaceuticals \/ Fuji Pharma","highestDevelopmentStatusID":"15","companyTruncated":"Mithra Pharmaceuticals \/ Fuji Pharma"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Fuji Pharma","pharmaFlowCategory":"D","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","country":"BELGIUM","productType":"Hormone","year":"2023","type":"Licensing 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                            01

                            Mithra Pharmaceuticals

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                            Lead Product(s) : Tibolone

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

                            Study Phase : Approved FDF

                            Sponsor : BIOSYENT PHARMA INC

                            Deal Size : Undisclosed

                            Deal Type : Acquisition

                            DEALS_DEV arrow-down

                            BioSyent Announces Agreement to Purchase Tibelia® (tibolone) Assets

                            Details : BioSyent has acquired intellectual property, global rights, certain licensing, distribution and supply agreements related to Tibelia (tibolone), a prescription hormone replacement therapy.

                            Product Name : Tibelia

                            Product Type : Other Small Molecule

                            Upfront Cash : Undisclosed

                            September 20, 2024

                            Lead Product(s) : Tibolone

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

                            Highest Development Status : Approved FDF

                            Sponsor : BIOSYENT PHARMA INC

                            Deal Size : Undisclosed

                            Deal Type : Acquisition

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                            02

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                            Lead Product(s) : Estetrol

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

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Caring Cross and ImmunoACT Ink Agreement to Commercialize TriCAR-T Immunotherapy

                            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.

                            Product Name : Donesta

                            Product Type : Hormone

                            Upfront Cash : Inapplicable

                            February 29, 2024

                            Lead Product(s) : Estetrol

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

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            03

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                            Lead Product(s) : Estetrol,Drospirenone

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

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Mithra Completes Pediatric Study of ESTELLE® in Adolescent Patients

                            Details : 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.

                            Product Name : Estelle

                            Product Type : Hormone

                            Upfront Cash : Inapplicable

                            December 20, 2023

                            Lead Product(s) : Estetrol,Drospirenone

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

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            04

                            Mithra Pharmaceuticals

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                            Lead Product(s) : Estetrol

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

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Mithra Receives Positive DSMB Opinion on DONESTA® European Phase 3 Trial

                            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.

                            Product Name : Donesta

                            Product Type : Hormone

                            Upfront Cash : Inapplicable

                            December 18, 2023

                            Lead Product(s) : Estetrol

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

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            05

                            Mithra Pharmaceuticals

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                            Mithra Pharmaceuticals

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                            Lead Product(s) : Estetrol

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

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Mithra Receives Guidance From the FDA for the DONESTA® NDA Marketing Authorization Filing in The United State...

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

                            Product Name : Donesta

                            Product Type : Hormone

                            Upfront Cash : Inapplicable

                            November 30, 2023

                            Lead Product(s) : Estetrol

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

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            06

                            Mithra Pharmaceuticals

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                            Lead Product(s) : Estetrol

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

                            Study Phase : Phase III

                            Sponsor : SEARCHLIGHT PHARMA

                            Deal Size : $17.9 million

                            Deal Type : Licensing Agreement

                            DEALS_DEV arrow-down

                            Mithra and Searchlight Pharma Sign DONESTA® Licensing Agreement for Canada

                            Details : 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 compare...

                            Product Name : Donesta

                            Product Type : Hormone

                            Upfront Cash : Undisclosed

                            October 26, 2023

                            Lead Product(s) : Estetrol

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

                            Highest Development Status : Phase III

                            Sponsor : SEARCHLIGHT PHARMA

                            Deal Size : $17.9 million

                            Deal Type : Licensing Agreement

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                            07

                            Mithra Pharmaceuticals

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                            Lead Product(s) : Estetrol,Drospirenone

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

                            Study Phase : Approved FDF

                            Sponsor : Fuji Pharma

                            Deal Size : $45.4 million

                            Deal Type : Licensing Agreement

                            DEALS_DEV arrow-down

                            Mithra to Receive EUR 2.5 Million Milestone Payment from Fuji Pharma under ESTELLE® Licensing Agreement

                            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, i...

                            Product Name : Estelle

                            Product Type : Hormone

                            Upfront Cash : Undisclosed

                            October 23, 2023

                            Lead Product(s) : Estetrol,Drospirenone

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

                            Highest Development Status : Approved FDF

                            Sponsor : Fuji Pharma

                            Deal Size : $45.4 million

                            Deal Type : Licensing Agreement

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                            08

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                            Lead Product(s) : Estetrol,Drospirenone

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

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Mithra Announces Completion of Recruitment in Pediatric Study of Estelle in Adolescent Patients

                            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.

                            Product Name : Estelle

                            Product Type : Hormone

                            Upfront Cash : Inapplicable

                            October 05, 2023

                            Lead Product(s) : Estetrol,Drospirenone

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

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            09

                            Mithra Pharmaceuticals

                            Belgium arrow
                            AMWC Asia-TDAC
                            Not Confirmed

                            Mithra Pharmaceuticals

                            Belgium arrow
                            AMWC Asia-TDAC
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
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                            Lead Product(s) : Estetrol

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

                            Study Phase : Phase II

                            Sponsor : H.C. Wainwright & Co

                            Deal Size : $70.1 million

                            Deal Type : Private Placement

                            DEALS_DEV arrow-down

                            Mithra Prices Private Placement to Raise EUR 20 Million in Equity

                            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 Zor...

                            Product Name : Donesta

                            Product Type : Hormone

                            Upfront Cash : Undisclosed

                            August 24, 2023

                            Lead Product(s) : Estetrol

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

                            Highest Development Status : Phase II

                            Sponsor : H.C. Wainwright & Co

                            Deal Size : $70.1 million

                            Deal Type : Private Placement

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                            10

                            Mithra Pharmaceuticals

                            Belgium arrow
                            AMWC Asia-TDAC
                            Not Confirmed

                            Mithra Pharmaceuticals

                            Belgium arrow
                            AMWC Asia-TDAC
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
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                            Lead Product(s) : Estetrol

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

                            Study Phase : Phase III

                            Sponsor : SEARCHLIGHT PHARMA

                            Deal Size : $18.7 million

                            Deal Type : Licensing Agreement

                            DEALS_DEV arrow-down

                            Mithra and Searchlight Pharma Announce Donesta® Licensing Agreement for Canada

                            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.

                            Product Name : Donesta

                            Product Type : Hormone

                            Upfront Cash : Undisclosed

                            July 31, 2023

                            Lead Product(s) : Estetrol

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

                            Highest Development Status : Phase III

                            Sponsor : SEARCHLIGHT PHARMA

                            Deal Size : $18.7 million

                            Deal Type : Licensing Agreement

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