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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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 29, 2024
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.
Lead Product(s): Estetrol,Drospirenone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Estelle
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2023
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 18, 2023
Details:
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2023
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 compared to placebo.
Lead Product(s): Estetrol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Donesta
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SEARCHLIGHT PHARMA INC
Deal Size: $17.9 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 26, 2023
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Fuji Pharma
Deal Size: $45.4 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 23, 2023
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 IIProduct 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
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: ApprovedProduct 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
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SEARCHLIGHT PHARMA INC
Deal Size: $18.7 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 31, 2023
Details:
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: PreclinicalProduct 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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