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Sumitovant and Myovant will strengthen Myovant's two products, Orgovyx® (relugolix) and Myfembree® capabilities and help continue to deliver innovative therapies addressing unmet patient needs in prostate cancer and women's health.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sumitovant Biopharma
Deal Size: $1,700.0 million Upfront Cash: $1,700.0 million
Deal Type: Acquisition March 10, 2023
Details:
Sumitovant and Myovant will strengthen Myovant's two products, Orgovyx® (relugolix) and Myfembree® capabilities and help continue to deliver innovative therapies addressing unmet patient needs in prostate cancer and women's health.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sumitovant Biopharma
Deal Size: $1,700.0 million Upfront Cash: $1,700.0 million
Deal Type: Acquisition October 23, 2022
Details:
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is a once-daily oral treatment approved by the U.S. Food and Drug Administration for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myfembree
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2022
Details:
ORGOVYX® (relugolix), is the first and only oral androgen deprivation therapy for an oral medication used to treat adult patients with advanced hormone-sensitive prostate cancer.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Brand Institute
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2022
Details:
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is first and only once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by USFDA with a treatment duration of up to 24 months.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myfembree
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2022
Details:
ORGOVYX® (relugolix), which is a gonadotropin-releasing hormone (GnRH) antagonist that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced prostate cancer.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Onco360
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2022
Details:
The sNDA proposes updates to MYFEMBREE (Relugolix) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study of MYFEMBREE in premenopausal women with heavy menstrual bleeding associated with uterine fibroids for up to two years.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myfembree
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2022
Details:
Myovant will continue to lead the global development of Orgovyx (relugolix) and provide product supply to Accord. Accord will be responsible for certain local clinical development, commercialization for its territories, and has the option to manufacture relugolix in future.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Accord healthcare
Deal Size: $140.5 million Upfront Cash: $50.0 million
Deal Type: Licensing Agreement May 09, 2022
Details:
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is first once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by U.S. FDA, with a treatment duration of up to 24 months.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myfembree
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 06, 2022
Details:
In HERO study, ORGOVYX met primary endpoint and achieved sustained testosterone suppression to castrate levels through 48 weeks in 96.7% of men, compared with 88.8% of men receiving leuprolide acetate injections, current standard of care.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2022
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