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Xaciato (clindamycin phosphate) vaginal gel 2% is a USFDA approved medication for the treatment of bacterial vaginosis (BV) in females 12 years of age and older.
Lead Product(s): Clindamycin Phosphate
Therapeutic Area: Infections and Infectious Diseases Product Name: Xaciato
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Daré Bioscience
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2024
Details:
Under the agreement, Organon becomes the sole distributor and promoter of Emgality (galcanezumab), a humanized monoclonal antibody calcitonin gene-related peptide (CGRP) antagonist, and RAYVOW™ (lasmiditan), a first-in-class serotonin 5-HT1F receptor agonist, in Europe.
Lead Product(s): Galcanezumab
Therapeutic Area: Neurology Product Name: Emgality
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 18, 2023
Details:
Hadlima (adalimumab-bwwd), a biosimilar of Humira (adalimumab), is a TNF blocker indicated to treat Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Yusimry will be the first biologic product offered by the Cost Plus Drugs.
Lead Product(s): Adalimumab-bwwd
Therapeutic Area: Immunology Product Name: Hadlima
Highest Development Status: ApprovedProduct Type: Large molecule
Recipient: Samsung Bioepis
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 07, 2023
Details:
Under the agreement, Daré has the global rights to Xaciato (clindamycin phosphate vaginal gel), an FDA-approved medication for the treatment of bacterial vaginosis (BV) in females 12 years of age and older.
Lead Product(s): Clindamycin Phosphate
Therapeutic Area: Infections and Infectious Diseases Product Name: Xaciato
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Daré Bioscience
Deal Size: $192.8 million Upfront Cash: $10.0 million
Deal Type: Licensing Agreement October 16, 2023
Details:
HADLIMA (Adalimumab-bwwd) is a biosimilar product of HUMIRA®, formulated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritisetc. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.
Lead Product(s): Adalimumab-bwwd
Therapeutic Area: Immunology Product Name: Hadlima
Highest Development Status: Phase IVProduct Type: Large molecule
Recipient: Samsung Bioepis
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2023
Details:
HADLIMA (adalimumab-bwwd) is a biosimilar product of HUMIRA®, formulated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritisetc. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.
Lead Product(s): Adalimumab-bwwd
Therapeutic Area: Immunology Product Name: Hadlima
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Samsung Bioepis
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2023
Details:
Approval of citrate-free, high-concentration HADLIMA™ (adalimumab-bwwd), TNF blocker indicator was based on clinical data from study that compare PK, safety, tolerability, and immunogenicity of two formulations of HADLIMA (100 mg/mL vs 50 mg/mL) in healthy volunteers.
Lead Product(s): Adalimumab,Methotrexate
Therapeutic Area: Immunology Product Name: Hadlima
Highest Development Status: ApprovedProduct Type: Large molecule
Recipient: Samsung Bioepis
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2022
Details:
Under the terms of the agreement, Cirqle will be responsible for conducting preclinical studies according to the mutually agreed research plan. Organon will obtain exclusive worldwide rights to develop and commercialize the asset OUI (mushroom-derived biopolymer).
Lead Product(s): Mushroom-Derived Biopolymer
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: OUI
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cirqle Biomedical
Deal Size: $370.0 million Upfront Cash: $10.0 million
Deal Type: Collaboration July 28, 2022
Details:
Under the agreement, Organon licensed global rights to XACIATO (clindamycin phosphate vaginal gel, 2%), an FDA-approved medication for the treatment of bacterial vaginosis in females 12 years of age and older.
Lead Product(s): Clindamycin Phosphate
Therapeutic Area: Infections and Infectious Diseases Product Name: Xaciato
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Daré Bioscience
Deal Size: $192.5 million Upfront Cash: $10.0 million
Deal Type: Licensing Agreement June 30, 2022
Details:
The agreement includes an option to negotiate an exclusive license for global commercialization rights for a biosimilar candidate referencing Yervoy ® (ipilimumab, HLX13), Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14).
Lead Product(s): Pertuzumab,Trastuzumab
Therapeutic Area: Oncology Product Name: HLX11
Highest Development Status: Phase IIIProduct Type: Large molecule
Recipient: Shanghai Henlius Biotech
Deal Size: $103.0 million Upfront Cash: $73.0 million
Deal Type: Licensing Agreement June 13, 2022
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