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Under the agreement, Alvotech will receive an exclusive license to commercialize AVT23 (also called ADL018), a proposed biosimilar to Xolair (omalizumab), which will be developed and manufactured by Kashiv.
Lead Product(s): Omalizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AVT23
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alvotech
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 03, 2023
Details:
ADL018 (omalizumab) is a monoclonal antibody that inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. It is being developed as a biosimilar candidate to XOLAIR® approved to treat chronic spontaneous urticaria.
Lead Product(s): Omalizumab
Therapeutic Area: Immunology Product Name: ADL018
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2023
Details:
ADL018 (omalizumab) is a monoclonal antibody that inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. It is being developed as a biosimilar candidate to XOLAIR® approved to treat chronic spontaneous urticaria.
Lead Product(s): Omalizumab
Therapeutic Area: Immunology Product Name: ADL018
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 05, 2023
Details:
Fylnetra (pegfilgrastim-pbbk) is a leukocyte growth factor which decreases the incidence of infection, indicated for patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Lead Product(s): Pegfilgrastim-pbbk
Therapeutic Area: Hematology Product Name: Fylnetra
Highest Development Status: ApprovedProduct Type: Large molecule
Recipient: Amneal Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2023
Details:
FYLNETRA® (pegfilgrastim-pbbk), used to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Fylnetra
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Brand Institute
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2022
Details:
FYLNETRA (Pegfilgrastim-pbbk) is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Fylnetra
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Amneal Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2022
Details:
FYLNETRA (pegfilgrastim), is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which is commonly experienced by patients undergoing chemotherapy.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Fylnetra
Highest Development Status: ApprovedProduct Type: Large molecule
Recipient: Amneal Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2022
Details:
U.S. FDA approved biologics license application for RELEUKO (filgrastim-ayow), a biosimilar referencing Neupogen, to treat neutropenia which is commonly experienced by patients undergoing chemotherapy, acute myeloid leukemia and nonmyeloid malignancies.
Lead Product(s): Filgrastim
Therapeutic Area: Oncology Product Name: Releuko
Highest Development Status: ApprovedProduct Type: Large molecule
Recipient: Amneal Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2022
Details:
Amneal Pharmaceuticals has completed its previously announced acquisition of a 98% interest in Kashiv Specialty Pharmaceuticals, a wholly-owned subsidiary of Kashiv focused on the development of complex generics, innovative drug delivery platforms and novel 505(b)(2) drugs.
Lead Product(s): Filgrastim
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Amneal Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition April 05, 2021
Details:
The acquisition enhances Amneal's R&D expertise with the addition of the Kashiv Specialty team and its impressive track record in developing complex generic products (e.g. Yuvafem and EluRyng) and innovative drug delivery technologies.
Lead Product(s): K102
Therapeutic Area: Neurology Product Name: K102
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Amneal Pharmaceuticals
Deal Size: $108.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition January 12, 2021
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