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PB016 (vedolizumab) is a humanized monoclonal antibody that specifically binds to the α4β7 integrin & blocks the interaction of α4β7 integrin. It is being evaluated for the treatment of Ulcerative Colitis.
Lead Product(s): Vedolizumab
Therapeutic Area: Gastroenterology Product Name: PB016
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 February 21, 2024
Details:
Tyruko (natalizumab-sztn) biosimilar is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple sclerosis lesion accumulation.
Lead Product(s): Natalizumab-sztn
Therapeutic Area: Neurology Product Name: Tyruko
Highest Development Status: ApprovedProduct Type: Large molecule
Recipient: Sandoz B2B
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2023
Details:
RVU120 is a selective, first-in-class dual CDK8/CDK19 kinase inhibitor that has shown signs of clinical activity in treated patients, as well as efficacy in numerous in vitro and in vivo models of hematologic malignancies and solid tumors.
Lead Product(s): RVU120
Therapeutic Area: Oncology Product Name: RVU120
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ryvu Therapeutics
Deal Size: $1.0 million Upfront Cash: Undisclosed
Deal Type: Agreement July 06, 2023
Details:
CIMERLI (Ranibizumab) is the first and only interchangeable biosimilar with an exclusivity for 12 months after market launch that is indicated for the treatment of all five Lucentis® indications and, as such, is a new medical option for patients with serious retinal diseases.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Cimerli
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2022
Details:
The COLUMBUS-AMD study, published in highly-regarded medical journal Ophthalmology, was the head-to-head study where CIMERLI (ranibizumab) met its primary endpoint of change from baseline in best corrected visual acuity (BCVA) at week 8 as compared to reference ranibizumab.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Cimerli
Highest Development Status: ApprovedProduct Type: Large molecule
Recipient: Coherus Biosciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 02, 2022
Details:
Tysabri® (natalizumab) - a monotherapy for adult patients with relapsing-remitting multiple sclerosis (RRMS) and adults with moderately-to-severely active Crohn’s disease.
Lead Product(s): Natalizumab
Therapeutic Area: Neurology Product Name: Undisclosed
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 29, 2022
Details:
PB006 (natalizumab) is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple sclerosis lesion accumulation.
Lead Product(s): Natalizumab
Therapeutic Area: Neurology Product Name: PB006
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Sandoz B2B
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2022
Details:
The partnership involves manufacturing of the drug substance of the clinical candidate PKL-021, needed to support the preclinical research program and the production of an investigational medicinal product for the phase one clinical trial.
Lead Product(s): PKL-021
Therapeutic Area: Neurology Product Name: PKL-021
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pikralida biopharmaceutical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 19, 2022
Details:
Natalizumab a proposed biosimilar to Tysabri is a humanised monoclonal antibody that blocks integrin α4β1-mediated leukocyte migration from blood vessels to the brain and prevent highly active relapsing-remitting multiple sclerosis.
Lead Product(s): Natalizumab
Therapeutic Area: Neurology Product Name: PB006
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Sandoz B2B
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2022
Details:
CIMERLI™ is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI™. Hypersensitivity reactions may manifest as severe intraocular inflammation
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Cimerli
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2022
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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
