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Details:
Under the terms of the agreement, Catalent will manufacture LUPKYNIS as a softgel dosage form at its pharmaceutical softgel center of excellence in St. Petersburg, Florida.
Lead Product(s):
Voclosporin,Mycophenolate Mofetil
Therapeutic Area: Nephrology
Product Name: Lupkynis
Highest Development Status: Approved
Product Type: Peptide
Partner/Sponsor/Collaborator:
Aurinia Pharmaceuticals
Deal Size: Undisclosed
Upfront Cash: Undisclosed
Deal Type: Agreement
February 18, 2021
Details:
Nefecon (budesonide) is a patented novel, investigational oral formulation of a potent and well-known active substance – budesonide – for targeted release. The formulation is designed to deliver the drug to the ileum where the Peyer’s patches are concentrated.
Lead Product(s):
Budesonide
Therapeutic Area: Nephrology
Product Name: Nefecon
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Calliditas Therapeutics AB
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
September 20, 2022
Details:
Kerendia (Finerenone) is non-steroidal, selective MR antagonist that block the harmful effects of MR overactivation. MR overactivation contributes to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.
Lead Product(s):
Finerenone
Therapeutic Area: Nephrology
Product Name: Kerendia
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
September 20, 2022
Details:
EC approval is based on positive results, which demonstrated that treatment with voclosporin (lupkynis), in combination with MMF and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to MMF and low-dose corticosteroids.
Lead Product(s):
Voclosporin
Therapeutic Area: Nephrology
Product Name: Lupkynis
Highest Development Status: Approved
Product Type: Peptide
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
September 20, 2022
Details:
LUPKYNIS (voclosporin) is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney.
Lead Product(s):
Voclosporin
Therapeutic Area: Nephrology
Product Name: Lupkynis
Highest Development Status: Approved
Product Type: Peptide
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
September 19, 2022
Details:
Forxiga (dapagliflozin) also significantly reduced the relative risk of death from any cause by 31% (ARR=2.1%, p=0.0035) compared to placebo6. The safety and tolerability of Forxiga were consistent with the well-established safety profile of the medicine.
Lead Product(s):
Dapagliflozin
Therapeutic Area: Nephrology
Product Name: Forxiga
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
September 05, 2022
Details:
The positive data from the pivotal Phase III FIGARO-DKD study demonstrated that Kerendia (finerenone) significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D.
Lead Product(s):
Finerenone
Therapeutic Area: Nephrology
Product Name: Kerendia
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
September 02, 2022
Details:
Kerendia (finerenone) is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation.
Lead Product(s):
Finerenone
Therapeutic Area: Nephrology
Product Name: Kerendia
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
August 29, 2022
Details:
Velphoro (sucroferric oxyhydroxide) ® is a non-calcium, iron-based, chewable phosphate binder approved for the control of phosphate levels in the blood of adults with chronic kidney disease on dialysis.
Lead Product(s):
Sucroferric Oxyhydroxide
Therapeutic Area: Nephrology
Product Name: Velphoro
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Vifor Pharma
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
August 22, 2022
Details:
FIDELITY investigated the efficacy and safety of Kerendia (finerenone) across a broad range of patients with early to late-stage CKD and T2D and provided insights into the relationship between CKD stage.
Lead Product(s):
Finerenone
Therapeutic Area: Nephrology
Product Name: Kerendia
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
August 22, 2022
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