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Details:
XENLETA (lefamulin) is first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Genetic Disease Product Name: Xenleta
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 28, 2022
Details:
Xenleta (lefamulin) is a novel, first-in-class, IV and oral pleuromutilin antimicrobial agent that has been demonstrated to be highly potent against S. aureus, including MRSA and strains obtained from patients with CF.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Genetic Disease Product Name: Xenleta
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2022
Details:
Under the terms of the agreement, Er-Kim gains exclusive rights to distribute XENLETA (lefamulin) in the following countries: Bulgaria, Croatia, Czechia, Greece, Hungary, Poland, Romania, Slovakia, and Slovenia.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Xenleta
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Erkim
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 18, 2022
Details:
XENLETA has the potential to provide a well-tolerated oral and intravenous anti-MRSA treatment option with a novel mechanism for this difficult to treat patient population. We look forward to sharing the results of this study with the medical community.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Genetic Disease Product Name: Xenleta
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 11, 2022
Details:
Sumitomo filed NDA to market oral and IV formulations of lefamulin,first systemic pleuromutilin antibiotic for the treatment of community-acquired pneumonia in adults in mainland China.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Xenleta
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2021
Details:
XENLETA is the first intravenous and oral pleuromutilin approved for the systemic treatment of community acquired bacterial pneumonia (CABP) in adults, and also reduced pro-inflammatory cytokines comparable to that observed with dexamethasone.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Xenleta
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021
Details:
XENLETA® (lefamulin) is first-in-class pleuromutilin antibiotic for treatment of community-acquired bacterial pneumonia (CABP). It's in vitro activity of lefamulin against Staphylococcus aureus isolated from lower respiratory tract of children with cystic fibrosis.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Genetic Disease Product Name: Xenleta
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 24, 2021
Details:
Sinovant’s multi-center, randomized, double-blind trial was designed to evaluate the safety and efficacy of intravenous (IV) to oral lefamulin compared to IV/oral moxifloxacin in 125 subjects with CABP.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Xenleta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Nabriva Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2021
Details:
The restructured agreement provides for additional manufacturing collaboration and regulatory support [to be provided to Sinovant by Nabriva] that is expected to help expedite the delivery of XENLETA to patients in greater China.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Xenleta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Nabriva Therapeutics
Deal Size: $101.0 million Upfront Cash: $5.0 million
Deal Type: Licensing Agreement December 07, 2020
Details:
Findings underscore potential of XENLETA as a first-in-class pleuromutilin antibiotic for the IV and oral treatment of CABP in adults, including older patients with comorbidities who are at risk of poor outcomes
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Xenleta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2020
Details:
In pre-clinical model, lefamulin shows anti-inflammatory activity comparable to dexamethasone.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Xenleta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 23, 2020
Details:
Nabriva Therapeutics has received approval from Health Canada to market oral and intravenous (IV) formulations of XENLETA® (lefamulin) for the treatment of community-acquired pneumonia (CAP) in adults.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Xenleta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2020
Details:
Under the terms of the NPP, XENLETA will be made available in 2 formulations - 150mg injection for IV administration and 600mg oral tablets - using named patient or expanded access managed by WEP to enable healthcare professionals to access XENLETA to meet clinical needs.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Infections and Infectious Diseases Product Name: Xenleta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: WEP
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 06, 2020
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