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Details:
ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function.
Lead Product(s): Amikacin
Therapeutic Area: Infections and Infectious Diseases Product Name: Arikayce
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2022
Details:
Under the terms of the agreement, taiba will be responsible for the named patient supply program with intent to commercialize ARIKAYCE in the region following receipt of marketing authorization(s) in the territory.
Lead Product(s): Amikacin
Therapeutic Area: Infections and Infectious Diseases Product Name: Arikayce
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Taiba Healthcare
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 14, 2021
Details:
The approval by the MHLW is based on results from the Phase 3 CONVERT study, which demonstrated that once-daily ARIKAYCE, with MDR, improved sputum culture conversion rates in patients with refractory NTM lung disease caused by MAC compared to MDR therapy alone.
Lead Product(s): Amikacin
Therapeutic Area: Infections and Infectious Diseases Product Name: Arikayce
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2021
Details:
The funding will support a clinical trial to determine whether high doses of inhaled nitric oxide are safe and effective when used in conjunction with current standard-of-care therapies, including amikacin and azithromycin.
Lead Product(s): Nitric Oxide,Amikacin,Azithromycin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cystic Fibrosis Foundation
Deal Size: $2.1 million Upfront Cash: Undisclosed
Deal Type: Funding February 16, 2021
Details:
First patient was dosed in late December, 2020, in the frontline clinical trial program of ARIKAYCE® (amikacin liposome inhalation suspension) in patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC).
Lead Product(s): Amikacin
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Arikayce
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2021
Details:
Valeo Pharma has recently received a Notice of Compliance from Health Canada granting market authorization for Amikacin, an antibiotic used within the hospital setting. Valeo also announced that shipments of Ethacrynate Sodium have commenced in the U.S. market.
Lead Product(s): Amikacin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2020
Details:
The CHMP opinion is based on results from the Ph 3 CONVERT study, which showed that once-daily ARIKAYCE, when combined with multi-drug regimen, improved sputum culture conversion rates in patients with refractory NTM lung disease caused by MAC compared to MDR therapy alone.
Lead Product(s): Amikacin
Therapeutic Area: Infections and Infectious Diseases Product Name: Arikayce
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 24, 2020
Details:
The evidence-based guidelines recommend the use of ARIKAYCE for the treatment of refractory NTM lung disease caused by Mycobacterium avium complex as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options.
Lead Product(s): Amikacin
Therapeutic Area: Infections and Infectious Diseases Product Name: Arikayce
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 07, 2020
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