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Agreements

Date: 2016-09-20

Type of information: Distribution agreement

Compound:

Company: Basilea Pharmaceutica (Switzerland) Unimedic Pharma

Therapeutic area: Infectious diseases

Type agreement: distribution

Action mechanism:

  • systemic antifungal agent/antibiotic/cephalosporin. Isavuconazole is an intravenous and oral broad-spectrum antifungal. It has a fungicidal effect by blocking the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of the enzyme lanosterol 14 alpha demethylase. In collaboration with Astellas Pharma, isavuconazole is being investigated in phase 3 clinical studies for the treatment of severe invasive fungal infections. The drug demonstrated in-vitro and in-vivo coverage of a broad range of yeasts (such as Candida species) and molds (such as Aspergillus species) as well as in-vitro activity against less prevalent but often fatal molds including those that cause mucormycosis. In clinical studies to date, isavuconazole achieved predictable drug levels supporting reliable dosing and a switch from intravenous administration to a once-daily oral dose. The intravenous formulation of isavuconazole, which is water-soluble, does not contain potentially kidney damaging solubilizers and has the potential to be given also to patients with pre-existing renal impairment.
  • Ceftobiprole belongs to the class of antibacterial agents known as cephalosporins. Its broad spectrum activity encompasses Gram-positive and Gram-negative bacteria, including anti-pseudomonal activity similar to cefepime. The rights for ceftobiprole have been transferred back to Basilea from Cilag GmbH International, a Johnson & Johnson company, in February 2011.

Disease: invasive aspergillosis, mucormycosis, severe community-acquired and hospital-acquired pneumonia

Details:

  • • On September 20, 2016, Basilea Pharmaceutica announced that it has entered into a license and distribution agreement with Unimedic Pharma for Basilea's antifungal Cresemba® (isavuconazole) and antibiotic Zevtera® (ceftobiprole) in the Nordic countries, including Sweden, Denmark and Norway, and Finland. Under the terms of the agreement, Unimedic is granted an exclusive license to import and commercialize isavuconazole and ceftobiprole in the region. Basilea will be eligible to receive an upfront and sales milestone payments. Basilea will remain the marketing authorization holder and Unimedic will be responsible for commercialization and distribution of isavuconazole and ceftobiprole in these countries.

Financial terms:

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