Date: 2016-09-13
Type of information: Distribution agreement
Compound: Cresemba® (isavuconazole) and Zevtera® (ceftobiprole)
Company: Basilea Pharmaceutica (Switzerland) Grupo Biotoscana (Uruguay)
Therapeutic area: Infectious diseases
Type agreement: distribution - licensing
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 13, 2016, Basilea Pharmaceutica announced that it has entered into a supply, distribution and license agreement with Grupo Biotoscana for Basilea's antifungal Cresemba® (isavuconazole) and Zevtera® (ceftobiprole) in 19 countries in Latin America including Brazil, Mexico, Argentina and Colombia.
- Under the terms of the agreement, Grupo Biotoscana holds an exclusive license to commercialize isavuconazole and ceftobiprole in key Latin American countries. Grupo Biotoscana will be responsible for marketing authorization applications, market access, commercialization and distribution of isavuconazole and ceftobiprole in the countries covered by the agreement.
Financial terms:
- In total, Basilea will receive upfront payments of CHF 11 million for both drugs and will be eligible to receive payments upon achievement of regulatory and commercial milestones.
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