Date: 2017-06-14
Type of information: Commercialisation agreement
Compound: Cresemba®
Company: Basilea Pharmaceutica (Switzerland) Pfizer (USA - NY)
Therapeutic area: Infectious diseases
Type agreement: commercialisation
Action mechanism:
- systemic antifungal agent. 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 Inc., 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 Aspergillusspecies) 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.
- Isavuconazole was approved in March 2015 by the FDA and in October 2015 by the EMA for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.
Disease: invasive aspergillosis and mucormycosis
Details:
- • On June 14, 2017, Pfizer and Basilea Pharmaceutica have entered into an agreement whereby Pfizer will be granted the exclusive commercialization rights in Europe to Cresemba® (isavuconazole), a novel anti-fungal treatment for adult patients with diagnosed invasive aspergillosis and mucormycosis, two serious infections associated with high morbidity and mortality among immunocompromised patients.
- Under the terms of the agreement, Pfizer will have exclusive rights to distribute and commercialize Cresemba® in Europe, including Austria, France, Germany, Italy and the United Kingdom, where it is currently available. These rights do not extend to the Nordic countries (Denmark, Finland, Norway, Sweden, Iceland). In addition, Pfizer will be responsible for additional Cresemba® launches, predominantly in Europe, which are expected throughout 2017 and 2018. Basilea will remain the marketing authorization holder for the European Union.
Financial terms:
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