Pfizer completes license agreement for the exclusive commercialization rights in Europe for Cresemba (isavuconazole), a novel treatment for potentially life-threatening fungal infections among immunocompromised patients.
Pfizer Inc. and Basilea Pharmaceutica Ltd., an international biopharmaceutical company specializing in the research and development of anti-infective and oncological medicines, announced they have completed the licensing agreement whereby Pfizer has obtained 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.
Pfizer is a global provider of anti-infective medicines, offering patients access to a diverse portfolio of more than 80 products. Since its pioneering work on penicillin in the 1940s, Pfizer has been actively engaged in the research and development of medicines, policies and educational programs to address the evolving needs of patients and physicians in the area of infectious diseases.
In December 2016, Pfizer completed the acquisition of AstraZeneca PLC’s small molecule anti-infective business, which includes both marketed agents and clinical development assets primarily outside the United States.
Cresemba is an intravenous (IV) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It was approved in March 2015 by the United States Food and Drug Administration (FDA) for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.
The European centralized marketing authorization was granted in October 2015 to isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.
Isavuconazole has orphan drug designation for the approved indications in Europe and the U.S. Basilea currently commercializes isavuconazole as Cresemba in Austria, France, Germany, Italy, and the United Kingdom. The drug is commercialized in the U.S. by Basilea’s license partner Astellas Pharma US.
Outside the U.S. and the EU, isavuconazole is not approved for commercial use. Pfizer does not have commercialization rights to Cresemba in the United States.
(Source: Business Wire)