Pfizer and Basilea Pharmaceutica announced that they 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.
“The addition of CRESEMBA to Pfizer’s broad anti-fungal portfolio reaffirms our commitment to provide innovative treatments to patients who are increasingly susceptible to life-threatening fungal infections,” said Richard Blackburn, Global President of Pfizer Europe, Africa/Middle East and Biosimilars. “We believe our well established global presence together with our deep knowledge of infectious diseases will enable us to meaningfully address a major unmet medical need.”
“Cresemba is a novel treatment that addresses a critical medical need among patients with invasive mold infections. This is reflected in Cresemba’s performance in both the U.S. and key European markets where it is available,” said Ronald Scott, Chief Executive Officer of Basilea. “Pfizer is a world leading pharmaceutical company in the anti-infective space with a long and successful track record of commercializing antifungals. We believe this collaboration will allow us to further optimize the value of this key asset in an important region of the world.”
Today, Pfizer is a leading global provider of anti-infective medicines, offering patients access to a diverse portfolio of 80 products. Since its pioneering work on penicillin in the 1940s, Pfizer has been actively engaged in the research and development of innovative 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.
About invasive aspergillosis and mucormycosis
Invasive fungal diseases (IFDs) are an increasingly common complication associated with high morbidity and mortality among immunocompromised patients such as those with advanced HIV infection, and those with Cancer. Rates of mortality associated with invasive fungal infections depend upon the pathogen, geographic location and underlying patient characteristics and can be as high as 80-90%. It is estimated that invasive aspergillosis accounts for nearly 70,000 deaths among immunocompromised patients per year in Europe. Mucormycosis, (also known as zygomycosis), another rapidly progressing fungal infection, is responsible for approximately 3,000 deaths per year in Europe.
About CRESEMBA (isavuconazole)
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 US. Basilea currently commercializes isavuconazole as CRESEMBA in Austria, France, Germany, Italy, and the United Kingdom. The drug is commercialized in the US by Basilea’s license partner Astellas Pharma US. Outside the US and the EU, isavuconazole is not approved for commercial use. Pfizer does not have commercialization rights to CRESEMBA in the United States.