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. (NYSE:PFE) and Basilea Pharmaceutica Ltd. (SIX:BSLN), an international biopharmaceutical company specializing in the research and development of anti-infective and oncological medicines, today 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.
Today, Pfizer is a leading 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 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 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.
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Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products that address the medical challenge of increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company uses the integrated research, development and commercial operations of its subsidiary Basilea Pharmaceutica International Ltd. to discover, develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and potentially life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com.
PFIZER DISCLOSURE NOTICE: The information contained in this release is as of July 20, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information related to CRESEMBA and a license agreement pursuant to which Pfizer obtained the exclusive commercialization rights in Europe for CRESEMBA, including their potential benefits, and the anticipated timing of additional launches of CRESEMBA, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, risks related to the ability to realize the anticipated benefits of the transaction, including the possibility that the expected benefits from the transaction will not be realized or will not be realized within the expected time period; risks related to the integration of CRESEMBA and potential disruption from the transaction making it more difficult to maintain business and operational relationships; unknown liabilities; the risk of litigation and/or regulatory actions related to the transaction; other business effects, including the effects of industry, market, economic, political or regulatory conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; the uncertainties inherent in research and development, including, among others, the ability to meet anticipated trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CRESEMBA; uncertainties regarding the commercial success of and ability to meet anticipated launch plans for CRESEMBA; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
Rachel Hooper, 916-708-1868
Ryan Crowe, 212-733-8160