Pfizer Receives Exclusive Commercialization Rights in Europe for CRESEMBA, a Novel Treatment for Potentially Life-Threatening Fungal Infections Among Immunocompromised Patients

Partnership with Basilea Reaffirms Pfizer’s Global Infectious Disease Commitment and Industry Leadership

Wednesday, June 14, 2017 1:20 pm EDT

Dateline:

NEW YORK & BASEL, Switzerland

Public Company Information:

NYSE:
PFE
US7170811035
"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"

NEW YORK & BASEL, Switzerland--(BUSINESS WIRE)--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 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.

Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

About Basilea

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 June 14, 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 the proposed transaction by Pfizer of the exclusive commercialization rights in Europe for CRESEMBA, including its potential benefits, the anticipated timing of additional launches of CRESEMBA and the anticipated timing of closing of the exclusive licensing agreement, 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 proposed transaction, including the possibility that the expected benefits from the proposed transaction will not be realized or will not be realized within the expected time period; risks related to the satisfaction of the conditions to closing the proposed transaction (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including the possibility that the proposed transaction does not close; risks related to the integration of CRESEMBA and potential disruption from the proposed transaction making it more difficult to maintain business and operational relationships; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed 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 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

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