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

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Wednesday, June 14th 2017 at 5:20pm UTC

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

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

Contacts

Pfizer Media:
Rachel Hooper, 916-708-1868
or
Pfizer
Investors:
Ryan Crowe, 212-733-8160

Source: Pfizer Inc.

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