Partnership Reaffirms Pfizer’s Leadership in Infectious Disease
and Extensive Expertise in Emerging Markets
NEW YORK--(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 development and commercialization rights in China and several
countries in the Asia Pacific region to CRESEMBA (isavuconazole).
CRESEMBA is a novel antifungal medicine for the treatment of adult
patients with diagnosed invasive aspergillosis and mucormycosis1,
two serious infections associated with significant morbidity and
mortality among immunocompromised patients, such as those with advanced
HIV and those with cancer.
Under the terms of the agreement, Pfizer will have exclusive rights to
develop, distribute and commercialize CRESEMBA in sixteen Asian Pacific
countries and China (including Hong Kong and Macao). These rights do not
include Japan. In addition, Pfizer will become the marketing
authorization holder for the Asia Pacific Region and China. The specific
financial terms of the agreement remain confidential. The agreement is
subject to customary regulatory approval.
In July 2017, Pfizer completed an agreement with Basilea to obtain the
exclusive commercialization rights to CRESEMBA in Europe (with the
exception of the Nordic countries). Since that time, Pfizer has assumed
responsibility for the commercialization of CRESEMBA in Austria, France,
Germany, Italy, and the United Kingdom and successfully launched
CRESEMBA in Spain with additional launches expected in 2018 and beyond.
CRESEMBA was developed in response to the urgent medical need for
antifungal medicines for the treatment of invasive fungal infections,
which are naturally resistant to many antifungal therapies and have
become increasingly resistant to other available therapies. Today,
invasive aspergillosis is the most frequently reported fungal infection
in immunocompromised individuals within the Asian Pacific region.
“We are excited to extend our partnership with Basilea, a company that
shares our passion and commitment to confronting the global challenges
of infectious disease management,” said Suneet Varma, global president
of Pfizer APAC, Greater China and Global Brands. “We believe our
extensive geographic footprint in APAC and China, together with our
expertise in successfully commercializing innovative medicines, will
help enable us to continue to address the unmet medical needs of
patients, especially in the area of anti-infectives.”
“CRESEMBA is a well differentiated drug that addresses a critical
medical need in patients with invasive mold infections,” said Ronald
Scott, chief executive officer of Basilea. “We are very pleased to be
expanding our partnership with Pfizer to China and Asia Pacific where it
has a strong commercial presence and a proven track record of
successfully developing and commercializing hospital antifungals. We
have now established partnerships for isavuconazole with leading
pharmaceutical companies in all major markets around the world.”
About Pfizer Anti-Infectives
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 and creation of 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%. Today, there are limited
treatment options available for patients diagnosed with invasive
aspergillosis and mucormycosis.
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. The drug is commercialized in
the US by 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.
About Basilea
Basilea Pharmaceutica Ltd. is a commercial stage 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 is committed to discovering, developing and
commercializing innovative pharmaceutical products to meet the medical
needs of patients with serious and 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.
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
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PFIZER DISCLOSURE NOTICE The information contained in this release is
as of December 1, 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
(isavuconazole) and an agreement whereby Pfizer will be granted the
exclusive development and commercialization rights in China and several
countries in the Asia Pacific region to 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 in the
expected time period; risks related to the satisfaction of the
conditions to closing the transaction (including the failure to obtain
necessary regulatory approvals)) in the anticipated timeframe or at all,
including the possibility that the transaction does not close; 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 regulation conditions; future exchange and interest rates; changes in
tax or 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; whether and when
new drug applications for CRESEMBA may be filed in China and other
countries in the Asia Pacific region; whether and when regulatory
authorities will approve any such applications, which will depend on the
assessment by such regulatory authorities of the benefit-risk profile
suggested by the totality of the efficacy and safety information
submitted; 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; uncertainties regarding the 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
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1 (for whom amphotericin B is inappropriate)
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View source version on businesswire.com: http://www.businesswire.com/news/home/20171130006333/en/
Source: Pfizer Inc.