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 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.
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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and @Pfizer_News,
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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 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.
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Contacts
Pfizer Inc.
Media:
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or
Investors
Ryan
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Source: Pfizer Inc.
Cet article 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 est apparu en premier sur EEI-BIOTECHFINANCES.