Pfizer Completes License Agreement For The Exclusive Commercialization Rights In Europe For CRESEMBA (isavuconazole), A Novel...
July 20 2017 - 1:23AM
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 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 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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Pfizer Inc.Media:Rachel Hooper, 916-708-1868orInvestorsRyan
Crowe, 212-733-8160
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