- Strong fit with Pfizer’s existing
anti-infective portfolio
- Pfizer’s focus on infectious disease
and expertise in this category will help enable broader access to
anti-infective portfolio
- Expected to enhance near-term
revenue growth potential for Pfizer’s Essential Health
business
Pfizer Inc. (NYSE:PFE) today announced that it has entered into
an agreement with AstraZeneca to acquire the development and
commercialization rights to its late-stage small molecule
anti-infectives business, primarily outside the United States. The
agreement includes the commercialization and development rights to
the newly approved EU drug Zavicefta™ (ceftazidime-avibactam), the
marketed agents Merrem™/Meronem™ (meropenem) and Zinforo™
(ceftaroline fosamil), and the clinical development assets
aztreonam-avibactam (ATM-AVI) and CXL. Zavicefta specifically
addresses multi-drug resistant Gram-negative infections, including
those resistant to carbapenem antibiotics, one of the most
significant unmet medical needs in bacterial infections treated
with hospital anti-infectives.
Under the terms of the agreement, Pfizer will make an upfront
payment of $550 million to AstraZeneca upon the close of the
transaction and a deferred payment of $175 million in January 2019.
In addition, AstraZeneca is eligible to receive up to $250 million
in milestone payments, up to $600 million in sales-related
payments, as well as tiered royalties on sales of Zavicefta and
ATM-AVI in certain markets.
“As we continue to reshape our Essential Health portfolio, we
are focusing on areas that further address global public health
needs and that complement our core capabilities and experience in
therapeutic areas, including anti-infectives. We are committed to
looking for ways to enhance our portfolio around the world where we
offer patients and healthcare professionals access to more than 60
anti-infective and anti-fungal medicines. The addition of
AstraZeneca’s complementary small molecule anti-infectives
portfolio will help expand patient access to these important
medicines and enhance our global expertise and offerings in this
increasingly important area of therapeutics, in addition to
providing the opportunity for near-term revenue growth,” said John
Young, group president, Pfizer Essential Health.
Luke Miels, executive vice president for Europe and head of the
Antibiotics Business Unit at AstraZeneca, said, “This agreement
reinforces our strategic focus to invest in our three main therapy
areas where we can make the greatest difference to patients’ lives.
We’re pleased that our strong science in antibiotics will continue
to serve a critical public health need through Pfizer’s dedicated
focus on infectious diseases, ensuring these important medicines
reach greater numbers of patients around the world.”
Zavicefta received European Commission approval for complicated
urinary tract infections (cUTI), complicated intra-abdominal
infections (cIAI), hospital acquired pneumonia/ventilator
associated pneumonia (HAP/VAP) and ‘treatment of aerobic gram
negative infections in adult patients with limited treatment
options on June 28, 2016.
The transaction is expected to close in the fourth quarter of
2016, subject to customary closing conditions, including antitrust
clearance in certain jurisdictions. Pfizer’s legal advisor for the
transaction was Ropes & Gray LLP.
This transaction will not impact Pfizer’s 2016 financial
guidance.
About AstraZeneca’s small molecule anti-infective
franchise
Product
Indication Zinforo (ceftaroline fosamil)
Zinforo was launched in October 2012 and
is an intravenous cephalosporin antibiotic intended for use as a
monotherapy in the treatment of adult patients with complicated
skin and soft tissue infections (cSSTI) or community-acquired
pneumonia (CAP). Zinforo is bactericidal and works by binding to
and inhibiting penicillin-binding proteins (PBPs). Zinforo has been
designed with a specific and novel mode of action which contributes
to its bactericidal activity against the common causative pathogens
of cSSTI, and CAP and shows a high affinity for particular PBPs in
MRSA in cSSTI and Streptococcus pneumoniae in CAP. Zinforo has now
been approved in 52 markets and launched in 32 markets.
AstraZeneca holds the global rights to
commercialize Zinforo, with the exception of North America and
Japan, where the rights are held by Allergan Pharmaceutical
Industries Limited and Takeda Pharmaceutical Company Limited,
respectively.
Zavicefta (CAZ-AVI)
Zavicefta (ceftazidime-avibactam) is a
combination antibiotic that has been developed to treat serious
Gram-negative bacterial infections. It consists of a combination of
avibactam and ceftazidime – a third generation antipseudomonal
cephalosporin with a well-established efficacy and safety profile.
Avibactam is a first-in-class broad-spectrum β-lactamase inhibitor,
which protects ceftazidime against degradation by Class A, C and
some D, β-lactamases. The addition of avibactam to ceftazidime
protects ceftazidime from breakdown by β-lactamases. Zavicefta
offers a differentiated profile versus existing treatment options
in serious Gram-negative infections through its coverage of a broad
range of species of Enterobacteriaceae including those that produce
extended-spectrum beta-lactamase and Klebsiella pneumonia
carbapenemase, together with activity against difficult-to-treat P.
aeruginosa.
AstraZeneca holds the global rights to
commercialize Zavicefta, with the exception of North America, where
the rights are held by Allergan.
Merrem/Meronem (meropenem)
Merrem/Meronem is a carbapenem
anti-bacterial used for the treatment of serious infections in
hospitalised patients. Meronem is a broad spectrum agent indicated
for the treatment of a wide variety of serious bacterial infections
in adults and children, including pneumonia, community acquired
pneumonia and nosocomial pneumonia; broncho-pulmonary infections in
cystic fibrosis; complicated urinary tract infections; complicated
intra-abdominal infections; intra- and post-partum infections;
complicated skin and soft tissue infections; and acute bacterial
meningitis in adults and children over 3 months of age. In the
U.S., Merrem is indicated as single agent therapy for the treatment
of intra-abdominal infections and bacterial meningitis when caused
by susceptible strains of the designated microorganisms in adult
and paediatric patients.
AstraZeneca holds the global rights to
commercialize Merrem, with the exception of Japan, China, Taiwan
and Korea, where the rights are held by Sumitomo Dainippon Pharma
Co., Ltd. In parallel with the transaction, Sumitomo Dainippon
Pharma Co., Ltd. will have the option to acquire the commercial
rights to Merrem in Thailand, Singapore, Vietnam, Malaysia,
Philippines, Indonesia and Hong Kong.
ATM-AVI
ATM-AVI is a bactericidal, injectable
combination of aztreonam (ATM) and a β-lactamase inhibitor,
avibactam (AVI, NXL104), which is in development for the treatment
of life-threatening Gram-negative bacterial infections caused by
multi-drug resistant (MDR) strains, including infections caused by
metallo-beta-lactamase (MBL)-producing pathogens. ATM-AVI has the
potential to be a replacement for, or alternative to, existing
antibacterial agents, including colistin and tigecycline. ATM-AVI
has completed its Phase I studies and is currently in Phase II
development.
AstraZeneca holds the global rights to
commercialize ATM-AVI, with the exception of North America, where
the rights are held by Allergan.
CXL
CXL is a novel, injectable bactericidal
β-lactam/β-lactamase inhibitor combination of ceftaroline fosamil
(marketed as Zinforo in AstraZeneca markets), a next-generation
cephalosporin with activity against multidrug-resistant
Gram-positive and common enteric Gram-negative pathogens, and
avibactam (AVI, NXL104), a potent β-lactamase inhibitor that
inhibits Ambler Class A (including ESBL producers and KPC
carbapenemases), Class C (Amp C) β-lactamase enzymes, and some
Class D β-lactamase enzymes.
AstraZeneca holds the global rights to
commercialize CXL, with the exception of North America, where the
rights are held by Allergan.
About Pfizer Inc:
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, Pfizer has worked to make
a difference for all who rely on us. For more information,
please visit us at www.pfizer.com. In addition, to learn more,
follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube
and like us on Facebook Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this
release is as of August 24, 2016. 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
Pfizer and the proposed acquisition of AstraZeneca’s small molecule
anti-infectives business by Pfizer that involves substantial risks
and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Forward-looking statements in this release include, among other
things, statements about the potential benefits of the proposed
acquisition, anticipated growth rates, Pfizer’s plans, objectives,
expectations and intentions, the financial condition, results of
operations and business of Pfizer, AstraZeneca’s late-stage small
molecule anti-infectives portfolio, and the anticipated timing of
closing of the acquisition. Risks and uncertainties include, among
other things, risks related to the satisfaction of the conditions
to closing the acquisition (including the failure to obtain
necessary regulatory approvals) in the anticipated timeframe or at
all, including the possibility that the acquisition does not close;
risks related to the ability to realize the anticipated benefits of
the acquisition, including the possibility that the expected
benefits from the proposed acquisition will not be realized or will
not be realized within the expected time period; the risk that the
businesses will not be integrated successfully; disruption from the
transaction making it more difficult to maintain business and
operational relationships; negative effects of this announcement or
the consummation of the proposed acquisition on the market price of
Pfizer's common stock and on Pfizer’s operating results;
significant transaction costs; unknown liabilities; the risk of
litigation and/or regulatory actions related to the proposed
acquisition; 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; future business combinations or
disposals; 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 any drug applications may
be filed in any jurisdictions for ATM-AVI or CXL; whether and when
regulatory authorities may approve any such applications, which
will depend on its assessment 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 any of AstraZeneca’s late-stage small molecule anti-infectives
assets; the commercialization of Zavicefta; 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, 2015 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:InvestorRyan Crowe,
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+353-87-6711651Dawn.Carty@pfizer.comorUS Media:Rachel
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