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Pfizer to Acquire Small Molecule Anti-Infective Business from AstraZeneca

Wednesday, August 24th 2016 at 6:00am UTC
  • 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

NEW YORK–(BUSINESS WIRE)– 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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Contacts

Pfizer:
Investor
Ryan Crowe, 212-733-8160
Ryan.Crowe@pfizer.com
or
UK
Media:

Dawn Carty, +353-87-6711651
Dawn.Carty@pfizer.com
or
US
Media:

Rachel Hooper, 212-733-2105
Rachel.Hooper@pfizer.com

Source: Pfizer Inc.

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