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Pfizer Completes Acquisition of Small Molecule Anti-Infective Business From AstraZeneca

Friday, December 23rd 2016 at 7:05am UTC

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE:PFE) today announced that it has completed the
acquisition of the development and commercialization rights to
AstraZeneca’s late-stage small molecule anti-infective 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 certain 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.

“The addition of AstraZeneca’s complementary small molecule
anti-infectives portfolio enhances our global expertise and offerings in
an increasingly important area of therapeutics that addresses the public
health needs of patients and healthcare professionals. Additionally this
acquisition is an example of how we are focusing our investments to
drive sustainable revenue growth potential for our Essential Health
business,” said John Young, group president, Pfizer Essential Health.

About the acquired assets

 
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 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.

 

Pfizer holds the global rights to commercialize Zinforo,
with the exception of North America (U.S. and Canada) 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
.

 

Pfizer holds the global rights to commercialize Zavicefta,
with the exception of North America (U.S. and Canada), 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
pediatric patients.

 

Pfizer holds the global rights to commercialize Merrem,
with the exception of Japan, China, Taiwan, Korea, Thailand, the
Philippines, Malaysia, Singapore, Vietnam and Hong Kong where the
rights are held by Sumitomo Dainippon Pharma Co., Ltd.

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.

 

Pfizer holds the global rights to commercialize ATM-AVI, with the
exception of North America (U.S. and Canada), 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.

 

Pfizer holds the global rights to commercialize CXL, with the
exception of North America (U.S. and Canada), where the rights are
held by Allergan.

 

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 @PfizerNews,
LinkedIn,
YouTube
and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release
is as of December 23, 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 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 acquisition, anticipated growth rates, Pfizer’s
plans,
objectives, expectations and intentions, the financial condition,
results of operations and business of Pfizer and AstraZeneca’s
late-stage small molecule anti-infectives portfolio. Risks and
uncertainties include, among other things, risks related to the ability
to realize the anticipated benefits of the acquisition, including the
possibility that the expected benefits from the 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 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 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.

The proposals set forth in this message are subject to compliance
with all local legal and regulatory obligations, including the
obligation to inform and or consult with labor organizations, works
councils, trade unions and employee representatives.

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Contacts

Pfizer Inc.
US Media:
Rachel Hooper,
+1-916-708-1868
Rachel.Hooper@pfizer.com
or
UK
Media:

Andrew Widger, +44-7970-149098
Andrew.Widger@pfizer.com
or
Investors:
Ryan
Crowe, +1-212-733-8160 (O)
+1-215-260-0914 (M)
Ryan.Crowe@pfizer.com

Source: Pfizer Inc.

Cet article Pfizer Completes Acquisition of Small Molecule Anti-Infective
Business From AstraZeneca
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