TIDMAZN
RNS Number : 9864H
AstraZeneca PLC
24 August 2016
This announcement contains inside information
24 August 2016 07:00
ASTRAZENECA TO SELL SMALL MOLECULE
ANTIBIOTICS BUSINESS TO PFIZER
Value-creating divestment supports AstraZeneca's focus on three
main therapy areas
Pfizer's dedicated focus on infectious diseases will
extend the reach of the antibiotics to more patients globally
and maximise the potential of the late-stage, small molecule
antibiotics business
AstraZeneca today announced that it has entered into an
agreement with Pfizer Inc. (Pfizer) to sell the commercialisation
and development rights to its late-stage small molecule antibiotics
business in most markets globally outside the US*. The agreement
reinforces AstraZeneca's focus on developing transformational
medicines in its three main therapy areas, while realising value
from the strong portfolio of established and late-stage small
molecule antibiotics through Pfizer's dedicated commercialisation
and development capabilities in anti-infectives. The portfolio
comprises the approved antibiotics Merrem, Zinforo and Zavicefta,
and ATM-AVI and CXL, which are in clinical development.
Under the terms of the agreement, Pfizer will make an upfront
payment to AstraZeneca of $550 million upon completion and a
further unconditional payment of $175 million in January 2019 for
the commercialisation and development rights to the late-stage
antibiotics business in all markets where AstraZeneca holds the
rights. In addition, Pfizer will pay up to $250 million in
commercial, manufacturing and regulatory milestones, up to $600
million in sales-related payments as well as recurring,
double-digit royalties on future sales of Zavicefta and ATM-AVI in
certain markets.
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."
John Young, Group President, Pfizer Essential Health, said: "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."
MedImmune's portfolio of biologics, on-market products such as
FluMist/Fluenz and Synagis, and AstraZeneca's stake in Entasis
Therapeutics, spun-off from AstraZeneca in 2015 and now operating
as a stand-alone company focused on the development of innovative
small-molecule anti-infectives, are not included as part of the
agreement.
Financial considerations
The agreement with Pfizer is expected to close in the fourth
quarter of 2016, subject to customary closing conditions. As
AstraZeneca will de-recognise an intangible product asset and does
not maintain a significant future interest in the late-stage small
molecule antibiotics business all payments will be reported as
Other Operating Income in the Company's financial statements. This
includes the upfront payment of $550 million and unconditional
payment of $175 million in 2019 (both to be recognised net of the
aforementioned product intangible in 2016), the milestones of up to
$250 million, the sales-related payments of up to $600 million and
the recurring double-digit royalties on sales of Zavicefta and
ATM-AVI.
AstraZeneca's established antibiotic medicines Merrem and
Zinforo are available in more than 100 countries and generated
Product Sales in 2015 of $250 million. The agreement does not
impact AstraZeneca's financial guidance for 2016.
About AstraZeneca's small molecule anti-infective business
Medicine Indication
------------------------- -------------------------------------------------
Merrem/Meronem Merrem/Meronem is a carbapenem anti-bacterial
(meropenem) used for the treatment of serious
infections in hospitalised patients.
Meropenem is a broad-spectrum agent,
originally created by Sumitomo Dainippon
Pharma Co., Ltd. and 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 US, 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 commercialise Merrem, with the
exception of Japan, China, Taiwan
and Korea, where the rights are held
by Sumitomo Dainippon Pharma Co.,
Ltd. In addition, Sumitomo Dainippon
Pharma has an option to commercialise
the product in Thailand, Singapore,
Vietnam, Malaysia, Philippines, Indonesia
and Hong Kong.
------------------------- -------------------------------------------------
Zinforo (ceftaroline Zinforo was launched in October 2012
fosamil) 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 unlike other cephalosporins,
shows a high affinity for particular
PBPs in MRSA. Zinforo has now been
approved in 52 markets and launched
in 32 markets.
*AstraZeneca holds the global rights
to commercialise 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 Zavicefta is a combination antibiotic
(ceftazidime-avibactam) 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 (AVI, NXL104)
is a first-in-class broad-spectrum
<BETA>-lactamase inhibitor, which
protects ceftazidime against degradation
by Class A, C and some D, <BETA>-lactamases.
The addition of avibactam to ceftazidime
protects ceftazidime from breakdown
by <BETA>-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 pneumoniae
carbapenemase, together with activity
against difficult-to-treat P. aeruginosa.
*AstraZeneca holds the global rights
to commercialise Zavicefta, with
the exception of North America, where
the rights are held by Allergan Pharmaceutical
Industries Limited.
------------------------- -------------------------------------------------
ATM-AVI ATM-AVI is a bactericidal, injectable
combination of aztreonam (ATM) and
a <BETA>-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 commercialise ATM-AVI, with the
exception of North America, where
the rights are held by Allergan Pharmaceutical
Industries Limited.
------------------------- -------------------------------------------------
CXL CXL is a novel, injectable bactericidal
<BETA>-lactam/<BETA>-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 <BETA>-lactamase
inhibitor that inhibits Ambler Class
A (including ESBL producers and KPC
carbapenemases), Class C (Amp C)
<BETA>-lactamase enzymes, and some
Class D <BETA>-lactamase enzymes.
CXL has completed a Phase II study
and is ready for progression into
Phase III.
*AstraZeneca holds the global rights
to commercialise CXL, with the exception
of North America, where the rights
are held by Allergan Pharmaceutical
Industries Limited.
------------------------- -------------------------------------------------
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. To learn more, please visit us at
www.pfizer.com. In addition, to learn more, follow us on Twitter at
@Pfizer and @Pfizer_News, LinkedIn, and like us on Facebook at
Facebook.com/Pfizer.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Respiratory & Autoimmunity,
Cardiovascular & Metabolic Diseases, and Oncology. The Company
is also active in inflammation, infection and neuroscience through
numerous collaborations. AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients
worldwide. For more information please visit:
www.astrazeneca.com
CONTACTS
Media Enquiries
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Vanessa Rhodes UK/Global +44 203 749 5736
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
+46 8 553 260
Jacob Lund Sweden 20
Michele Meixell US +1 302 885 2677
Investor Relations
UK
Thomas Kudsk
Larsen +44 203 749 5712
Finance, Fixed +44 7881 615
Craig Marks Income, M&A 764
Respiratory &
Nick Stone Autoimmunity +44 203 749 5716
Henry Wheeler Oncology +44 203 749 5797
Christer Gruvris Infection & Neuroscience +44 203 749 5711
US
Cardiovascular
Lindsey Trickett & Metabolic Diseases +1 240 543 7970
Mitchell Chan Oncology +1 240 477 3771
Toll free +1 866 381 7277
Adrian Kemp
Company Secretary
AstraZeneca PLC
-ENDS-
This information is provided by RNS
The company news service from the London Stock Exchange
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