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 used for the |
|(meropenem) |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 |Zinforo was launched in October 2012 and is an intravenous   |
|(ceftaroline |cephalosporin antibiotic intended for use as a monotherapy in|
|fosamil) |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 that has been   |
|(ceftazidime |developed to treat serious Gram-negative bacterial |
|-avibactam) |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   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 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 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 |
| |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   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. 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

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AstraZeneca PLC

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