AstraZeneca Announces Positive Results from Benralizumab Phase III Program in Severe Asthma
Benralizumab first AstraZeneca respiratory biologic to complete Phase III
AstraZeneca today announced that benralizumab, a potential new medicine and anti-eosinophil monoclonal antibody, was well
tolerated and achieved the primary endpoint in two pivotal Phase III registrational trials (SIROCCO and CALIMA), demonstrating
significant reductions in the annual asthma exacerbation rate compared to placebo.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “Severe asthma affects the
health and quality of life of millions of people around the world, and exacerbations can be life threatening for these
patients. We are pleased with the top-line results from these pivotal trials as they demonstrate the potential for
benralizumab to improve outcomes for patients with severe asthma. Benralizumab is AstraZeneca’s first respiratory
biologic and its development underscores our commitment to transform the treatment of asthma and chronic respiratory
disease with our next generation of respiratory medicines.”
The trials evaluated the efficacy and safety of two dose regimens of benralizumab as an add-on therapy for severe uncontrolled
asthma with eosinophilic inflammation in adults and adolescents 12 years of age and older.
In SIROCCO and CALIMA, the primary analysis population included patients on high-dose inhaled corticosteroids (ICS) plus
long-acting β2-agonist (LABA) with a baseline blood eosinophil count ≥ 300 cells/microliter. Patients were randomized to receive
benralizumab 30mg every 4 weeks; 30mg every 4 weeks for the first three doses followed by 30mg every 8 weeks; or placebo. The
safety and tolerability findings for benralizumab were generally consistent with those reported in previous trials.
Mark FitzGerald, MD, director of the Centre for Heart and Lung Health at the Vancouver Coastal Health Research Institute
and Principal Investigator in the CALIMA trial, said: “We are learning more about different sub-types of asthma, and these trials
investigate a potential new treatment to address the underlying driver for some patients. Within the appropriate patient
population, the anti-eosinophil effect of benralizumab has the potential to deliver uniquely-targeted treatment for patients whose
asthma is driven by eosinophilic inflammation.”
Eosinophils are the biological effector cells that drive inflammation and airways hyper-responsiveness in approximately 50% of
asthma patients, leading to frequent exacerbations, impaired lung function and reduced quality of life. Benralizumab is an
anti-eosinophil monoclonal antibody that depletes eosinophils via antibody‐dependent cell-mediated cytotoxicity (ADCC), the process
by which natural killer cells are activated to target eosinophils. Benralizumab induces direct, rapid, and near complete depletion
of eosinophils in the bone marrow, blood and target tissue. Benralizumab was developed by MedImmune, AstraZeneca’s global biologics
research and development arm.
Results from the SIROCCO and CALIMA trials will be presented at a future medical meeting. Regulatory submissions in the US and
EU are anticipated in the second half of 2016.
NOTES TO EDITORS
Asthma is a common, chronic condition in which inflammation and narrowing of the airways may cause wheezing, breathlessness,
chest tightness and coughing.
An estimated 10% of patients with asthma worldwide have severe disease, 40% of whom have uncontrolled asthma. Systemic steroid
exposure can lead to serious adverse effects, including osteoporosis, anxiety, depression, weight gain and diabetes. There is also
a significant physical and socio-economic burden of asthma, with severe asthma accounting for 50% of intangible asthma-related
costs.
About the WINDWARD Program
SIROCCO and CALIMA are both part of the comprehensive WINDWARD program in asthma (comprised of six Phase III trials), the
largest Phase III development program for a biologic in respiratory disease.
The two registrational trials, SIROCCO and CALIMA , are randomized, double-blind, parallel group, placebo-controlled trials
designed to evaluate the efficacy and safety of a fixed 30 mg dose of benralizumab administered subcutaneously in patients with a
history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without OCS and additional asthma
controllers.
A total of 2,511 patients (1,205 in SIROCCO and 1,306 in CALIMA) were randomized globally and received benralizumab 30mg every 4
weeks; 30mg every 4 weeks for the first three doses followed by 30mg every 8 weeks; or placebo.
In addition to WINDWARD, the Phase III VOYAGER program is currently underway, evaluating benralizumab in patients with severe
chronic obstructive pulmonary disease (COPD).
About Benralizumab
Benralizumab is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd. Under the exclusive
license agreement, Kyowa Hakko Kirin/BioWa have exclusive development and commercialization rights for benralizumab in Japan and
certain countries in Asia. AstraZeneca has exclusive rights for benralizumab in all other countries including the US and Europe.
BioWa is eligible to milestone payments and royalties from AstraZeneca related to the development and commercialization of
benralizumab in those countries.
In July 2015, AstraZeneca entered an agreement with Kyowa Hakko Kirin Co. Ltd. (Kyowa Hakko Kirin) for an exclusive option to
commercialize benralizumab for asthma and COPD in Japan. Under the terms of the agreement, AstraZeneca will pay Kyowa Hakko Kirin a
$45 million up-front option fee and subsequent payments for regulatory filing, approval and commercial milestones, and sales
royalties. Kyowa Hakko Kirin will continue to be responsible for the research and development of benralizumab in Japan. On
exercising the option, AstraZeneca will be responsible for all sales and marketing in asthma and COPD in Japan. Kyowa Hakko Kirin
will retain the rights to participate in certain commercial activities alongside AstraZeneca.
About Respiratory, Inflammation and Autoimmunity
Respiratory, Inflammation and Autoimmunity (RIA) is one of AstraZeneca’s main therapy areas. Our strong pipeline has
the potential to deliver up to seven launches between 2016 and 2020. In respiratory disease, our aim is to transform asthma and
COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient
populations, and scientific advancements in disease modification. We are building on a 40-year heritage in respiratory disease, and
our capability in inhalation technology spans both pressurized metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), as
well as our unique Co-Suspension™ Technology.
In Inflammation and Autoimmunity, our aim is to develop innovative therapies for the treatment of autoimmune and rheumatoid
diseases, with a lead program in systemic lupus erythematosus. Across respiratory, inflammation and autoimmune diseases, our
research is focused on four key biological pathways: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology,
and autoimmunity.
About MedImmune
MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical
business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines.
MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory,
inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The
MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centers, with additional sites in
Cambridge, UK and Mountain View, CA. For more information, please visit www.medimmune.com.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and
commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory,
inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and
neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information please visit: www.astrazeneca-us.com.
Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection,
Neuroscience and Gastrointestinal
AstraZeneca
Media Inquiries
Michele Meixell +1 302-885-2677
Abigail Bozarth +1 302-885-2677
or
Investor Inquiries
UK
Thomas Kudsk Larson +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
Henry Wheeler Oncology +44 7788 354619
Christer Gruvris ING, Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology +1 240-543-7970
Mitch Chan Oncology +1 240-477-3771
Dial / Toll-free +1 866-381-7277
View source version on businesswire.com: http://www.businesswire.com/news/home/20160517005434/en/