Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of March 2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
US
FDA grants saracatinib ODD for IPF
18 March 2019 07:00 GMT
US FDA grants saracatinib Orphan Drug Designation
for idiopathic pulmonary fibrosis
The US Food and Drug Administration (FDA) has granted Orphan Drug
Designation (ODD) for saracatinib, a potential new medicine for the
treatment of idiopathic pulmonary fibrosis (IPF), a type of lung
disease that results in scarring (fibrosis) of the lungs.
Saracatinib is an inhibitor of src kinase which regulates
broad cell functions including cell growth and cell
differentiation.1Saracatinib
has completed Phase I development.
IPF is a chronic, progressive, irreversible and usually fatal
interstitial lung disease1 which
affects approximately 100,000 people in the US.2 On
average, patients who are diagnosed with IPF live between two and
five years from diagnosis, given the limited medicines available to
treat the disease.1 The
FDA grants ODD status to medicines intended for the treatment,
diagnosis or prevention of rare diseases or disorders that affect
fewer than 200,000 people in the US.
Mene Pangalos, Executive Vice President, R&D
BioPharmaceuticals, said: "Idiopathic pulmonary fibrosis has a
significant impact on patients' lives and new therapies are
urgently needed. IPF is a recent addition to our respiratory
research strategy and we are interested to see
whether saracatinib could be a useful approach for
the treatment of this intractable disease."
IPF is characterised by thickening and scarring of the connective
(interstitial) tissue in the lungs. The cause is thought to be due
to an abnormal wound-healing process that results in excessive
tissue build-up in the lung.1 Pre-clinical
trials of saracatinib showed that it inhibits fibroblast activity
and collagen deposition, which are key features of lung
fibrosis.3
About IPF
IPF causes shortness of breath and progressive damage of the lung,
resulting in life-threatening complications such as respiratory
failure. IPF progression varies greatly between patients but over
time, most experience increasing respiratory symptoms, increased
scarring of the lungs and a gradual decline in lung function.
'Idiopathic' refers to the unknown cause of disease, however there
is proof of genetic predisposition in some
patients.1
About saracatinib
Saracatinib is a small molecule, highly-potent and selective
inhibitor of src tyrosine kinase.3 The
potential new medicine was discovered by AstraZeneca and has
previously been in clinical development in oncology. Phase II
trials for saracatinib in IPF have not yet
commenced.
About AstraZeneca in Respiratory Disease
Respiratory is one of AstraZeneca's main therapy areas, and our
medicines reached more than 18 million patients as maintenance
therapy in 2018. AstraZeneca's 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.
The Company is building on a 40-year heritage in respiratory
disease and AstraZeneca's capability in inhalation technology spans
pressurised metered-dose inhalers and dry powder inhalers, as well
as the Aerosphere Delivery Technology. The Company also has a
growing portfolio of respiratory biologics,
including Fasenra (anti-eosinophil, anti-IL-5rɑ), now
approved for severe, eosinophilic asthma and in development for
severe nasal polyposis, and tezepelumab (anti-TSLP), which has been
granted Breakthrough Therapy designation by the US Food and Drug
Administration in patients with severe asthma, and is in Phase III
trials. AstraZeneca's research is focused on addressing underlying
disease drivers focusing on the lung epithelium, lung immunity and
lung regeneration.
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 therapy areas - Oncology, Cardiovascular, Renal &
Metabolism and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. For more information, please
visit astrazeneca.com and
follow us on Twitter@AstraZeneca.
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1.
Lederer, D J and Martinez F J. Idiopathic Pulmonary Fibrosis. N
Engl J Med. 2018;378:1811-23.
2.
Genetic Home Reference of the National Institutes of Health
National Library of Medicine, accessed on 16 October
2018.
3.
Hu, M et al. Therapeutic targeting of src kinase in myofibroblast
differentiation and pulmonary fibrosis. J Pharmacol Exp Ther 2014;
351:87-95.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
18 March 2019
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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