<SEC-DOCUMENT>0001654954-19-001020.txt : 20190205
<SEC-HEADER>0001654954-19-001020.hdr.sgml : 20190205
<ACCEPTANCE-DATETIME>20190205061627
ACCESSION NUMBER:		0001654954-19-001020
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20190205
FILED AS OF DATE:		20190205
DATE AS OF CHANGE:		20190205

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		19566136

	BUSINESS ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA
		BUSINESS PHONE:		011 44 20 7304 5000

	MAIL ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ZENECA GROUP PLC
		DATE OF NAME CHANGE:	19930422
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a0843p.htm
<DESCRIPTION>US FDA GRANTS BREAKTHROUGH THERAPY DESIGNATION
<TEXT>
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FORM 6-K</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">SECURITIES
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<font style="font-family: Times New Roman; font-size: 13px">For the
month of <font style="font-size: 13px">February
2019</font></font></div>
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AstraZeneca PLC</font></div>
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Francis Crick Avenue</font></div>
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20-F X Form 40-F __</font></div>
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82-_____________</font></div>
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AstraZeneca PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">INDEX
TO EXHIBITS</font></div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="font-family: Times New Roman; font-size: 13px">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px">US FDA grants
Breakthrough Therapy Designation</font></div>
</div>
</div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
5 February 2019 07:05 GMT</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
US FDA grants Breakthrough Therapy Designation</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
for potential next-generation RSV medicine MEDI8897</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Designation based on positive&#xA0;primary analysis of the Phase
IIb</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
trial that demonstrated the safety and efficacy of
MEDI8897</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca and its global biologics research and development arm,
MedImmune, today announced that the US Food and Drug Administration
(FDA) has granted Breakthrough Therapy Designation (BTD) for
MEDI8897, an extended half-life respiratory syncytial virus (RSV) F
monoclonal antibody (mAb) being developed for the prevention of
lower respiratory tract infection (LRTI) caused by
RSV.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
A BTD is designed to expedite the development and regulatory review
of medicines that are intended to treat a serious condition and
that have shown encouraging early clinical results, which may
demonstrate substantial improvement on a clinically-significant
endpoint over available medicines. MEDI8897 is being developed in
partnership with Sanofi Pasteur and received Fast Track designation
from the US FDA in March 2015.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Mene Pangalos, Executive Vice-President, R&amp;D
BioPharmaceuticals, said: "MEDI8897 is our next-generation
preventive medicine for respiratory syncytial virus, which has the
potential to address an important unmet need for infants, families
and caregivers. The Breakthrough Therapy Designation, together with
its recent PRIME eligibility from the European Medicines Agency,
will help us to bring MEDI8897 to all infants at risk for RSV as
quickly as possible."</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The BTD is based on the primary analysis of
the&#xA0;</font><font style="text-decoration: underline; color: #0000FF">Phase IIb
trial</font><font style="color: #000000">&#xA0;to evaluate the
safety and efficacy of MEDI8897, which met its primary endpoint
defined as a statistically-significant reduction in the incidence
of medically-attended LRTI caused by reverse transcriptase
polymerase chain reaction-confirmed RSV, for 150 days after dosing
in healthy preterm infants. Full results from the Phase IIb trial
will be presented at a forthcoming medical
meeting.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About MEDI8897</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
MEDI8897 is an extended half-life RSV F mAb being developed for the
prevention of LRTI caused by RSV.&#xA0;MEDI8897 is being developed
for use in a broader infant population than the current standard of
care for RSV prevention,&#xA0;</font><font style="font-style: italic; color: #000000">Synagis</font><font style="color: #000000">&#xA0;(palivizumab), which in the US is only
approved for use in high-risk infants. Additionally, MEDI8897 is
being developed so that it may only require one dose during a
typical five-month RSV season, vs. monthly injections with current
standard of care.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The development programme for MEDI8897 also includes a Phase III
trial in late preterm and healthy full-term infants. AstraZeneca
will also conduct a Phase II/III study in&#xA0;</font><font style="font-style: italic; color: #000000">Synagis</font><font style="color: #000000">-eligible paediatric patients to generate
additional data for use in this population.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-size: 70%; vertical-align: top; color: #000000; font-family: Times New Roman">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
In February 2019, the EMA granted&#xA0;</font><font style="text-decoration: underline; color: #0000FF">PRIME
eligibility</font><font style="color: #000000">&#xA0;to
MEDI8897.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
In March 2017, AstraZeneca and Sanofi
Pasteur&#xA0;</font>announced<font style="color: #000000">&#xA0;an&#xA0;</font><font style="text-decoration: underline; color: #0000FF">agreement</font><font style="color: #000000">&#xA0;to
develop and commercialise MEDI8897 jointly. In November 2018,
AstraZeneca&#xA0;</font><font style="text-decoration: underline; color: #0000FF">announced</font><font style="color: #000000">&#xA0;Swedish
Orphan Biovitrum AB (publ) (Sobi) has the right to participate in
payments that may be received from the US profits or losses for
MEDI8897.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About RSV</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
RSV is the most common cause of LRTI in infants and young children
worldwide, and 90% of children are infected with RSV in the first
two years of life. Of those, up to 40% will experience a LRTI with
the initial episode, making the development and availability of
effective prevention methods a critical public health
priority.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;In
the US,&#xA0;there is currently one approved medicine for RSV
prophylaxis,&#xA0;</font><font style="font-style: italic; color: #000000">Synagis</font><font style="color: #000000">&#xA0;(palivizumab), indicated for high-risk
children (premature infants &#x2264; 35 weeks gestational age,
children with chronic lung disease of prematurity, and children
with haemodynamically significant chronic heart
disease).</font><font style="font-size: 70%; vertical-align: top; color: #000000">3</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 13px">
About MedImmune</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
MedImmune is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
small molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Oncology, Respiratory, Cardiovascular, Renal and Metabolic
Diseases, and Infection and Vaccines. The MedImmune headquarters is
located in Gaithersburg, Md., one of AstraZeneca's three global
R&amp;D centres, with additional sites in Cambridge, UK and South
San Francisco, CA. For more information, please
visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">www.medimmune.com</font>.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #0000FF; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About AstraZeneca</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
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 &amp;
Metabolism and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide.&#xA0;For more information, please
visit</font><font style="text-decoration: underline; color: #0000FF">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #0000FF">&#xA0;</font><font style="color: #000000">and
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References</font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">1.&#xA0;&#xA0;Domachowske JB, Khan AA, Esser MT,
et al.&#xA0;Safety, Tolerability, and Pharmacokinetics of MEDI8897,
an Extended Half-Life Single-Dose Respiratory Syncytial Virus
Prefusion F-Targeting Monoclonal Antibody Administered as a Single
Dose to Healthy Preterm Infants.&#xA0;</font><font style="font-style: italic; color: #000000">The Pediatric Infectious
Disease Journal</font><font style="color: #000000">. September
2018:886-892. doi:10.1097/inf.0000000000001916.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">2.&#xA0;&#xA0;Adamko DJ, Friesen M. Why does
respiratory syncytial virus appear to cause
asthma?&#xA0;</font><font style="font-style: italic; color: #000000">Journal of Allergy and
Clinical Immunology</font><font style="color: #000000">.
2012;130(1):101-102.
doi:10.1016/j.jaci.2012.05.024.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">3.&#xA0;&#xA0;</font><font style="font-style: italic; color: #000000">Synagis</font><font style="color: #000000">&#xA0;Prescribing Information.</font></font></div>
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SIGNATURES</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">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.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Date:
<font style="font-weight: bold; font-size: 13px">05 February
2019</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
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<font style="font-family: Times New Roman; font-size: 13px">Name:
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