<SEC-DOCUMENT>0001654954-19-003729.txt : 20190401
<SEC-HEADER>0001654954-19-003729.hdr.sgml : 20190401
<ACCEPTANCE-DATETIME>20190401063409
ACCESSION NUMBER:		0001654954-19-003729
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20190401
FILED AS OF DATE:		20190401
DATE AS OF CHANGE:		20190401

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:		19718724

	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>a5844u.htm
<DESCRIPTION>SELUMETINIB GETS BREAKTHROUGH THERAPY DESIGNATION
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<font style="font-size: 13px; font-family: Times New Roman">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px">Selumetinib gets
Breakthrough Therapy Designation</font></div>
</div>
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&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
1 April 2019 07:00 BST</font></div>
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&#xA0;</font></div>
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<font style="color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 13px">
Selumetinib granted US Breakthrough Therapy</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Designation in neurofibromatosis type 1</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; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Designation based on Phase II SPRINT trial in</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">
paediatric patients with NF1 plexiform neurofibromas</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="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Selumetinib is a MEK 1/2 Inhibitor being co-developed by
AstraZeneca and MSD</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">
AstraZeneca and MSD, Inc., Kenilworth, NJ, US (MSD: known as Merck
&amp; Co., Inc. inside the US and Canada) today announced that the
US Food and Drug Administration (FDA) has granted Breakthrough
Therapy Designation (BTD) for the MEK 1/2 inhibitor and potential
new medicine selumetinib.</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">
This designation is for the treatment of paediatric
patients&#xA0;aged three years and older&#xA0;with
neurofibromatosis type 1 (NF1) symptomatic and/or progressive,
inoperable plexiform neurofibromas (PN), a rare, incurable genetic
condition.</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">
Jos&#xE9; Baselga, Executive Vice President, Research and
Development, Oncology, said: "Selumetinib shows promise in the
treatment of NF1-related plexiform neurofibromas, a rare and
debilitating disease with no approved medications to date. The
Breakthrough Therapy Designation acknowledges the significant unmet
need of these patients and the potential benefit of selumetinib in
this setting."</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">
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, at MSD Research Laboratories,
said: "This new designation validates our ongoing development of
selumetinib.&#xA0;As a result of this, selumetinib has the
potential to receive expedited regulatory review and we hope to
bring this medicine to patients as soon 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 Phase II data from the SPRINT trial, testing
selumetinib as an oral monotherapy in paediatric patients, aged
three years or older with inoperable NF1-related
PN.&#xA0;</font><font style="text-decoration: underline; color: #0000FF">The results of the
trial</font><font style="color: #000000">&#xA0;were presented by
the National Cancer Institute (NCI) at the 2018 American Society of
Clinical Oncology Annual 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="color: #000000; font-family: Times New Roman; font-size: 13px">
This is the ninth BTD that AstraZeneca has received from the FDA
since 2014. 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.</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">
Selumetinib was granted Orphan Drug Designation for the treatment
of NF1 by the US FDA in February 2018 and the European Medicines
Agency in August 2018.</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">
Selumetinib is a MEK 1/2 inhibitor and potential new medicine
licensed by AstraZeneca from Array BioPharma Inc. in 2003.
AstraZeneca and MSD entered a co-development and
co-commercialisation agreement for selumetinib in
2017.</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&#xA0;</font><font style="font-style: italic; color: #000000">NF1</font><font style="color: #000000">&#xA0;gene provides instructions for making a
protein called neurofibromin, which negatively regulates the
RAS/MAPK pathway, helping to control cell growth, differentiation
and survival. Mutations in the&#xA0;</font><font style="font-style: italic; color: #000000">NF1</font><font style="color: #000000">gene may result in dysregulations in
RAS/RAF/MEK/ERK signalling, which can cause cells to grow, divide
and copy themselves in an uncontrolled manner, and may result in
tumour growth. Selumetinib inhibits the MEK enzyme in this pathway,
potentially leading to inhibition of tumour
growth.</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-family: Times New Roman; font-size: 13px">
Selumetinib is being assessed as a monotherapy and in combination
with other treatments in ongoing trials.</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 SPRINT</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 SPRINT trial is a US Cancer Therapy Evaluation Program (CTEP)
NCI-sponsored Phase I/II trial. The Phase I trial was designed to
identify the optimal Phase II dosing regimen, and the results were
published in the&#xA0;</font><font style="font-style: italic; color: #000000">New England Journal of
Medicine</font><font style="color: #000000">.</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-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About NF1</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">
Neurofibromatosis type 1 (NF1) is an incurable genetic condition
that affects one in 3,000 to 4,000 individuals.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,3</font><font style="color: #000000">&#xA0;It
is caused by a spontaneous or inherited mutation in
the&#xA0;</font><font style="font-style: italic; color: #000000">NF1</font><font style="color: #000000">&#xA0;gene and is associated with many symptoms,
including soft lumps on and under the skin (cutaneous
neurofibromas), skin pigmentation (so-called '</font><font style="font-style: italic; color: #000000">cafe au
lait'</font><font style="color: #000000">&#xA0;spots) and, in
20-50% of patients, tumours develop on the nerve sheaths (plexiform
neurofibromas). These plexiform neurofibromas can cause clinical
issues such as pain, motor dysfunction, airway dysfunction,
bowel/bladder dysfunction and disfigurement as well as having the
potential to transform into malignant peripheral nerve sheath
tumours (MPNST).</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">
People with NF1 may experience a number of complications such as
learning difficulties, visual impairment, twisting and curvature of
the spine, high blood pressure, and epilepsy. NF1 also increases a
person's risk of developing other cancers, including malignant
brain tumours, MPNST and leukaemia. Symptoms begin during early
childhood, with varying degrees of severity, and can reduce life
expectancy by up to 15 years.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4</font></font></div>
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announced a global strategic oncology collaboration to co-develop
and co-commercialise&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;(olaparib), the world's first PARP inhibitor
and potential new medicine selumetinib, a MEK inhibitor, for
multiple cancer types. Working together, the companies will
develop&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;and selumetinib in combination with other
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AstraZeneca has a deep-rooted heritage in Oncology and offers a
quickly-growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With at
least six new medicines to be launched between 2014 and 2020, and a
broad pipeline of small molecules and biologics in development, we
are committed to advance New Oncology as one of AstraZeneca's five
Growth Platforms focused on lung, ovarian, breast and blood
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By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
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redefine cancer treatment and one day eliminate cancer as a cause
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1 Dombi E,&#xA0;</font><font style="font-style: italic; color: #000000">et al</font><font style="color: #000000">. Activity of Selumetinib in Neurofibromatosis
Type 1-Related Plexiform Neurofibromas.&#xA0;</font><font style="font-style: italic; color: #000000">N Engl J
Med</font><font style="color: #000000">. 2016;
375:2550-2560.</font></font></div>
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2 NHS Choices. Neurofibromatosis Type 1. Available
at&#xA0;</font><font style="text-decoration: underline; color: #0000FF">https://www.nhs.uk/conditions/neurofibromatosis-type-1/</font><font style="color: #000000">.
Accessed March 2019.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
3 Johnson KJ,&#xA0;</font><font style="font-style: italic; color: #000000">et al</font><font style="color: #000000">. Development of an International Internet-based
Neurofibromatosis Type 1 Patient Registry.&#xA0;</font><font style="font-style: italic; color: #000000">Contemporary Clinical
Trials</font><font style="color: #000000">.
2013;34:305-311.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
4 Evans DGR,&#xA0;</font><font style="font-style: italic; color: #000000">et al</font><font style="color: #000000">. Reduced Life Expectancy Seen in Hereditary
Diseases Which Predispose to Early-Onset
Tumors.&#xA0;</font><font style="font-style: italic; color: #000000">Appl Clin
Genet</font><font style="color: #000000">. 2013;
6:53-61</font></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">01 April
2019</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Name:
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Title:
Company Secretary</font></div>
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