<SEC-DOCUMENT>0001654954-18-011204.txt : 20181016
<SEC-HEADER>0001654954-18-011204.hdr.sgml : 20181016
<ACCEPTANCE-DATETIME>20181016071120
ACCESSION NUMBER:		0001654954-18-011204
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20181016
FILED AS OF DATE:		20181016
DATE AS OF CHANGE:		20181016

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:		181123528

	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>a1192e.htm
<DESCRIPTION>FDA ORPHAN DRUG FOR LYNPARZA IN PANCREATIC CANCER
<TEXT>
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TO EXHIBITS</font></div>
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<font style="font-size: 13px; font-family: Times New Roman">1.</font></div>
<div style="text-align: left; display: table-cell"><font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">FDA
Orphan Drug for Lynparza in pancreatic cancer</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 style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
16 October 2018 07:00 BST</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="color: #000000">US FDA grants&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;Orphan Drug Designation for pancreatic
cancer</font></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: 16px">
&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-style: italic; font-family: Times New Roman; font-size: 13px">
Fourth Orphan Drug Designation in the US for AstraZeneca and MSD's
Lynparza</font></div>
<div style="text-align: left; margin-left: 120px; 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">
AstraZeneca and Merck &amp; Co., Inc., Kenilworth, N.J., US (Merck:
known as MSD outside the US and Canada) today announced that they
were granted orphan drug designation (ODD) by the US Food and Drug
Administration (FDA) for&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;(olaparib) for the treatment of pancreatic
cancer.</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">
Pancreatic cancer is a rare, life-threatening disease that accounts
for about 3% of all cancers in the US.</font><font style="font-size: 70%; vertical-align: top; color: #000000">i</font><font style="color: #000000">&#xA0;Due
to the late onset of symptoms, patients are often diagnosed after
the cancer has progressed to locally advanced or metastatic stages
of the disease.</font><font style="font-size: 70%; vertical-align: top; color: #000000">ii</font><font style="color: #000000">&#xA0;Five-year
survival rates remain low in the US at 8.5%.</font><font style="font-size: 70%; vertical-align: top; color: #000000">iii</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">
Sean Bohen, Executive Vice President, Global Medicines Development
and Chief Medical Officer said: "Pancreatic cancer is an area of
significant unmet medical need. This is especially true for
patients with metastatic disease where the benefits of current
treatment options are very limited."</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">
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, at MSD Research Laboratories,
said: "Pancreatic cancer is a relatively less common, but
life-threatening, form of cancer. The FDA granting Orphan Drug
Designation is a positive step for patients with pancreatic cancer
and continues to reinforce the importance of our collaboration in
bringing&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;to more patients in
need."</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: 66px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">ODD status was granted for the treatment of
ovarian cancer in October 2013. Earlier this year an amended ODD
status was granted to include both fallopian tube and primary
peritoneal cancers following the expanded US approval
of&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;in August 2017 for the maintenance treatment
of adult patients with recurrent epithelial ovarian, fallopian tube
or primary peritoneal cancer, who are in a complete or partial
response to platinum-based chemotherapy. The FDA grants ODD
status&#xA0;to medicines intended for the treatment, diagnosis or
prevention of rare diseases or disorders that affect fewer than
200,000 people in the US.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 66px; 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: 66px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">The use of&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;in pancreatic cancer is being assessed in
the ongoing Phase III POLO trial, which is
testing&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;as maintenance monotherapy vs placebo in
patients with germline&#xA0;</font><font style="font-style: italic; color: #000000">BRCA</font><font style="color: #000000">-mutated metastatic pancreatic cancer whose
disease has not progressed following 1st-line platinum-based
chemotherapy. Results from the POLO trial are expected in the first
half of 2019.</font></font></div>
<div style="text-align: left; 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 the POLO Phase III trial</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">
POLO is a Phase III, randomised, double-blinded, placebo-controlled
trial to evaluate the efficacy and safety
of&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;tablets (300 mg twice daily) as maintenance
monotherapy compared with placebo, in patients with
germline&#xA0;</font><font style="font-style: italic; color: #000000">BRCA</font><font style="color: #000000">-mutated metastatic pancreatic cancer whose
disease has not progressed following 1st-line platinum-based
chemotherapy. The trial randomised 145 patients to
receive&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;or placebo (3:2). The primary endpoint is
progression-free survival.</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; font-family: Times New Roman; font-size: 13px">
<font style="color: #000000">About&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font></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="font-style: italic; color: #000000">
Lynparza</font><font style="color: #000000">&#xA0;(olaparib) was
the first in class PARP inhibitor and the first targeted treatment
to potentially exploit DNA damage response (DDR) pathway
deficiencies, such as&#xA0;</font><font style="font-style: italic; color: #000000">BRCA</font><font style="color: #000000">&#xA0;mutations, to preferentially kill cancer
cells. Specifically, in vitro studies have shown
that&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">-induced cytotoxicity may involve inhibition of
PARP-enzymatic activity and increased formation of PARP-DNA
complexes, resulting in DNA damage and cancer cell
death.</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="font-style: italic; color: #000000">
Lynparza</font><font style="color: #000000">, which has the
broadest clinical development programme of any PARP inhibitor, is
being investigated in a range of DDR-deficient tumour types, and is
the foundation of AstraZeneca's industry-leading portfolio of
compounds targeting DDR mechanisms in cancer
cells.</font></font></div>
<div style="text-align: left; 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 the AstraZeneca and MSD Strategic Oncology
Collaboration</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 July 2017, AstraZeneca and Merck &amp; Co., Inc., Kenilworth,
NJ, US, known as MSD outside the United States and Canada,
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">, 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
potential new medicines and as monotherapies. Independently, 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 their
respective PD-L1 and PD-1 medicines.</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 AstraZeneca in Oncology</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 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 Oncology as a key growth driver focused on
lung, ovarian, breast and blood cancers. In addition to our core
capabilities, we actively pursue innovative partnerships and
investments that accelerate the delivery of our strategy as
illustrated by our investment in Acerta Pharma in
haematology.</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">
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
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment and one day eliminate cancer as a cause
of death.</font></div>
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About AstraZeneca</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
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.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
For more information, please visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">www.astrazeneca.com</font><font style="color: #000000">&#xA0;and
follow us on Twitter @AstraZeneca.</font></font></div>
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Adrian Kemp</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Company Secretary</font></div>
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AstraZeneca PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 70%; vertical-align: top; color: #000000">
i</font><font style="color: #000000">&#xA0;American Cancer Society.
Key statistics for pancreatic cancer. Available
at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF">https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html</font><font style="color: #000000">.
Accessed October 2018.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 70%; vertical-align: top; color: #000000">
ii</font><font style="color: #000000">&#xA0;Noone AM, Howlader N,
Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z, Mariotto
A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer
Statistics Review, 1975-2015, National Cancer Institute. Bethesda,
MD,&#xA0;</font><font style="text-decoration: underline; color: #0000FF">https://seer.cancer.gov/csr/1975_2015/</font><font style="color: #000000">,
based on November 2017 SEER data submission, posted to the SEER
website, April 2018.</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 70%; vertical-align: top; color: #000000">
iii</font><font style="color: #000000">&#xA0;Noone AM, Howlader N,
Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z, Mariotto
A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer
Statistics Review, 1975-2015, National Cancer Institute. Bethesda,
MD,&#xA0;</font><font style="text-decoration: underline; color: #0000FF">https://seer.cancer.gov/csr/1975_2015/</font><font style="color: #000000">,
based on November 2017 SEER data submission, posted to the SEER
website, April 2018.</font></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>
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<font style="text-decoration: underline; font-family: Times New Roman; font-size: 13px">
SIGNATURES</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<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>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div>
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<font style="font-family: Times New Roman; font-size: 13px">AstraZeneca
PLC</font></div>
</td>
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</div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Date:
<font style="font-weight: bold">16</font> <font style="font-weight: bold; font-size: 13px">October
2018</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">By: /s/
Adrian Kemp</font></div>
</td>
</tr><tr>
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<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: top; width: 29%">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Name:
Adrian Kemp</font></div>
</td>
</tr><tr>
<td style="vertical-align: top; width: 71%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: top; width: 29%">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Title:
Company Secretary</font></div>
</td>
</tr></table>
</div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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