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 October 2018
Commission
File Number: 001-11960
AstraZeneca PLC
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
FDA
Orphan Drug for Lynparza in pancreatic cancer
16 October 2018 07:00 BST
US FDA grants Lynparza Orphan Drug Designation for pancreatic
cancer
Fourth Orphan Drug Designation in the US for AstraZeneca and MSD's
Lynparza
AstraZeneca and Merck & 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 Lynparza (olaparib) for the treatment of pancreatic
cancer.
Pancreatic cancer is a rare, life-threatening disease that accounts
for about 3% of all cancers in the US.i 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.ii Five-year
survival rates remain low in the US at 8.5%.iii
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."
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 Lynparza to more patients in
need."
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 Lynparza 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 to medicines intended for the treatment, diagnosis or
prevention of rare diseases or disorders that affect fewer than
200,000 people in the US.
The use of Lynparza in pancreatic cancer is being assessed in
the ongoing Phase III POLO trial, which is
testing Lynparza as maintenance monotherapy vs placebo in
patients with germline BRCA-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.
About the POLO Phase III trial
POLO is a Phase III, randomised, double-blinded, placebo-controlled
trial to evaluate the efficacy and safety
of Lynparza tablets (300 mg twice daily) as maintenance
monotherapy compared with placebo, in patients with
germline BRCA-mutated metastatic pancreatic cancer whose
disease has not progressed following 1st-line platinum-based
chemotherapy. The trial randomised 145 patients to
receive Lynparza or placebo (3:2). The primary endpoint is
progression-free survival.
About Lynparza
Lynparza (olaparib) was
the first in class PARP inhibitor and the first targeted treatment
to potentially exploit DNA damage response (DDR) pathway
deficiencies, such as BRCA mutations, to preferentially kill cancer
cells. Specifically, in vitro studies have shown
that Lynparza-induced cytotoxicity may involve inhibition of
PARP-enzymatic activity and increased formation of PARP-DNA
complexes, resulting in DNA damage and cancer cell
death.
Lynparza, 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.
About the AstraZeneca and MSD Strategic Oncology
Collaboration
In July 2017, AstraZeneca and Merck & 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 Lynparza, the world's first PARP inhibitor and potential
new medicine selumetinib, a MEK inhibitor, for multiple cancer
types. Working together, the companies will
develop Lynparza and selumetinib in combination with other
potential new medicines and as monotherapies. Independently, the
companies will develop Lynparza and selumetinib in combination with their
respective PD-L1 and PD-1 medicines.
About AstraZeneca in Oncology
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.
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.
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 www.astrazeneca.com and
follow us on Twitter @AstraZeneca.
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Adrian Kemp
Company Secretary
AstraZeneca PLC
i American Cancer Society.
Key statistics for pancreatic cancer. Available
at: https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html.
Accessed October 2018.
ii 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, https://seer.cancer.gov/csr/1975_2015/,
based on November 2017 SEER data submission, posted to the SEER
website, April 2018.
iii 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, https://seer.cancer.gov/csr/1975_2015/,
based on November 2017 SEER data submission, posted to the SEER
website, April 2018.
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:
16 October
2018
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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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