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
2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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82-_____________
23 October 2017 07:00 BST
ASTRAZENECA AND MSD RAPIDLY ADVANCE LYNPARZA
IN JAPAN WITH A SECOND REGULATORY SUBMISSION
Potential to offer a new treatment option for patients
with
germline BRCA-mutated, HER2-negative metastatic breast
cancer
AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as
MSD outside the US and Canada) today announced that they have
submitted a new drug application (NDA) to Japan's Pharmaceuticals
and Medical Devices Agency (PMDA) for the use of
Lynparza
(olaparib) tablets in unresectable or
recurrent BRCA-mutated breast cancer, with a decision expected in
the second half of 2018.
The Japan NDA is based on the positive results from the
Phase III
OlympiAD trial published in
the New
England Journal of Medicine.
This is the second NDA for Lynparza in Japan where the medicine is currently under
review for use in ovarian cancer, with a PMDA decision for this
indication anticipated in the first half of
2018.
Lynparza tablets are currently
being tested in a range of tumour types in addition to ovarian and
breast, including prostate and pancreatic
cancers.
About OlympiAD
OlympiAD is a randomised, open-label, multicenter Phase III trial
assessing the efficacy and safety of Lynparza tablets (300mg twice daily) compared to
'physician's choice' chemotherapy (capecitabine, vinorelbine,
eribulin) in 302 patients with HER2-negative metastatic breast
cancer with germline BRCA1 or BRCA2 mutations, which are predicted
or suspected to be deleterious. The international trial was
conducted in 19 countries across Europe, Asia, North America and
South America.
About Lynparza (olaparib)
Lynparza was the first
FDA-approved oral poly ADP-ribose polymerase (PARP) inhibitor that
may exploit tumour DNA damage response (DDR)-pathway deficiencies
to potentially 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 is the foundation of
AstraZeneca's industry-leading portfolio of potential new medicines
targeting DDR mechanisms in cancer cells.
About Germline BRCA mutations
BRCA1 and BRCA2 are human genes that produce proteins responsible
for repairing damaged DNA and play an important role in maintaining
the genetic stability of cells. When either of these genes is
mutated, or altered, such that its protein is either not made or is
faulty, DNA damage may not be repaired properly. As a result, cells
are more likely to develop additional genetic alterations that can
lead to cancer.1
About Breast Cancer in Japan
In
Japan, breast cancer is the fifth leading cause of death among
women.2 In
Japanese women, breast cancer incidence peaks in the late forties,
whereas in the US and Europe the peak incidence is in women over 60
years of age3-5. Despite more treatment options becoming
available during the past three decades, there is currently no cure
for patients diagnosed with metastatic (Stage IV) breast
cancer. In Japan, 5- and 10-year relative survival rates for
patients with Stage IV breast cancer are as low as 32.6% and 15.6%,
respectively.6 Therefore, the primary aim of treatment is to slow
progression of the disease for as long as possible and improving or
maintaining a patient's quality of life.7
About the AstraZeneca and MSD Strategic Oncology
Collaboration
On 27 July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ,
US announced
a global strategic oncology collaboration to jointly develop and
commercialise AstraZeneca's Lynparza,
the world's first and leading PARP inhibitor, and potential new
medicine selumetinib, a MEK inhibitor, for multiple cancer types.
The collaboration is based on increasing evidence that PARP and MEK
inhibitors can be combined with PD-L1/PD-1 inhibitors for a range
of tumour types and is aimed at maximising the potential
of Lynparza to
become the preferred backbone of combination therapies. Working
together, the companies will develop Lynparza and
selumetinib in combination with other potential new medicines and
as a monotherapy. 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 New Oncology as one of AstraZeneca's five
Growth Platforms 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 majority 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 & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of autoimmunity, neuroscience and infection. 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
1 National Cancer Institute. BRCA1 and BRCA2: Cancer Risk
and Genetic Testing. Available
Online. Accessed October
2017.
2 .National
Cancer Institute: Cancer Information Services: Cancer death data
calculated by demographic statistics
(1985~2015) http://ganjoho.jp/data/professional/statistics/odjrh3000000hwsa-att/cancer_mortality(1958-2015).xls.
3.Toi M, Ohashi Y, Seow A,
Moriya T, Tse G, Sasano H, Park BW, Chow LW, Laudico AV, Yip CH,
Ueno E, Ishiguro H, Bando H. The Breast Cancer Working Group
presentation was divided into three sections: the epidemiology,
pathology and treatment of breast cancer. Jpn J Clin Oncol.
2010;40(Suppl 1):i13-8.
4. Iwasaki M, Tsugane S. Risk factors for breast cancer:
epidemiological evidence from Japanese studies. Cancer Sci.
2011;102:1607-14.
5. Matsuda A, Matsuda T, Shibata A, Katanoda K, Sobue T,
Nishimoto H, Japan Cancer Surveillance Research Group. Cancer
incidence and incidence rates in Japan in 2007: a study of 21
population-based cancer registries for the Monitoring of Cancer
Incidence in Japan (MCIJ) project. Jpn J Clin Oncol.
2013;43:328-36.
6. Ministry of Health, Labor
and Welfare of Japan (2007) Survival rate surveillance (in
Japanese). http://www.gunma-cc.jp/sarukihan/seizonritu/seizonritu2007.html.
Accessed October 2017
7. O'Shaughnessy J. Extending Survival with Chemotherapy in
Metastatic Breast Cancer. The Oncologist
2005;10(3):20-29.
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:
23 October 2017
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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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