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 December 2019
Commission File Number: 001-11960
AstraZeneca PLC
1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge CB2 0AA
United Kingdom
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F X Form 40-F __
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes __ No X
If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________
AstraZeneca PLC
INDEX TO EXHIBITS
1.
Enhertu (trastuzumab deruxtecan) approved in the US for HER2-positive unresectable or metastatic breast cancer following two or more prior
anti-HER2 based regimens
anti-HER2 based regimens
23 December 2019 07:00 GMT
Enhertu (trastuzumab deruxtecan) approved in the US for HER2-positive unresectable or metastatic breast cancer following two or more prior
anti-HER2 based regimens
Accelerated Approval of AstraZeneca and Daiichi Sankyo's Enhertu based on the DESTINY-Breast01 trial that showed clinically meaningful and durable responses
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
Enhertu is a HER2-directed antibody-drug conjugate (ADC) and the FDA approval is based on the results of the registrational Phase II trial DESTINY-Breast01 of Enhertu (5.4mg/kg) monotherapy in patients with HER2-positive metastatic breast cancer. All patients received prior trastuzumab, trastuzumab emtansine and 66% had prior pertuzumab.
Financial considerations
Following US approval, an amount of $125m is due from AstraZeneca to Daiichi Sankyo as the first milestone payment in HER2-positive breast cancer. Upon approval, this will be capitalised together with the upfront payment already made earlier in the year 2019.
Future sales of Enhertu in the US will be recognised by Daiichi Sankyo. AstraZeneca will report its share of gross profit margin from the sales in the US as collaboration revenue in the Company's financial statements. For further details on the financial arrangements, please consult the announcement of the collaboration agreement from March 2019.
About HER2
About DESTINY-Breast01
In March 2019, AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.
About AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) 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 and Metabolism, and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
Media Relations | ||
Gonzalo Viña | +44 203 749 5916 | |
Rob Skelding | Oncology | +44 203 749 5821 |
Rebecca Einhorn | Oncology | +1 301 518 4122 |
Matt Kent | BioPharmaceuticals | +44 203 749 5906 |
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Michele Meixell | US | +1 302 885 2677 |
Investor Relations | ||
Thomas Kudsk Larsen | +44 203 749 5712 | |
Henry Wheeler | Oncology | +44 203 749 5797 |
Christer Gruvris | BioPharmaceuticals (Cardiovascular, Metabolism) | +44 203 749 5711 |
Nick Stone | BioPharmaceuticals (Renal) Environmental, Social and Governance | +44 203 749 5716 |
Josie Afolabi | BioPharmaceuticals (Respiratory) Other medicines | +44 203 749 5631 |
Craig Marks | Finance Fixed income | +44 7881 615 764 |
Jennifer Kretzmann | Corporate access Retail investors | +44 203 749 5824 |
US toll-free | +1 866 381 72 77 |
References
1. ENHERTU® [fam-trastuzumab deruxtecan-nxki] US prescribing information; 2019.
3. Tandon A, et al. HER-2/neu Oncogene Protein and Prognosis in Breast Cancer. J Clin Oncol. 1989;7(8):1120-8.
4. Sledge G, et al. Past, Present, and Future Challenges in Breast Cancer Treatment. J Clin Oncol. 2014;32(19):1979-1986.
5. de Melo Gagliato D, et al. Mechanisms of Resistance and Sensitivity to Anti-HER2 Therapies in HER2+ Breast Cancer. Oncotarget. 2016;7(39):64431-46.
6. National Comprehensive Cancer Network (NCCN). NCCN Guidelines. Breast Cancer. Available at https://nccn.org. Accessed December 2019.
7. American Cancer Society. Breast Cancer HER2 Status. Available at https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html. Accessed December 2019.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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.
AstraZeneca PLC |
Date: 23 December 2019
By: /s/ Adrian Kemp | |
Name: Adrian Kemp | |
Title: Company Secretary |