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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 September
2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AstraZeneca to fully acquire Caelum Biosciences
29 September 2021 07:00 BST
AstraZeneca to fully acquire Caelum Biosciences
AstraZeneca will advance and accelerate ongoing Phase III clinical
development of
CAEL-101, a potential first-in-class medicine for AL
amyloidosis
AstraZeneca's Alexion has exercised its option to acquire all
remaining equity in Caelum Biosciences for CAEL-101, a
potentially first-in-class fibril-reactive monoclonal antibody
(mAb) for the treatment of light chain (AL)
amyloidosis.
AL amyloidosis is a rare disease in which misfolded amyloid
proteins build up in organs throughout the body, including the
heart and kidneys, causing significant organ damage and
failure that may ultimately be fatal.1,2 Approximately
20,000 people across the US, France, Germany, Italy, Spain and the
UK live with AL amyloidosis classified as Mayo stage IIIa or IIIb
disease.3
CAEL-101 is currently being evaluated in the Cardiac Amyloid
Reaching for Extended Survival (CARES) Phase III clinical programme
in combination with standard-of-care (SoC) therapy in AL
amyloidosis. Two parallel Phase III trials in patients with Mayo
stage IIIa disease and in patients with Mayo stage IIIb disease
respectively are ongoing.4,5
Marc Dunoyer, Chief Executive Officer, Alexion, said: "With a
median survival time of less than 18 months following diagnosis,
there is an urgent need for new treatments for this devastating
disease. CAEL-101 has the potential to be the first therapy
to target and remove amyloid deposits from organ tissues,
improve organ function, and, ultimately, lead to longer lives for
these patients."
Financial considerations
In 2019 Caelum and Alexion first entered into a collaboration
whereby Alexion acquired a minority equity interest and an
exclusive option to acquire the remaining equity in
Caelum. Alexion currently consolidates Caelum and reflects a
non-controlling interest of $150m. Upon closing the
acquisition, which is expected to take place on 5 October 2021,
Alexion will pay Caelum the agreed option exercise price of
approximately $150m, with the potential for additional payments of
up to $350m upon achievement of regulatory and commercial
milestones.
AL amyloidosis
AL amyloidosis is a rare disease caused by defective plasma cells
in the bone marrow that produce abnormal antibody (immunoglobulin)
proteins.1 These
abnormal proteins misfold and aggregate to form amyloids that may
deposit in tissues and/or organs.1,2 Amyloid
accumulation in organs, particularly in the heart and kidneys, can
cause widespread and progressive organ damage and high mortality
rates, with death most frequently occurring as a result of cardiac
failure.1,2
CAEL-101
CAEL-101 is a potentially first-in-class mAb designed to improve
organ function by reducing or eliminating amyloid deposits in the
tissues and organs of patients with AL amyloidosis. The antibody is
designed to bind to misfolded light chain proteins and
amyloid and shows binding to both kappa and lambda subtypes.
CAEL-101 has received Orphan Drug Designation from both the US Food
and Drug Administration (FDA) and the European Commission as a
potential therapy for patients with AL amyloidosis. Additionally,
the US FDA granted Fast Track Designation to CAEL-101 for AL
amyloidosis in June 2021.
CARES Phase III clinical programme
The CARES clinical programme consists of two parallel global Phase
III trials which are evaluating the efficacy and safety of
CAEL-101 in AL amyloidosis patients who are newly diagnosed and
naïve to SoC treatment (based on a
cyclophosphamide-bortezomib-dexamethasone regimen). One trial is
enrolling approximately 270 patients with Mayo stage IIIa disease
and one trial is enrolling approximately 110 patients with Mayo
stage IIIb disease. The primary endpoint for both clinical
trials is overall survival and enrolment is underway.
In each study, participants are being randomised in a 2:1 ratio to
receive either CAEL-101 plus SoC or placebo plus SoC once weekly
for four weeks. This will be followed by a maintenance dose
administered every two weeks until the last patient enrolled
completes at least 50 weeks of treatment. Patients will continue
follow-up visits every 12 weeks and will subsequently be
enrolled in an open-label extension study.
Alexion
Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca
focused on rare diseases, created following the 2021 acquisition of
Alexion Pharmaceuticals, Inc. As a leader in rare diseases for
nearly 30 years, Alexion is focused on serving patients and
families affected by rare diseases and devastating conditions
through the discovery, development and commercialisation of
life-changing medicines. Alexion focuses its research efforts on
novel molecules and targets in the complement cascade and its
development efforts on haematology, nephrology, neurology,
metabolic disorders, cardiology and ophthalmology. Headquartered in
Boston, Massachusetts, Alexion has offices around the globe and
serves patients in more than 50 countries.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Diseases, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, 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.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. Desport, E., Bridoux, F., Sirac, C. et al. AL Amyloidosis.
Orphanet J Rare Dis 7, 54 (2012).
2. Sanchorawala, V. Light-Chain (AL) Amyloidosis: Diagnosis and
Treatment. Clin J Am Soc Nephrol 1: 1331-1341, 2006.
3. Quock, et al. Epidemiology of AL amyloidosis: A real-world study
using US claims data, Blood Adv. 2018 May 22; 2(10):
1046-1053.
4. ClinicalTrials.gov. A Study to Evaluate the Effectiveness and
Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis.
NCT Identifier: NCT04512235. Available online. Accessed September
2021.
5. ClinicalTrials.gov. A Study to Evaluate the Effectiveness and
Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis.
NCT Identifier: NCT04504825. Available online. Accessed
September 2021.
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.
Date:
29 September
2021
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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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