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 January
2020
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 recover the global rights to brazikumab (MEDI2070) from
Allergan
27 January 07.00 GMT
AstraZeneca to recover the global rights to
brazikumab (MEDI2070) from Allergan
Agreement strengthens AstraZeneca's respiratory and immunology
pipeline
AstraZeneca will recover the global rights
to brazikumab (formerly MEDI2070), a monoclonal
antibody targeting IL23, from Allergan. Brazikumab is
currently in a Phase IIb/III programme in Crohn's disease
(CD)1 and
a Phase IIb trial in ulcerative colitis (UC).2
AstraZeneca and Allergan will terminate
their existing license
agreement and all rights
to brazikumab will revert to AstraZeneca. The transaction is
expected to complete in the first quarter of 2020, subject to
regulatory approvals associated with AbbVie's proposed acquisition
of Allergan and its timely completion.
Mene Pangalos, Executive
Vice President, BioPharmaceuticals R&D, said: "We're pleased to
bring brazikumab back into the AstraZeneca pipeline. With our
expanding presence in immunology, there is an opportunity to
address a significant unmet need in inflammatory bowel diseases
where the majority of patients are unable to achieve clinical
remission with current treatment options. This agreement creates an
opportunity for us to complete the full development programme and
bring this potential new treatment option to patients as quickly as
possible."
AstraZeneca's mid to late-stage pipeline of biologic medicines in
respiratory and immunology includes Fasenra (benralizumab) which is being evaluated in
eight eosinophil-driven diseases beyond severe asthma, tezepelumab
in Phase III development for severe, uncontrolled asthma,
anifrolumab for the treatment of systemic lupus erythematosus which
is being prepared for regulatory submission in the second half of
2020, and MEDI3506 (IL33 monoclonal antibody), a potential new
medicine for the treatment of dermatological and other diseases
entering Phase II trials.
Financial considerations
Under the termination agreement, Allergan will fund up to an agreed
amount, estimated to be the total costs expected to be incurred by
AstraZeneca until completion of development for brazikumab in CD
and UC, including the development of a companion
diagnostic.
Pursuant to the 2012
collaboration between
Amgen and AstraZeneca to jointly develop and commercialise a
clinical-stage inflammation portfolio, Amgen is entitled to receive
a high single-digit to low double-digit royalty on sales of
brazikumab if approved and launched. This includes the original
inventor royalty. Other than this, AstraZeneca will own all rights
and benefits arising from the product with no other payments due to
Amgen.
Brazikumab
Brazikumab is a monoclonal antibody that binds to the IL23
receptor and is in development for CD and UC with a companion
biomarker. Brazikumab selectively blocks the IL23 immune signal,
preventing intestinal inflammation. In Phase II trials, it
demonstrated a clinical effect at week eight in tumour necrosis
factor-resistant CD patients.3 The
Phase IIb/III INTREPID programme is underway to assess brazikumab
compared to placebo or adalimumab in CD. The Phase II EXPEDITION
trial is underway to assess brazikumab compared to placebo or
vedolizumab in UC. With current
biologic medicines, 40% to 55% of patients have no response to
therapy, and 65% to 80% of patients do not experience a full
remission.4 AstraZeneca's
development of brazikumab originates from the 2012 collaboration
with Amgen mentioned above.
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.
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References
1. Clinicaltrials.gov. An Active and Placebo-Controlled Study of
Brazikumab in Participants With Moderately to Severely Active
Crohn's Disease . Available at: https://clinicaltrials.gov/ct2/show/NCT03759288 [Last
accessed: January 2020].
2. Clinicaltrials.gov. An Active and Placebo-Controlled Study of
Brazikumab in Participants With Moderately to Severely Active
Ulcerative Colitis. Available at: https://clinicaltrials.gov/ct2/show/NCT03616821 [Last
accessed: January 2020].
3. Sands BE, Chen J, Feagan BG et al. Efficacy and Safety of MEDI2070, an Antibody
Against Interleukin 23, in Patients With Moderate to Severe Crohn's
Disease: A Phase 2a Study. Gastroenterology.
2017;153:77-86.
4. Sandborn W. J. (2016).
The Present and Future of Inflammatory Bowel Disease
Treatment. Gastroenterology
& hepatology, 12(7),
438-441.
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:
27 January
2020
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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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