NASDAQ : AstraZeneca to recover the global rights to brazikumab (MEDI2070) from Allergan

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 (https://www.astrazeneca.com/investor-relations/stock-exchange
-announcements/2016/medimmune-out-licenses-potential-medicine-for-inflammatory
-diseases-to-allergan-03102016.html) 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 (https://www.astrazeneca.com/media
-centre/press-releases/2012/astrazeneca-and-amgen-announce-collaboration
-02042012.html) 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 (http://www.astrazeneca.com/) and follow the Company on
Twitter @AstraZeneca (https://twitter.com/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

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