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 January
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
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to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Completion
of divestment of US Synagis rights
25 January 2019 14:00 GMT
Completion of the divestment of
US Synagis rights to Sobi
AstraZeneca and its global biologics research and development arm,
MedImmune, has completed the agreement to
sell its US rights to Synagis (palivizumab), used for the prevention of
serious lower respiratory tract infection (LRTI) caused by
respiratory syncytial virus (RSV), to Swedish Orphan Biovitrum AB
(publ) (Sobi).
Sobi will commercialise Synagis in the US and around 130 AstraZeneca
employees have transferred to Sobi as part of the
transaction.
Sobi will also have the right to participate in payments from the
US profits or losses for potential new medicine MEDI8897 in
development for RSV-induced LRTI. AstraZeneca will continue to
develop MEDI8897 in collaboration with Sanofi Pasteur, the vaccines
division of Sanofi S.A.
Financial considerations
Under the terms of the agreement, AstraZeneca has received a total
consideration of $1.6bn, consisting of $1.0bn in cash and
$590m in ordinary shares of Sobi, equating to an ownership
interest of 8%. AstraZeneca has committed to retaining the
shares for 12 months.
The majority of the consideration is allocable to the divestment of
the US rights to Synagis and, after netting off an appropriate
derecognition of the intangible asset, will be reported within
Other Operating Income & Expense in the Group's financial
statements in the first quarter of 2019. A financial liability will
be recognised for the consideration received in relation to
MEDI8897. Further details will be included in the Q1 2019
financial disclosures once an exercise to allocate the fair value
of the consideration between the two assets has been
completed.
AstraZeneca will also receive sales-related payments
for Synagis and profit- and development-related
milestones and non-contingent payments for MEDI8897 from
Sobi.
As stated previously in the agreement, for the purposes of the UK
Listing Authority's Listing Rule LR 10.4.1 R (Notification of class
2 transactions), the total book value of gross assets attributable
to the RSV franchise were $2.2bn at 31 December 2017, of which
approximately $1.0bn was attributable to Synagis in
the US. In the year to 31 December 2017, the pre-tax profits
attributable to Synagis in
the US were approximately $118m.
About Synagis
Synagis is indicated for
the prevention of serious LRTI caused by RSV in infants and young
children at high risk of RSV disease. RSV is the most-prevalent
cause of LRTI among infants and young
children. Synagisis an RSV F protein inhibitor monoclonal antibody
(mAb) that acts as a prophylaxis against serious RSV
disease1.
It is the only medicine approved for the prevention of serious RSV
disease2.
AstraZeneca has an agreement with AbbVie Inc. for the distribution
of Synagis outside the US, which is not impacted by the
transaction with Sobi.
About MEDI8897
MEDI8897 is a single dose extended half-life anti-RSV (F) mAb being
developed for the prevention of LRTI caused by RSV in all infants
entering their first RSV season and children with chronic lung
disease or congenital heart disease entering their first and second
RSV season. It is being developed for the passive immunisation of a
broad infant population and has been engineered to have a long
half-life so that only one dose will be needed for the entire RSV
season3.
The current development plan includes initiation of a Phase III
trial in healthy full-term and late pre-term infants. MEDI8897
received Fast Track Designation from the US FDA in March
2015.
In March 2017, AstraZeneca and Sanofi Pasteur announced an
agreement to develop and commercialise MEDI8897. Under
the agreement,
AstraZeneca is responsible for all development activity through
initial approvals, as well as manufacturing of MEDI8897, while
Sanofi Pasteur leads commercialisation activities. The two
companies share all costs and profits equally.
About Sobi
Sobi is a leading integrated biopharmaceutical company focused on
rare diseases and specialty healthcare products, headquartered in
Solna, Sweden; it has approximately 850 employees. The company
operates in over 20 countries in Europe and the Middle East, as
well as in the US and Canada.
About MedImmune
MedImmune is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
small molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Oncology, Respiratory, Cardiovascular, Renal and Metabolic
Diseases, and Infection and Vaccines. The MedImmune headquarters is
located in Gaithersburg, Md., one of AstraZeneca's three global
R&D centres, with additional sites in Cambridge, UK and South
San Francisco, CA. For more information, please
visit www.medimmune.com.
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, Renal &
Metabolism and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. For more information, please
visit astrazeneca.com and
follow us on Twitter @AstraZeneca.
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Media Relations
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Gonzalo
Viña
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UK/Global
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+44 203 749 5916
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Karen
Birmingham
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UK/Global
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+44 203 749 5634
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Rob
Skelding
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UK/Global
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+44 203 749 5821
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Matt
Kent
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UK/Global
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+44 203 749 5906
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Jennifer
Hursit
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UK/Global
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+44 203 749 5762
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Christina
M Hägerstrand
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Sweden
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+46 8 552 53 106
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Michele
Meixell
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US
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+1 302 885 2677
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Investor Relations
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Thomas
Kudsk Larsen
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+44 203 749 5712
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Henry
Wheeler
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Oncology
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+44 203 749 5797
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Christer
Gruvris
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BioPharma - Cardiovascular; Metabolism
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+44 203 749 5711
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Nick
Stone
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BioPharma - Respiratory; Renal
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+44 203 749 5716
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Josie
Afolabi
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Other
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+44 203 749 5631
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Craig
Marks
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Finance; Fixed Income
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+44 7881 615 764
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Jennifer
Kretzmann
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Retail Investors; Corporate Access
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+44 203 749 5824
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US
toll-free
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+1 866 381 72 77
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. Synagis US prescribing information, May
2017.
2. Villafana, T. et al. Expert Review of Vaccines
2017.
3. Zhu et al. Science Translational Medicine
2017.
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:
25 January
2019
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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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