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 November
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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reports under cover of Form 20-F or Form 40-F.
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AstraZeneca
to divest US Synagis rights to Sobi
This announcement contains inside information
13 November 2018 07:00 GMT
AstraZeneca to divest
US Synagis rights to Sobi
Transaction grants Sobi the right to participate in US profits and
losses for MEDI8897
Upfront consideration of $1.5bn plus further contingent
payments
AstraZeneca has agreed to sell 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 will transfer to Sobi as part of the
transaction.
Sobi will also have the right to participate in AstraZeneca's share
of US profits and losses related to potential new medicine
MEDI8897. AstraZeneca will continue to develop MEDI8897 in
collaboration with Sanofi Pasteur, the vaccines division of Sanofi
S.A.
Pascal Soriot, Chief Executive Officer, said: "We continue to
streamline our portfolio, allowing AstraZeneca to allocate
resources more effectively, while Sobi's focus
on Synagis will enable infants in the US to continue
benefiting from this important treatment. Meanwhile, the successful
development and commercialisation of MEDI8897 remains important for
AstraZeneca."
Sobi President and CEO Guido Oelkers said: "I am excited about
adding Synagis to our portfolio as it remains the only
product preventing RSV infection in this vulnerable patient group
with a great medical need. The addition of Synagis will become an important catalyst for Sobi's
future development and will form a powerful platform for growth in
rare diseases."
Financial considerations
Under the agreement, AstraZeneca will receive an upfront
consideration of $1.5bn, consisting of $1.0bn in cash and $500m in
ordinary shares of Sobi upon completion. This would equate to an
ownership interest of 8%, based on the current Sobi share price.
AstraZeneca has undertaken not to sell the shares received as
consideration for a period of 12 months following the closing date
of the transaction. The cash proceeds from the transaction will be
used for general corporate purposes.
AstraZeneca will also receive up to $470m in sales-related payments
for Synagis, a $175m milestone following the submission of
the Biologics License Application for MEDI8897; potential net
payments of approximately $110m on achievement of other MEDI8897
profit and development-related milestones; and a total of $60m in
non-contingent payments for MEDI8897 during 2019-2021. Under the
agreement, Sobi will have the right to participate in payments that
may be received by AstraZeneca from the US profits or losses for
MEDI8897. The agreement is subject to customary closing conditions
and is currently expected to complete very early 2019. AstraZeneca
will provide additional information if closing conditions are
achieved earlier and the agreement can complete late
2018.
Net income attributable to the arrangements will be recorded in the
Company's financial statements upon completion as Other Operating
Income. As part of the agreement, AstraZeneca will
de-recognise on a proportionate basis a significant intangible
asset related to Synagis. The transaction does not impact the Company's
financial guidance for 2018.
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 (palivizumab) is
indicated for the prevention of serious lower respiratory tract
infection (LRTI) caused by respiratory syncytial virus (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. Synagis is a RSV F protein inhibitor monoclonal
antibody (mAb) that acts as a prophylaxis against serious RSV
disease.1 It
is the only medicine approved for the prevention of serious RSV
disease.2 AstraZeneca
has an agreement with AbbVie Inc. for the distribution
of Synagis outside the US, which will not be impacted
by the proposed 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
season.3 The
current development plan includes initiation of a Phase III trial
in healthy full-term and late pre-term infants. MEDI8897 has
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 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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Adrian Kemp
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AstraZeneca PLC
References
1 Synagis (palivizumab) 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:
13 November
2018
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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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