a1097f
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 March 2022
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.
Settlement of
patent litigation for Ultomiris
17 March 2022 07:00 GMT
AstraZeneca reaches settlement
agreement resolving patent litigation related
to Ultomiris
Alexion, AstraZeneca's Rare Disease group, has entered into a
settlement agreement with Chugai Pharmaceutical Co., Ltd. (Chugai),
resolving all patent disputes between the two
companies related to Ultomiris (ravulizumab).
In accordance with the settlement agreement, Alexion and Chugai
have taken steps to withdraw patent infringement proceedings filed
with US District Court for the District of Delaware and Tokyo
District Court.
Marc Dunoyer, Chief Executive Officer, Alexion, said: "With this
settlement, we will continue to advance
our Ultomiris development programmes in new indications
and focus on our mission to transform the lives of people
affected by rare diseases."
Financial considerations
Under the terms of the agreement, Alexion will make a single
payment of $775m in the second quarter of 2022, for which a charge
will be recognised through the non-core P&L in the first
quarter of 2022. No further amounts are payable by either party.
The settlement does not impact AstraZeneca's financial guidance for
2022.
Notes
Ultomiris patent
proceedings
US
In November 2018, Chugai filed a lawsuit against Alexion in the
Delaware District Court alleging that Ultomiris infringes US patent No. 9,890,377 held by
Chugai. Upon issuance of US patent No. 10,472,623 in November 2019,
Chugai filed a second lawsuit in the same court alleging
that Ultomiris also infringes that patent. The two lawsuits
were consolidated in December 2019.
Japan
In December 2018, Chugai filed a lawsuit in the Tokyo District
Court against Alexion Pharma GK alleging
that Ultomiris infringed two Japanese patents (Japanese
Patent No. 4954326 and No. 641743) held by Chugai. Chugai's
complaint sought unspecified damages and certain injunctive relief.
Also beginning in 2016, Alexion had challenged the validity of four
of Chugai's Japanese patents. The IP High Court in Japan had found
these patents invalid. Chugai filed a correction of these patents
with the Japanese Patent Office. The Japanese Patent Office found
the corrected patents invalid, and Chugai appealed the Patent
Office's decision to the IP High Court in
Japan.
Europe
Beginning in 2016, Alexion challenged the validity of five of
Chugai's European patents. One patent was maintained by the
Opposition Division of the European Patent Office while four were
revoked. Three of the five decisions by the Opposition Division
have been appealed to the Boards of Appeal for the European Patent
Office.
Ultomiris
Ultomiris (ravulizumab),
the first and only long-acting C5 complement inhibitor, offers
immediate, complete, and sustained complement inhibition. The
medication works by inhibiting the C5 protein in the terminal
complement cascade, a part of the body's immune system. When
activated in an uncontrolled manner, the complement cascade
over-responds, leading the body to attack its own healthy
cells. Ultomiris is
administered intravenously every eight weeks or, for paediatric
patients less than 20kg, every four weeks, following a loading
dose. Ultomiris is
approved in the US for the treatment of adults and children (one
month of age and older) with PNH; in the EU for adults, as well as
for children (with a body weight of 10kg or above) and adolescents
with PNH who experience haemolysis with clinical symptom(s)
indicative of high disease activity, as well as for individuals who
are clinically stable after having been treated
with Soliris for at least the past six months; and in
Japan as a treatment for adults with PNH. It is also approved in
the US for aHUS to inhibit complement-mediated thrombotic
microangiopathy in adult and paediatric (one month of age and
older) patients, in the EU for the treatment of adults and children
with a body weight of at least 10kg with aHUS, as well as in Japan
for adults and children with aHUS.
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.
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:
17 March 2022
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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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