REG - AstraZeneca PLC - Settlement of patent litigation for Ultomiris

AstraZenecaAnnouncement

17/03/2022 07:00

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RNS Number : 1095F  AstraZeneca PLC  17 March 2022

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 (http://www.astrazeneca.com/)  and follow the
Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca) .

 

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

 

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