RCS - Hikma Pharmaceutical - Richter and Hikma sign agreement for denosumab

Hikma PharmaceuticalsAnnouncement

09/12/2021 07:00

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RNS Number : 1121V  Hikma Pharmaceuticals Plc  09 December 2021

Richter and Hikma sign exclusive commercialisation and license agreement for
denosumab in the US, a proposed biosimilar referencing Prolia® and Xgeva

 

 

Budapest, Hungary - London, UK - 9 December 2021 - Gedeon Richter Plc.
("Richter") and Hikma Pharmaceuticals PLC ("Hikma") today announced that they
have entered into an exclusive license agreement to commercialise Richter's
denosumab, comprising two biosimilar products referencing Prolia(®) and
Xgeva(®) ("Products"), in the United States ("US"). The Products are used
for the treatment of osteoporosis and fractures due to bone metastasis
respectively and are currently in global Phase 1 and Phase 3 clinical
studies

 

According to the agreement, Richter is responsible for the development of the
Products (to conduct both Phase 1 and Phase 3 global clinical studies) and
will supply finished commercial Products for the US market. Hikma is
responsible for registering the Products with the US Food and Drug
Administration and will have exclusive rights to commercialise them in the US.

 

Under the financial arrangements of the licensing agreement, Richter is
eligible for an upfront payment upon signature as well as certain milestone
payments linked to reaching defined development stages totalling a
double-digit million USD figure.

 

"We are looking forward to collaborating with Hikma on this important
biosimilar project targeting the US market," said Gábor Orbán, Chief
Executive Officer of Richter. "Extending our partnership with a highly
respected company having a strong US presence further increases our confidence
in the viability of our specialty pharma strategy."

"Biosimilars are a growing area of interest for Hikma and we are delighted to
add two new products to our portfolio, building on our position as one of the
leading suppliers of sterile injectable medicines in the US," said Siggi
Olafsson, Chief Executive Officer of Hikma. "This key collaboration is highly
complementary and strengthens our US oncology and auto-immune
offerings. Gedeon Richter brings strong technical capabilities for biological
products which, combined with our well-established commercial presence in the
US market makes for a partnership with exciting potential."

 

This agreement, which builds on Richter and Hikma's existing partnership in
MENA, will help equip doctors and patients in the US with more treatment
options.

 

About denosumab

 

Denosumab is marketed under two brands - it is a biosimilar to the reference
products Prolia(®) (60 mg/ml solution for injection in PFS)  and Xgeva(®)
(120 mg/1,7 ml solution for injection in vial), a human monoclonal antibody
for the treatment of osteoporosis and fractures due to bone metastasis.
Denosumab is a RANKL inhibitor which works by preventing the development of
osteoclasts, which are cells that break down bone. It is used for patients
with osteoporosis at high risk for fractures, bone loss due to certain
medications, and in cancer patients with bone metastases or giant cell tumours
of the bone.

 

 

Enquiries

Richter:

 

 Investors:

 Katalin Ördög     +36 1 431 5680
 Media:

 Zsuzsa Beke:      +36 1 431 4888

Hikma Pharmaceuticals PLC

 Investors:

 Susan Ringdal                                +44 (0)20 7399 2760/ +44 7776 477050

 EVP, Strategic Planning and Global Affairs   uk-investors@hikma.uk.com (mailto:uk-investors@hikma.uk.com)

 Media:

 Steve Weiss                                  +1 732 720 2830/ +1 732 788 8279

 David Belian                                 +1 732 720 2814/+1 848 254 4875

 US Communications and Public Affairs         uscommunications@hikma.com (mailto:sweiss@hikma.com)

 

About Hikma

(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and
BBB-/stable Fitch)

Hikma helps put better health within reach every day for millions of people
around the world. For more than 40 years, we've been creating high-quality
medicines and making them accessible to the people who need them.
Headquartered in the UK, we are a global company with a local presence across
the United States (US), the Middle East and North Africa (MENA) and Europe,
and we use our unique insight and expertise to transform cutting-edge science
into innovative solutions that transform people's lives. We're committed to
our customers, and the people they care for, and by thinking creatively and
acting practically, we provide them with a broad range of branded and
non-branded generic medicines. Together, our 8,600 colleagues are helping to
shape a healthier world that enriches all our communities. We are a leading
licensing partner, and through our venture capital arm, are helping bring
innovative health technologies to people around the world. For more
information, please visit: www.hikma.com
(https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D2531421-1%26h%3D3823969217%26u%3Dhttp%253A%252F%252Fwww.hikma.com%252F%26a%3Dwww.hikma.com&data=02%7C01%7Csweiss%40Hikma.com%7C4a35048c8c764c63c86308d70efbac9e%7C178c1a723d3c40afbaa754615303bcdc%7C0%7C1%7C636994346427346162&sdata=lHZaoOb0u30Y6re6yfLW1Ar4vvBS%2FnjEUNdB00TBaTI%3D&reserved=0)

 

About Richter

 

Gedeon Richter Plc. (www.richter.hu), headquartered in Budapest/Hungary, is a
major pharmaceutical company in Central Eastern Europe, with an expanding
direct presence in Western Europe, in China and in Latin America. Having
reached a market capitalization of EUR 3.8 billion (USD 4.7 billion) by the
end of 2020, Richter's consolidated sales were approximately EUR 1.6 billion
(USD 1.8 billion) during the same year. The product portfolio of Richter
covers many important therapeutic areas, including Women's Healthcare, Central
Nervous System and Cardiovascular areas. Having the largest R&D unit in
Central Eastern Europe, Richter's original research activity focuses on CNS
disorders. With its widely acknowledged steroid chemistry expertise, Richter
is a significant player in the Women's Healthcare field worldwide. Richter is
also active in biosimilar product development.

 

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