Hikma Pharmaceuticals Plc Richter and Hikma sign agreement for denosumab
December 09 2021 - 2:00AM
RNS Non-Regulatory
TIDMHIK
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(R) and Xgeva
B udapest, 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(R) and Xgeva(R)
("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(R) (60 mg/ml solution for injection
in PFS) and Xgeva(R) (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
EVP, Strategic Planning and Global Affairs 477050
uk-investors@hikma.uk.com
Media:
Steve Weiss +1 732 720 2830/ +1 732 788
David Belian 8279
US Communications and Public Affairs +1 732 720 2814/+1 848 254 4875
uscommunications@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
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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