BUDAPEST, Hungary and
LONDON, Dec. 9, 2021 /PRNewswire/ -- 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
EVP, Strategic
Planning and Global Affairs
|
+44 (0)20 7399 2760/
+44 7776 477050
uk-investors@hikma.uk.com
|
|
|
Media:
Steve
Weiss
David
Belian
US Communications and
Public Affairs
|
+1 732 720 2830/ +1
732 788 8279
+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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SOURCE Hikma Pharmaceuticals USA Inc.