Hikma Pharmaceuticals Plc Hikma enters agreement to commercialise Ryaltris(TM)
February 27 2020 - 2:05AM
RNS Non-Regulatory
TIDMHIK
Hikma Pharmaceuticals Plc
27 February 2020
London, February 27, 2020 - Hikma Pharmaceuticals PLC (Hikma,
Group), the multinational generic pharmaceutical company, and
Glenmark Specialty S.A., a Swiss subsidiary of Glenmark
Pharmaceuticals, a global innovative pharmaceutical company, today
announce the signing of an exclusive US license agreement to
commercialise Ryaltris(TM) (olopatadine hydrochloride and
mometasone furoate nasal spray), an investigational fixed-dose
combination nasal spray for the treatment of seasonal allergic
rhinitis (SAR).
Under the terms of the agreement, Glenmark will be responsible
for the continued development and regulatory approval of
Ryaltris(TM) by the US Food and Drug Administration (FDA). Hikma
will be responsible for the commercialisation of Ryaltris(TM) in
the US following approval. Hikma would also have the ability to
produce the product utilizing its nasal manufacturing capabilities
in Columbus, Ohio. Hikma will provide Glenmark with an upfront
payment, regulatory approval and commercial milestone payments as
well as royalties.
"We are pleased to form this partnership with Glenmark, which
builds on our market-leading position in nasal allergy sprays and
advances our objective of growing our specialty business in the
US," said Brian Hoffmann, President of Hikma Generics. "Hikma is
the largest supplier of generic nasal sprays in the US. Adding
Ryaltris(TM) is a significant step forward in expanding our US
nasal spray leadership into branded medicines. Importantly, it will
allow us to leverage our strong, existing specialty salesforce
already calling on doctors with our specialty portfolio, and to
potentially leverage our nasal spray manufacturing capabilities in
Columbus, Ohio. We look forward to bringing this important new
treatment option to millions of US patients."
"We are happy to partner with Hikma in the US as Ryaltris(TM) is
a perfect strategic fit in their near-term plan to build a branded
nasal spray portfolio. This partnership gives us an opportunity to
tap into the largest pharmaceutical market in the world. This step
is aligned with our vision to make Ryaltris(TM) the first global
brand of Glenmark by launching it in several markets across the
globe," said Glenn Saldanha, Chairman and Managing Director of
Glenmark Pharmaceuticals.
Glenmark has studied Ryaltris(TM) in seven clinical trials
involving more than 4,000 adult and adolescent patients (12 years
of age and older). The FDA issued a Complete Response Letter (CRL)
to Glenmark regarding the NDA for Ryaltris(TM) in June 2019, citing
deficiencies pertaining to the proposed manufacturing facility. The
CRL did not specify any deficiencies with the clinical data
supporting the NDA for Ryaltris(TM).
About Seasonal Allergic Rhinitis
According to the most recent CDC data, almost 20 million adults
in the United Sates are affected by seasonal allergic rhinitis
every year. It is the primary diagnosis in over 11 million doctor's
visits annually and is estimated to affect more than seven percent
of adults aged 18 years and over in the United States.
- ENDS -
Enquiries
Glenmark Pharmaceuticals
Madhurima Gupta Jain +91 22 4018 9606
Senior Manager, Corporate Communications corpcomm@glenmarkpharma.com
Hikma Pharmaceuticals PLC
Susan Ringdal +44 (0)20 7399 2760/ +44 7776
EVP, Strategic Planning and Global Affairs 477050
uk-investors@hikma.uk.com
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
u scommunications @hikma.com
About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a global research-led
pharmaceutical company with presence across Generics, Specialty and
OTC business with operations in over 50 countries. Glenmark's key
therapy focus areas globally are respiratory, dermatology and
oncology. It is ranked among the top 80 Pharma & Biotech
companies of the world in terms of revenue (SCRIP 100 Rankings
published in the year 2019). For more information, visit
www.glenmarkpharma.com
About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1/stable
Moody's and BB+/positive S&P)
Hikma helps put better health within reach every day for
millions of people in more than 50 countries 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
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