LONDON, Feb. 27, 2020 /PRNewswire/ -- 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™
(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™
by the US Food and Drug Administration (FDA). Hikma will be
responsible for the commercialisation of Ryaltris™ 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™ 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™ 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™ 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™ 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™ 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™.
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.
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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SOURCE Hikma Pharmaceuticals