Hikma Pharmaceuticals Plc Hikma completes FDA response for generic Advair® (7649U)
27 Novembre 2019 - 8:00AM
UK Regulatory
TIDMHIK
RNS Number : 7649U
Hikma Pharmaceuticals Plc
27 November 2019
London, 27 November, 2019 - Hikma Pharmaceuticals PLC (Hikma)
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1/stable
Moody's and BB+/positive S&P), the multinational pharmaceutical
company, today announces that it has submitted to the US Food and
Drug Administration (FDA) its response to deficiencies in its
abbreviated new drug application (ANDA) for a generic version of
GlaxoSmithKline's Advair Diskus(R) (fluticasone propionate and
salmeterol inhalation powder).
Following receipt of a complete response letter (CRL) from the
FDA, Hikma initiated a clinical endpoint study in 2018. This study
has been completed and it, along with other information requested
by the FDA, has been submitted to the FDA for review. The
submission addresses the outstanding questions raised by the FDA in
its CRL.
Siggi Olafsson, Chief Executive Officer of Hikma, said "Our team
has worked extremely hard with Vectura to complete a large and
challenging clinical study, which we believe demonstrates the
safety and effectiveness of our product, and I am very pleased to
have responded to the FDA. As we continue to develop our pipeline
of complex generics, respiratory products are a key strategic focus
for Hikma and our generic Advair submission is an important
milestone. We are confident in our ability to bring a generic
version of Advair to the US market, which would enable us to
improve patient access to this important medicine."
- ENDS -
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal
EVP, Strategic Planning and Global +44 (0)20 7399 2760/ +44 7776
Affairs 477050
Lucinda Baker +44 (0)20 7399 2765/ +44 7818
Director, Investor Relations 060211
FTI Consulting
Ben Atwell +44 (0)20 3727 1000
About Hikma
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. 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
8,400 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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