Hikma Pharmaceuticals Plc Hikma updates on ANDA for generic Advair Diskus(R) (6530Z)
22 Settembre 2020 - 8:00AM
UK Regulatory
TIDMHIK
RNS Number : 6530Z
Hikma Pharmaceuticals Plc
22 September 2020
London, 22 September 2020 - Hikma Pharmaceuticals PLC (Hikma or
the Group), the multinational pharmaceutical company, annou nces
that it has received a minor complete response letter (CRL) from
the US Food and Drug Administration (FDA) in relation to its
abbreviated new drug application (ANDA) for its generic version of
GlaxoSmithKline's Advair Diskus(R)1 (fluticasone propionate and
salmeterol inhalation powder).
Hikma is working closely with the FDA to quickly address the
small number of questions raised in the CRL. Once answered, Hikma
can expect to receive a response from the FDA within 90 days. Hikma
now expects to receive approval for its generic Advair Diskus(R) in
early 2021. As a result, Generics revenue is now anticipated to be
in the range of $710 million to $730 million and core operating
margin to be in the range of 18% to 19% for 2020 full year.
Hikma and its partner Vectura Group, are committed to bringing
this important product to the US market and remain confident in the
submission.
(1) Advair(R) and Advair Diskus(R) are registered trademarks of
Glaxo Group Limited.
- ENDS -
Enquiries
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
uscommunications@hikma.com
Teneo (Press):
Charles Armitstead / Camilla Cunningham +44 (0)7703 330 269/ +44
(0)7464 982 426
About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1/stable
Moody's and BBB-/stable 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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