Hikma Pharmaceuticals Plc Hikma update on ANDA for generic Advair Diskus (8287E)
May 11 2017 - 2:50AM
UK Regulatory
TIDMHIK
RNS Number : 8287E
Hikma Pharmaceuticals Plc
11 May 2017
Hikma provides an update on the status of its ANDA for generic
Advair Diskus(R)
London, 11 May 2017 - Hikma Pharmaceuticals PLC (Hikma) (LSE:
HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody's / BB+
S&P, both stable), the fast growing multinational
pharmaceutical group, today announces that it has received a
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) (fluticasone propionate and salmeterol inhalation
powder).
The FDA has categorised the CRL as 'Major'. Hikma is in the
process of reviewing the response and will provide an update on its
application as soon as practicable once it has completed its review
of the CRL and discussed this with the FDA. Based on the initial
assessment, no material issues were raised regarding the
substitutability of the proposed device.
Given the nature of the feedback, Hikma believes there is a low
likelihood of approval this year. Hikma is committed to bringing
this important product to the US market and will work
collaboratively with the FDA to address their outstanding
questions.
Hikma's fluticasone propionate and salmeterol inhalation powder
is indicated for the treatment of asthma and the maintenance
treatment of airflow obstruction and reducing exacerbations in
patients with chronic obstructive pulmonary disease and is
delivered using Vectura's proprietary dry powder inhaler and
formulation technology.
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Enquiries
Investor Relations
Susan Ringdal, VP Corporate Strategy +44 (0)20 7399 2760/
and Investor Relations +44 7776 477050
Lucinda Baker, Deputy Director +44 (0)20 7399 2765/
of Investor Relations +44 7818 060211
Media
+44 (0)20 7399 2795/
Brooke Clarke, VP Corporate Affairs +44 7970 338 250
Ben Atwell/ Matthew Cole, FTI
Consulting +44 (0)20 3727 1000
About Hikma
Hikma Pharmaceuticals PLC is a fast growing multinational group
focused on developing, manufacturing and marketing a broad range of
both branded and non-branded generic and in-licensed products.
Hikma operates through three businesses: "Injectables", "Branded"
and "Generics", based principally in the United States, the Middle
East and North Africa (MENA) and Europe. In 2016, Hikma achieved
revenue of $1,950 million and profit attributable to shareholders
of $155 million. In the United States, Hikma operates through its
wholly owned subsidiary, West-Ward Pharmaceuticals Corp., with
operations based in New Jersey, Ohio and Tennessee.
This information is provided by RNS
The company news service from the London Stock Exchange
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