Hikma Pharmaceuticals Plc Update status on ANDA for generic Advair Diskus® (3435H)
March 12 2018 - 3:00AM
UK Regulatory
TIDMHIK
RNS Number : 3435H
Hikma Pharmaceuticals Plc
12 March 2018
Hikma provides an update on the status of its ANDA for generic
Advair Diskus(R)
London, 12 March 2018 - Hikma Pharmaceuticals PLC (Hikma, Group)
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody's /
BB+ S&P, both stable) announces that it is has received a
response from the United States 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).
On 11 May 2017, Hikma announced it had received a complete
response letter (CRL) from the FDA. In the following months, Hikma
worked collaboratively with the FDA and was able to address and
clarify the majority of the questions raised. However, there
remained an outstanding issue regarding the clinical endpoint study
and, in response, the company decided to engage in the FDA's
dispute resolution process.
The FDA has now concluded this process, upholding its original
determination and requesting the completion of an additional
clinical endpoint study. In anticipation of this as one of the
potential outcomes, Hikma has already finalised the planning of a
new clinical study and expects to start patient enrolment in the
coming weeks. Hikma anticipates being able to submit a response to
the FDA with new clinical data as early as possible in 2019.
Hikma remains committed to bringing this important product to
the US market. 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.
-- ENDS --
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal, VP Corporate
Strategy and
Director of Investor +44 (0)20 7399 2760/ +44
Relations 7776 477050
Virginia Spring Investor +44 (0)20 3892 4389/ +44
Relations Manager 7973 679502
FTI Consulting
Ben Atwell/ Brett Pollard +44 (0)20 3727 1000
About Hikma
Hikma Pharmaceuticals PLC is a multinational pharmaceutical
group focused on developing, manufacturing and marketing a broad
range of both branded and non-branded generic and in-licensed
products. Hikma's operations are conducted through three
businesses: 'Injectables,' 'Generics' and 'Branded,' based
primarily in the Middle East and North Africa (MENA) region, where
it is a market leader, the United States and Europe. In 2016, Hikma
achieved revenues of $1,950 million and profit attributable to
shareholders of $155 million.
The information contained within this announcement is deemed by
the Company to constitute inside information stipulated under the
Market Abuse Regulation (EU) No. 596/2014. Upon the publication of
this announcement via the Regulatory Information Service, this
inside information is now considered to be in the public
domain.
This information is provided by RNS
The company news service from the London Stock Exchange
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