Consort Medical PLC DEV610: FDA approval for Mylan's generic Advair (6480O)
31 January 2019 - 6:01PM
UK Regulatory
TIDMCSRT
RNS Number : 6480O
Consort Medical PLC
31 January 2019
Consort Medical plc
31 January 2019
DEV610 Update: FDA approval for Mylan's generic version of
Advair
Consort Medical plc (LSE: CSRT) ("Consort" or "Consort
Medical"), a leading developer and manufacturer of drugs and
premium drug delivery devices, notes the announcement from the US
Food and Drug Administration (FDA) that it has granted abbreviated
new drug application (ANDA) approval for Mylan's Wixela(TM)
Inhub(TM) (fluticasone propionate and salmeterol inhalation powder,
USP), the first FDA-approved generic of ADVAIR DISKUS(R)
(fluticasone propionate and salmeterol inhalation powder).
Consort has constructed a 5,500 square metre dedicated building
and clean room at its King's Lynn site with appropriate
manufacturing capacity to support Mylan in producing the
proprietary dry powder inhaler (DPI) for their generic of Advair
Diskus. As detailed in our interim results announcement, Consort
looks forward to continuing to support Mylan on their product
launch.
The Board's outlook for the Group remains unchanged.
Jonathan Glenn, Consort Medical's Chief Executive Officer,
commented:
"We are delighted that Mylan has received approval for their
generic of Advair Diskus, which incorporates Consort's global
market leading expertise in respiratory drug delivery devices, and
we look forward to continuing to partner with them on the launch of
this product. The production of this high volume, premium-quality
drug delivery device supports Consort's well-established strategy
of driving sustainable organic growth."
This development programme is referred to as DEV610 in the
Consort development portfolio.
Enquiries:
Consort Medical Tel: +44 (0) 1442 867920
Jonathan Glenn - Chief Executive Officer
Paul Hayes - Chief Financial Officer
FTI Consulting Tel: +44 (0) 20 3727
1000
Ben Atwell / Simon Conway
About Consort Medical plc
Consort Medical plc is a leading, global, single source pharma
services drug and delivery device company. We are at the leading
edge of innovation and we are committed to investing in patient,
clinician and customer driven innovation to create new treatments,
new markets and new opportunities.
Our businesses:
Bespak is a global market leader in the manufacture of drug
delivery devices for pharmaceutical partner companies, including
respiratory, nasal, injectables and ocular products, and the
manufacture of devices for the point of care diagnostics market.
www.bespak.com.
Aesica is a leading provider of finished dose and active
pharmaceutical ingredient (API) development and manufacturing
services to pharmaceutical partners. www.aesica-pharma.com.
We employ approximately 2,000 people globally of which
approximately 1,400 are located in the UK. We have UK facilities in
King's Lynn, Cambridge, Nelson, Milton Keynes, Cramlington,
Queenborough and Hemel Hempstead, German facilities in Monheim and
Zwickau and a facility in Pianezza, Italy. Consort Medical is a
public company quoted on the premium list of the London Stock
Exchange (LSE: CSRT). www.consortmedical.com.
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END
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