Consort Medical PLC DEV610: FDA approval for Mylan's generic Advair (6480O)

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: [phone] 
 Jonathan Glenn - Chief Executive Officer 
 Paul Hayes - Chief Financial Officer 
 
 FTI Consulting                             Tel: [phone] 
                                             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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January 31, 2019 02:01 ET (07:01 GMT)