CSRT.L Regulatory News (CSRT)

Consort Medical plc

16 June 2016

DEV610 update

DEV610 is a dry powder inhaler initially for use in Mylan's generic version of Advair which they have submitted for US approval

FDA has set potential approval date (GDUFA date) at 28 March 2017

DEV610 expected to be significant revenue opportunity for Bespak

Consort Medical plc (LSE: CSRT) ("Consort", "Consort Medical" or the "Group"), a leading, global, single source pharma services drug and delivery device company, is pleased to provide a progress update on Bespak's DEV610 development programme, for a proprietary dry powder inhaler (DPI).

Our partner Mylan, a global pharmaceutical company, announced in February 2016 that its abbreviated new drug application (ANDA) for fluticasone propionate 100, 250, 500 mcg and salmeterol 50 mcg inhalation powder has been accepted for filing by the US Food and Drug Administration (FDA). The FDA provided Mylan a potential GDUFA (Generic Drug User Fee Act) date of 28 March 2017.

This product is the generic version of Advair, which is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, the device is expected to provide a platform for launch of additional products in the Mylan pipeline.

For Bespak this is a significant opportunity, which required the construction of a 5,500 square metre dedicated building and clean room at the King's Lynn site to accommodate the necessary manufacturing capacity to produce the expected volumes. Revenues from the contract will be dependent on sales following regulatory approval and launch of any products utilizing the device.

The contract further leverages Bespak's operational and regulatory expertise in the production of high volume, premium-quality drug delivery devices, and represents a further execution of its strategy for organic growth.

Jon Glenn, Chief Executive Officer of Consort Medical, commented:

"Consort Medical's Bespak business is a global market leader in respiratory drug delivery devices. This contract with Mylan further leverages its operational and regulatory expertise in the production of high volume, premium-quality drug delivery devices, and represents a further example of execution of Consort's strategy for diversified organic growth."

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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 more than 2000 people globally of which 1400 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.