ADR Programme, FDA Update and US Appointment

RNS Number : 5572S

Angle PLC

25 September 2014

 



For immediate release

25 September 2014

ANGLE plc

("ANGLE" or the "Company")

ADR PROGRAMME, FDA UPDATE AND US APPOINTMENT

ANGLE plc (AIM: AGL), the specialist medtech company, is pleased to announce that it is establishing a Level 1 American Depositary Receipt (ADR) programme to meet demand from US investors seeking to invest in ANGLE's equity securities via a US exchange in US dollars.

ANGLE believes the ADR programme will benefit existing shareholders by making its shares more accessible to US investors, and will provide ANGLE with increased liquidity and visibility within the US investment market. 

The Bank of New York Mellon has been appointed to act as the depositary to establish and maintain the ADR programme.  The ANGLE ADR is expected to begin trading next month on the OTCQX marketplace operated by OTC Markets Group Inc. Aegis Capital Corp. has been appointed to serve as ANGLE's Principal American Liaison ("PAL") on OTCQX, responsible for providing professional guidance on OTCQX requirements. 

The ADR programme is one of a number of steps that ANGLE is taking to build up its business in the US, where ANGLE has been operating since 2000.  The Parsortix technology was originally developed in the US and ANGLE has a laboratory and office facility in Philadelphia.

The US market is the largest medical diagnostic market in the world and is a key priority for commercialisation of the Parsortix system, ANGLE's innovative technology for the capture, harvesting and analysis of circulating tumour cells (CTCs). ANGLE is developing relationships in the US market with major cancer research centres as key opinion leaders for the Parsortix system.  The first of these relationships focuses on metastatic breast cancer and is with the University of Southern California Norris Comprehensive Cancer Center, as announced on 19 September 2014.

Work continues with the US Food and Drug Administration (FDA) for the regulatory approval of the Parsortix system.  ANGLE is seeking clearance for the use of the system as a platform for the capture and harvesting of large cells from blood for the purposes of analysis.  If authorised by the FDA, this will enable the Parsortix system to be used for all types of cancer cells, and any approved form of analysis. 

We believe ANGLE is the first company seeking an approval for harvesting CTCs for analysis.  Presently the only FDA authorised system for CTCs is CellSearch, its authorisation being limited to the enumeration of CTCs for prognostic purposes for a limited number of cancer types.  Specifically, its authorisation does not extend to harvesting CTCs for molecular analysis, which is a key value-added component of the Parsortix system. 

As expected, the FDA has raised various questions in relation to our submission and an ongoing dialogue is in progress. It is not possible to predict with certainty when the process will be completed. However, we are pleased to report that the FDA has indicated its enthusiasm for the Parsortix system and is taking a constructive and supportive approach to the regulatory approval process. 

To capitalise on the US market opportunity, to drive relationships with US key opinion leaders and to accelerate US sales and corporate deals with major pharmaceutical and medtech companies, ANGLE has appointed a senior US business development executive, Peggy Robinson. Peggy will be joining ANGLE next month as a US Vice President and is exceptionally well qualified for this role.

From 2007 to 2011, Peggy was director of marketing for Johnson & Johnson company Veridex, and its predecessor Immunicon, responsible for the launch and market expansion of CellSearch. Following this, in 2011 and 2012, Peggy was Director of Strategic Alliances / Services for Veridex.  During this time she developed and implemented strategies to form collaborations for CellSearch with pharmaceutical and biotech companies.  More recently, Peggy has been consulting on business strategies, marketing, strategic alliances, key opinion leaders and product development of new technologies, with an emphasis on cancer, chronic disease and companion diagnostics. 

ANGLE's Founder and Chief Executive, Andrew Newland, commented:

"We believe that the steps that we are taking will substantially strengthen ANGLE's position in the USA, the world's largest market for medical diagnostics.  The ADR programme on the OTCQX marketplace will meet US investor demand and increase liquidity in ANGLE's shares to the benefit of our shareholders. We have a constructive dialogue ongoing with the FDA in relation to the approval of the Parsortix system and will update the market as new information becomes available.  We are delighted that we have been able to expand the senior management team with the CTC skills and experience that Peggy Robinson brings to ANGLE."

For further information:

ANGLE plc	01483 685830
Andrew Newland, Chief Executive Ian Griffiths, Finance Director
Cenkos Securities Stephen Keys, Dr Christopher Golden (Nominated adviser) Andy Roberts, Christian Hobart (Sales)	020 7397 8900
Buchanan Mark Court, Fiona Henson, Sophie Cowles	020 7466 5000

 

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