Lombard Medical Technologies PLC Trading Update
London, UK, 25 August 2006 - Lombard Medical Technologies PLC (“Lombard” or “the Company”) provides a trading update, following the announcement earlier today of its agreement with Boston Scientific Limited (“Boston”) that it was not in the interests of either party at the present time for Boston to exercise its option to act as exclusive distributor of the Company’s Aorfix™ abdominal and thoracic stent grafts outside the USA.
In consideration of this possibility, Lombard has been strengthening its sales and marketing infrastructure in the UK and in key European markets over the past few months, notably in Italy, France, Spain and Germany. Together with the support of recently appointed local distributors, product orders have started to show promising growth in the summer months as clinicians become increasingly aware of the growing body of superior clinical data for the product, giving grounds for optimism for the prospects for Aorfix™. Twenty-four month clinical data will be presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) meeting in Rome in September 2006.
One of the Company’s key objectives is the maintenance of high standards of production reliability and continuous quality improvement. It has experienced some delays in recent months in certain product shipments as a result of meeting the challenges of moving from development to commercial manufacturing operations. With the appointment of experienced personnel in several key areas, these challenges have now been met and overcome.
European CE Mark submission of the endovascular stapler occurred in June and approval is expected by the end of the year with FDA approval now expected in the second half of 2007. The Company is currently in late-stage contract negotiations with a major medical device company with respect to this product. Heads of terms have been agreed that could lead to Lombard retaining more rights than originally envisaged and receiving a $3m milestone payment upon FDA approval in 2007. This will create greater long-term value for the Company, despite the absence of the £2.5m licence fee previously forecast for 2006.
Although later than planned due to delays in negotiating clinical contracts and the product shipment issues, the pivotal US clinical trial of the Aorfix™ endovascular stent graft in the treatment of abdominal aortic aneurysms is now gaining momentum. A meeting of key US clinical investigators took place earlier this month in which widespread support for Aorfix™ was expressed with particular interest being shown for the product’s unique ability to treat aneurysms with tortuous iliac arteries or with neck angulations of greater than 60° (estimated to be 40% of AAA cases).
There have been several positive developments at the Company’s Polymer Coatings Division, such as the recent announcement with Axordia over the development of a revolutionary drug eluting stent (“DES”) containing stem-cells to promote early healing of the artery after angioplasty, and the DES coating collaboration with Amgen for which pre-clinical trials are due to start later this year.
Alistair Taylor, Chairman of Lombard Medical, commented:
“The Company is making strong progress on several fronts. The commercialisation of Aorfix TM in the UK and Europe is well under way, and we are in late-stage discussions with a major distribution partner for our Endostapler product line. The value of our polymer coatings technology is being recognised by companies such as Amgen and Axordia with whom we are progressing exciting projects in the $6bn DES market. The long-term prospects for the Company are very promising.”
Enquiries:
Lombard Medical Technologies PLC Tel: 01235 750 800
Alistair Taylor, Executive Chairman
Brian Howlett, Chief Executive Officer
Tim Hall, Finance Director
Financial Dynamics Tel: 020 7831 3113
David Yates / John Gilbert
Notes to editors
About Lombard Medical
Lombard Medical Technologies PLC is a medical devices group developing stent grafts and other medical products for use in the treatment of vascular disease. The Company’s lead product, Aorfix™, is a stent graft for the treatment of aortic aneurysms, a balloon-like enlargement of the aorta which, if untreated, may rupture and cause death. Abdominal and thoracic aortic aneurysms are the 13th largest cause of death in the US and the market is estimated to be worth approximately US$2 billion by 2010. Aorfix™ is currently being commercialised in the EU, with US clinical trials having commenced during 2006. The Company’s Polymer Coatings Division primarily develops polymer coatings for use in drug eluting stents and has a number of research collaborations developing novel products for this $6bn market.
Lombard Medical has recently successfully completed its initial public offering on AIM and was admitted to listing in December 2005, raising £23.9 million, net of expenses. The Company, based in Oxfordshire & Yorkshire, currently employs 82 people.
Further background on the Company can be found at www.lombardmedical.com.