St Albans, UK, 21st June 2005 -- ML Laboratories plc (LSE: MLB) today announces that, with effect from 30 December 2005, Shire Pharmaceuticals will return to ML all its rights to market Adept, ML's adhesion reduction solution. The return of marketing rights to ML has arisen as a result of a change in Shire's strategic focus. ML is now reviewing the future marketing of Adept in Europe as well as continuing licensing discussions for the US and Japan, as previously announced.
ML successfully launched Adept for the reduction of adhesions following abdominal surgery in the UK in May 2000 and licensed Europe-wide rights to Shire in October 2001. Since then, Shire has launched Adept across all the key EU markets and has entered agreements to distribute the product in other EU countries. Adept currently has sales of $5m per annum.
In line with the terms of the agreement, ML is due to receive a payment from Shire in relation to the Adept pivotal study in the US ("the PAMELA study"). Data from the PAMELA study, announced on 6 December 2004, will form the basis for the Adept Marketing Authorisation Application to the US Food and Drug Administration (FDA), expected in the coming months.
The return of rights from Shire enables ML to consider a number of possible options, including continued licensing of Adept on a regional or global basis. ML is also reviewing the opportunity to return to marketing the product directly within the EU. ML hopes to make further announcements about the licensing and marketing of Adept in the near future.
Joseph Rus, Executive Vice President and General Manager, International at Shire Pharmaceuticals PLC commented:
"Following a change in our strategic priorities after a review of our business last year, we have decided to return to ML all Shire's rights to market ADEPT. We are proud of the success we have brought to ADEPT and wish ML Laboratories future success with the brand. "
Kieran Murphy, Chief Executive Officer of ML, said: "ML recognises that Shire has been a most able partner over the past three years, having significantly raised awareness among surgeons of the need to consider adhesion prevention strategies with Adept when carrying out abdominal surgery. The new clinical data from our pivotal US Phase III study, will drive opportunities for ML to consider a number of options for Adept which will reflect the Group's future strategic direction."
ML Laboratories plc Tel: 01727 739300
Kieran Murphy, Chief Executive Officer
Paul Ballington, Director of Marketing & Business Development
Financial Dynamics Tel: 020 7831 3113
Julia Phillips / David Yates