21st Jun 2005 12:00
M.L. Laboratories PLC21 June 2005 ML Laboratories plc Milestone Payment and Return of Adept Marketing Rights in Europe St Albans, UK, 21st June 2005 -- ML Laboratories plc (LSE: MLB) today announcesthat, with effect from 30 December 2005, Shire Pharmaceuticals will return to MLall its rights to market Adept, ML's adhesion reduction solution. The return ofmarketing rights to ML has arisen as a result of a change in Shire's strategicfocus. ML is now reviewing the future marketing of Adept in Europe as well ascontinuing licensing discussions for the US and Japan, as previously announced. ML successfully launched Adept for the reduction of adhesions followingabdominal surgery in the UK in May 2000 and licensed Europe-wide rights to Shirein October 2001. Since then, Shire has launched Adept across all the key EUmarkets and has entered agreements to distribute the product in other EUcountries. Adept currently has sales of $5m per annum. In line with the terms of the agreement, ML is due to receive a payment fromShire 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 basisfor the Adept Marketing Authorisation Application to the US Food and DrugAdministration (FDA), expected in the coming months. The return of rights from Shire enables ML to consider a number of possibleoptions, including continued licensing of Adept on a regional or global basis.ML is also reviewing the opportunity to return to marketing the product directlywithin the EU. ML hopes to make further announcements about the licensing andmarketing of Adept in the near future. Joseph Rus, Executive Vice President and General Manager, International at ShirePharmaceuticals PLC commented: "Following a change in our strategic priorities after a review of our businesslast 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 Laboratoriesfuture success with the brand." Kieran Murphy, Chief Executive Officer of ML, said: "ML recognises that Shirehas been a most able partner over the past three years, having significantlyraised awareness among surgeons of the need to consider adhesion preventionstrategies with Adept when carrying out abdominal surgery. The new clinical datafrom our pivotal US Phase III study, will drive opportunities for ML to considera number of options for Adept which will reflect the Group's future strategicdirection." Contacts: ML Laboratories plc Tel: 01727 739300Kieran Murphy, Chief Executive OfficerPaul Ballington, Director of Marketing & Business Development Financial Dynamics Tel: 020 7831 3113Julia Phillips / David Yates Notes to Editors ML operates through two divisions, both focused on the development of high valuepharmaceutical products - Innovata Biomed, the Group's respiratory division, andML Pharmaceuticals, a pharmaceutical product development business. Innovata Biomed (IB) is a leading independent provider of inhaled drug deliverytechnologies to the global pharmaceutical industry, formulating dry powders anddeveloping proprietary inhaler systems through to full industrialisation. IB'sproven delivery technologies are available for proof-of-principle testing and asfast-to-market drug delivery solutions. It has a number of respiratory productsboth in development and marketed by pharmaceutical company licensees includingCelltech, Otsuka and Pliva. ML's pharmaceutical product development division, ML Pharmaceuticals, containsboth marketed products and new therapeutics in clinical development. Marketedproducts include Extraneal for the treatment of renal failure, which has beenlicensed to Baxter, and Adept for the reduction of adhesions in abdominalsurgery. New therapeutic products in development include Alpharen, a phosphatebinder to assist the management of kidney failure, treatments for prostate andskin cancer and a pain management compound. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
Shire