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RNS Number:5141O M.L. Laboratories PLC 11 August 2003 Embargoed until 07.00 11th August 2003 ADEPT ADHESION REDUCTION THERAPY INTERIM ANALYSIS OF US PHASE III DATA The independent Data Monitoring Committee ("DMC") of ML's US Phase III pivotal study to determine the efficacy and safety of Adept in the reduction of post surgical adhesions after laparoscopic surgery ("the PAMELA study") has completed its analysis of the data relating to the first set of 205 completed patients in accordance with the strict protocol approved by the US Food and Drug Administration ("FDA"). ML is pleased to announce that the DMC has reported that there are no concerns relating to the safety of Adept and has recommended that the study should continue. The data from the remaining patient set are required to confirm the safety profile and to provide sufficient evidence to demonstrate the efficacy of Adept to the satisfaction of the FDA. The study is anticipated to complete in Q3 2004. The PAMELA study is a pivotal Phase III clinical evaluation of Adept solution as an adjunct to adhesiolysis surgery being conducted in 15 gynaecology units in the US. The total proposed patient numbers (410) were based on statistical analysis of a previous five centre Phase II study. PAMELA is a double blind comparison of Adept and standard therapy (Ringer's lactate solution), and the protocol included a provision for an independent interim analysis of the data after completion of 50% (205) of the patients. This analysis was conducted by an independent external organisation and appropriate information blinded by treatment group was supplied directly to members of the DMC. Adhesions are a serious and frequent complication following abdominal and gynaecological surgery and are expensive to treat, often requiring further surgery and hospitalisation. Adept offers significant advantages over competing products as it is an easy to use, low viscosity solution which can be delivered via a laparoscope in minimally invasive (keyhole) surgery and is readily incorporated into routine surgical procedures. Furthermore, Adept is significantly less expensive than other products. Adept is currently on sale throughout Europe via Shire Pharmaceuticals to whom the European rights were licensed in October 2001. ML has retained all rights to Adept for the rest of the world and discussions are ongoing with potential licencees regarding the rights for several territories. - Ends - Enquiries: Tel: ML Laboratories PLC - Corporate S.W. Sim - Executive Chairman 01925 844 700 P.J. Shennan - Chief Operating Officer 01925 844 700 and Finance Director ML Laboratories PLC - Adept Licensing A.L. Barrett - Business Development Manager 01635 298 138 Weber Shandwick Square Mile Kevin Smith/Cass Helstrip 020 7067 0700 Note to Editors: ML is a biopharmaceutical product development company with a track record of successful clinical development, regulatory approval and licensing of pharmaceutical products and a pipeline of future products targeted at specialist markets. ML's activities are supported by a growing income stream from marketed products it has successfully developed and licensed to other pharmaceutical companies, which include Baxter, Shire and Celltech. New therapeutic products in clinical development include cancer treatments, a pain management compound prepared to enter Phase III studies, a preventative of sexually transmitted infections, including HIV, and a phosphate binder to assist the management of kidney failure. ML's portfolio of early stage development projects includes unique polymer/drug molecules to provide safer and more potent cancer chemotherapy and technologies for use in the discovery and manufacture of biotechnology products. In addition ML provides inhaled drug delivery solutions to the global pharmaceutical industry through its dedicated respiratory subsidiary Innovata Biomed. More information about ML Laboratories PLC can be found at www.mllabs.co.uk Except for the historical information herein, the matters discussed in this news release include forward-looking statements that may involve a number of risks and uncertainties. Actual results may vary significantly based upon a number of factors, which include without limitation risks in obtaining and maintaining regulatory approval for existing, new or expanded indications for its products, other regulatory risks, risks relating to M L Laboratories' ability to manufacture pharmaceutical products on a large scale, risks that customer inventory will be greater than previously thought, risks concerning ML Laboratories' ability to manage growth, market a pharmaceutical product on a large scale and integrate and manage an internal sales and marketing organization and maintain or expand sales and market share for its products, risks relating to the identification and appointment of licensees, risks relating to the ability to ensure regulatory compliance, risks related to the research, development and regulatory approval of new pharmaceutical products, risks related to research and development costs and capabilities, market acceptance of and continuing demand for M L Laboratories' products and the impact of increased competition, risks associated with anticipated top and bottom line growth and the possibility that upside potential will not be achieved, competitive products and pricing, and risks associated with the ownership and use of intellectual property rights. This information is provided by RNS The company news service from the London Stock Exchange END MSCEAPPPEAFDEFE
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