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-- ---------------------------------------------------------------------------- ---------------------------------------------------------------------------- ---- ----------------------------------------------------------------------------Found this announcement on the Doctor's Guide (link below) and have included the article in case any of you only have e-mail and not web access.
http://www.pslgroup.com/dg/141d16.htm
Adept Approved In E.U. For Post-Operative Adhesion Reduction
LONDON, UK -- November 3, 1999 -- ML Laboratories PLC, has received notification that approval has been granted to market Adept, its post-operative adhesions solution, throughout the European Union.
Adhesions, a serious and frequent complication following abdominal surgery where scarred tissue binds to adjacent tissue, can result in serious consequences such as bowel obstruction, infertility and chronic pain. Surgery is the only treatment for adhesions. Recent studies have identified the magnitude of the problem, suggesting that a third of all abdominal surgery patients are readmitted to hospital at least twice for further surgery because of adhesions.
Extensive pre-clinical testing has demonstrated that when Adept is used both during and after surgery, there is a significant reduction in post-surgical adhesions to a degree comparable to currently marketed products.
In contrast with existing products which are either films or gels requiring special handling, Adept is a non-viscous solution which can be introduced into surgical practice without any change in surgical procedure. The active ingredient of Adept, icodextrin, has a reassuring safety profile having been used on a daily basis as an intraperitoneal dialysis agent for many years in thousands of patients.
ML believes that Adept’s safety profile, ease of use and the fact that it can be used in keyhole surgery should position it as the preferred treatment for adhesion reduction.
The approval of Adept has been issued by the regulatory authority approximately six months earlier than anticipated. Clinical trials in support of a US marketing authorisation are currently ongoing in five centres in the US. Results from those initial studies will be published in Q1 2000.
ML believes Adept should command a high margin in a large market independently assessed to be worth $1.5 billion annually.
Several multi-national pharmaceutical companies are currently negotiating over the worldwide marketing rights to Adept whilst, in parallel, ML is evaluating the feasibility of marketing the product itself in Europe. Announcement of the marketing plans for Adept can be expected during Q1 2000.
All contents Copyright (c) 1999 P\S\L Consulting Group Inc. All rights reserved.