Britannia Pharmaceuticals Launches Surgical Adhesion Trials with AdSurf; New Clinical Approach Has Potential to Prevent Post-Surgical Complications Including Infertility and Chronic Pain.

Business Editors and Health/Medical Writers

LONDON--(BW HealthWire)--April 18, 2002

Britannia Pharmaceuticals announced today that it has begun clinical trials for a novel method of preventing surgical adhesions, a dry powder known as AdSurf(R). Initial results from animal studies show that AdSurf(R) effectively prevents the development of surgical adhesions.

The Phase III clinical studies are being conducted in the UK at Ninewells Hospital in Dundee and at Mater Hospital in Brisbane, Australia and are expected to be complete in early 2003. Adhesions occur in up to 90% of patients following major abdominal surgery and in 60-90% of the women undergoing pelvic surgery. In the United States alone, close to $2 billion are spent each year on hospital and surgery fees for adhesions.

Surgical adhesions commonly develop within 3 to 5 days after surgery, forming as a part of the body's healing process. Adhesions become problematic when they form abnormal scar tissue that links tissues and organs which are not normally connected, leading to complications for hundreds of thousands of patients each year such as bowel obstruction, female infertility and chronic pain. The most common treatment for adhesions is surgery to repair the damage caused and to cut the adhesions. However, in up to 80% of cases the adhesions re-grow, requiring the need for further surgeries.

"Post-operative surgical adhesions can be devastating for patients, causing pain and long-term difficulties such as infertility. A significant proportion of patients require repeated hospital admissions and further surgery to sever the adhesions," said Mr. Sami Shimi, Senior Lecturer and Consultant Surgeon in Department of Surgery and Molecular Oncology at Ninewells Hospital. "There are a number of preventative products - gels, liquids and other barrier technologies - that are available today, but they are not very widely used because they are difficult to administer during surgery and there is a lack of convincing efficacy data. If the results of these trials prove positive, we believe AdSurf(R) will likely be more broadly adopted than some of the previous anti-adhesion products because of the ease of its administration and spread within the peritoneal cavity."

AdSurf(R) is a new clinical approach to the prevention of surgical adhesions. It is administered as a sterile dry powder via aerosol prior to surgical closure, giving it a distinct ease of application advantage. The powder melts at just below normal body temperature and coats the internal surface tissues, preventing the formation of adhesions.

The product not only replaces the body's natural surface coatings, or surfactant, that helps tissues heal normally, but also assists the body's mechanism to regenerate more needed surfactant. Furthermore, whereas other treatments act to reduce adhesion formation very locally when applied to the tissues, AdSurf(R) disperses throughout the peritoneal cavity, creating a better chance for the prevention of adhesions.

Adhesions are the primary cause of intestinal obstruction and are responsible for over one-third of bowel obstruction surgeries performed. Adhesions are also a particular health concern for women, responsible for up to 20% of infertility cases and noted as one of the primary causes of chronic and acute gynecologic pain. According to the National Center for Health Statistics (NCHS), there are 400,000 surgeries performed on women in the U.S annually for peritoneal adhesiolysis.

The trials currently underway at Ninewells are being conducted by Sir Alfred Cushieri, Professor of Surgery and Molecular Oncology and Director of the Surgical Skills Unit at the University of Dundee, and Mr. Sami Shimi to examine the effects of AdSurf(R) in preventing surgical adhesion formation in 112 patients following abdominal surgery. Sir Alfred and Shimi expect to have interim results available in 8 -12 months. At Mater, Professor Leslie Nathanson will be looking at the results of endoscopic treatment of adhesions by AdSurf(R) in 40 patients. Professor Nathanson will have results in 2003.

AdSurf(R) is a unique formulation of the naturally occurring phospholipids Dipalmitoylphosphatidycholine (DPPC) and Phosphatidyl Glycerol (PG) and its approved name is Pumactant. It was originally developed by Britannia as a lung surfactant for Infant Respiratory Distress Syndrome and licensed in the UK as ALEC(R). In keeping with Britannia's mission to find new uses for existing therapeutic molecules, the company has reformulated and re-developed the product for the prevention of post-operative surgical adhesions and it also testing its effectiveness in the treatment of asthma and other respiratory disorders.

About Britannia Pharmaceuticals

Founded in 1981, Britannia Pharmaceuticals Limited is a United Kingdom based pharmaceutical firm whose mission is to become a leading supplier of innovative products for niche medical conditions. The company has pioneered new treatments for some of the worlds' most debilitating conditions including asthma, Parkinson's disease, drug addiction, erectile dysfunction and surgical adhesions. In addition to these treatments, Britannia has also developed nasal and respiratory drug delivery technology that are applicable to a range of treatments. Britannia is a Forum Bioscience company. Visit Britannia's website at www.britannia-pharm.co.uk.