British Biotech plc; Acute care drug, Lexipafant, starts pivotal Phase III clinical trial in patients with acute pancreatitis.

OXFORD--(BUSINESS WIRE)--Nov. 21, 1994--

Highlights

British Biotech announces the start of a Phase III clinical trial of lexipafant, its potent PAF antagonist, in patients with acute pancreatitis.

Phase III is the final stage of clinical testing prior to applying for a Marketing Authorization Application.

o Lexipafant is British Biotech's second drug to enter Phase III trials.

o Batimastat, British Biotech's leading cancer product, began Phase III clinical trials earlier this month.

o Pancreatitis is a serious inflammatory disease of the pancreas which affects approximately 250,000 people annually in the United States and Europe.

Commenting on today's announcement, Dr. Keith McCullagh, British Biotech's chief executive officer, said, "Following the encouraging results of Phase II trials of lexipafant in pancreatitis which the company announced in September, we have moved quickly to start this definitive Phase III trial. The objective is to confirm that lexipafant brings clinical benefits to patients with this serious disease. If successful, the trial could lead to a European-wide Marketing Authorization Application." -0-

British Biotech plc today announces the start of a Phase III clinical trial of lexipafant, its potent PAF antagonist, in patients with severe acute pancreatitis.

Lexipafant is British Biotech's second drug to progress to Phase III trials. Batimastat, British Biotech's leading cancer drug, began Phase III clinical trials earlier this month. Phase III is the final stage prior to applying for a Marketing Authorization Application.

Phase III study design in pancreatitis

The Phase III double-blind study is being conducted in the U.K. in up to 15 hospitals in 300 patients with acute pancreatitis. The trial will compare lexipafant treatment with placebo-treated patients, who will receive supportive treatment alone. The trial will focus on patients with a high risk of developing severe disease, as defined by the APACHE II scoring system. Patients will receive an intravenous infusion of 100 mgs of lexipafant per day for up to seven days.

Clinical end-points

Primary study end-points will be patients' organ failure score and the incidence of severe acute pancreatitis as measured by local and systemic complications of the disease. Inflammatory markers, including interleukin-8, interleukin-6 and E-selectin, will also be monitored.

Results of recent Phase II trial in pancreatitis

In September, British Biotech announced encouraging results of its Phase II study of lexipafant in patients with acute pancreatitis. In this study, patients received a repeated dose of 15 mgs of lexipafant administered intravenously at six hourly intervals over a three-day period. This study showed a trend towards improvement in clinical severity and reduction in systemic and pancreatic inflammation when measured by three different surrogate markers of inflammation, IL-8, IL-6 and E-selectin.

Pancreatitis - an unmet medical need

Pancreatitis is a serious inflammatory disease of the pancreas resulting in severe abdominal pain which usually requires hospitalization for treatment. It is most commonly caused by gall stones or excess alcohol. Patients with pancreatitis are currently treated with supportive therapy, often in an intensive care setting, since no specific drug or surgical procedures are currently available. The condition is therefore an unmet medical need affecting approximately 200,000 patients in the United States annually and, at current levels of diagnosis, 50-60,000 patients in Europe. Most patients are at risk of progressing to the severe form of pancreatitis. In 25% of cases, severe complications result which require treatment in intensive care units. Despite the best medical and surgical care, 8 to 10% of all patients die. 1993 U.S. sources estimate the daily average cost of treating pancreatitis patients at $1,245 per day.

Lexipafant - technical information

Lexipafant (BB-882) is a potent and specific PAF (platelet activating factor) antagonist. It is a small molecule drug made by chemical synthesis which has been designed to fit in the PAF receptors on the surface of cells and, by so doing, block activation of these receptors by PAF itself. The inflammatory agent PAF has been implicated in the causation of a number of inflammatory diseases including pancreatitis and asthma. Two separate product formulations of lexipafant are undergoing development: an oral tablet which is being evaluated as a new treatment for chronic asthma by Glaxo under a collaborative arrangement with British Biotech; and an intravenous solution being developed by British Biotech for acute care conditions in hospitalized patients.

Background

British Biotech plc, founded in 1986, combines approaches in molecular biology and synthetic chemistry to develop new therapeutic agents primarily for the treatment of cancer. In addition, the company is pursuing research in inflammatory, vascular and viral diseases. The company has recently established a new subsidiary, Neures, to investigate the role of metalloproteinase inhibitors in neuro-inflammatory diseases. British Biotech, based in Oxford, is listed on the London Stock Exchange and quoted on NASDAQ under the symbol BBIOY. A U.S. subsidiary, British Biotech Inc., was established in Annapolis, Md., in December 1993.

CONTACT: British Biotech plc, Oxford

             Peter Lewis or Katie Arber, 011-44-865 748747
                  or
             British Biotech Inc., Annapolis
             Peter McCann, 410/266-7909
                  or
             G.A. Kraut Co., New York
             Gerard Coffey, 212/696-5600