Cortecs International receives 510(K) clearance from the FDA for Helisal Rapid Blood.

LONDON--(BUSINESS WIRE)--May 30, 1996--Cortecs International (NASDAQ:DLVRY/ LSE:COR/ASX:CRI) today announced that it has received 510(k) clearance in the U.S. from the Food and Drug Administration (FDA) for its Helisal Rapid Blood diagnostic kit for the detection of the bacterium Helicobacter pylori. Cortecs' licensed marketing partner for Helisal in the U.S., Boehringer Mannheim Corp., will now be able to commence marketing in the U.S.

H. pylori is now known to be the most common cause of gastritis and peptic ulcer. It has also been linked with stomach cancer and heart disease and has been declared a Class One carcinogen by the World Health Organization (WHO). Helisal Rapid Blood uses a finger-stick whole blood sample to establish the presence of antibodies to H. pylori in patients presenting with ulcer symptoms. The simple, self-contained and cost effective test can be used in the doctor's office and gives an accurate result (equivalent to laboratory analysis) within five minutes and without the use of any additional equipment. The test can help the doctor make immediate decisions concerning management of the patients, including the option of prescribing therapy to eradicate H. pylori to prevent recurrence of the ulcer.

Cortecs' Helisal Rapid Blood test is also licensed to European-based Boehringer Mannheim under a separate agreement, covering Europe and eighty-seven other countries. It is anticipated that the sales from the product should start to accelerate in early 1997. Cortecs also has an agreement with Astra in Europe concerning the use of Cortecs' rapid test to assist in Astra's educational activities on H. pylori. The product is also licensed in Japan to Zenyaku Kogyo.

Commenting on the announcement, Mr. Glen Travers, Chairman of Cortecs International, said today: "We are very pleased that this important step has now been achieved and that our partner in the U.S., Boehringer Mannheim, can now proceed with marketing and selling the rapid test in the U.S. It is now estimated that one in three people world-wide are afflicted with the bacterium. The indications are that H. pylori is causative in a growing number of disease states beyond peptic ulcers, therefore affecting the well-being of millions of people. Rapid point-of-care diagnosis is the first step in achieving better management of important disease states like infection with H. pylori and the U.S. is an important market for us to address."

Commenting, John Saharek, Marketing Manager for Boehringer Mannheim Corp., added: "We are extremely excited about the addition of the Cortecs H. pylori rapid assay to our existing AccuStat portfolio. This new test, to be called "AccuStat H. pylori" meets the needs of our health care professional market by providing accurate reliable information from a small sample of whole blood. The clearance of this new point-of-care rapid test combined with currently accepted eradication therapies makes cost effective disease management for H. pylori a reality."

Cortecs is a British-based company quoted on the London Stock Exchange, the Australian Stock Exchange and on NASDAQ. The Company specializes in the development of new pharmaceutical delivery systems and point-of-care rapid diagnostics which provide the opportunity to advance the management of serious diseases such as:

OSTEOPOROSIS

Oral Calcitonin - an oral therapy for the prevention of bone breakdown. In Phase II.

Osteosal - a rapid doctors' office test in collaboration with Osteometer to detect increased bone breakdown indicating the risk of the disease osteoporosis and also to monitor the adequacy of therapy. In development.

HELICOBACTER PYLORI Helisal - a rapid doctors' office whole blood test for the detection of Helicobacter pylori in the market and a rapid saliva test in development.

Oral Therapeutic Vaccine in development to stimulate immunity.

Oral Therapeutic in research to improve eradication results.

DIABETES Oral Insulin - human tests planned in 1996.

Glycosal - a rapid doctors' office test in collaboration with Exocell to assist in the management and identification of diabetics. In development.

CYSTIC FIBROSIS Pseudostat - oral therapeutic antigens to treat and prevent lung infection with Pseudomonas aeruginosa. Entering Phase II trials in 1996.

INFLUENZA Flustat - an oral vaccine against influenza. Entering human trials in 1996.

THRUSH Moniliastat - an oral therapeutic vaccine against vaginal thrush. Enters human trials in 1996.

DIARRHOEA Adept - an oral system to treat diarrhoea without antibiotics. Entering Phase II trials.

MALE HORMONE DEFICIENCY Halo Testosterone - an oral male hormone replacement therapy in development to treat male hypogonadism.

Cortecs also markets a range of ethical and OTC medicines and diagnostic products.

NOTE TO EDITORS: Press releases and other Cortecs International Limited information are available on the Cortecs International Limited web site: http://www.cortecs.com.

CONTACT: Dr. Michael Flynn Van Negris

Cortecs International Kehoe, White, Savage & Co., Inc.

011 44 181 568-7071 212/888-1616

or or

Dr. Geoffrey Hill Zena Bates 

Cortecs Diagnostics Buchanan Communications

011 44 124 428-8781 011 44 171 489-1441