Cortecs' annual general meeting: summary of remarks.

LONDON--(BUSINESS WIRE)--Nov. 13, 1996--Cortecs International (NASDAQ:DLVRY / LSE:COR / ASX:CRI) today released the following summary of remarks made today by Glen Travers, Executive Chairman, at the Company's Annual General Meeting of Shareholders.

Recent Corporate Events

New Director - We have been fortunate in having had Mr. Herve Rudaux as a non-executive director of our UK operating company since 1989. I would now like to welcome him to the main Board of Cortecs International. Mr. Rudaux is Vice-President of Compagnie Financier de Paribas, one of the largest investment Banks in Europe, responsible for their healthcare, chemical and pharmaceutical investments. His company is a major shareholder in Cortecs International and we value the strength of his presence on the Board.

New Key Management - I am very pleased that Dr. Martin Preuveneers has joined us as International Operations Director, bringing with him thirteen years experience at GlaxoWellcome and latterly his experience as CEO of the biotechnology company Therexsys. I would also like to welcome Mr. John Curtis who has many years experience in the medical diagnostics industry as Managing Director of Cortecs Diagnostics. As our projects begin to mature, new qualified and experienced staff are required to ensure their successful conclusion and this year we have recruited 21 senior qualified staff. New Structure Cortecs was founded eleven years ago as an Australian registered company. As we have developed, matured and indeed become more international, the Company's main base of operations has become centered in the UK. To meet the challenges presented by our success so far, we need to become a UK registered company and to seek PLC status here. At the Annual General Meeting, we gained shareholder approval for this step.

Collaborations

New Topical Diabetes Treatment - Cortecs have signed an agreement with the International Diabetes Institute (IDI), based in Melbourne, Australia, for the development of a new product for the treatment for diabetic peripheral neuropathy. Under the agreement, the product concept and intellectual property are exclusively licensed to Cortecs who will provide funding for further clinical testing and who will also apply the Macrosol delivery to the product concept. Further Phase II clinical trials are planned to commence during the first half of 1997 at the IDI.

New Ways of Differentiating Helicobacter Disease - Cortecs have signed a new agreement with the Department of Microbiology, National University of Singapore in the field of H. pylori research. Under the new agreement, in return for a royalty on eventual product sales and an expansion of support for work carried out on H. pylori at the University, Cortecs obtains exclusive rights to new intellectual property which has emerged from the work. Research to date supports the concept that different manifestations of Heliocbacter disease may be associated with differing clinically observable reponses. Researching New Eradication Therapy for H. pylori Cortecs have signed an agreement with a London teaching hospital to jointly investigate novel therapies for gastrointestinal infections.

Oral Delivery of Biotechnology Drugs

New Peptides for Oral Delivery - The success of our oral delivery technology to date has encouraged approaches from three groups with intellectual property rights to peptides which might be candidates for oral delivery. At this stage we are not able to disclose more information but are gratified that our oral delivery technology is being recognized by the industry.

Oral Insulin Studies in Diabetic Patients - A second Phase I trial has been completed. The results confirmed the first trial and an effect on blood glucose control and suggests some suppression of the bodies own insulin which would be expected if oral insulin were being absorbed. Further oral insulin trials are planned in early 1997 using an encapsulated form of oral insulin administered by mouth on healthy volunteers and also diabetic patients.

Pivotal Data for Oral sCT Submission - An additional study in healthy elderly volunteers has been completed to determine whether there was any restriction in the time of day for dosing with calcitonin. The trial carefully evaluated the excretion of bone breakdown markers over a 48 hour period in subjects who were institutionalized for the trial. The recent phase I trial showed that, using injected calcitonin, dosing in the morning or evening produced similar effects in reducing bone turnover and it is therefore probable that oral calcitonin would not be constrained to morning or evening dosing but could be given at either time according to convenience.

Calcitonin Market Breakthrough in The U.S. - A recent report stated that salmon calcitonin has recently 32% of new prescriptions for post-menopausal osteoporosis achieved in the US which is very encouraging for the potential of an oral form.

Oral Mucosal Therapeutic Vaccines

Pseudostat - Independent analysis of interim results from the ongoing Pseudostat double-blind clinical trial in Australia is now available and closely follow the pattern of the open Broncheictasis trial reported earlier this year. Pseudostat is designed to boost a patient's own immune response to the bacteria most commonly associated with chronic bronchitis, Pseudomonas aeruginosa and Haemophilus Influenzae. These results obtained from this early stage of the trial are very encouraging.

Flustat Oral Influenza Vaccine - Flustat is scheduled to commence clinical testing in November 1996. The first trial will investigate the ability of the vaccine to stimulate an immune response and to prime the mucous linings of the respiratory tract to mount a rapid defensive response if exposed to influenza virus.

Moniliastat Oral Vaccine - This is an oral vaccine against Candida albicans, the organism responsible for the disease "Thrush". The target indication is vaginal thrush in women with repeated and persistent infections. Pending ethical committee approval, recruitment for this trial will commence in December 1996. The trial will investigate immune response in healthy female volunteers.

Oral Testosterone - A formulation of oral testosterone is being completed using Cortecs' HALO technology. First clinical tests are expected in 1997. Testosterone given by the oral route is largely destroyed in the liver immediately after absorption from the intestine and sometimes causes liver damage during the process. Cortecs' HALO technology is designed to avoid uptake by the liver after absorption to avoid this effect and enable lower, safer doses to be administered.

Rapid Point of Care Diagnostics

Cortecs' rapid point of care diagnostic technology, already launched in the form of Helisal(TM) Rapid Blood, is proving to be adaptable and can use analytes associated with other major diseases in addition to that used to detect antibodies to H. pylori in our Helisal(TM) Rapid Blood product. Through collaborations with groups that have expertise and analytes in other important disease states, we have established the feasibility of additional rapid point of care tests. These tests have the ability to impact dramatically and beneficially the treatment, control and subsequent outcomes in the diseases they address by providing immediate, simple, cost-effective point of care diagnosis.

H. Pylori one-step (blood and saliva) - Development is well advanced on both one-step tests and the one step whole blood test is currently with partners evaluating the product, to be followed by the one step saliva test. Further studies on the H. pylori coccoid form at the National University of Singapore have indicated the feasibility of developing a rapid point of care diagnostic kit for this form of H. pylori. Sales of Helisal remain flat, but in line with contract.

Osteosal rapid point of care test for bone breakdown - The bone marker CrossLapsTM has received US FDA approval in the laboratory urine based format (not owned by Cortecs). Cortecs' first point of care test is being developed as a non-invasive urine test and is targeted to be completed by current financial year end.

Glycosal three rapid point of care tests - The first of these for glycosylated albumin is on track for completion prior to the end of the current financial year in a whole blood format.

Summary

Cortecs has now reached an important stage in its history where its R&D programs have delivered encouraging proof that our core enabling technologies can be developed to provide rapid point of care diagnostics, oral delivery of hitherto injected therapeutic drugs and to orally administer a new class of mucosal vaccines. In turn these platforms will have a significantly beneficial impact on the ability of healthcare providers to more cost-effectively manage serious diseases and obtain better patient outcomes.

About Cortecs

Cortecs International 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/III.

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 H. pylori. in the market and a rapid saliva test in development. A 'one step whole blood' test for the detection of H. pylori. in development.

Oral Therapeutic Vaccine - in development to stimulate immunity.

Oral Therapeutic - in research to improve eradication results.

DIABETES Glycosal - three rapid doctors' office tests in collaboration with Exocell to assist in the management and identification of diabetes. In development.

CYSTIC FIBROSIS & CHRONIC BRONCHITIS Pseudostat - oral therapeutic antigen to treat and prevent lung infection with Pseudomonas aeruginosa now in Phase II trials.

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 financial year.

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.

"Safe Harbor" Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward-looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results or events could differ materially from those described in the forward looking statements due to a variety of factors, including those set forth in the Company's filings with the US Securities and Exchange Commission. -0-

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, President John P. Kehoe/Van Negris

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

011 44 181 569 7312 [phone]

or

Ms. Zena Bates 

& Ms. Lisa Baderoon

Buchanan Communications

011 44 171 489 1441