Cortecs Announces Positive European Phase II/III Trial Results For Macritonin.

LONDON--(BUSINESS WIRE)--May 13, 1997--Cortecs International ("Cortecs") (NASDAQ:DLVRY / LSE:COR / ASX:CRI) the U.K. based pharmaceutical company, today announced positive results on its ongoing double-blind European Phase II/III Macritonin(TM) clinical trials. Analyses by external consultants of three month end-point data has shown both biological and statistically significant responses in 400iu and 800iu doses. Macritonin(TM) is Cortecs' oral formulation of salmon calcitonin. Calcitonin is a well tolerated treatment for osteoporosis presently given by injection and (in some countries) intranasally.

The trial analyses included data from 212 women aged between 55 and 77 years who had osteoporosis diagnosed by measurement of bone mineral density. Treatment in the trial is planned to continue for two years, during which the effects of Macritonin(TM) on bone mineral density will also be evaluated. There are three UK centers in the trial. The fourth and lead centre is the Centre for Clinical and Basic Research at Ballerup in Denmark which is among the World's foremost institutions for research in bone disease.

CrossLaps(TM) is the term for a group of chemicals which are excreted in the urine when bone is broken down. A large European study (EPIDOS) showed that high levels of CrossLaps(TM) excretion correlate with increased risk of fractures.

Results of treatment with 400iu and 800iu Macritonin(TM), when combined, showed a statistically significant reduction in the excretion of CrossLaps(TM) in the urine compared to the placebo control group who were receiving concomitant administration of vitamin D and calcium. Intranasal calcitonin was given as a positive control in the trial. Nasal calcitonin is already a registered product in a number of countries and has been shown to be effective in the treatment of osteoporosis. As expected nasal calcitonin also showed a significant reduction of CrossLaps(TM) excretion in urine in this trial. No serious side effects were observed in any treatment group.

Dr. Michael Flynn, President of Cortecs International commented: "We are very pleased with this outcome which is consistent with the European Phase II result reported last year, while the similar efficacy of Macritonin(TM) 400iu and 800iu oral doses confirms what we saw in our Phase I trials. The statistical analyses, have also yielded information which will be very useful for our USA program. The broader implications for Cortecs relate to the potential for applying the oral delivery technologies to other macromolecules."

This trial is planned to be pivotal for the European registration program and in the USA this trial is viewed as Phase II.

Osteoporosis is a very common disease. At least 200 million people worldwide suffer from the disease. Almost half of all women will have bone fractures related to the disease by the time they reach 70. The disease in the USA alone costs over US$10 Billion per year and can have a high mortality rate. About one fifth of those with hip fractures, a result of osteoporosis, die from conditions related to the fracture itself or as a result of related surgery. In the UK the disease costs the National Health Service an estimated 750 million pounds per annum

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:

o OSTEOPOROSIS - Macritonin - An oral calcitonin therapy

for the prevention of bone breakdown.

In European Phase II/III trials.

- Osteosal - A rapid doctors' office test in

development to detect increased bone

breakdown indicating the risk of the

disease osteoporosis and also to monitor

the adequacy of therapy.

o DIABETES - Oral Insulin - Preparing for European Phase II trials.

- Glycosal - Rapid doctors' office tests in

development to assist in the management

and identification of diabetes.

- Neurulin - A topical product to treat diabetic

neuropathy. In Phase II trials in Australia.

o INFECTIOUS - Pseudostat - Oral therapeutic

DISEASE immunostimulant to treat Lung infection with

Pseudomonas aeruginosa in cystic fibrosis and

chronic bronchitis. In Phase II trials

in Australia.

- Flustat - An oral vaccine against influenza in

Phase I trials in Australia.

- Helisal - A rapid doctors' office whole

blood test for the detection of

Helicobacter pylori. Launched.

- A one-step whole blood test for H.pylori

Launched in the U.K.

- Further rapid tests in development including

test for saliva and the coccoid form of H. pylori.

- Oral Therapeutic Vaccine - In development to

stimulate immunity against H. pylori.

o CANCER - Cellcom - A novel class of molecules to inhibit

signaling pathways within cancer cells

and to control their unrelenting growth.

- NPC TEST - A rapid test to assist in

diagnosing nasopharyngeal cancer.

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

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

"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 of 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.

CONTACT: Cortecs International Limited

Dr. Michael Flynn, President, 011-44-181-568-7071

or

Kehoe, White, Savage & Company, Inc.

John P. Kehoe/Van Negris, 212/888-1616

or

Buchanan Communications

Zena Bates/Lisa Baderoon, 011-44-171-489-1441

or

Brandon Harris

Dr. Geoffrey Brandon, 011-44-171-407-6854