Cortecs Plans First European Macritonin Registration by end August; Further Positive Trials Data Received.

LONDON--(BW HealthWire)--Aug. 7, 1997--Statistical analysis of the three-month clinical end-point of Cortecs International's ongoing double-blind European Phase II/III trial of Macritonin(TM) in osteoporosis has now been completed. The final data provides additional information and confirmation of the initial positive results announced on May 13th and confirms the ability of Cortecs' technology to deliver orally the peptide calcitonin. The findings in this trial are also consistent with those in earlier Phase I and Phase II Macritonin(TM) studies and the Company intends to file its first registration application within Europe before the end of August. The registration application will be the first registration application of an oral version of the approved peptide drug, salmon calcitonin. Macritonin(TM) is Cortecs' oral formulation of salmon calcitonin which is a well tolerated treatment for osteoporosis presently given by injection and (in some countries) intranasally.

The ongoing European Phase II/III Macritonin(TM) trial is planned to continue for two years, during which time the effects of Macritonin(TM) on bone mineral density will also be measured at the one and two year time points. This data will be required for our US registration programme. The Company already has IND status in the US for Macritonin(TM) and aims to commence its US clinical trials programme in the fourth quarter 1997.

The final results announced today contain data for three bone break down markers namely, deoxypyridinoline ("DPD"), pyridinoline ("PYD") and CrossLaps(TM) which are recognized as being the most reliable bone markers of high bone turn over. DPD and CrossLaps(TM) are approved by the US Food and Drug Administration. The three markers were used to demonstrate the effectiveness of oral calcitonin in reducing bone destruction by measuring the reduction of their excretion in urine when bone is broken down. The final data has shown that the three markers have established that the actions of oral calcitonin and the registered product, intranasal calcitonin, are similar. A clear dose response effect was seen for DPD and PYD, with optimal effect at the 400iu dose as observed with CrossLaps(TM) in earlier trials. The final analysis shows that for DPD and PYD, the Macritonin(TM) 400iu and the 800iu doses were significantly different from placebo, (P<0.002) and (P<0.02) respectively, as was nasal calcitonin (P<0.03). The mean effect on DPD and PYD and the variance were similar with 400iu Macritonin(TM) and nasal calcitonin.

Commenting, Dr. Michael Flynn, President of Cortecs, said: "The results are as we expected and we now have a series of trials which demonstrate that oral calcitonin has similar activity to nasal calcitonin. Macritonin(TM) should be our first major therapeutic product to be registered, following which we would intend to work towards a product launch at the earliest opportunity in the first European countries. We are also completing our manufacturing unit for Macritonin and are preparing to manufacture for our U.S. clinical trials programme.

The Company has received approaches from a number of interested potential marketing partners. Oral delivery of peptide and protein biotechnology drugs, which are normally only administered by injection, has long been an industry goal. The broader implications for Cortecs' success in delivering a peptide orally relate to the potential for applying our oral delivery technologies to other macromolecules such as insulin where we are preparing for a European Phase II study."

Osteoporosis is very common and 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 has recently been estimated to cost over US$14 billion per year and can have a high mortality rate. About one fifth of those with hip fractures resulting from osteoporosis, die from conditions related to the fracture itself or as a result of related surgery within twelve months of the fracture. In the UK the disease costs the National Health Service an estimated 750 million British Pounds per annum.

Calcitonin is presently only available as an injectable or intranasal product. Current sales world wide are estimated to be U.S.$800 million per annum in these forms. However, the rapid success of the intranasal product in gaining more than a 32% (Scrip World Pharmaceutical News October 11, 1996) of all new US prescriptions for post-menopausal osteoporosis following its launch in the US, indicates that there is a demand for calcitonin in a non-injectable form. Cortecs believes that an oral product will be much more acceptable to patients for treatment over a long term, leading to better compliance.

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 oral pharmaceutical delivery systems, new oral mucosal vaccines and point-of-care rapid diagnostics which provide the opportunity to advance the management of serious diseases such as:

OSTEOPOROSIS Macritonin(TM) Oral calcitonin therapy for the

prevention of bone breakdown.

Preparing for first European

country registration application.

Osteosal(TM) Rapid Doctors' office test to detect

increased bone breakdown indicating the

risk of osteoporosis and also to

monitor the adequacy of

osteoporosis therapy. In late stage

development DIABETES Macrulin(TM) Oral formulation of insulin. Preparing

for European Phase II trials.

Glycosal(TM) Rapid doctors' office tests in

development to assist in the

management and identification of

diabetes.

Neurulin l(TM) Topical product to treat diabetic

neuropathy. In Phase II trial INFECTIOUS Pseudostat(TM) Oral therapeutic vaccines to DISEASE prevent and treat lung infection with

Pseudomonas aeruginosa in cystic

fibrosis and chronic bronchitis. In

Phase II trials.

INFLUENZA lustat(TM) Oral vaccine against influenza in

Phase I trial. H. PYLORI Helisal(TM) Rapid doctors' office whole blood

test to detect H.pylori. Launched.

'One-step' A whole blood 'one step'

test for H. pylori. Launched in the

UK.

Further rapid tests in

development including test for the

coccoid form of H.pylori.

Ulsastat(TM) Oral Therapeutic Vaccine in

development to stimulate immunity

against H.pylori

CANCER Cellcom Novel class of molecules to inhibit

signaling pathways within cancer

cells and to control their unrelenting

growth. In pre-clinical trials.

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

"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. -0- Cortecs Internet Web site - http://www.cortecs.com

CONTACT: Inquiries:

Cortecs International Limited

Dr. Michael Flynn, President

Tel [phone]

or

Buchanan Communications

Zena Bates/Lisa Baderoon

Tel: [phone]

Brandon Harris

Dr. Geoffrey Brandon

Tel: - [phone]