Cortecs International announces positive results for first Phase II trial of oral salmon calcitonin in postmenopausal osteoporosis.

LONDON--(BUSINESS WIRE)--April 10, 1996--Cortecs International (NASDAQ:DLVRY / LSE:COR / ASX:CRI) today announced positive final results of the first Phase II clinical trial of its oral salmon calcitonin formulation which has been carried out in Europe. Salmon Calcitonin (sCT) is an approved therapeutic drug which is effective in the treatment of osteoporosis but which is normally administered by injection or intranasally. The double blind trial evaluated the effect of Cortecs' oral formulation of salmon calcitonin on inhibiting the breakdown of bone measured by the excretion of the bone marker CrossLaps(TM).

In a double-blind randomized trial, 12 patients received oral sCT 400IU daily for six months and 12 patients received placebo. Serial early morning urine samples were taken before daily treatment. The main response criterion was changes in urinary excretion of the bone resorption marker CrossLaps(TM) (Osteometer), a marker of bone resorption which has recently been approved by the U.S. Food and Drug Administration (FDA). These results follow the positive preliminary Phase II results announced in November 1995 where patients treated with oral calcitonin showed a significant fall in the rate of bone breakdown during the first 12 hours after each dose.

A 50% difference was observed between the two groups for this marker after six months of treatment. The difference between oral sCT and placebo increased significantly between the 4th and the 24th weeks of treatment (p<0.05). The CrossLaps(TM) assay highly differentiates between different levels of bone resorption. Bone mineral density did not change significantly during this six month study.

Bone resorption causes osteoporosis and occurs when the body's natural process of bone removal and replacement gets out of balance, caused either by natural events, such as the menopause, or by diet and life-style. It is estimated that over 200 million people world-wide have osteoporosis. Almost half of all women will have had related bone fractures by the time they are 70. The disease has a significant mortality. For example, about 20% of those who suffer hip fractures due to osteoporosis die as a result of related conditions or as a result of related surgery. Furthermore, it is estimated that in the U.S. alone, osteoporosis costs US$10 billion a year, while in the U.K. the current estimated cost to the National Health Service (NHS) is 750 million pounds.

Dr. Michael Flynn, President of Cortecs International Limited, commented: "This result is very important for our program with oral salmon calcitonin We already knew from the interim results, announced last November, that the type of response obtained with oral sCT during the first 12 hours after dosing was similar in patients and in healthy subjects and that CrossLaps(TM) seemed to be the most sensitive indicator of effect. The main challenge of the present trial was to determine if the long term baseline of CrossLaps(TM) excretion could also be reduced.

Dr. Flynn also commented: "The recent FDA approval of CrossLaps(TM) as a measure of bone resorption is also good news for both the oral calcitonin program which is scheduled for its first registration application at the end of 1996 and our collaboration with Osteometer to produce a rapid point-of-care test to detect increased bone breakdown."

Professor Claus Christiansen, Chairman of Osteometer and the Centre for Basic and Clinical Research in Denmark, an acknowledged world expert on osteoporosis, added: "Nasal calcitonin would produce about 30% reduction of CrossLaps(TM) excretion, so Cortecs must be encouraged with this result. We would not normally expect to see an effect on bone mineral density in such a small and relatively short trial. We are looking forward now to a comparative trial of oral and nasal salmon calcitonin in osteoporosis."

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 management of serious diseases such as:

OSTEOPOROSIS Oral Calcitonin - an oral therapy for the prevention of bone breakdown.

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

HELICOBACTER PYLORI Helisal(TM) - rapid doctors' office whole blood test for the detection of Helicobactor pylori 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 development in collaboration with Exocell to assist in the management and identification of diabetics.

CYSTIC FIBROSIS Pseudostat - oral therapeutic antigens to treat and prevent lung infection with Pseudomonas aeruginosa entering Phase II Trials.

INFLUENZA Flustat - oral vaccine against influenza entering human trials this year.

DIARRHOEA Adept - an oral system to treat diarrhoea with out antibiotic's entering Phase II trials.

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

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

CONTACT: Cortecs International Ltd., London

Dr. Michael Flynn, 011 44 181 568-7071

or

Buchanan Communications

Zena Bates, 011 44 171 489-1441

or

Kehoe, White, Savage & Co., Inc., New York

Van Negris, 212/888-1616