Cortecs announces positive preliminary Phase II results for oral delivery of salmon calcitonin for the treatment of osteoporosis.

LONDON--(BUSINESS WIRE)--Nov. 14, 1995--Cortecs International (NASDAQ:DLVRY/LSE:COR.L/ASX:CRI)("Cortecs"), today announced preliminary results of its Phase II trial of oral salmon calcitonin currently under way in Europe.

The double blind trial evaluated the effect of oral salmon calcitonin administered to patients in normal daily doses of 400 iu on inhibiting the breakdown of bone. Preliminary results reviewing the excretion of the bone maker deoxypyridinoline (DPD) and CrossLaps(TM), after oral calcitonin show a significant fall in the rate of bone breakdown. CrossLaps(TM), a marker of bone breakdown, was developed by Cortecs and is marketed by Osteometer AB.

Oral Calcitonin is administered using a proprietary technology for the oral delivery of biotechnology drugs developed by Cortecs. Salmon calcitonin is an approved therapeutic drug which is effective in the treatment of osteoporosis but which is normally administered by injection or intranasally.

Bone breakdown (bone resorption), causes osteoporosis and occurs when the body's natural process of bone removal and replacement gets out of balance, caused either by normal events in the body's life-cycle, such as the menopause, or by diet and life-style imposed on the body. It is estimated that over 200 million people are afflicted with osteoporosis world-wide. Almost half of all women will have had related bone fractures by the time that they are 70. Furthermore, it is estimated that in the USA alone, osteoporosis costs US $10 billion a year, whilst in the UK the current estimate is 750 million pounds.

Cortecs president Dr. Michael Flynn said today: "These preliminary results are encouraging and lead us to be quite optimistic for the whole trial. Furthermore, success in the oral delivery of an approved drug like salmon calcitonin opens up the prospect of success with other oral formulations of approved biotechnology drugs."

Prof. Claus Christiansen, an acknowledged world expert on osteoporosis from the Centre for Clinical and Basic Research in Denmark, added: "These interim results must be very encouraging for Cortecs. From existing knowledge about osteoporosis and calcitonin, if this oral formulation can reduce bone resorption, then it should translate into an effect on bone mineral density. The most important point, however, is that in this delivery system calcitonin appears to be absorbed to the extent that it has a clear biological effect in osteoporosis patients."

In May of this year, Cortecs announced a collaboration with Prof. Christiansen's company Osteometer AB to develop a rapid diagnostic product for the doctor's office to detect bone breakdown. In July, a collaboration was announced with Prof. Christiansen's Centre for Clinical and Basic Research to finance and carry out further clinical trials necessary to satisfy European regulatory requirements for the registration and commercialization of Cortec's oral salmon calcitonin formulation for the treatment of osteoporosis.

Cortecs is a British-based company quoted on the London Stock Exchange, Nasdaq and the Australian Stock Exchange. The company specializes in the development of new pharmaceutical delivery systems and rapid point-of-care diagnostics for the healthcare industry. Other major areas include:

o Oral Calcitonin - a system has been developed for the oral delivery of biotechnology drugs such as Calcitonin, which is a treatment for the bone-wasting condition Osteoporosis, and which is presently in Phase II clinical trails.

o Oral pseudomonas and Flu Preventatives and Treatments - orally delivered treatments against diseases such as influenza and also pseudomonas infection (in cystic fibrosis) which is currently in Phase I/II trials.

o Oral Anti-Diarrhoeal - an oral system to prevent diarrhoea without antibiotics.

o Point-of-Care Diagnostics - a range of innovative diagnostic kits

including:

- Helisal - rapid doctor's office test for the detection of

Helicobacter pylori.

- A rapid doctor's office test in development to detect bone

breakdown indicating the presence of the disease Osteoporosis.

- A rapid doctor's office test in development to assist in the

monitoring of the medium and longer-term control of diabetes.

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

CONTACT: Cortecs International

Jonathan Pockson, 011 44 181 568-7071

or

Kehoe, White, Savage & Co. Inc.

Van Negris, 212/888-1616

or

Buchanan Communications

Zena Bates, 011 44 171 248-3780