Cortecs signs development agreement for rapid diagnostic products for the detection of Osteoporosis.

LONDON--(BUSINESS WIRE)--May 4, 1995--Cortecs International (NASDAQ:DLVRY/LSE:SEAQ Domestic ASX:CRI), the U.K.-based oral drug delivery company, has signed a collaboration agreement with the Danish diagnostics company Osteometer BioTech A/S ("Osteometer") for the development of a rapid, whole blood, point-of-care diagnostic product for the detection of collagen breakdown which is a key indicator of Osteoporosis.

Osteometer is recognized as one of the leading companies in the world in the diagnosis of Osteoporosis.

The agreement links together two of Cortec's divisions, its Rapid Diagnostics division with its Research division into the development of an oral version of calcitonin, used in the treatment of Osteoporosis.

The market for the treatment of Osteoporosis is substantial; at least 200 million people worldwide suffer from the disease. Almost half of all women will have had related bone fractures by the time they reach 70. The disease in the U.S.A. alone costs over $10 billion per annum and has a high mortality rate. For example, 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. The disease costs the U.K. National Health Service an estimated 750 million pounds per year.

The main features of the agreement are as follows:

o A range of diagnostic tests involving blood, plasma, serum

and possibly other biological fluids are proposed for

development.

o Osteometer's unique bone resorption marker technology

called Cross-laps(TM) will be joined with Cortecs' rapid

diagnostics technologies.

o The intended products are to identify patients with

increased bone resorption and to monitor responses to

anti-resorption treatments such as calcitonin.

o The strong patent position of Osteometer's and Cortecs'

technologies.

o Cortecs and Osteometer will jointly develop the products

and The Center for Clinical and Basic Research in Denmark

under the direction of Professor Claus Christiansen, a

leading authority on Osteoporosis, will coordinate the

clinical testing.

o Cortecs will manufacture the finished products and

distributors will be chosen from international corporations

involved in the management of Osteoporosis.

o Cortecs will retain the distribution rights for the U.K.

and Australia.

o The agreement is a profit-sharing arrangement and it is

planned to have products in clinical evaluation this year.

o The developed products should identify patients at

increased risk of Osteoporosis which will aid

prevention and cost containment.

Dr. Michael Flynn, president of Cortecs International and head of its Research and Development programs stated that "We are excited by this joint program with Osteometer. Since the FDA approval of nasal calcitonin in the U.S. earlier this year, there has been a growing interest in calcitonin and in Cortecs' calcitonin developments. Rapid point-of-care tests linked with effective treatments are important steps in the evolving objectives of Total Disease Management to anticipate disease, reduce costs of diagnosis and initiate treatment before complications occur."

At the end of last year, Cortecs launched the world's first whole blood rapid diagnostic kit for the detection of Helicobacter pylori, the major cause of stomach ulcers. This test can be carried out in five minutes in the doctor's office. European agreements for the H. pylori test have been signed with Astra and Boehringer Mannheim; in Japan, an agreement has been signed with Zenyaku Kogyo.

Cortecs is quoted on the London Stock Exchange, the Australian Stock Exchange and on NASDAQ. The company specializes in the development of new pharmaceutical delivery systems for the heathcare industry. Other major areas include:

o Oral Therapeutic Antigens - oral delivery of therapeutic

antigens against diseases such as influenza and pseudomonas 

infection (in cystic fibrosis) which is currently in Phase

I/II trials.

o ADEPT - an oral system to prevent and treat diarrhea

without antibiotics.

o Cortecs Healthcare markets a range of ethical and OTC 

medicines and diagnostic products.

Note to Editors

Some experts consider the incidence of Osteoporosis to have risen to epidemic proportions; it affects both sexes but postmenopausal women are most at risk. Osteoporosis is a disease involving loss of bone density resulting in brittle, easily fractured bones and affects patients in mid to old age.

There are three main types of fractures associated with Osteoporosis:

o Hip fractures, the most severe, stretch healtcare resources

and cost an estimated US$7 billion in the U.S. and U.K.

together (500 million pounds U.K). In addition, the mortality

rate is high at twenty percent in the first year.

o Colles' fractures (wrist) is the next most common with the

incidence rate being six to eight times more prevalent in

women, being most common in postmenopausal women up to 65

years of age.

o Verterbral fractures which may occur without pain and are

then difficult to detect but in most cases cause chronic

back pain especially in women over the age of 50.

Twenty-five percent of 70 year old women will have at

least one vertebral fracture.

o The disease or its effects often require hospitalization

and surgery, accounting for a high usage of hospital beds,

often leaving patients with loss of mobility and

independence and with a higher dependence on relatives

following release from the hospital.

The approved drug calcitonin offers an effective treatment. At present, calcitonin can only be administered by injection or nasally. However, Cortecs' Macromol oral delivery technology promises the possibility of an oral therapy obviating the need for injection. Cortecs perceives that the introduction of a rapid diagnostic kit for Osteoporosis together with oral delivery of calcitonin should be important for the management of Osteoporosis.

Cortecs foresaw the need for a rapid diagnostic kit in the mid eighties for the bacterium Helicobacter pylori following the discovery that it was the major cause of gastritis and peptic ulcers. The bacterium is the second most common infection in man after tooth decay. Cortecs' Helisal Rapid Blood kit was launched at the end of last year and is the world's first point-of-care diagnostic kit for H. pylori. H. pylori has also been linked to heart disease and has been declared a Class One carcinogen by the World Health Organization.

The kit provides a cost-effective accurate diagnosis enabling immediate prescription of eradication therapy which leads to a complete cure from peptic ulcers in over ninety percent of patients treated. Potential cost savings to the National Health Service (NHS) in the U.K. deriving from introduction of the test have been estimated to be in the region of 100 million pounds annually.

CONTACT: Cortecs International Limited, London

Dr. Michael Flynn/Jonathan Pockson

011-44-181-568-7071

or

Buchanan Communications, London

Zena Bates/Lisa Baderoon

011-44-171-489-1441

or

Kehoe, White Savage & Co. Inc.

Van Negris, 212/888-1616