Cortecs signs innovative agreement to finance clinical testing and registration of Oral Calcitonin for treatment of osteoporosis; European clinical double-blind oral calcitonin trials ongoing and being expanded.

LONDON--(BUSINESS WIRE)--July 14, 1995--Cortecs International (NASDAQ:DLVRY)(LSE:SEAQ)(ASX:CRI)("Cortecs"), the U.K.-based oral drug delivery company, today announced that it has signed a new agreement with The Center for Clinical and Basic Research ("CCBR") and Osteometer BioTech A/S of Ballerup in Denmark.

Osteometer will finance and CCBR will carry out the further clinical trials necessary to satisfy European regulatory requirements for the registration and commercialization of Cortecs' oral calcitonin formulation which is currently in clinical trials in the treatment of Osteoporosis.

CCBR is one of the world's leading research establishments in Osteoporosis. They will provide resource and expertise which will be invaluable in taking Cortecs' oral calcitonin formulation through its final clinical trials and on to registration. Under the agreement, certain trials may be performed under a U.S. IND (Investigational New Drug) application to support an eventual U.S. NDA (New Drug Application). Subject to the results of ongoing trials, expected within this year, and additional data required for registration purposes, it is intended to have a product license application during 1996. This agreement was signed after biological samples from some of Cortecs' Phase I tests had been assayed at Osteometer for levels of CrossLaps(TM), a marker of bone turnover the excretion of which falls when anti-resorptive treatment is used.

In return for financing this phase in the product's development, Osteometer will receive a royalty on Cortecs' oral calcitonin income. This is an innovative arrangement to finance the costly late-stage clinical trials necessary for registration and commercialization of a care therapeutic product.

The market for the management of Osteoporosis is substantial. At least 200 million people world-wide suffer from the disease. Almost half of all women will have related bone fractures by the time they reach 70. The disease in the U.S.A. alone costs over US$10 billion per year and can have a high mortality rate. For example, about one-fifth of those with hip fractures due to Osteoporosis die from the fracture and its complications. In the U.K., the disease costs the National Health Service an estimated 640 million pounds per year.

Dr. Michael Flynn, president of Cortecs International, stated: "This collaboration is a logical step following our earlier agreement with Osteometer to develop rapid point-of-care diagnostic kits for the assessment of bone collagen breakdown, a key indicator that a patient may be excessively resorbing bone. Such tests, linked with effective treatments, are important steps in the evolving objectives of Total Disease Management to anticipate disease, simplify, accelerate and reduce costs of diagnosis and initiate treatment before complications occur. This agreement with CCBR and Osteometer enables the company to bring world-leading clinical expertise into the program, as well as funding expensive clinical trials. It also allows the company to retain flexibility to take the product through to registration before bringing in a marketing partner should it so wish."

Cortecs International also issued an update of its Oral Calcitonin Clinical Program. Cortecs' European clinical double-blind trials of oral calcitonin in patients with Osteoporosis is ongoing and being expanded. One protocol allows for independent interim analyses without revealing the code to the company or the investigators. Independent analyses so far cover the first few time-points of the trial and early results conform to expectations. However, evidence of therapeutic effect on bone resorption would not be expected until time-points covering three to six months of treatment have been evaluated. No significant adverse events have been reported and the trials are continuing.

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 for the healthcare industry. Other major areas include:

-- MACROMOL - a system for the oral delivery of biotechnology drugs, such as Calcitonin, which is presently in Phase II clinical trials.

-- Oral Therapeutic Antigens - orally delivered treatments against diseases such as influenza and pseudomonas infection (in cystic fibrosis) which is currently in Phase I/II trials.

-- ADEPT - an oral system to prevent and treat diarrhea without antibiotics.

-- Point of Care Diagnostics - a range of diagnostic kits including:

-- HELISAL for the detection of Helicobacter pylori.

-- A rapid test in development to detect bone breakdown

indicating the presence of the disease Osteoporosis.

-- A rapid 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. -0-

Note to Editors

DISEASE MANAGEMENT

On May 4, 1995, Cortecs announced a collaboration with Osteometer to develop rapid point-of-care versions of CrossLaps(TM) for the detection and monitoring of Osteoporosis. The concept of an accurate, cost-effective, point-of-care diagnostic test, combined with an effective and safe oral therapeutic, provides the prospect of a radical change in the management of a disease which has been described by the National Osteoporosis Society in the U.K. as having reached epidemic proportions.

The disease affects both sexes but post-menopausal 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:

-- Hip fractures, the most severe, stretch healthcare resources and cost an estimated US$7 billion in the U.S. and U.K., together (500 million pounds in the U.K.). In addition, the mortality rate is high at twenty percent (20%) in the first year.

-- 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.

-- Vertebral 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 (25%) of 70 year-old women will have at least one vertebral fracture. 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.

CONTACT: Cortecs International

Dr. Michael Flynn

011-44-181-568-7071

or

Buchanan Communications

Zena Bates 

011-44-171-489-1441

or

Kehoe, White, Savage & Co., Inc.

Van Negris, 212/888-1616