Cortecs signs collaboration and distribution agreement with Japanese based Towa Pharmaceutical for Oral Salmon Calcitonin.

LONDON, ENGLAND, UK--(BUSINESS WIRE)--Dec. 5, 1995-- Cortecs International (NASDAQ:DLVRY/LSE:COR.L/ASX:CRI) ("Cortecs"), today announced that it has signed an exclusive 15 year sales and distribution agreement for Japan with the Osaka-based Towa Pharmaceutical Co., Ltd. (Towa) for Cortecs' oral formulation of salmon calcitonin for the treatment of osteoporosis. Towa Pharmaceutical is a growing Japanese quoted company with annual sales of US$200 million.

The main features of the 15 year agreement are as follows:

Significant milestone payments to Cortecs, commencing on signing of the agreement. Towa granted exclusive sales and distribution rights in Japan, but Towa may appoint other promotional partners in Japan to maximize sales of the product.

Towa will carry out all necessary clinical trials at their cost and obtain medical registration of the product in Japan.

Towa has the right to any improvements in the delivery system for the formulation of oral salmon calcitonin.

On November 14, 1995, Cortecs announced successful preliminary interim results of its Phase II double-blind trial of oral salmon calcitonin currently under way in Europe. Salmon calcitonin is an approved therapeutic drug which is effective in the treatment of osteoporosis but currently can oly be administered by injection or intranasally. Towa already sells injectable calcitonin in Japan and makes an ideal partner as a Japanese pharmaceutical company with relevant experience in the calicitonin market there.

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 menopause, or by diet and lifestyle imposed on the body. It is estimated that over 200 million people are afflicted with osteoporosis worldwide of whom only 10 million are currently receiving treatment. 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 U.S. alone, osteoporosis costs US$10 billion a year. Cortecs is also developing a rapid point-of-care diagnostic with a unique bone marker to help identify these untreated patients. Commenting on the agreement Dr. Michael Flynn, President of Cortecs, said: "We are very pleased to have signed this important collaboration agreement for oral salmon calcitonin with Towa. Towa is an ambitious company in Japan with an impressive projected growth rate. Furthermore, Towa's experience with calcitonin in Japan will be invaluable in obtaining registration and maximum market penetration for our oral formulation of this approved drug which is currently only approved there in its injectable form. The market for osteoporosis drugs in Japan is estimated to grow from US$1.1 billion to more than US$3 billion during the next 5 years."

Mr. Itsuro Yoshida, Executive Managing Director of Towa Pharmaceutical, stated: "This is an important step for Towa and represents our single largest commitment to date with a European company. Cortecs is a well known world leader in the field of oral delivery of biotechnology drugs. The recent European Phase II preliminary results on their oral formulation give us increased confidence that oral calcitonin is a viable therapeutic in the battle against osteoporosis."

The development process for registration of oral calcitonin in Japan will take several years; however, Towa's estimated sales during the first 5 years after launch are expected to exceed US$680 million. 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:

Oral Pseudomonas and Oral "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.

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

Point-of-Care Diagnostics - A range of innovative diagnostic kits including:

HELISAL - A rapid doctor's office test for the detection of Helicobacter pylori.

OSTEOSAL - A rapid doctor's office test in development to detect bone breakdown indicating the presence of the disease Osteoporosis.

GLYCOSAL - 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.

Cortecs already has a sales and distribution agreement in Japan for its Helisal range of rapid doctors' office diagnostic kits for the detection of the bacterium Helicobacter pylori. H. pylori is now known to be the most common cause of gastritis and peptic ulcers and is a W.H.O. Class One carcinogen. This agreement is with Tokyo-based Zenyaku Kogyo and contemplates sales in Japan over the next 7 years of #20 million.

CONTACT: Dr. Michael Flynn Van Negris

Cortecs International Kehoe, White, Savage & Co., Inc.

011 44 181 568-7071 [phone]

or

Zena Bates 

Buchanan Communications

011 44 171 489-1441