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Cortecs Signs Important Exclusive Distribution Agreement With Boehringer Mannheim on Helisal Diagnostic Kit.


LONDON--(BUSINESS WIRE)--Nov. 14, 1995--Cortecs International (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:DLVRY/LSE:SEAQ/ASX:CRI CRI

constant-rate infusion.
)("Cortecs"), announced today that it has signed a distribution and collaboration agreement with Boehringer Mannheim Corporation of Indianapolis, Indiana ("Boehringer") for exclusive distribution in the United States of Cortec's Helisal(TM) Rapid Blood diagnostic kit. The Helisal(TM) kit is a unique doctor's office test for the detection of the bacterium Helicobacter pylori Helicobacter pylori
A gramnegative rod-shaped bacterium that lives in the tissues of the stomach and causes inflammation of the stomach lining.

Mentioned in: Indigestion, Ulcers

Helicobacter pylori
. Boehringer is the U.S. arm of Boehringer Mannheim in Mannheim Germany, the second largest diagnostic company in the world, and is a part of the Corange Group, the global health care and diagnostic company.

The agreement runs for a minimum term of ten years, with anticipated revenues of US$24 million during the first six years based on Boehringer's sales projections.

The announcement follows on a similar pound 19 million agreement with Boehringer in March, 1995 for Helisal Rapid Blood, covering 87 countries outside of the U.S.A., and an exclusive worldwide distribution agreement with Boehringer in October, 1994 for a serum-based ELISA ELISA (e-li´sah) Enzyme-Linked Immuno-Sorbent Assay; any enzyme immunoassay using an enzyme-labeled immunoreactant and an immunosorbent.

ELISA
n.
 H. pylori antibody laboratory test.

Under the terms of the agreement, Boehringer has the first right to negotiate for other Helisal(TM) products and rights to any improvements to the Helisal(TM) Rapid Blood test, while Cortecs has the option of appointing an additional pharmaceutical marketing partner in the U.S.

Cortecs has already filed a 510(k) application with the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) for the Helisal(TM) Rapid Blood test.

The H. pylori bacterium is the most common cause of gastritis and peptic ulcers and has been declared a Class One carcinogen carcinogen: see cancer.
carcinogen

Agent that can cause cancer. Exposure to one or more carcinogens, including certain chemicals, radiation, and certain viruses, can initiate cancer under conditions not completely understood.
 by The World Health Organization. It is now estimated that as many as 1 in every 3 people are afflicted with this bacterium throughout the world. Simple, cost and time effective, the Helisal Rapid Blood test provides effective screening for those most at risk to infection with H. pylori due to age, sociological or familial reasons.

Glen Travers, Executive Chairman of Cortecs said today: "We are delighted to expand our collaboration with Boehringer on the distribution of Helisal(TM) to the U.S. market. Combined with existing eradication therapies, the Helisal(TM) point-of-care test will assist in achieving Total Disease Management, a concept which is being increasingly demanded and adopted by U.S. health care authorities and those responsible for managing health care programs. We are proud to offer an accurate, cost-effective, point-of-care rapid diagnostic test product such as Helisal(TM) Rapid Blood that has attracted the interest and participation of international healthcare companies of world stature such as Boehringer Mannheim, Astra Hassle and Zenyaku Kogyo in Japan. The three major distribution agreements in place anticipate sales of Helisal(TM) in excess of pound 50 million in the next five to seven years following registration in the U.S. and Japan, which is expected in 1996."

Cortecs is a British-based company quoted on the London Stock Exchange London Stock Exchange

London marketplace for securities. It was formed in 1773 by a group of stockbrokers who had been doing business informally in local coffeehouses.
, Nasdaq and the Australian Stock Exchange Australian Stock Exchange (ASX)

Australia's major securities market, formed when the six state stock exchanges (Adelaide, Brisbane, Hobart, Melbourne, Perth, and Sydney stock exchanges) were merged in 1987.
. 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 calcitonin /cal·ci·to·nin/ (-to´nin) a polypeptide hormone secreted by C cells of the thyroid gland, and sometimes of the thymus and parathyroids, which lowers calcium and phosphate concentration in plasma and inhibits bone resorption.  - 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 trials.

o Oral pseudomonas Pseudomonas

A genus of gram-negative, nonsporeforming, rod-shaped bacteria. Motile species possess polar flagella. They are strictly aerobic, but some members do respire anaerobically in the presence of nitrate.
 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:

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

o A rapid doctor's office test in development to detect bone breakdown indication the presence of the disease Osteoporosis.

o A rapid's 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 OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
 medicines and diagnostic products.

CONTACT: Cortecs International

Dr. Michael Flynn, 011 44 181 568-7071

or

Buchanan Communications

Zena Bates Bates   , Katherine Lee 1859-1929.

American educator and writer best known for her poem "America the Beautiful," written in 1893 and revised in 1904 and 1911.
, 011 44 171 489-1441

or

Kehoe, White, Savage & Co., Inc.

Van Negris, 212/888-1616

INDUSTRY KEYWORD: MEDICINE REPEATS: New York 212-575-8822 or 800-221-2462; Boston 617-236-4266 or

80
COPYRIGHT 1995 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1995, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Nov 14, 1995
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