FDA Clears Diagnostic Test for Screening more than 25 Rare Diseases in Newborns; First Diagnostic Product from Glyko Biomedical Features its Patented Technology.

NOVATO, Calif.--(BUSINESS WIRE)--Nov. 8, 1995--Glyko Biomedical Ltd. (Toronto Stock Exchange:GBL; NASDEBB:GLYK) announced today that the U.S. Food and Drug Administration (FDA) has given clearance for the company to market the first screening test for children capable of detecting more than 25 lysosomal diseases.

Lysosomal diseases are hereditary defects of the lysosomal enzymes that break down and recycle carbohydrates or sugar chains in the body. These defects contribute to more than 25 separate diseases that result in neuromuscular and intellectual impairment, and in some cases, early childhood death. Lysosomal disorders -- from the more prevalent Tay-Sachs and Gaucher's diseases to the rarer Hurler and Hunter MPS diseases -- result from the accumulation of incompletely degraded sugar chains. These harmful carbohydrates build up in the body, leading to disease.

Although the incidence of any one lysosomal disease is low, as a group, lysosomal diseases are among the top ten inborn diseases, with a total incidence of about five in 10,000 births. Glyko estimates that about 30,000 people in the U.S. have a lysosomal disorder. With a wide variety of lysosomal diseases, and the cost and time of testing for each one, most medical experts agree that historically, these conditions have been underdiagnosed.

"The FACE(R) Urinary Carbohydrate Analysis Kit is a single test that gives health care providers a fast, reliable and cost-effective way to screen for a whole range of diseases that are often difficult to diagnose and costly to treat if detected at a late stage," said John C. Klock, M.D., president and chief executive officer of Glyko Biomedical. "By screening newborns and testing suspected children, we can help reduce the financial and social costs that result from late detection of these rare diseases."

Because of the wide variety of complex carbohydrates associated with each lysosomal disease, diagnosis has been difficult and usually requires early detection of symptoms, combined with a sequence of tests for each possible disease. Although some patients show severe symptoms at birth, most newborns with lysosomal disease show few or no symptoms. Most patients benefit from treatment if a lysosomal disorder is detected early enough.

With the clearance of Glyko's FACE Urinary Carbohydrate Analysis Kit, clinical laboratories now have the first single analytical method available that can be used as a primary screening test for many lysosomal diseases. Existing testing methods for various lysosomal storage diseases are cumbersome and use several different techniques. The FACE test employs a single method to screen for many lysosomal diseases simultaneously with improved accuracy and ease of use.

Glyko's new diagnostic test, which screens for these lysosomal diseases using a single urine sample, features the company's patented FACE technology (Fluorophore-Assisted Carbohydrate Electrophoresis). FACE is used to depict characteristic carbohydrate banding patterns associated with specific lysosomal diseases.

Glyko said the FACE diagnostic test will be available immediately for commercial and hospital-based laboratories. During the product's market introduction phase, Glyko also will provide its own clinical diagnostic service to accelerate the availability of the screening test. For technical or clinical information packages about the FACE Urinary Carbohydrate Analysis Kit, contact Glyko at 800/334-5956.

Glyko Biomedical, Ltd. is a Canadian holding company. The company is traded on the Toronto Stock Exchange (GBL) and the National Association of Security Dealers Electronic Bulletin Board (GLYK). Glyko, Inc., the company's U.S. subsidiary, is based in Novato, California and develops and manufactures diagnostic testing tools based on carbohydrate analysis. The company also manufactures enzymes, chemicals, imaging equipment and software for carbohydrate and sugar chain analysis used in pharmaceutical, biological, food and industrial applications. -0-

Corporate Fact Sheet

Overview

Founded in 1990, Glyko Biomedical Ltd. (TSE:GBL,NASDEBB:GLYK) is a pioneer in the field of advanced carbohydrate technology. The company is focused on developing and marketing novel applications of its carbohydrate analysis technology for use in the research, diagnostic and pharmaceutical areas. The company's products are simple, rapid and reliable carbohydrate analysis systems based on a patented FACE(R) (Fluorophore-Assisted Carbohydrate Electrophoresis) technology.

Carbohydrates

Carbohydrates are the subject of growing scientific interest, as recent research has shown that these naturally-occurring substances play a broad and varied role in human health and disease. This research demonstrates that carbohydrates perform an array of vital metabolic functions comparable to those of protein and DNA. In addition, carbohydrates are increasingly used in the food industry to replace fats in processed foods, and are being utilized with greater frequency in industrial applications.

FACE Products

FACE systems provide a complete, rapid and cost-effective approach to carbohydrate analysis. These systems, including recombinant enzymes, chemicals, imaging equipment and software, are designed for use in pharmaceutical, biotechnology, food and beverage, and industrial applications. Glyko's first diagnostic product is a newborn screening test for hereditary disorders, such as Gaucher's and Tay-Sachs disease, that result from an inability to break down carbohydrates. Commercially released in November 1995, the Urinary Carbohydrate Analysis Kit is the first such test cleared for marketing by the FDA.

Business Overview

Glyko is headquartered in a 25,000-square-foot scientific and administrative facility in Novato, Calif. and has 18 employees. In April 1995, the company completed a private placement equity offering that totalled $2.78 million. Glyko has 12 distributor relationships in Europe, Asia and Latin America, as well as collaborative research and distribution agreements with Beckman Instruments and Toyobo, Co. Ltd. and MC Medical, Inc. (Japan). The company's stock trades on the Toronto Stock Exchange (GBL), and on the National Association of Security Dealers Electronic Bulletin Board (GLYK).

Management

John C. Klock, M.D., President and Chief Executive Officer Christopher M. Starr, Ph.D., Vice President, Research and Development John Dorson, Ph.D., Vice President and General Manager John F. Hamilton, Vice President, Finance and Chief Financial Officer

Lysosomal Storage Diseases Fact Sheet

Overview

Lysosomal Storage Diseases (LSD) are a class of inherited metabolic diseases characterized by an inability to break down and recycle carbohydrate (sugar) components in the body. These defects contribute to more than 25 separate disorders -- including Gaucher's disease and Tay-Sachs disease -- that result in neuromuscular and intellectual impairment, and, in some cases, early childhood death. As many as 30,000 people in the United States may be afflicted with an LSD, which as a group constitute one of the top ten inherited metabolic diseases affecting children.

Current Diagnosis

Traditionally, children are tested for an LSD if there are clinical symptoms such as intellectual or growth impairment presented. If such symptoms go untreated, permanent, serious damage may result. Between 5,000 and 10,000 children older than newborns are tested annually for LSD in the U.S. Some children remain undiagnosed, however, because current testing methods are incapable of detecting all LSDs. Glyko's Urinary Carbohydrate Analysis test is able to detect more of these diseases and at a higher level of sensitivity. Bone marrow transplantation or enzyme therapy can often correct these conditions if the disease is detected and properly diagnosed at an early age. The only way to prevent many of the debilitating consequences of LSDs is to diagnose and begin treatment as early as possible. The company believes that its new test, if used to screen newborns from high risk groups and if used early for infants with delayed development, will result in improved diagnosis and therapy of these conditions.

Glyko Urinary Carbohydrate Analysis Kit

Commercially released in November 1995, the Glyko Urinary Carbohydrate Analysis Kit is the first such diagnostic test cleared for marketing by the Food and Drug Administration. The new test, which is used to identify "abnormal" carbohydrates in the urine of affected patients, is capable of detecting more than two dozen conditions in the LSD group. Simpler to administer, more efficient and more quantitative than existing testing methods, the Lysosomal Diagnostic Test is suitable for use as a primary newborn screening test for the majority of LSDs. The test is based on Glyko's proprietary FACE(R) (Fluorophore-Assisted Carbohydrate Electrophoresis) technology, which is used to depict characteristic carbohydrate banding patterns associated with specific LSDs.

The Market

The current market for screening Lysosomal Storage Diseases has been estimated at $4 million. Glyko believes that in the future additional indications could be approved for using its test to monitor treatments. This could bring the market potential to between $15 and $20 million.

CONTACT: Glyko Biomedical

John F. Hamilton, 415/382-3500

or

StratiPoint Group

Mike Jackman, 415/388-3216