News | February 16, 1999

Synsorb Biotech Inc. Announces Commencement of Operations at Calgary Manufacturing Facility

CALGARY, ALBERTA (Feb. 16) BUSINESS WIRE -Feb. 16, 1999-- SYNSORB Biotech Inc.(NASDAQ:SYBBF) (TSE:SYB.)

State of the art facility to be used for commercial manufacture of SYNSORB Pk(R) and SYNSORB Cd(R)

SYNSORB Biotech Inc. ("SYNSORB") proudly announced today that it has commenced operations and systems validation at its flagship fine chemical manufacturing facility in Calgary, Alberta, Canada. Design on the 30,000 square foot facility christened "Prospect Place", began in November of 1997 and in March 1998, construction began and continued through the year. It is one of the only manufacturing facilities of its kind in Canada and is designed to meet the requirements of current Good Manufacturing Practice (cGMP) for pharmaceutical products.

Prospect Place was built with loan assistance totaling $11 million from CIBC Knowledge Based Business and FINOVA (Canada) Capital Corporation. The facility has been designed and constructed to enable commercial manufacturing of the Company's two lead products, SYNSORB Pk(R) and SYNSORB Cd(R) from raw materials through to finished dosage form using the Company's proprietary and unique carbohydrate chemical technology. SYNSORB expects that the facility's capacity is capable of meeting the demands of the global market for these products. SYNSORB Pk(R) and SYNSORB Cd(R) will be the first finished products to emerge from the new facility, but the Company anticipates that future products will also be manufactured there.

SYNSORB Pk(R) is currently being tested as a treatment for the severe complications associated with verotoxigenic E. coli (VTEC) infections (including E. coli O157:H7), a food-borne disease which primarily affects children. The VTEC toxin affects a number of different parts of the body including the gut wall, red blood cells, the kidneys and the Central Nervous System, leading to conditions such as Hemorrhagic Colitis, Hemolytic Anemia, Hemolytic Uremic Syndrome and death, respectively. Approximately 5 to 20 percent of children who contract VTEC infections progress to Hemolytic Uremic Syndrome (HUS). SYNSORB Pk(R) is currently in Phase III clinical trials and continues to enroll patients at 3 sites in Canada, 11 in the US and 4 in Argentina.

Results from an open-label study on SYNSORB Pk(R) conducted by SYNSORB's corporate partner in Japan, Takeda Chemical Industries Ltd., were announced in November. The Principal Investigator concluded that when SYNSORB Pk(R) is administered with antibiotics in the early stages of the disease, the drug is safe and effective in preventing the progression to serious complications, such as HUS. The Japanese trial also revealed that SYNSORB Pk(R) strongly bound the toxin produced by VTEC. Patients who had high levels of toxin in their stool when enrolled had no detectable toxin after just one day of taking SYNSORB Pk(R).

The Company continues to conduct an interim analysis on the SYNSORB Pk(R) data and a meeting has been scheduled with the US Food and Drug Administration in March, 1999, to discuss these data and explore possibilities for accelerating completion of the SYNSORB Pk(R) program.

SYNSORB Cd(R) is designed to treat severely recurrent Clostridium difficile associated diarrhea (CDAD), commonly caused by extended antibiotic therapy. SYNSORB Cd(R) is undergoing Phase II clinical trials and patient enrollment continues to accelerate in Canada and the US. Currently, there are 10 sites actively enrolling in Canada and 15 sites enrolling in the US. The US arm has a further 6 sites targeted for inclusion in the trial.

"Our commitment to these products is unequivocal and is evidenced by the fact that we have invested significant money and other resources in manufacturing and clinical trial infrastructure," said Dr. David Cox, President and C.O.O. of SYNSORB Biotech Inc., "We continue to devote the preponderance of our resources on the development of these two drugs. The Company is doing everything we can to see that SYNSORB Pk(R) and SYNSORB Cd(R) progress as quickly as possible."

In addition to having two late stage products in clinical trials, SYNSORB has also expanded its strategic direction to include the clinical development of other small molecule-based therapeutics within SYNSORB's targeted disease indications. This is exemplified by the research agreement recently announced with Ocean Pharmaceuticals Inc., a biotech firm that specializes in finding new classes of antibiotics from marine microorganisms, and the letter of intent with GeneSense Technologies Inc., a Toronto company developing antisense technology targeting cancer. These agreements are intended to provide potential compounds for clinical development that supplement SYNSORB's products presently in clinical trials.

SYNSORB Biotech Inc. is an innovative Canadian pharmaceutical company that is focussed on drug development. Its core competence is in acquiring potential products or compounds emerging from the research and development of third parties, developing these compounds, and providing channels to market. The Company currently has two products in late stage clinical trials, SYNSORB Pk(R) and SYNSORB Cd(R). SYNSORB Pk(R), in Phase III trials in North and South America, is designed to treat verotoxigenic E. coli (VTEC) infections (including O157:H7). SYNSORB Cd(R), is in Phase II trials in Canada and the United States for recurring or relapsing antibiotic-associated diarrhea (CDAD). SYNSORB has additional compounds in pre-clinical development, including potential cancer treatments and novel antibiotics, with inflammation and anti-virals targeted in the Company's research and development program.

Shares of SYNSORB Biotech Inc. trade on the Toronto Stock Exchange in Canada (symbol "SYB") and on NASDAQ in the United States (ticker "SYBBF").

This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending clinical trials, actions by the FDA/HPB and those factors detailed in the Company's registration statement on Form 20 F filed with the Securities and Exchange Commission.

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CONTACT: SYNSORB Biotech Inc.

           Dr. David Cox, 403/ 283-5900 

403/ 283-5907 (FAX)

           http://www.synsorb.com 

or

           The Equicom Group 

Jason Hogan, 416/ 815-0700 ex 222

           416/ 815-0080  (FAX) 

United States: (800) 385-5451

               or 

SYNSORB Biotech Inc.

           Dr. Murray Ratcliffe, 403/ 283-5900 

403/ 283-5907 (FAX)

               or 

SYNSORB Biotech Inc.

           Mr. Doug Froom, 403/ 283-5900 

403/ 283-5907 (FAX)

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