SYBB gapping Company Press Release
SYNSORB Biotech Inc. Announces Synsorb Pk -R- Receives Fast Track Product Designation From USFDA
CALGARY, Alberta--(BUSINESS WIRE)--March 13, 2000--SYNSORB Biotech Inc. (``SYNSORB') (TSE: SYB - news; Nasdaq: SYBB - news) today announced that SYNSORB Pk© has received formal notification of Fast Track Product designation from the United States Food and Drug Administration (FDA) for the prevention of Hemolytic Uremic Syndrome (HUS), a debilitating kidney disease most often associated with E. coli O157:H7 infections.
``SYNSORB is very excited about SYNSORB Pk© being granted this designation for the serious and life-threatening HUS condition,' stated Dr. David Cox, President and CEO of SYNSORB. ``We continue to enroll patients in the Phase III trial, and are currently conducting an interim analysis on the data from which we expect to have further information by the end of the second quarter. This analysis will enable SYNSORB to determine future timelines for this product, which if successful in trials, may provide clinicians with the first and only therapy available to combat this dreadful disease.'
Fast Track is a highly desirable designation for drugs undergoing clinical development, and is only granted to products that are intended to treat serious or life-threatening conditions, and for which there is an unmet medical need. Fast Track drugs receive special assistance and support from the FDA during their development and the review process for these products is shorter than would otherwise be the case, thus allowing the drugs to reach market more quickly, if approved. Fast Track designation has been granted to SYNSORB Pk© for the prevention of HUS as it is considered a serious or life-threatening condition that represents a critical aspect of E. coli O157:H7 infections. The FDA believes that the mode of action of SYNSORB Pk© offers a new therapy that can potentially treat this serious illness, which has no alternate therapy available.
In July 1999, the FDA granted SYNSORB Pk© Fast Track Product Designation for the treatment of diarrhea associated with E. coli O157:H7 infections. SYNSORB Pk© is currently being tested only as a prevention of HUS therapy, not as a diarrhea treatment; therefore the Company requested that the previous designation be changed to reflect the more serious consequences of the disease. Therefore, SYNSORB Pk© now has Fast Track Designation as a therapy for the prevention of HUS.
SYNSORB is a Canadian-based pharmaceutical company dedicated to drug development and manufacturing. The Company has two late-stage products, both of which are based on SYNSORB's proprietary carbohydrate chemistry platform technology. SYNSORB Cd© will commence Phase III trials within the first half of 2000, and is designed to treat recurrent Clostridium difficile antibiotic-associated diarrhea (CDAD), a common hospital acquired infection. SYNSORB Pk© is in Phase III clinical trials, and is designed to prevent the progression to Hemolytic Uremic Syndrome (HUS) in children who have contracted verotoxigenic E. coli (VTEC) infections, including E. coli O157:H7. SYNSORB has built a cGMP-compliant manufacturing facility that has the capacity to meet or exceed the expected global demand for the Company's products. A pipeline of future products is accessible through SYNSORB's carbohybrid program.
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 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.
Cindy Gray, 403/270-1315
403/ 283-5907 (FAX)
cgray@synsorb.com
synsorb.com
or
The Equicom Group
Jason Hogan, 416/815-0700
416/815-0080 (FAX)
jhogan@equicomgroup.com |
