THE PRESS RELEASE FROM SEPT. 30/99
SYNSORB Biotech Inc. Announces Canadian Marketing and Distribution Agreement for SYNSORB Cd(R) With Paladin Labs Inc.
CALGARY, ALBERTA--SYNSORB Biotech Inc. ("SYNSORB") (TSE: SYB, Nasdaq: SYBB) today announced that it has signed its first exclusive licensing agreement for the marketing and distribution rights for SYNSORB Cd(R) in Canada with Montreal-based Paladin Labs Inc. ("Paladin") (VSE:PLB).
SYNSORB Cd(R) is SYNSORB's second product entering Phase III clinical trials, after SYNSORB Pk(R). The product is designed to treat the recurrent form of Clostridium difficile-associated diarrhea (CDAD), a common hospital borne infection that is associated with extended antibiotic therapy. A Phase II clinical trial for SYNSORB Cd(R) recently reached an accelerated conclusion after an interim analysis of the data showed statistically compelling evidence of efficacy at the high dose.
The rate of recurrence for the patients receiving the high dose of SYNSORB Cd(R) was 13%, compared to 63.6% for patients receiving placebo. The trial was halted and planning for Phase III testing began immediately.
"SYNSORB is very excited to be announcing this partnership for SYNSORB Cd(R)," said Dr. David Cox, President and CEO of SYNSORB. "Not only did we recently announce better than expected results from our Phase II study, we have also already concluded our first partnership for the product. We are delighted to be working with Paladin for the marketing and distribution in Canada of both SYNSORB Pk(R) and SYNSORB Cd(R)."
Under the terms of the agreement, SYNSORB and Paladin will share equally in future revenues from Canadian sales of SYNSORB Cd(R). Paladin has made an initial up-front payment to SYNSORB on signing, with additional milestone payments to be triggered by the approval of a Canadian New Drug Submission (NDS), and the achievement of certain sales levels. SYNSORB will continue the development of SYNSORB Cd(R) and will manufacture and supply the product to Paladin as part of the Agreement. Paladin will be responsible for all aspects of the marketing and sale of SYNSORB Cd(R) in Canada.
Paladin is a Canadian pharmaceutical company with proven expertise in the marketing and distribution of niche products in Canada. Paladin also has the rights to market and distribute SYNSORB Pk(R) in Canada. "We are thrilled to expand our relationship with SYNSORB to include another of SYNSORB's promising innovative products in our pipeline," stated Jonathan Goodman, President of Paladin. "Based on our market research, we know that SYNSORB Cd(R) is designed to treat a significant unaddressed medical need and are confident that the product will be well received by Canadian physicians."
SYNSORB's first product, SYNSORB Pk(R), is undergoing Phase III testing for the prevention of Hemolytic Uremic Syndrome (HUS) associated with E. coli infections. This trial continues to enroll patients at sites across North and South America.
Paladin, headquartered in Montreal, Quebec is a Canadian developer, marketer and distributor of innovative pharmaceuticals currently offering products in urology, dermatology, rheumatology and other specialty markets. For more information about Paladin, please visit the Paladin Web Site at www.paladin-labs.com or send e-mail to ir@paladin-labs.com.
Paladin is a public company whose shares trade on the Vancouver Stock Exchange under the symbol "PLB".
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 Pk(R) 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 Cd(R) will commence Phase III trials in the first part of next year, and is designed to treat recurrent antibiotic-associated diarrhea (CDAD), a common hospital acquired infection. 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 subsidiary companies and 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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