Stock to watch. SYB on TSE and SYBBF on Nasdaq.
Synsorb Biotech Inc. Announces Commencement of Operations at
Calgary Manufacturing Facility
February 16, 1999 8:56 AM EST
CALGARY, ALBERTA--(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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