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Exhibit No. 99.1
NEWS RELEASE
FOR IMMEDIATE RELEASE
INKINE PHARMACEUTICAL ANNOUNCES FDA APPROVAL OF VISICOL(TM) TABLETS
At Market Early 2001
BLUE BELL, PA, September 21, 2000 - InKine Pharmaceutical Company, Inc, (Nasdaq:
INKP) today announced that the U.S. Food and Drug Administration (FDA) approved
Visicol(TM) tablets (brand of sodium phosphate) for cleansing of the bowel as a
preparation for colonoscopy.
This approval occurred in ten months from NDA submission and includes full
labeling of the product as agreed to by FDA and InKine.
Leonard S. Jacob, M.D., Ph.D., Chairman and CEO of InKine said, "We are thrilled
that Visicol(TM) has been approved and thank FDA for fulfilling their commitment
to rapidly review this important new drug. Our open and professional
communications between FDA and InKine enabled us to negotiate final acceptable
labeling for our first commercial product. We look forward to making Visicol(TM)
available to patients undergoing colonoscopy in early January 2001."
InKine stated that it looks forward to continuing work with the FDA's Division
of Gastrointestinal and Coagulation Drug Products on its second drug candidate,
CBP-1011, as it advances to later stage clinical trials for inflammatory bowel
disease.
"I would like to thank all our employees, and in particular, our development and
regulatory staff who led our efforts in taking Visicol(TM) from IND submission
to NDA approval in less than 27 months," continued Dr. Jacob. "A special note of
gratitude is extended to Craig Aronchick, M.D., Head of Endoscopy, Department of
Gastroenterology, Pennsylvania Hospital and a scientific founder of InKine. His
invention of Visicol(TM) was his response to patients pleas for a better
tolerated purgative preparation and thereby increasing the number of patients
who would undergo colonoscopy to prevent colon cancer, the second leading cause
of death due to cancer in the United States."
The Company will be hosting a conference call 10:00 am ET, Friday, September 22,
to further discuss the FDA approval of Visicol(TM) and its impact on InKine. To
participate, please dial 913-981-4902, confirmation # 660958 10-15 minutes prior
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to start time. The conference call will also be available on replay starting at
1:00 pm ET on September 22, and running through October 13, at 12:00 am ET. For
the replay, please dial 719-457-0820, confirmation # 660958.
InKine Pharmaceutical Company, Inc. is a publicly traded biopharmaceutical
company focused on the diagnosis and treatment of cancer and autoimmune
diseases. The company's development strategy is to acquire late-stage drug
candidates with short time lines to commercialization. Support early-stage
product opportunities come through university-based sponsored research.
The company's lead product, Visicol(TM), was approved by the FDA in September
2000 and is the first and only tablet purgative preparation indicated for bowel
cleansing prior to colonoscopy. InKine's portfolio also includes a late-stage
clinical compound, CBP-1011, a steroid molecule in Phase III trials for the
treatment of idiopathic thrombocytopenic purpura and Phase II trials for the
treatment of inflammatory bowel disease. In addition, the Company is developing
preclinical compounds including Angiocidin, a potent and specific angiogenesis
inhibitor for potential use in cancer patients.
This announcement contains certain forward-looking statements that are subject
to risks and uncertainties, including in particular the statement regarding
"advancing our second drug candidate, CBP-1011, to later stage clinical trials
for inflammatory bowel disease." Actual results could differ materially from
those currently anticipated as a result of a number of factors, including, but
not limited to, the risks and uncertainties discussed under "Other Factors to be
Considered" and "Management's Discussion and Analysis of Financial Condition and
Results of Operations" in the Company's Annual Report on Form 10-K for the
fiscal year ended June 30, 1999, as filed with the Securities and Exchange
Commission.
Contacts:
Sandra D. Jacob, Corporate Communications InKine Pharmaceutical
Tel: 610-260-9363
Anne McBride, Investor Relations The Anne McBride Co
Tel: 212-983-1702
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