BLUE BELL, PA November
25,
2003
--
InKine
Pharmaceutical
Company,
Inc.
(Nasdaq:
INKP) today announced the filing of a provisional
United
States patent
application
for a new
generation
of purgative
products. The
inventors
include
Stephen Skiendzielewski,
Vice President
of Manufacturing
and Martin
Rose, M.D.,
J.D., Executive
Vice President
of Research
and Development,
both of InKine.
The invention covers several highly soluble
colonic purgative formulations in solid dosage forms that
can be used to soften stool, promote laxation and/or induce
complete purgation. If
a patent
issues, the new product will be protected for a significant
period
beyond the 2013 patent expiration of our current franchise
product,
Visicol.
Clinical batches of this new product
have been manufactured and formulated to yield smaller tablets
that may be easier to ingest. Additionally, the new product does not contain
any microcrystalline cellulose, or MCC, which is a common
inert, but highly insoluble excipient. Finally,
the Company
plans to conduct clinical studies and apply for FDA approval
of this new product using alternative dosing regimens that
utilize fewer tablets and allow for single-day administration.
"We are excited about this new patent filing which will continue
to build upon the existing competitive advantages of our franchise
product, Visicol. We are committed to improving our products
to make them the most acceptable to both physicians and patients
and to help maintain a sustainable competitive advantage in
our markets," said Leonard S. Jacob, M.D., Ph.D., Chairman and
CEO of InKine. "An MCC-free product is a great example
of our team's efforts. We believe that FDA approval of
this new product, with a reduced tablet dosing regimen and single-day
administration, would increase the acceptance of our product
and quickly gain market share. This highly soluble, new
generation product should provide physicians additional flexibility
to better meet their patients' needs and schedules," added Dr.
Jacob.
About InKine Pharmaceutical
InKine Pharmaceutical Company, Inc. is a publicly traded
specialty pharmaceutical company focused on developing and commercializing
pharmaceutical products for the diagnosis and treatment of gastrointestinal
disorders. The Company's development strategy is to acquire late-stage drug
candidates with short time lines to commercialization. The Company's franchise
product, Visicol ® is the only tablet purgative preparation indicated
for bowel cleansing prior to colonoscopy. InKine's second product, IB-Stat ® ,
is an oral hyoscyamine spray for the treatment of a variety of indications. Additionally,
the Company is developing Colirest(TM), which is in clinical trials for the treatment
of Crohn's disease. For further information, please visit InKine on its web
site http://www.inkine.com .
In addition to historical facts or statement of current condition, this press release may contain forward-looking statements. Forward-looking statements provide InKine's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings projections, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. InKine's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties such as those set forth in its reports on Form 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, InKine does not intend (and it is not obligated) to update publicly any forward-looking statements. This discussion is permitted by the Private Securities Litigation Reform Act of 1995.
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