InKine Reports Seven INKP-102 Study Data Abstracts Accepted for Presentation at the Annual Scientific Meeting of the American Co
August 03 2005 - 3:47PM
Business Wire
InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced
that seven abstracts with data from clinical studies of the
Company's next-generation purgative product, INKP-102, have been
accepted for poster presentations at the 70th Annual Scientific
Meeting of the American College of Gastroenterology (ACG), to be
held from October 28 to November 2, 2005, at the Honolulu
Convention Center. The abstracts are based on the results of two
randomized, multicenter, investigator-blinded clinical trials
comparing various dosing regimens of INKP-102 to 40 Visicol(R)
tablets in adults undergoing colonoscopy, including a Phase 2
dose-ranging trial and a Phase 3 pivotal trial. These trials
indicate that INKP-102 may have important advantages over
Visicol(R) tablets in efficacy, safety, and acceptance by patients.
Visicol(R) is the Company's currently marketed sodium phosphate
tablet purgative, which is indicated for cleansing of the bowel as
a preparation for colonoscopy in adults 18 years of age or older.
INKP-102 tablets contain the same active ingredients as Visicol(R),
but are smaller in size and easier to swallow. Also, the new
tablets contain no microcrystalline cellulose (MCC), an inert, but
highly insoluble, tablet binder that is present in Visicol(R). The
Company has filed patent applications that, if granted, would
protect INKP-102 until 2024. The seven abstracts are authored by a
total of 20 academic and community gastroenterologists and
colorectal surgeons who were study investigators, as well as by
Company scientists. The abstracts present a broad range of data
relating to the efficacy, safety and patient acceptance of INKP-102
tablets, including: -- Efficacy results of the Phase 2 dose ranging
study, suggesting that several of six tested dosing regimens of
INKP-102, including regimens of 28, 32, or 40 tablets, provided
colon cleansing at least comparable to or better than marketed
Visicol(R) tablets; -- Efficacy results of the Phase 3 pivotal
trial, indicating that 32 or 40 INKP-102 tablets provided overall
colon cleansing at least comparable to Visicol(R), with
significantly better cleansing in the ascending colon; --
Additional efficacy results of the Phase 3 trial, indicating that
INKP-102 tablets provided excellent colon cleansing for both
morning and afternoon colonoscopy procedures; -- Results from the
Phase 3 study indicating that patients found 32 INKP-102 tablets to
be easier to take and preferable for a future colonoscopy than 40
Visicol(R) tablets; -- Results from the combined data of the Phase
2 and Phase 3 studies indicating that the safety and efficacy of
INKP-102 tablets were similar in patients 65 and older compared to
younger patients; -- Safety results from the combined data of the
two studies indicating that 32 INKP-102 tablets were associated
with a significantly lower rate of adverse events than 40
Visicol(R) tablets; and -- Results from the combined safety
database indicating that 32 INKP-102 tablets were associated with a
better electrolyte profile than 40 Visicol(R) tablets. The accepted
abstracts will be published in an upcoming edition of the American
Journal of Gastroenterology. "The upcoming ACG meeting will be the
first forum where the gastroenterology community is exposed to the
outstanding results of our two completed trials of INKP-102," said
Robyn G. Karlstadt, M.D., F.A.C.G., InKine's Vice President for
Clinical Operations. "We believe that these studies, conducted in
over 1,000 patients, are consistent in demonstrating the excellent
colon cleansing of 32 tablets of INKP-102 throughout the colon in
adults of all ages, regardless of the time of day the colonoscopy
was performed. The studies also indicate that the 32 tablet dose of
INKP-102 has a better safety profile than 40 Visicol(R) tablets and
is consistently preferred by patients," added Dr. Karlstadt. "The
results of our two studies of INKP-102 indicate that we have made a
very good purgative, Visicol(R) tablets, even better," stated
Martin Rose, M.D., J.D., InKine Executive Vice President for
Research and Development. "We believe that the data show that our
next generation purgative provides comparable or better colon
cleansing than Visicol(R) at a lower total dose of sodium
phosphate, with enhanced safety and patient acceptance. We think
that physicians who have already switched to Visicol(R) will find
that they and their patients will like INKP-102 even more. Those
physicians who have tried Visicol(R) and found the MCC residue to
be bothersome ought to be very pleased by the improved cleansing of
INKP-102, especially in the cecum and ascending colon. All
physicians should appreciate the improved safety of the lower dose,
and patients will like the smaller tablet," added Dr. Rose. InKine
submitted a New Drug Application (NDA) during the second quarter of
2005 for US marketing of INKP-102. The US Food and Drug
Administration (FDA) recently informed InKine that the NDA was
accepted for filing and will be reviewed. The Company anticipates
that the commercial launch of INKP-102 will occur in the first half
of 2006. However, there can be no assurance INKP-102 will receive
FDA approval. Without FDA approval, the Company cannot market or
sell INKP-102. 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 has been to acquire late-stage drug
candidates with short time lines to commercialization. The
Company's franchise product, Visicol(R) is the only tablet
purgative preparation indicated for bowel cleansing prior to
colonoscopy. InKine's second product, IB-Stat(R), is an oral
hyoscyamine spray for the treatment of a variety of indications.
Additionally, the Company is developing INKP-102, an advanced
generation purgative, which we recently submitted a new drug
application to FDA for bowel cleansing prior to colonoscopy and
developing Visicol(R) for use as a laxative in treating patients
with chronic constipation. For further information, please visit
InKine on its web site http://www.inkine.com. This press release
contains forward-looking statements, including statements regarding
our expectations regarding INKP-102, including the potential
benefits of INKP-102, the timing of commercial launch of INKP-102
and expectations of physician and patient acceptance of INKP-102.
Such forward-looking statements are based on InKine's current
expectations or forecasts of future events. 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, InKine's ability to
commercialize INKP-102 and grow product revenue and the effects of
the other risks and uncertainties set forth in InKine's 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 may elect to update
forward-looking statements, but the Company disclaims any
obligation to do so.
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