Inkine Pharmaceutical (NASDAQ:INKP)
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InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today
announced that on April 29, 2005 the Company submitted an electronic
New Drug Application (NDA) for the United States marketing approval of
its next generation sodium phosphate tablet, INKP-102.
The NDA is based on data from two randomized, multicenter,
investigator-blinded clinical trials comparing INKP-102 to 40
Visicol(R) tablets, including a Phase 2 dose-ranging trial and a Phase
3 pivotal trial. Based on the results of these trials, the dose of
INKP-102 proposed for marketing is 32 tablets (48 g), compared to the
approved dose of 40 tablets (60 g) for Visicol(R) tablets. The
clinical trials indicated that the 32 tablet INKP-102 dose was
comparable or significantly superior to 40 Visicol(R) tablets in all
tested efficacy parameters, and met the primary efficacy endpoint of
non-inferiority for the overall colon cleansing response rate in the
Phase 3 trial. In the combined safety database, the 32 tablet INKP-102
dose was significantly superior to Visicol(R) tablets in several key
safety parameters. In the Phase 3 trial, patient acceptance was
significantly greater with INKP-102 compared to patients who took
Visicol(R) tablets. Significantly more patients who took 32 INKP-102
tablets indicated that they would be willing to take the same
preparation again for a future colonoscopy compared to those who took
Visicol(R) tablets. Results in the Phase 2 trial were supportive.
"The data in this NDA support our original belief that our new
MCC-free sodium phosphate tablet would result in improved colon
cleansing compared to currently marketed Visicol(R) tablets," said
Martin Rose, M.D., J.D., Executive Vice President for Research and
Development at InKine. "In our studies, INKP-102 was given at a lower
dose with fewer tablets than Visicol(R). It has a better safety
profile and is better accepted by patients," added Dr. Rose.
"We are pleased to report that we have submitted our NDA for
review by FDA two months ahead of our internal forecasted timeline'"
said Leonard S. Jacob, M.D., Ph.D., Chairman and Chief Executive
Officer of InKine. "Based on the improved efficacy, safety and patient
acceptance attributes, we believe that INKP-102, if approved by FDA,
will be the best purgative on the market and should significantly
expand InKine's share of the market for colon cleansing products,"
added Dr. Jacob.
INKP-102 tablets are smaller in size and easier to swallow than
the Company's currently marketed sodium phosphate tablet product,
Visicol(R). The new INKP-102 tablets contain no microcrystalline
cellulose (MCC), an inert, but highly insoluble, tablet binder. The
Company has filed a patent application that, if granted, would protect
INKP-102 until 2024.
There can be no assurance the FDA will accept the NDA for filing
or that 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 is 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
studying 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. 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, market acceptance of product introductions
by InKine and its competitors, InKine's success in implementing sales
and marketing changes 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.