BLUE BELL, PA
January 14, 2004 - InKine Pharmaceutical Company, Inc.
(Nasdaq: INKP) ) today announced that the Company had a meeting with the United States Food and Drug Administration (FDA) and reached agreement on the design of a Phase 2 study for a new generation of colon cleansing tablets. The new tablets are smaller and contain no microcrystalline cellulose (MCC). InKine’s new generation purgative tablet is covered by the Company’s provisional United States patent application filed late last year. If issued, products under the patent will receive protection through 2024. The Company plans to file patent applications worldwide during 2004.
"We are pleased with the results of our meeting with FDA regarding the design of a Phase 2 study and the outline of a highly efficient development program for the regulatory approval of our new highly soluble colon cleansing tablets,” said Martin Rose, M.D., J.D., Executive Vice President of Research and Development of InKine. “We will be working with a very experienced group of investigators to perform the study and are anxious to begin testing our new potential product at numerous dosing regimens, which should enhance acceptance by patients and physicians,” added Dr. Rose.
The Phase 2 study is expected to begin in the first half of 2004 and will compare InKine’s marketed purgative, Visicol? tablets, against several dosing regimens of the new product in patients undergoing colonoscopy. These regimens will include one similar to the approved regimen for Visicol as well as several lower dose regimens, including dosing regimens completed by patients entirely the evening before the colonoscopy procedure. The FDA has indicated that if results of the Phase 2 study are supportive, than only one pivotal study would be required for approval of the new tablets.
“We continue to look to expand our commercial operations through the development of our existing products and potential acquisitions. While our franchise product, Visicol, continues to gain market share, we look forward to advancing our new generation purgative through clinical development,” said Leonard S. Jacob, M.D., Ph.D., Chairman and Chief Executive Officer of InKine. “With the completion of a co-promotion deal in late 2003 and our development path in place for 2004, we expect to provide 2004 income statement guidance during our fourth quarter earnings call,” added Dr. Jacob.
About InKine Pharmaceutical
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. The
Company's first product, Visicol™ is the first and only
tablet purgative preparation indicated for bowel cleansing
prior to colonoscopy. InKine's second product, IBStat™, is a
novel oral hysocyamine spray for the treatment of Irritable
Bowel Syndrome (IBS) and spasm of the colon. Additionally,
the Company is developing other clinical compounds such as
Colirest™, which is in clinical trials for the treatment of
Crohn's disease and completed Phase II trials for the
treatment of ulcerative colitis. For further information,
please visit InKine on their 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. |
