By Mary Welch

InKine Pharmaceutical Co. Inc. submitted its first new drug application (NDA) for Diacol, a purgative agent for adults undergoing colonoscopic testing.

¿Of course, we¿re very excited, especially since we reached this point in less than 18 months,¿ said Leonard Jacob, the company¿s chairman and CEO. ¿We filed the NDA based on two Phase III trials showing Diacol was as good as the leading brand in cleaning the colon, but had significantly less adverse events such as nausea and vomiting.

Diacol, a patented anhydrous sodium phosphate tablet, is designed to be used as a purgative agent prior to colonoscopy, a procedure used to screen for colon cancer. A clean bowel allows doctors to view any polyps and detect early colon cancer.

¿There is a huge demand for an effective colon purgative agent,¿ said Richard Lilly, a principal of Indianapolis Security, of Boca Raton, Fla. ¿InKine has produced the only effective colon cleanser that you can comfortably ingest.¿

The filing was based on two Phase III trial results of 800 people who tested Diacol against the leading purgative agent, cherry-flavored NuLytely. The trials showed the cleansing was the same or better, but not significantly, for Diacol patients. Not only did Diacol patients have fewer side effects, but the Diacol group strongly preferred taking that product to NuLytely. (See BioWorld Today, April 30, 1999, p. 1.)

In fact, six times as many patients in the NuLytely group were unable to complete the treatment of the prescribed dose, compared to those taking the Diacol tablet. In addition, 90 percent of those taking Diacol said they would take it again, while only 20 percent of those taking NuLytely said that about the liquid.

¿If you ever have had to digest NuLytely, you¿d understand,¿ said Lilly. ¿It¿s one of the most terrible things imaginable to ingest. And you have to drink a large amount of it.¿

Patients about to undergo a colonoscopy must take a cleansing agent every 15 minutes for 90 minutes the night prior to the test and again for 90 minutes the day of the test.

InKine, based in Blue Bell, Pa., is confident the product will be well received with patients and doctors. ¿There is a lot more public awareness of colon cancer,¿ said Jacob. ¿It¿s the second leading cause of cancer deaths in the U.S., even above breast cancer. The reality is that a colonoscopy is a diagnostic procedure that allows you to prevent colon cancer. If you remove the polyps in the colon, you¿ve removed the chance of cancer growing there. There are 7.5 million cases diagnosed each year in the U.S., and it¿s growing by 15 percent annually.¿

Lilly believes InKine can capture about half of the $200 million market. ¿Charging $16 per procedure, we estimate that they¿ll be at $107 million in five years time and their potential is far better than that. It¿s important to remember that the alternatives are not desirable. Compliance is not good with NuLytely and unless the colon is as clean as a whistle, I don¿t care how good your gastroenterologist is, unless you have a clean colon, the diagnosis is greatly impaired. This is a totally preventable cancer, and it¿s a shame it kills so many people.¿

InKine¿s stock (NASDAQ:INKP) closed Tuesday at $1.968, up 9.38 cents.