InKine Pharmaceutical Co. Inc. filed for marketing approval of its next-generation purgative, INKP-102, earlier than expected.

The Blue Bell, Pa.-based company submitted a new drug application to the FDA April 29, roughly two quarters ahead of "our original development schedule, and two months ahead of our most recent forecast," said Leonard Jacob, CEO, during a conference call to discuss the company's first-quarter earnings.

Although InKine ran up research and development costs last quarter associated with the late-stage work and NDA filing for INKP-102, Jacob said, if approved, the product "will provide the gastroenterologists the best cleansing agent" and provide patients "the additional benefit of smaller tablets with a waxy coating, making them easier to swallow," and fewer prescribed pills needed prior to the procedure.

InKine anticipates a 10-month standard review period by the FDA, and is looking at launching the product in 2006.

The company already has one purgative product on the market, Visicol, which captured about 15 percent of the $300 million bowel preparation market in 2004. Following approval of INKP-102, a sodium phosphate tablet for pre-colonoscopy bowel cleansing, the company hopes to increase its share up to 50 percent, Jacob told BioWorld Today in February, while reporting positive results from a Phase III trial comparing INKP-102 to Visicol.

The NDA was based on data from two trials, which found INKP-102 to be comparable or superior to Visicol. A Phase III study showed that 32 tablets of INKP-102 tested as well, or better, than 40 tablets of Visicol, and the drug met all efficacy endpoints of non-inferiority for the overall colon cleansing response rate, and demonstrated superiority to the marketed drug in cleansing the ascending colon, the most difficult part of the organ to clean.

INKP-102 also was found to be statistically superior to Visicol in secondary endpoints because it caused less material to be retained in the ascending colon. Visicol's formulation includes microcrystalline cellulose (MCC) as a tablet binder, which causes non-soluble residue that has to be removed before the colonoscopy, but INKP-102's formulation does not contain any MCC and is completely water soluble.

When InKine received marketing approval for Visicol in 2001, it was better tolerated than its liquid competitors. But, if INKP-102 is approved, it is likely Visicol will be phased out in favor of the improved product.

The company has filed a patent application for INKP-102 that would protect the product until 2024, 11 years after Visicol would be off patent, Jacob said.

InKine is studying Visicol as a treatment for chronic constipation, but "since INKP-102 moved along so quickly, we are considering that compound as the one to be developed for the constipation indication," he said. With the constipation program, the company is seeking a partner.

For the first quarter, InKine reported research and development costs of $1.8 million, twice the figure reported for the first three months of 2004, due mostly to costs associated with INKP-102. Product sales totaled $5.2 million, a 20 increase from $4.4 million reported a year ago.

Prescriptions for Visicol grew by 27 percent, a figure Jacob would "have liked to be more robust." He attributed the slower growth to new competitors in the market, including a generic polyethylene glycol product and a liquid competitor.

But the company reported a total of 130,000 prescriptions for the quarter, and said the number is expected to increase throughout the year.

But that slower growth might mean the company has to reduce or postpone some of its development programs later this year to maintain a positive cash flow.

The company also revised its 2005 guidance, expecting revenues to be between $23 million and $27 million for the year, down from $28 million to $32 million. The earnings projections dropped from 8 cents to 11 cents per share to 6 cents to 9 cents per share.

As of March 31, the company had about $10.6 million in cash.

Along with Visicol, InKine has another marketed product, IB-STAT, an oral spray formulation of hyoscyamine sulfate for irritable bowel syndrome in adult women and for reducing bowel motility during certain diagnostic procedures.

Shares of InKine (NASDAQ:INKP) lost 44 cents Tuesday, or 17.7 percent, to close at $2.05.