By Kim Coghill
InKine Pharmaceutical Company Inc. said Thursday the FDA approved Visicol, a drug used for cleansing the bowel as a preparation for colonoscopy.
Visicol, formerly called Diacol, is a tablet that cleans the bowel so doctors can view polyps and detect early colon cancer. It was approved 10 months after the new drug application submission.
"We are thrilled that Visicol has been approved and thank the FDA for fulfilling its commitment to rapidly review this important new drug," Leonard Jacob, chairman and CEO of Blue Bell, Pa.-based InKine, said in a prepared statement. "Our open and professional communications with the FDA enabled us to negotiate final acceptance labeling for our first commercial product."
Jacob told BioWorld Today Visicol will be available in early January. The company plans to market the tablet but will continue its relationship for sales purposes with Innovex Inc., a subsidiary of Quintiles Transnational Corp., of Research Triangle Park, N.C. Jacob said Innovex will now gear up for sales with 30 sales people, three district managers and a national manager.
Visicol has no competition in the tablet form, he said, and "I'm not aware of any products being studied."
Jacob said analysts are predicting Visicol will generate $11 million in first-year sales.
The tablet's primary competition is NuLytely, a cherry-flavored liquid that Diacol was tested against. In the Phase III trials, 800 people tested Diacol against NuLytely and the results showed cleansing due to the tablet 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 the tablet to NuLytely. (See BioWorld Today, April 30, 1999, p. 1; and Nov. 24, 1999, p. 1.)
"The [colonoscopy] is not a pleasant procedure anyway," Jacob said. "The tablet is tasteless and it can be taken with any liquid."
InKine focuses 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.
Jacob said InKine's portfolio also includes a late-stage clinical compound, CBP-1011, a steroid molecule in Phase III trials for the treatment of idiopathic thrombocytopenic purpura and Phase II trials for the treatment of inflammatory bowel disease. The company also is developing preclinical compounds including Angiocidin, a potent and specific angiogenesis inhibitor for potential use in cancer patients.
InKine's stock (NASDAQ: INKP) gained $1.187, or 15 percent, Thursday to close at $9.125.