By Lisa Seachrist
Buoyed by positive Phase II results of its oral liquid heparin formulation, Emisphere Technologies Inc., of Tarrytown, N.Y., is planning to initiate Phase III studies of the blood-thinning drug by the end of this year.
Last week, the company presented positive Phase II results of a study testing the oral formulation of heparin as a way to prevent deep-vein thrombosis (DVT) following hip replacement. This week the company met with the Gastrointestinal and Coagulation Drug Products Division of the FDA to discuss the direction to take the development of the drug.
"The FDA was extremely helpful," said Lou Bender, senior vice president of business development and manufacturing for Emisphere. "They proposed all sorts of alternatives to our trial design to get this drug into Phase III trials faster and get us through faster. It was a very positive meeting."
Heparin is an anticoagulant, antithrombotic compound that is prescribed for a variety of cardiovascular indications including DVT. Thirty percent to 50 percent of all patients who undergo hip replacement and knee replacement surgeries will develop DVT without preventive treatment. DVT can lead to life-threatening pulmonary embolisms.
Currently, DVT is treated with heparin injections for up to two weeks. Worldwide sales of anticoagulant compounds including injectable low-molecular-weight heparins and warfarin are believed to exceed $2 billion per year.
By moving toward Phase III studies, Emisphere is one step closer to entering the market. While the company and the agency have yet to finalize a Phase III protocol, Bender said that any trial of its formulation likely would enroll 2,000 to 3,000 participants. Until then, the company is looking for a development and marketing partner to move the product through Phase III studies and onto the market.
"There is a lot of interest in this product from big pharmaceutical companies," Bender said. "We are looking actively for a development and marketing partner."
Emisphere's stock (NASDAQ:EMIS) closed Tuesday at $12.875, down 43.75 cents.