By Matthew Willett
Incara Pharmaceuticals Corp. and Elan Corp. plc entered a collaboration to develop a subcutaneous ultra-low molecular weight heparin using Elan's Medipad delivery system for treatment of inflammatory bowel disease.
The companies will immediately initiate a 270-patient Phase II/III pivotal trial of the candidate, OP2000, in patients with ulcerative colitis, comparing the treatment to standard therapy with aminosalicylates.
According to a prospectus supplement filed Dec. 22, the companies will form a joint venture called Incara Development Ltd. to develop OP2000. Elan also will make a $4 million equity investment in Incara unrelated to the joint venture's formation.
Ownership of Incara Development Ltd. initially will be split, with Incara owning 80 percent of the new entity. But through the issuance of a variety of Incara and Incara Development Ltd. securities that will provide operating capital for the joint venture, Elan will have the option to gain up to 50 percent ownership in the joint venture within six years.
A series of potential funding mechanisms for the venture and Incara are spelled out in a prospectus supplement filed with the SEC.
The candidate is a heparin derivative, a chemically broken down fragment of the therapeutic. It's antithrombic and anti-inflammatory properties have been shown in small clinical studies, and it is used, Incara said, as a heparin replacement in several indications.
Dublin, Ireland-based Elan's Medipad system combines a transdermal patch and the drug delivery capacities of an infusion pump in a disposable unit. It's capable of infusing drugs over a 48-hour time frame.
Bennett Love, Incara's vice president, corporate planning/communications, said the deal is a risk-sharing, revenue-sharing arrangement.
"They [Elan] believe in the program and we like their people a lot," Love said. "We think there's a promise to the technology."
And though he wouldn't put a dollar value on the market for an ulcerative colitis therapy, Love said the potential is there.
"Inflammatory bowel disease and ulcerative colitis are markets that we think at this point are not well served. It's a significant problem both in the U.S. and outside," Love said.
If the Phase II/III trial is completed on time, around the end of 2001 or the beginning of 2002, Love said, the company will likely complete at least one further confirmatory trial.
Incara licensed OP2000 from Opocrin S.p.A, of Modena, Italy.