By Matthew Willett

Staff Writer

Corixa Corp. and CoPharma Inc. entered a license, development and commercialization agreement for Corixa's preclinical cardioprotectant, RC.522.

The compound, an aminoalkyl glucosaminide 4-phosphate (AGP), is believed to spare tissue from ischemic damage by inducing nitric oxide synthase, and is designed for treatment and prevention of cardiac disorders, neuronal damage and ischemia-reperfusion injuries.

The deal calls for CoPharma, of Hopkinton, Mass., to pay Corixa, of Seattle, a license fee, success-based milestone payments and a combination of royalties and a share of profits from commercialized products in exchange for exclusive rights to develop and market RC.522 in the U.S., Canada, Japan, Australia and New Zealand. The deal also covers marketing rights in certain countries in Asia, the Middle East and Africa.

RC.522 is one of a family of compounds acquired through the 1999 merger with Ribi ImmunoChem Research Inc. Corixa acquired that company's 21 million outstanding shares for $56.3 million, and the cardioprotectant isn't the only compound showing promise from the Ribi pipeline. (See BioWorld Today, June 11, 1999.)

Most notable among the former Ribi compounds is Melacine, Corixa's melanoma therapeutic. Phase III trials are complete, and Melacine's biologics license application is currently in the works for submission to the FDA in mid-2001, company officials said.

CoPharma's Chief Business Officer Dave Fanning told BioWorld Today his company, which specializes in the clinical advancement of in-licensed compounds, will advance the cardioprotectant before seeking a marketing partner for its commercialization.

"CoPharma is a company that focuses on clinical development. We'll typically partner with a company that has identified a compound they may have tested in early clinical trials, or the product may be ready to go into clinical trials," Fanning said. "We take the drug candidate from the point of filing an IND with the FDA straight through the evaluation process, then seek to license it out to a partner who can market the drug for us. It's really a new type of company, since we don't focus on research."

Clinical need, therapeutic rationale and market potential all contribute to the company's evaluation of a potential drug for in-licensing. Fanning said Corixa's compound met all the standards.

"This particular drug candidate is a compound, it's a glucosaminide, a synthetic small molecule used to protect myocardia for patients undergoing heart surgery who are at risk of having an event on the operating table, like myocardial infarction that leads to ischemic death of heart tissue," Fanning said. "It has shown the ability in animal models and in clinical work established with the first generation of the drug to very dramatically reduce damage as a result of ischemic shock."

He said CoPharma expects to file an IND to begin Phase II trials of RC.552 in the second quarter and begin a Phase II trial in the third quarter testing the drug as a protectant against ischemic damage during coronary artery bypass grafting procedures.

"We would take the drug into the clinic and look at treated vs. untreated patients and determine whether the drug has effectiveness," Fanning said.

Though a drug marketed for that indication would potentially serve a subset of the 600,000 coronary artery bypass grafting procedures performed every year in the U.S., Fanning said, pricing for the treatment would depend on reimbursement, which is contingent on efficacy, so estimating a market size for RC.522 is difficult at this point.

"The total cost of that procedure is in the range of $20,000 to $30,000, if you look at the statistics, and obviously a drug that could have an impact on the total cost of that procedure would be highly valuable," Fanning said.

Corixa officials were unavailable for comment Wednesday.

In addition to Melacine, Corixa is pursuing approval for Bexxar, its CD20 antigen-specific antibody therapeutic for non-Hodgkin's lymphoma developed by Coulter Pharmaceuticals Inc., which was acquired by Corixa late last year. (See BioWorld Today, Oct. 17, 2000.)

Corixa has 10 compounds in clinical trials, among them treatments for psoriasis, rheumatoid arthritis, multiple sclerosis, breast, ovarian and pancreatic cancers and hepatitis B.

Corixa's stock (NASDAQ:CRXA) closed Wednesday at $26.062, down $3.437.