By Mary Welch

In order to prepare for the U.S. sales and distribution of its lead drug, Aptosyn (exisulind), Cell Pathways Inc. signed three agreements with companies to handle these functions.

"This is pretty straightforward," said Robert Towarnicki, the Horsham, Pa., company's president and CEO. "This is how Cell Pathways is expecting to handle the sales and distribution of our drug upon approval and retain control of the product. It's a straight contract - pay-for-services. We want to limit the significant up-front expenses and help our cash flow, but still have a dedicated sales force and distribution system."

Aptosyn is an oral cancer medication that is designed to trigger cell death by apoptosis in abnormal precancerous and cancerous cells without the toxicities of other therapeutic agents. It comes from a new class of compounds called selective apoptotic anti-neoplastic drugs (SAANDs). The company filed a new drug application in August for patients with familial adenomatous polyposis (FAP). (See BioWorld Today, Aug. 27, 1999, p. 1.)

The drug is also in clinical trials for prostate, breast, and lung cancers, Barrett's esophagus and sporadic colonic polyps.

The first contract is with Innovex, of Research Triangle Park, N.C., for hiring and training a dedicated sales force to launch and promote Aptosyn upon approval. Cell Pathways will retain decision-making control on strategic and tactical sales and marketing issues. Innovex, which has built 57 sales teams and launched more than 25 new products in the U.S. over the past four years, is a business unit of Quintiles Transnational Corp., of Research Triangle Park.

The second agreement is with Livingston Healthcare Services Inc., of Newark, Del. Livingston will be responsible for customer service, order management, distribution, accounts receivables and contract chargeback administration, and sample literature distribution of Aptosyn.

The third agreement is with The Lash Group Inc., of Charlotte, N.C., one of the largest reimbursement consulting firms serving the pharmaceutical, biotech and medical technology industries. It is a business unit of Bergen Brunswig Corp., of Orange, Calif., and a sister company of Integrated Commercialization Solutions, of Dallas.

The Lash Group will be responsible for the development and implementation of reimbursement support services for Aptosyn. The company will establish and maintain a reimbursement hotline for health-care providers and patients, develop and distribute a payer information package to introduce Aptosyn to third-party payers, and develop a patient reimbursement and advocacy guide.

"We have worked with The Lash Group before so we're expanding our relationship," Towarnicki said. "The other two are new relationships, but we believe they're among the best in their business. They are well respected and we look forward to working with them."

The agreements are only for the U.S. Cell Pathways expects to file for marketing approval in Europe in the "late second quarter or early third quarter," he said.

For product commercialization in Europe, the company intends to establish a subsidiary in Europe and then establish relationships with regional pharmaceutical companies for distribution.

"All of our actions are aimed at allowing Cell Pathways to retain control of the product," Towarnicki said.

Cell Pathways' stock (NASDAQ:CLPA) closed Wednesday at $26.875, up $1.375.