Immunomedics to sell MoAbs direct; firm eyes surgical probe market

Company calls off relationship with Mallinckrodt

If you want something done right, do it yourself. Immunomedics has taken that age-old adage to heart by implementing a plan to directly market its monoclonal antibody-based nuclear medicine imaging and therapeutic agents. The Morris Plains, NJ, biotechnology company is also seeking to expand applications of its CEA-Scan colorectal cancer imaging agent by building a clinical case for dual use of the agent in external and intraoperative scanning applications.

Immunomedics last month reported the termination of its marketing and distribution ties with Mallinckrodt of St. Louis for CEA-Scan in the U.S. and Europe (SCAN 2/18/98). In announcing the move, Immunomedics stated that it was dissatisfied with Mallinckrodt's marketing effort, and planned to assume marketing responsibilities itself using a sales force it has been building over the past several months. Immunomedics believes it will gain more control over CEA-Scan's marketing program by taking over the product, according to Dr. David Goldenberg, chairman and CEO.

"There is great value in doing it yourself," he said. "You know exactly what your (sales) staff is doing. When you have a partner you really don't know on a daily or weekly basis who they are calling on. You can't, on a direct basis, evaluate their success in either educating referring doctors or training nuclear physician users. (The sales force) also has to become better specialized in this product because that is all they are doing."

The company's sales group is composed of 15 representatives in the U.S., but will grow when Immunomedics' second product, LeukoScan, reaches market. That agent has been approved in Europe for the diagnosis of osteomyelitis. In Europe, Immunomedics has formed Immunomedics Europe, based in Hillegom, the Netherlands, and that subsidiary is also building its own sales and marketing operations, Goldenberg said.

Immunomedics does not expect to accomplish all of its sales and marketing objectives alone, however, and the company is pursuing partnerships to complement direct sales. LeukoScan is already distributed by Eli Lilly in Europe, and CEA-Scan will likely be distributed by Lilly in that market also, Goldenberg said. In the U.S., the company is in final contract negotiations with a pharmaceutical distribution partner for CEA-Scan but has not yet announced who that is.

On the marketing side, Immunomedics is talking to companies about working with its direct sales force in approaching the large and diverse universe of referring physicians for its agents, he said.

"Because there is such a large number of (referring) surgeons, medical oncologists, gastroenterologists, and even radiologists, we can use as much help as we can get from marketing and promotional organizations," Goldenberg said.

Immunomedics hopes that the number of its referring surgeons will grow in the future as more of these physicians take advantage of CEA-Scan to improve detection of tumors while operating. CEA-Scan has already been shown to improve external detection of tumors over competing imaging modalities, such as CT, and the agent could have application in breast and lung cancer imaging.

Another potential benefit to surgeons has also been discovered, at no additional cost. If an operation takes place within 48 hours of the external scan, a surgeon can make use of the residual activity of technetium-labeled CEA-Scan to track tumor sites in the body using a hand-held, radiation-detecting probe, Goldenberg said. No additional injection or billing is required, and the procedure could potentially reveal sites not found externally.

"We hope to provide CEA-Scan as the only available product (including FDG-PET) that can be used in the nuclear medicine and surgical settings," he said.

Immunomedics is discussing with the Food and Drug Administration the initiation of trials to justify expanding CEA-Scan's labeling to include intraoperative applications, Goldenberg said. The firm received a patent this year that includes the use of monoclonal antibody fragments in conjunction with intraoperative probes and laparoscopic technology to detect and treat disease.

Surgeons do not need additional FDA certification to use residual counts from a CEA-Scan to assist in intraoperative detection, since the agent is already certified for external imaging and the probe technology is approved for intraoperative use, he said. Immunomedics is in discussion with probe companies on potential cooperation in developing this dual-use technology, Goldenberg said.