Immunomedics of Warren, NJ, signed a letter of understanding last month with Boehringer Ingelheim International, a major German pharmaceutical company, for the negotiation of exclusive distribution and manufacturing rights in Europe and possibly other markets. If finalized, the agreement would cover all Immunomedics in vivo monoclonal antibody imaging and therapy agents.
According to Immunomedics financial documents, BII will pay the biotechnology company up to $4.6 million as an advance on licensing fees during the negotiation period. Immunomedics common stock will be placed in escrow for BII in consideration for the advanced funds over $600,000. The U.S. company will repurchase the stock within 12 months if negotiations break down.
Immunomedics will continue to pursue negotiations with other pharmaceutical companies for possible marketing and R&D arrangements during the BII talks, the company said.
"There is a series of products we expect to negotiate with Boehringer. The first is our ImmuRaid-CEA product line, which covers colorectal, breast and lung imaging. They (BII) offer the opportunity to have a top-flight sales and marketing organization work with our products," said Lonnie Bookbinder, director of in vivo products for Immunomedics.
BII has also developed monoclonal antibody products of its own and is interested in applying these to imaging and disease therapy fields. This opens up the possibility of cooperation in research and development, he said.
Apart from BII's sales strengths in Europe, the German company could help Immunomedics through the European regulatory process. Immunomedics is watching Cytogen's application to the Committee for Proprietary Medicinal Products with interest (see following story). If the CPMP accepts applications based on U.S. clinical data, the European approval process could be facilitated for all monoclonal companies, Bookbinder said.
Immunomedics is also hopeful that its strong U.S. patent position can be transferred to Europe. Last spring, the European patent office upheld Immunomedics' European patent on the use of radiolabeled monoclonal antibody fragments for tumor imaging, which was opposed by other companies. That decision is under appeal.
Funds received from BII will help Immunomedics proceed with R&D and clinical trials for future imaging and therapy agents, Bookbinder said.
"We have a complete stable of antibodies that are ready for full development, but we have not had the funding to pursue this," he said. A previous development relationship with Johnson & Johnson was discontinued last year.
Immunomedics is also seeking a partner in the U.S., although the company would like to maintain a direct role in the sale of agents in this market, Bookbinder said. The most likely U.S. scenario would be for Immunomedics to handle sales to the nuclear medicine community, while a pharmaceutical partner targets referring physicians, he said.
BII's overture to Immunomedics is not the first time the drug company has eyed a U.S. contrast agent developer. Boehringer is financing the development efforts of Alliance Pharmaceutical of San Diego and has licensed marketing rights for Alliance's perfluorocarbon-based imaging technology outside of North America (SCAN 2/28/90).
