Immunomedics of Warren, NJ, signed a letter of understanding lastmonth with Boehringer Ingelheim International, a major Germanpharmaceutical company, for the negotiation of exclusive distributionand manufacturing rights in Europe and possibly other
Immunomedics of Warren, NJ, signed a letter of understanding lastmonth with Boehringer Ingelheim International, a major Germanpharmaceutical company, for the negotiation of exclusive distributionand manufacturing rights in Europe and possibly other markets.If finalized, the agreement would cover all Immunomedics in vivomonoclonal antibody imaging and therapy agents.
According to Immunomedics financial documents, BII will paythe biotechnology company up to $4.6 million as an advance onlicensing fees during the negotiation period. Immunomedics commonstock will be placed in escrow for BII in consideration for theadvanced funds over $600,000. The U.S. company will repurchasethe stock within 12 months if negotiations break down.
Immunomedics will continue to pursue negotiations with otherpharmaceutical companies for possible marketing and R&D arrangementsduring the BII talks, the company said.
"There is a series of products we expect to negotiatewith Boehringer. The first is our ImmuRaid-CEA product line, whichcovers colorectal, breast and lung imaging. They (BII) offer theopportunity to have a top-flight sales and marketing organizationwork with our products," said Lonnie Bookbinder, directorof in vivo products for Immunomedics.
BII has also developed monoclonal antibody products of itsown and is interested in applying these to imaging and diseasetherapy fields. This opens up the possibility of cooperation inresearch and development, he said.
Apart from BII's sales strengths in Europe, the German companycould help Immunomedics through the European regulatory process.Immunomedics is watching Cytogen's application to the Committeefor Proprietary Medicinal Products with interest (see followingstory). If the CPMP accepts applications based on U.S. clinicaldata, the European approval process could be facilitated for allmonoclonal companies, Bookbinder said.
Immunomedics is also hopeful that its strong U.S. patent positioncan be transferred to Europe. Last spring, the European patentoffice upheld Immunomedics' European patent on the use of radiolabeledmonoclonal antibody fragments for tumor imaging, which was opposedby other companies. That decision is under appeal.
Funds received from BII will help Immunomedics proceed withR&D and clinical trials for future imaging and therapy agents,Bookbinder said.
"We have a complete stable of antibodies that are readyfor full development, but we have not had the funding to pursuethis," he said. A previous development relationship withJohnson & Johnson was discontinued last year.
Immunomedics is also seeking a partner in the U.S., althoughthe company would like to maintain a direct role in the sale ofagents in this market, Bookbinder said. The most likely U.S. scenariowould be for Immunomedics to handle sales to the nuclear medicinecommunity, while a pharmaceutical partner targets referring physicians,he said.
BII's overture to Immunomedics is not the first time the drugcompany has eyed a U.S. contrast agent developer. Boehringer isfinancing the development efforts of Alliance Pharmaceutical ofSan Diego and has licensed marketing rights for Alliance's perfluorocarbon-basedimaging technology outside of North America (SCAN 2/28/90).