Immunomedics Inc. got some good and some bad news Thursday.Pharmacia Inc., its partner in the development of Immunomedics'ImmuRAID-CEA imaging product for colorectal, lung and breastcancer, has reaffirmed its commitment to the product. But ashareholder has filed suit against Immunomedics allegingmisstatements in the company's public disclosures about the imagingagent.The actions followed the announcement May 25 that the FDA hasdeclared ImmuRAID-CEA not approvable at this time. Theannouncement resulted in an immediate 36 percent drop in the price ofImmunomedics' (NASDAQ:IMMU) stock to $3.50. On Friday itclosed at $3.69.Immunomedics has refused to make public the reasons given for theFDA's action.In a statement Friday, the company said it plans to meet promptly withthe FDA, and added: "The FDA letter applied specifically to the PLA(product license application) for colorectal cancer imaging and doesnot address the potential use of the product for other indications, nordoes it generally address the use of the company's other radiolabeledantibodies for imaging."Pharmacia, formerly Adria Laboratories until its acquisition bySweden's Pharmacia Biotech AB, entered into a collaboration withImmunomedics in July 1991. Under the agreement, Pharmaciaobtained North American marketing rights for ImmuRAID-CEA andtwo other imaging products: ImmuRAID-LL2 for lymphoma, andImmuRAID-AFP for liver and germ cell cancer. The Dublin, Ohio-based company also agreed to share in the development of theseproducts.According to Bethany Beck, senior vice president and general counselfor Pharmacia, her company will no longer participate in thedevelopment of the lymphoma and liver and germ cell imagingproducts, and has returned the North American rights to these productsto Immunomedics. She said this was because Immunomedics nowplans to market them as a package with its ImmuRAIT cancertherapeutic products, which were not part of the agreement between thetwo companies.In a statement released by Immunomedics, Pharmacia's presidentFernando da Costa said, "Pharmacia remains committed toImmuRAID-CEA. We are supportive of the company in its efforts toobtain U.S. FDA approval of ImmuRAID-CEA for colorectal imagingand are confident that the approval will ultimately be achieved."Beck said Pharmacia will continue to support the development ofImmuRAID-CEA as a lung and breast cancer imaging agent. Theproduct is now in Phase III trials for the lung indication. The breastcancer trials are at an earlier stage.Amy Factor, Immunomedics' vice president for finance, said theMorris Plains, N.J. company will assume financial responsibility forcontinuing the development of its lymphoma and liver and germ cellimaging products. ImmuRAID-LL2 is about to enter Phase III trials.ImmuRAID-AFP is in Phase I/II trials in Europe.Under the agreement with Pharmacia, Immunomedics will lose some ofthe milestone payments associated with these products. For all threeproducts, these payments could have amounted to $14.4 millionthrough 1996. Certain licensing fees will also be lost.Factor said the lawsuit brought against the company by a shareholderalleges that Immunomedics made misstatements about its colorectalimaging product in its public disclosures since Jan. 30, 1992. Thecomplaint seeks unspecified damages and other relief."The company believes that the complaint is without merit and hasreferred the matter to legal counsel, who have indicated that they intendto vigorously defend the company," Immunomedics' chairman, DavidGoldenberg said.
-- Philippa Maister
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