Immune Response Corp. is seeking an expedited court hearing in aU.S. District Court in a dispute with Rhone-Poulenc Rorer, its jointventure partner in a program to develop an HIV immunotherapeutic.Immune Response alleges that Rhone-Poulenc is not complying withan arbitrator's ruling. Rhone-Poulenc says it is "surprised andfrustrated" by this action, and will ask the arbitrator to intervene.The dispute began in February when the two companies, equalshareholders in Immunization Products Ltd., a joint venture created todevelop an HIV immunotherapeutic, agreed to arbitration to settle adisagreement over the control of clinical and regulatory aspects of newdrug development.On May 11, the arbitrator ruled that, under the 1988 agreementbetween the two companies, Immune Response had the right to controlall research and development, including, without limitation, clinicaland regulatory activities through final regulatory approval. Rhone-Poulenc said it would abide by the arbitrator's decision.In filing its petition to the U.S. District Court in Illinois, Carlsbad,Calif.-based Immune Response charged that Rhone-Poulenc is notcomplying with the arbitrator's ruling, particularly as it relates toImmune Response's right to control FDA regulatory activities ofImmunization Products Ltd.Charles Cashion, Immune Response's chief financial officer, saidRhone-Poulenc has failed to sign the appropriate documentation theFDA needs to establish that Immune Response has the authority to acton behalf of the joint venture on regulatory issues. "The FDA prefers towork directly with one party. It is not efficient to divide theseresponsibilities," Cashion said.Collegeville, Pa.-based Rhone-Poulenc expressed surprise at the filing,"particularly in view of the arbitrator's express direction that the partiesattempt in the first instance to resolve any disagreements concerningcompliance with the decision between themselves. RPR believes that ithas complied in good faith with the arbitrator's decision and, as thearbitrator has expressly retained jurisdiction over all issues raised in thearbitration, RPR will again request his intervention," the company saidin a prepared statement.Bob Pearson, Rhone-Poulenc's director of product communications,told BioWorld the first indication his company had of the court filingcame Thursday. He said the filing was not consistent with thearbitration agreement. "We are happy to talk with them (ImmuneResponse) as we have been doing and hope to continue to do."Cashion said favorable results of a Phase II/III clinical trial of the jointventure's HIV drug were published in the Journal of InfectiousDiseases. He said the drug might qualify for approval under the FDA'sexpedited approval process which would require a clinical endpointstudy. He said launching of this study might begin this year. n
-- Philippa Maister
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