Immune Response Corp. and Rhone-Poulenc Rorer Inc. aregoing into arbitration to resolve a dispute over management oftheir joint venture, Immunization Products Ltd. (IPL). Thecompanies announced Monday that they have filed a demandfor arbitration with the American Arbitration Association.

Immune Response of Carlsbad, Calif., said the companiesdisagree over their respective rights "to manage the jointventure and to control the clinical and regulatory aspects ofresearch and development" of their HIV vaccine.

Rhone-Poulenc, however, said the issue is over the nature ofthe joint venture. Bob Pearson, director of worldwide productcommunication, said that when IPL became operational in1992, the two companies agreed that the joint venture wouldfocus on manufacturing, clinical development and marketing ofthe HIV immunotherapeutic.

Dennis Carlo, Immune Response's executive vice president andchief operating officer, told BioWorld that under the original1988 agreement, Immune Response had control over clinicaland regulatory matters and the right to delegate suchauthority. Once the vaccine entered larger trials, Carlo said, "wefelt it was better to delegate clinical and regulatory authority"to a larger company. Immune Response selected Rhone-Poulencbecause the two were already partners. Since then, Carlo said,Immune Response has grown and now has the medicalexpertise to resume control of the clinical trials and regulatoryfilings. The 1988 agreement specified that if differencesbetween the companies evolved they would seek arbitration.

The companies' goal is to complete Phase III trials and file aproduct license application. In December, IPL submitted themedical summary from the Phase II/III clinical trial with theHIV vaccine to FDA. Interim results from this trial werepresented at the Ninth International AIDS Conference in Berlinlast June (see BioWorld, June 10, 1993). The study of 103asymptomatic HIV-positive individuals was inconclusive.Although the vaccine slowed the rate of increase of HIV inperipheral blood compared with placebo as measured bypolymerase chain reaction (PCR), the findings didn't stand up toa less sensitive assay. Pearson said subsequent data showedthat the vaccine appeared to have an effect on CD4 counts.

Originally developed by Jonas Salk, the vaccine is designed toprevent or delay progression of HIV infection to AIDS bystimulating a patient's immune system to attack the virus.Immune Response and Rhone-Poulenc of Collegeville, Pa., planto conduct a dose-optimization study, a Phase III clinicalendpoint trial and a study on lymph nodes and viral burden.

Immune Response's stock (NASDAQ:IMNR) closed at $12.75 ashare on Monday, up 13 cents.

-- Brenda Sandburg News Editor

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