MBI files IND application for Oralex

July 27, 1994

Ultrasound contrast agentdeveloper Molecular Biosystems this month took another step towardcommercializing a new ultrasound agent. The San Diego-based firmhas filed an investigational new drug (IND) application with theFood and Drug Administration for

Ultrasound contrast agentdeveloper Molecular Biosystems this month took another step towardcommercializing a new ultrasound agent. The San Diego-based firmhas filed an investigational new drug (IND) application with theFood and Drug Administration for Oralex, an oral ultrasound agentfor abdominal imaging.

Oralex is designed to fill the stomach and upper gastrointestinaltract, displacing air and improving visualization of organs suchas the pancreas and gallbladder. MBI estimates that about fourmillion abdominal ultrasound scans are performed each year inthe U.S.

Pending FDA approval of the IND, MBI will sponsor phase-oneclinical trials at two university sites. The primary goals ofthe trials will be to evaluate the safety, preliminary efficacyand dose-ranging effects of Oralex.

MBI has licensed European rights to Oralex to Italian contrastsupplier Bracco of Milan (SCAN 6/30/93). MBI does not have a licensingpartner for the agent outside Europe.

In addition to proceeding with clinical development of Oralex,MBI has cleared up legal interference with competitor ImaRx Pharmaceuticalconcerning the agent. ImaRx, of Tucson, AZ, filed suit againstMBI last year, alleging that MBI misappropriated ImaRx trade secretsto develop Oralex (SCAN 7/14/93). ImaRx is developing SonoRx,an oral gastrointestinal ultrasound agent licensed to Squibb Diagnostics.

In a lawsuit filed in the U.S. District Court of Arizona, ImaRxalleged that MBI violated a non-disclosure agreement by usingproprietary information about ImaRx technology to develop Oralex.

MBI and ImaRx settled the lawsuit and a related patent infringementclaim in May, according to Sherry L. Mesman, CFO and vice presidentof finance for MBI. MBI did not disclose the terms of the settlement.

In other MBI news, the company said that researchers at OschnerMedical Institution in New Orleans reported successful resultsin canine testing with FS069, a new second-generation contrastagent for transpulmonary myocardial perfusion echocardiography.The results were reported at the American Society of Echocardiographymeeting in San Francisco last month.