NeoRx's OncoTrac Small Cell Lung Cancer Imaging Kit took asignificant step closer to the market on Wednesday with the filing byNeoRx's partner, Boehringer Ingelheim GmbH (BI), of a productlicense application (PLA) and a simultaneous filing by BI's subsidiary,Dr. Karl Thomae GmbH (Thomae), of an establishment licenseapplication (ELA).If approved by the FDA, this diagnostic tool will be the first productcommercialized by Seattle-based NeoRx.NeoRx (NASDAQ:NERX) has traveled this road before; it filed a PLAfor OncoTrac in 1989, but ran into trouble when the company selectedto manufacture the product went out of business. Instead of seekinganother manufacturer, NeoRx entered into an agreement with BI ofIngelheim on the Rhine, Germany. BI agreed to provide $10 million fordevelopment of the product and also purchased $8 million worth ofNeoRx's stock. The company also agreed to pay NeoRx an additional$3.6 million when FDA equivalency data qualifying BI as themanufacturer was filed. This payment has already been triggered. BIalso received two warrants to buy an additional 2.5 million shares ofNeoRx stock for $11.9 million, but has not yet exercised thosewarrants.Backed by the expertise of BI, NeoRx expects no problems this time,even though it has not yet received FDA approval for OncoTrac."When our previous PLA was filed, the FDA indicated that they had noquestions as to the clinical utility of our product," Paul Abrams,NeoRx's president and chief executive officer, told BioWorld. "Sincethe clinical part of the application has already been reviewed, eventhough nothing is final, we believe we are beyond the 'does the productwork and is it safe?' stage and into the nitty-gritty aspects of themanufacturing process."At the request of the FDA, NeoRx initiated a limited clinical trial inMay 1993 to qualify BI subsidiary Thomae as the manufacturer. Theaim of the trial was to demonstrate that Thomae's facility andmanufacturing procedures meet FDA standards. In announcing the newfiling, Abrams said he was confident that Thomae was well-positionedto meet these requirements.Under its agreement with BI, Thomae will have worldwidemanufacturing rights for OncoTrac at its German facility. BI will haveexclusive marketing rights outside North America and will pay an as-yet-unspecified royalty to NeoRx. However, no attempt has yet beenmade to register the product in other countries. Abrams told BioWorldthat NeoRx is negotiating with several parties for marketing rights inthe U.S. and expects to make a choice in the second quarter of thisyear.According to Abrams, OncoTrac will be the first biotechnologyproduct that BI has manufactured for sale in the U.S. He said BIalready manufactures and markets Genentech Inc.'s tissue plasminogenactivator (t-PA) and gamma interferon for markets outside the U.S.OncoTrac consists of a form of radioactivity linked to an antibody thatallows tumor imaging with a camera. The radioactivity, calledtechnetium-99m, is linked to the antibody by NeoRx's patented methodand then injected into a vein. The radiolabeled antibody binds to thetumor, allowing a camera outside the patient's body to detect the tumor,based upon the regions in which the radiation is concentrated."No anesthesiology is necessary," Abrams noted. "In clinical trials,patients are injected with OncoTrac in the afternoon, go home andreturn the next morning for imaging. We estimate it costs about half the$2,500 that other imaging tests require. The test can be done in anyhospital that has a nuclear medicine facility, including communityhospitals."Abrams said OncoTrac is already being used to select patients toparticipate in Phase I clinical trials of Avicidin, a cancer therapyNeoRx is developing. Avicidin employs a different version of theantibody used in OncoTrac and binds to the same tumors.NeoRx also has completed Phase III trials of a diagnostic kit for non-small cell lung cancer, and the data are being analyzed. Abrams saidthe company does not intend to seek marketing approval for thisproduct until OncoTrac has been cleared.NeoRx's stock closed at $6.63 a share on Wednesday, down 13 cents.
-- Philippa Maister
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