Mallinckrodt adds agents with licensing/R&D mix

Mallinckrodt Medical of St. Louis has combined a strong internalR&D program with aggressive licensing of outside technologyto build a stable of contrast agents in all the medical imagingmodalities.

"We seek a balance of both (internal development and licensing).We are good at development but don't expect all great ideas inscience and medicine to come out of our laboratories," saidWilliam J. Mercer, group vice president for medical imaging.

An example of a successful internally developed agent is Optiray,a nonionic, low-osmolar radiographic contrast product introducedin 1989. Optiray helped boost Mallinckrodt's radiology and cardiologysales by 50% last year, according to the company's annual report.Mallinckrodt Medical is a separately incorporated subsidiary ofImcera Group.

Mallinckrodt became the first company to introduce a low-osmolarradiographic contrast agent in the U.S. in 1985 when it initiatedsales of Hexabrix, an agent licensed from Guerbet of France.

"One of our strengths historically has been the abilityto develop products rapidly and bring them to market," Mercertold SCAN. "Over the last two years we have been seekinga better balance by strengthening our internal research to complementthe development side. We brought in Dr. (J. Eugene) Fox to headup our total R&D effort here." Fox is vice presidentfor science and technology.

Other products under internal development include a technetium-labeledcardiac nuclear agent for single-photon emission computed tomographyimaging and a blood-flow magnetic resonance imaging agent, hesaid.

Mallinckrodt's internally developed MRI agents will also becombined with products licensed from outside. The first of theseis an oral gastrointestinal agent developed by Advanced Magnetics(SCAN 8/1/90).

"We have a number of contacts we are working with on theoutside to find new MR contrast agents," Mercer said.

MALLINCKRODT HAS A STAFF of about 10 executives charged with exploringnew venture opportunities and technology assessment, he said.

"The first thing we always look for (when evaluating outsidepartners) is technology. After that, we look at the people and,third, good geographic fit," Mercer said.

Mallinckrodt is interested in agents that suit its own coretechnology, he said.

"We want to be best in diagnostic imaging. We don't, forinstance, want to make calls in physicians' offices," Mercersaid.

The firm is cooperating with NeoRx in the development of monoclonalantibody-based imaging agents. It will also be the exclusive marketerin North and South America for Molecular Biosystems' Albunex ultrasoundcontrast agents. No monoclonal imaging agents or ultrasound contrastproducts have as yet been approved by the Food and Drug Administrationfor sale in the U.S.

While waiting for monoclonal agents to reach the market, Mallinckrodtsigned a worldwide development and marketing agreement in Marchwith Sandoz of Switzerland and University Hospital Dijkzigt ofRotterdam. The agreement involves cancer imaging agents basedon a derivative of the naturally occurring peptide somatostatin.

"We think this opens up a whole new area for nuclear medicine,"Mercer said. "Everyone has been focused on monoclonal antibodies,but we don't have the first product approved by FDA. An approachusing the labeling of peptides may offer a new area for our scientiststo work on in targeting tumors."

Sandostatin, a somatostatin-based therapeutic agent producedby Sandoz, has been approved by the FDA. If this agent can beradiolabeled, it may be possible to combine therapeutic and imagingapplications, he said.