MBI Applies for Imaging Agent Tests

Molecular Biosystems Inc. has applied for federal Food and Drug Administration permission to begin clinical tests of its Albunex cardiac ultrasound contrast agent. Developed as a diagnostic aid for heart problems, Albunex could find a multimillion-dollar market, MBI officials and analysts say.

But the payoff on Albunex, assuming that the FDA grants permission and that clinical trials are successful, will not be soon in coming. If the FDA classifies Albunex as a drug and not a device as the company expects, clinical trials of up to three years may be necessary before the product is ready for market.

Moreover, MBI expects formidable competition from more experienced and better capitalized pharmaceutical companies for an imaging-agent market that could total $750 million annually by 1991. Ultrasound imaging involves the injection into the bloodstream of agents that deflect sound waves and thereby create images.

Still, MBI President Vincent Frank felt confident enough about the company’s future to take the unusual step at Monday’s annual shareholders meeting of projecting $70 million in sales and between $20 million and $30 million in after-tax earnings by 1991, a huge jump from MBI’s 1987 sales of $2.3 million and net income of $575,864.

‘Conservative Assumptions’

The 1991 figures, he told the gathering, are based on “conservative assumptions” relating to projected sales of the ultrasound contrast agent and MBI’s other principal line of products: DNA-probe diagnostic kits for infectious diseases and other medical conditions.

Thomas Griffith, president of Hayes & Griffith Inc., a Chicago investment and research firm, was somewhat more cautious about MBI’s prospects. “This is an application we’re talking about, not an approval,” Griffith said.

“It’s potentially a very attractive product and whether they are the first ones there is anyone’s guess. The work our firm has done indicates they have as good an opportunity as anyone in the field,” Griffith said.

Albunex’s potential is based, Frank said, on the fact that it is the only non-radioactive imaging agent now under development or in use. The most widely used imaging agent, Thalium, which last year had a 95% share of the $100-million imaging-agent market, is radioactive. MBI officials said cardiologists and technicians will more willingly handle non-radioactive products than radioactive products.

Cardiologists May Keep Patients

Another attribute in Albunex’s favor is that it will enable cardiologists who perform ultrasound tests to keep their patients, instead of “giving them up” to radiologists who perform the tests involving radioactive agents.

Albunex consists of tiny bubbles called “microspheres” that are smaller than a red blood cell and covered with a shell of hardened albumin, a blood protein. MBI acquired rights to the product in November, 1986, from University of Chicago researcher Dr. Steven Feinstein, who will receive a royalty on all Albunex sales.

The company expects to spend as much as $4 million on clinical trials to be conducted at several university hospitals, a cost that MBI will shoulder on its own. Unlike its DNA-probe diagnostic kits that are licensed to and distributed by Du Pont, MBI expects to manufacture and distribute the Albunex product itself, at least in the United States.

MBI said it will apply this month for FDA approval to begin selling its first two DNA probe diagnostic kits in the clinical market. To date, MBI has sold a dozen separate kits to researchers only.