European MoAb takeoff slower than anticipated

October 21, 1992

Faster review of monoclonal antibody imaging agents by Europeanregulatory authorities led many in the U.S. nuclear medicine fieldto look across the Atlantic for the first commercial success ofthis targeted tracer technology. Unfortunately, the European

Faster review of monoclonal antibody imaging agents by Europeanregulatory authorities led many in the U.S. nuclear medicine fieldto look across the Atlantic for the first commercial success ofthis targeted tracer technology. Unfortunately, the European fieldneeds more cultivating than was first thought.

Cytogen of the U.S. last year became the second monoclonalcompany to receive a go-ahead from Europe's Committee for ProprietaryMedicinal Products (SCAN 7/3/91). The CPMP nod was followed shortlyby several national marketing approvals for Cytogen's OncoScintagent (SCAN 10/9/91).

But, ironically, while the CPMP and referring physicians arewilling, enthusiasm among European nuclear medicine physiciansis weak.

Cytogen was able to move quickly through the European approvalprocess because its U.S. clinical test results were accepted assupport for the application. European regulatory relations andmarketing are being handled for Cytogen by EuroCetus, a Europeanunit of U.S.-based Chiron.

Significant clinical use of monoclonal antibodies has takenplace in Europe, but not all with the favorable results that OncoScintfound in its U.S. trials. This has served to shade the image ofmonoclonals among European nuclear medicine physicians, accordingto Thomas J. McKearn, Cytogen president.

More importantly, European nuclear medicine physicians haveproved less than eager to use monoclonal agents, despite demandfrom referring physicians, he said.

"They (nuclear physicians) were not especially willingto do this scan. The best words we can use to describe it is thatthey were not comfortable with it," McKearn told SCAN.

OncoScint is used for targeting both colorectal and ovariancancer. Cytogen and EuroCetus began promotion of the agent inEurope with the balance of focus tilted to oncologists and surgeons.But when these doctors referred, the nuclear physicians did notadminister the agent.

"We have always felt that we needed to cover both constituenciesin order to have a successful launch," McKearn said. "Itis going to take time. We have to be patient with the nuclearmedicine doctors and help bring them up to a level of proficiencyusing our product. Then I am confident we will see them usingit on a routine basis as we will also see in the U.S."

Cytogen has not yet received marketing approval for OncoScintin all major European markets. The agent is approved in Germany,Italy, Holland and Spain. It is not available commercially inFrance or the U.K.

EuroCetus has initiated a European training program with afocus on nuclear physicians in the two major markets of Germanyand Italy. A medical consulting firm has been hired to handleGerman training, while a major cancer center in northern Italyis helping with the training in that country, he said.

"We are pleased with their (EuroCetus') response to thesituation and feel very confident," McKearn said. The twofirms reached an agreement in August to expand EuroCetus' exclusivemarketing and distribution responsibility for OncoScint to EasternEurope, he noted.

PRICE COULD BE A FACTOR behind sluggish demand for the agent.Cost of the OncoScint kit along with the indium-111 radioisotopeis comparable to the price of a CT exam, McKearn said. This isin addition to the base cost of the nuclear scan.

"While that (price) is a little less than it is domestically(in the U.S.), this is not an inexpensive test, certainly notlike a monoclonal antibody in vitro blood test," he said.

Revenue from the agent is coming in at about half the six-monthlevel that Cytogen originally anticipated, McKearn said. The firmhopes that its numbers will be back on track next year.

"I don't expect much to happen through the rest of thisyear as we go back into the training mode. It is now a questionof looking at it again in the first half of 1993," he said.

Cytogen is, in effect, paying a fee to fertilize the Europeanmonoclonal antibody imaging market. The only other monoclonalimaging agent approved in Europe, Centocor's heart agent Myoscint,is not targeted at cancer.

"As somebody once said, the pioneer is the one with thearrows in his back," McKearn noted.

OncoScint is in the final stages of its application to theFood and Drug Administration in the U.S. That agency has takena prolonged time to confer its first approval on a monoclonalimaging agent.

"As far as we are concerned, the process is concluded,"McKearn said. "We are expecting positive indication fromthe FDA very soon."

BRIEFLY NOTED:

  • Increased compliance with breast cancer screening guidelinesand improvements in breast cancer therapy will help balance theU.S. supply of and demand for breast imaging equipment. This combinationof factors will help the industry avoid excess production capacityand shake itself out of a five-year sales slump, according tothe Diagnostic Imaging technology report, Breast Imaging and Therapy:Market Trends and Clinical Practice in the U.S.

Breast screening compliance has risen significantly in recentyears. Guideline compliance grew from 31% in 1990 to 41% in 1992(see graph). The proportion of women who have had at least onemammogram rose from 64% in 1990 to 74% in 1992. Of 42 millionwomen age 40 and older in 1986, only 20% had received a mammogramin the previous year. Only one of three had ever had the procedure.

For further information on this detailed analysis of the mammographymarket, contact project manager Sally Shankland at 212/683-9294.

  • Fischer Imaging of Denver and ADAC Laboratories of Milpitas,CA, formed a worldwide marketing and product partnership thismonth for sales and service of angiographic and cardiovascularx-ray systems. Fischer will integrate ADAC's digital angiographytechnology with its cardiovascular x-ray system. The combinedproduct will continue under the Fischer label.

"Our direct sales force is concentrating on specificmarkets such as electrophysiology and mammography. We have beeninadequately represented in the cardiovascular markets. ADAC'sexperienced sales force, which is dedicated to cardiovascularimaging, along with a state-of-the-art imaging system, will provideFischer with a strong marketing channel to the cardiovascularmarket," said Sam Langstaff, manager of cardiovascular imagingsystems for Fischer.

The combined cardiovascular imaging product will be displayednext month at both the American Heart Association meeting in NewOrleans and the Radiological Society of North America conferencein Chicago.