Amersham prepares to take on Cardioliteafter FDA approves Myoview imaging agent

Du Pont agent holds lion's share of technetium market

For the past five years Du Pont Merck has dominated the nuclearcardiology market for technetium-tagged radiopharmaceuticals.Its Cardiolite product has accounted for about 99% of technetiumsales, according to Du Pont Merck estimates, with the only challengerbeing Bracco's Cardiotec. But the dynamics of this market couldsoon change: On Feb. 9, the Food and Drug Administration approvedAmersham International's Myoview for sale in the U.S.

Myoview, which is already available in Europe and Japan, representsa new generation of technetium heart agents, according to itsdeveloper, Amersham International of Buckinghamshire, U.K. Myoviewis easier to prepare, offers greater flexibility in conductingpatient exams, and provides diagnostic results faster than competingagents, according to William Ehmig, vice president of professionalaffairs at Amersham's U.S. subsidiary, Amersham/Medi-Physics inArlington Heights, IL. The end result of these advantages couldbe substantial cost savings for users, he said.

Medi-Physics is planning to launch Myoview sales in April.The first step will be to offer the product to a limited numberof customers through Medi-Physics' network of 120 radiopharmaciesin the U.S. Within the next five years, Ehmig hopes the agentwill account for a major proportion of the estimated $110 millionto $135 million annual market for technetium agents in the U.S.To meet that goal, the company plans to focus on the usability,throughput, and economic aspects of the product.

Medi-Physics strategists will likely bundle Myoview with certainother products and services for sale to managed-care organizations.Additionally, the company plans to make available software forquantitative analysis of images using CEqual, a software programdeveloped by Cedars-Sinai Medical Center in Los Angeles.

Peter Card, former Cardiolite product manger and currentlydirector of strategic and new product planning at Du Pont Merck,believes that the promotion of Myoview could benefit Cardioliteby speeding the demise of thallium-201.

"Having two firms out there talking about the virtuesof technetium is going to be a plus," Card said.

Last year, thallium products, which are marketed by both DuPont Merck and Medi-Physics, accounted for about half the salesof nuclear cardiac agents in the U.S. But the use of thalliumhas been declining in recent years, a trend that will continuewith the launch of Myoview, Card said. Whether Myoview will alsocut into Cardiolite sales, however, is more difficult to predict.

Medi-Physics hopes to enlighten the cardiology community withdata to be published in coming months that compare Cardioliteand Myoview. In the meantime, the company will focus on data generatedon 764 subjects studied during the nearly two years of clinicaltrials that were used to support the company's FDA application.

The data also indicate that Myoview is rapidly cleared fromnon-target organs, providing the ability to image the patient15 minutes after injection. Ehmig notes that Myoview shows noevidence of myocardial redistribution, which means that Myoviewimages of stress perfusion can be acquired at any time up to fourhours after stress is induced either by exercise or by pharmacologicalmethods.

The rapid clearance of Myoview provides the opportunity toperform single-day protocols involving both stress and rest images,although two-day protocols can also be scheduled. Single-day protocolscan save the imaging department time by providing the abilityto perform more studies in a day, while sparing outpatients theinconvenience and cost of returning for a second day to completethe testing.