Myoview receives approvable letter; New product saves time, reduces cost of diagnosing heart problems.

ARLINGTON HEIGHTS, Ill.--(HealthWire)--July 17, 1995-- Medi-Physics, Inc., Amersham Healthcare -- a leader in the $175 million heart imaging market -- has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Myoview (kit for the preparation of technetium 99m tetrofosmin), a new product that will make diagnosing heart problems more accurate and cost-effective.

Widely Used Heart Assessment

Myocardial perfusion imaging, one of the most important nuclear medicine procedures performed in the U.S., Europe and Japan, allows physicians to assess the blood supply to the heart, indicating the quality of the heart muscle itself and its ability to function as a pump. Data gained from examining the heart at rest and under stress (either through exercise challenge or with pharmacological stress agents that simulate exercise) enable cardiologists to decide how best to manage the patient's heart disease.

Facilitates Superior Images

According to Robert C. Hendel, M.D., Assistant Professor of Medicine, Division of Cardiology, at Northwestern University Medical Center in Chicago, one of the Phase III clinical investigators, clearance of tetrofosmin from the lung and liver occurs significantly faster than with DuPont-Merck's Cardiolite. Thus imaging may begin sooner (15 minutes post injection, versus 60 minutes).

Another investigator, Robert F. Caretta, M.D., Director of Nuclear Medicine, Roseville Hospital, Roseville, CA, explains, "Because thallium is cyclotron-produced, its availability depends on delivery schedules not entirely under the physician's control. Myoview, however, is technetium-labeled, so it will be readily available when needed by hospitals and clinics. Myoview can be easily prepared with no boiling requirements in about 15 minutes."

Improves Utilization and Reduces Costs

According to John McCarthy, Medi-Physics Vice President and General Manager, Myoview offers a significant potential for savings to hospitals, patients and their insurance carriers, especially in comparison with other cardiac imaging agents. "The ability to set a flexible imaging schedule with Myoview significantly improves utilization and reduces costs in the nuclear medicine department. Since the unique properties of Myoview give the department so many options in scheduling and imaging patients, camera utilization should improve. Patients can be fully scanned and diagnosed with Myoview in a single day, unlike with other techniques that can require the patient to return on the second day. This goes beyond convenience to the patient and the department. It can significantly reduce the cost in dollars and time for all involved."

"Further," he added, "since the drug can be made up quickly without tedious preparation steps, it is available to the emergency department for use as soon as a patient presenting with chest pain is stabilized. As many as 30 percent of the chest-pain patients presenting at the emergency department do not have heart disease, but, to be safe, they are nearly all admitted to high cost cardiac care units. Patients receiving Myoview, and then scanned when they are stable, can be properly classified for admission or dismissal, with significant savings while maintaining high standards of cardiac care without compromising the patients."

The imaging agent thallium-201, also a Medi-Physics, Inc., Amersham Heathcare product, has long set the standard for myocardial perfusion imaging. This is a widely accepted technique, and has resulted in the positive treatment of hundreds of thousands of patients, but physicians have sought better agents than thallium, which has several significant disadvantages. First, thallium is made in cyclotrons, which adds to the cost of manufacture. Secondly, it has a half-life of just less than three days, adding to the difficulty and cost of distribution and stocking it for routine use. The energy of thallium is also suboptimal for imaging with the nuclear medicine cameras currently in use.

The receipt of an FDA approvable letter is considered a major milestone in the ultimate release of drugs for U.S. marketing, with final approval usually following within a few months. Myoview is already available in Japan and Europe, where physicians favor its accessibility, flexible protocols, early results and high quality images without the need for boiling or filtering.

Myoview will be sold directly to qualified institutions and distributed through the Medi-Physics nationwide network of more than 100 select radiopharmacies -- facilities in which specially trained and qualified pharmacists prepare and quality-check unit doses of radiopharmaceuticals and deliver them to hospitals, clinics and imaging centers just in time for use.

Medi-Physics, Inc., Amersham Healthcare, is a wholly owned subsidiary of the UK-based health-science company Amersham International plc, based in Amersham, Buckinghamshire, England. The parent company has world-wide manufacturing facilities in the U.S., continental Europe and Japan. It is the leader in innovative products and services for nuclear medicine, and is the sole supplier of Ceretec (technetium 99m-exametazine injection), used for brain imaging and labeling white blood cells to detect infection and inflammatory processes; Metastron (strontium-89 chloride injection), a palliation therapy for bone cancer that has metastasized from other sites (usually prostate or breast cancer); I-125 Seeds and I-125 RAPID Strand (implantable devices for early-stage prostate cancer); and a number of other proprietary radiopharmaceuticals. Amersham is also the world's leading supplier of life-science products for university and pharmaceutical basic and applied research. -0-

Note to Editors: Myoview is the trademark of Amersham International plc. I-125 Seeds and I-125 RAPID Strand are registered trademarks of Medi-Physics Inc., Amersham Healthcare. Ceretec and Metastron are the registered trademarks of Amersham International plc. Cardiolite is the registered trademark of DuPont-Merck Pharma.

CONTACT: Medi-Physics Inc., Amersham Healthcare

William A. Ehmig, 708/593-6300 ext. 244