By Jim Shrine

The FDA approved expanded indications for MedImmune Inc.'s CytoGam, allowing the cytomegalovirus (CMV) treatment to be used in a number of transplant settings.

CytoGam, an immune globulin, has been approved since 1990 for use in preventing CMV in kidney transplant patients. It now is indicated for prophylaxis against CMV disease associated with kidney, lung, liver, pancreas and heart transplants.

The polyclonal antibody already was being widely used off-label for these and other indications, with some estimates showing half the product's business involved off-label usage. The new approvals will allow MedImmune, of Gaithersburg, Md., to promote the product for the additional indications.

"We're finally able to distribute promotional materials and a lot of data that has been amassed over the years in different indications," said Mark Kaufmann, MedImmune's director of planning and analysis. "[The expanded label] is significant to the company, in that it allows us to market the product to some very important physicians who potentially could use the product. That may translate into better sales."

Sales Growing 30 Percent A Year

Sales of the product have grown consistently since launch, at rate of about 30 percent per year. CytoGam sales in 1997 reached $20.3 million and, according to analysts' estimates, will total between $28.8 million and $30.3 million this year. MedImmune markets the product with its own sales force.

CMV is the most common cause of infection after any solid-organ transplant. The expanded indication lets MedImmune market CytoGam for use in about 20,000 kidney, lung, liver, pancreas and heart transplants performed annually in the U.S., rather than restricting the company's sales to physicians involved in roughly 2,000 kidney transplants from CMV seropositive donors to CMV seronegative recipients.

"The main focus on CytoGam is international growth," he said. "We've been filing in a number of different countries over the past months, and will continue to do that over the next six to 12 months, and hope [the result of] that will be a large portion of the growth of the product. It's a competitive market."

MedImmune's newest product, Synagis, is a humanized monoclonal antibody approved in June for preventing respiratory syncytial virus (RSV) in children and infants. (See BioWorld Today, June 22, 1998, p. 1.)

Kaufmann said the company was prepared to launch the product for this year's RSV season, which runs from about September through March. MedImmune has disclosed no further details about the launch. Synagis is partnered with Abbott Laboratories, of Abbott Park, Ill., and is expected to replace much of the use of another MedImmune treatment, the polyclonal antibody RespiGam, though the company still will make RespiGam available. *

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