Status: marketed in Europe, not U.S.

Organizations involved:

Biotest AG – Manuf.; R&D; Tech.; Europe mark.

Cross ref: See Immune Globulin Products (#743).

Description: Cytofect is an aqueous plasma-derived immune globulin preparation containing a standardized amount of polyclonal antibodies to cytomegalovirus (CMV). Cytotect is packaged in vials containing 10 ml (500 U), 20 mL (100 U), and 50 mL (2500 U).

Nomenclature: Cytotect [TR]; Cytomegalovirus Immune Globulin Intravenous (Human) [FDA, if approved in U.S.]; CMV-IGIV [SY]

Companies.: Cytotect was developed and is manufactured and marketed by Biotest AG.

Trials: In Oct. 2005, Biotest reported results from a study that “doubles the market potential.” In a large Italian study, Cytotect for the first time was shown effective against CMV infections during pregnancy, with newborn infants from treated mothers showing congenital disorders markedly less frequently than the children of untreated mothers. The study in 181 pregnant women with primary CMV infection concluded that both the therapeutic and prophylactic administration of Cytotect drastically reduced severe malformations. Only 3% of children showed these disorders in the therapy group compared with 50% in the control group (p <0.001). No undesirable effects during treatment with Cytotect were observed. Biotest concludes that Cytotect “is thus the only drug that is suitable for treating cytomegalovirus infection during pregnancy. Conventional drugs (virostatics) cannot be used because of their side effects.”

Status: Cytotect is currently used mainly in European countries for transplantation Indications: (much like CytoGam) to prevent life-threatening CMV infections and, presumably, has orphan status for this indication. it is also likely used sometimes for treatment of CMV retinitis, which may be an off-label indication.

Biotest is working to obtain orphan designation for Cytotect in the European Union for use in pregnant women, and will be seeking approval for this indication.

Market: Biotest claims Cytotect is “the world’s leading hyperimmunoglobuin for treating cytomegalovirus infection.”

If approved in the European Union for use during pregnancy, Biotest stated “The market potential should be in excess of 30 million Euro if approval is granted throughout Europe. Cytomegalovirus infection occurs in around 7000 pregnancies each year in Germany alone.”

From Biotest’s statements about Cytotect’s market potential, current sales are apparently on the order of $15 million/year (which appears to be less than CytoGam sales, conflicting with Biotest’s statement that CytoTect is the market leader worldwide).