Nova Pharmaceutical Corp. said Monday that it has receivedapproval from the Food and Drug Administration to beginlimited sales of Pergamid, a bone marrow purging agent.
Under Treatment Investigational New Drug status, patientswith serious or life-threatening conditions can receive a drugprior to marketing approval. Nova, which received thetreatment IND in June, will be allowed to charge patients whoare not enrolled in company-sponsored clinical trials.According to Nova, several hundred patients are receivingPergamid on an experimental basis for the treatment of avariety of cancers.
The charge of $1,068 for a 200 mg. single dose coversmanufacture, research, development and handling costs,according to the company.
Pergamid is used to enhance the success of autologous (self-donated) bone marrow transplants. It is used to remove cancercells from a patient's bone marrow prior to reinfusion of themarrow into the patient.
Pergamid is in Phase III trials for treatment of patients withacute myelogenous leukemia. Nova plans to file for marketingapproval some time in 1992. The company received orphandesignation for Pergamid in 1990.
Stock of Baltimore-based Nova (NASDAQ:NOVX) closed at $6, up25 cents, on Monday.
-- Steve Usdin BioWorld Washington Bureau
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