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CYTOGEN WILL LAUNCH ONCOSCINT CR/OV "WITHIN THE NEXT 30 DAYS,"

Executive Summary

CYTOGEN WILL LAUNCH ONCOSCINT CR/OV "WITHIN THE NEXT 30 DAYS," Chairman and CEO George Ebright reported at a Jan. 5 press conference. The monoclonal antibody-based imaging agent was approved Dec. 29 for the imaging of known colorectal and ovarian cancers ("The Pink Sheet" Jan. 4, p. 12). Cytogen's fourth quarter losses will be less than anticipated as a result of the end-of-year approval. On Dec. 31, Cytogen released estimated results for the 1992 fiscal year ended Jan. 2 that include the impact of a one-time $2 mil. milestone payment from Knoll Pharmaceuticals, which will copromote OncoScint (satumomab pendetide). Cytogen will make future royalty payments on sales of the product to the National Cancer Institute, whose researcher Jeffrey Schlom developed the monoclonal antibody (B72.3). The company estimates its net loss for the fourth quarter of 1992 at $2.6 mil., down from the $3.1 mil. loss reported for the same period in 1991. Fourth quarter revenues are expected to be $4.8 mil., as compared to $5 mil. in revenues for the fourth quarter of 1991. Operating expenses declined from 1991 to 1992 because of a one-time charge of $1.6 mil. recorded during the fourth quarter of 1991. Total revenues for 1992 are expected to be $16.5 mil., or 51% above 1991 revenues of $10.9 mil. Net loss for 1992 is estimated at $12.9 mil. compared to a $15.3 mil. loss reported in 1991. Cytogen plans to file a PLA for OncoScint PR for the detection of prostate cancer in the second quarter of this year, Ebright said. In October, the company submitted data to FDA supporting the safety and efficacy of repeated administrations of OncoScint CR/OV. The imaging agent is currently approved for one-time use only. OncoScint CR/OV labeling notes that preliminary data are available from 69 patients who have received 105 repeat doses of the diagnostic agent. However, labeling states that "there are insufficient data to determine the safety and efficacy of this product after repeat administration." The adverse reactions section of OncoScint CR/OV labeling notes that side effects seen with repeat administration of the product included fever, abdominal pain, and flank pain. Labeling for the imaging agent includes a patient information section that discusses the risks of human anti-mouse antibodies (HAMA) seen in 40% of patients treated with OncoScint CR/OV. "While the limited data exist concerning the clinical significance of HAMA, the presence of HAMA may interfere with murine-antibody based immunoassays, could compromise the efficacy of diagnostic or therapeutic murine antibody-based agents, and may increase the risk of adverse reactions," labeling states. "For these reasons patients should be informed that the use of this product could affect the future use of other murine-based products including OncoScint CR/OV-In [OncoScint CR/OV linked with Indium- III], and should be advised to discuss prior use of murine-antibody based products with their physicians," labeling adds. Clinical trial information in the labeling notes that in patients with recurrent colorectal carcinoma, a single 1 mg dose of OncoScint CR/OV when compared to computed tomography detected a greater proportion of lesions in the pelvis (75% vs. 55%) and in the extrahepatic abdomen (67% vs. 28%). CT scan was superior to OncoScint CR/OV in detecting liver lesions (88% vs. 38%). Using the two diagnostic tests in combination resulted in a sensitivity of 88%. For surgically confirmed ovarian cancer recurrences "the sensitivity of OncoScint CR/OV-In was significantly higher than that of CT scanning (59% vs. 29%)," labeling notes.
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