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CENTOCOR REPORTS STATUS OF HA-1A(TM) LICENSE APPLICATION AT FDA

 CENTOCOR REPORTS STATUS OF HA-1A(TM) LICENSE APPLICATION AT FDA
 MALVERN, Pa., April 15 /PRNewswire/ -- Centocor, Inc. (NASDAQ: CNTO) today announced that the Food and Drug Administration (FDA) has advised the company that there is insufficient evidence of efficacy for approval at this time of HA-1A been requested.
 Centocor personnel continue to work intensively with the agency's staff to identify the most effective manner in which to develop the additional clinical data which is desired to support the efficacy of HA-1A.
 Last September, the product was endorsed by an advisory committee; however, at that time, the agency staff had not realized that some interim efficacy data had been examined before a revised analytical plan was finalized. While there was no examination of data concerning the groups in which efficacy was observed until months after the revised analytical plan was finalized, the company said it regrets any actions on its part which may have led to misunderstandings. The agency said it does not believe it is appropriate to utilize the revised analytical plan, and therefore has analyzed the data from the clinical trial according to the original protocol.
 The patient data base accumulated during the pivotal trial of HA-1A remains unimpeached. Statistically significant reductions in mortality were observed in septic patients with Gram negative bacteremia at days 3, 7 and 28, and throughout the 28 day period. However, the reduction in mortality at day 14, a primary endpoint in the protocol, was not statistically significant. In patients with Gram negative bacteremia and septic shock, statistically significant reductions in mortality were observed at all time points including day 14 and day 28; however, this patient population was not defined as a primary group in the protocol. For these reasons, the agency said it does not consider the analysis of the data from the pivotal trial according to the protocol to provide sufficient evidence of efficacy.
 "We have the utmost respect for the professionalism and dedication of the FDA staff members who have devoted enormous effort to the review of the product license application for HA-1A," said James E. Wavle Jr., Centocor's president and chief executive officer. "While we believe that our data are strong, we respect FDA's desire for additional assurance of HA-1A's efficacy, and appreciate the collaborative manner in which the agency's staff is working with us. We remain hopeful that approval can be achieved later this year."
 Centocor, based in Malvern, develops, manufactures, and markets diagnostic and pharmaceutical products for human health care. The company's products are based on monoclonal antibody technology and are primarily intended for use in the management of patients with infectious, cardiovascular, and autoimmune diseases and cancer.
 /delval/
 -0- 4/15/92
 /CONTACT: Richard M. Koenig of Centocor, 215-651-6122/
 (CNTO) CO: Centocor, Inc. ST: Pennsylvania IN: MTC SU: PDT


MP -- PH008 -- 8524 04/15/92 09:21 EDT
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Publication:PR Newswire
Date:Apr 15, 1992
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