Centocor Receives Complete Review Letter From the FDA for Infliximab
PR Newswire - June 30, 1998 17:51
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MALVERN, Pa., June 30 /PRNewswire/ -- Centocor, Inc. (Nasdaq: CNTO) announced today that it received a Complete Review letter from the Food and Drug Administration (FDA) for infliximab, formerly known as Avakine(TM), the company's treatment for patients with Crohn's disease. It is expected that final approval for marketing will be granted by the agency following successful resolution of outstanding matters related to final labeling, an agreement on a Phase IV (post-marketing) clinical trial to explore longer term use and the pre-approval inspection of the manufacturing facility.
"We are pleased with the agency's rapid progress with this priority review," said David P. Holveck, chief executive officer at Centocor. "We will continue to work very closely with the FDA to resolve the final labeling and post-marketing clinical trial. Full responses have been submitted on all questions raised during the pre-approval manufacturing inspection."
Crohn's disease is a chronic and debilitating disorder characterized by inflammation of the gastrointestinal tract that can greatly impact a patient's quality of life. For some patients, Crohn's disease causes fistulas, painful complications of the condition in which openings (sores) occur into nearby organs or through the surface of the skin, causing drainage of mucous and/or fecal material.
Centocor is a biopharmaceutical company that develops or acquires and commercializes novel therapeutic products that solve critical needs in human healthcare. The company's primary technology focus is on monoclonal antibodies and DNA-based products. For more information about infliximab, visit Centocor's website at www.centocor.com.
Certain of the matters discussed herein with respect to FDA action and the company's expectations regarding FDA approval, and the manufacturing and marketing of infliximab constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations, estimates and projections about the Company's industry, management's beliefs and certain assumptions made by the Company's management. Investors are cautioned that matters subject to forward-looking statements involve risks and uncertainties, including economic, competitive, governmental, technological and other factors discussed in the Company's filings with the Securities and Exchange Commission, which may affect the Company's business and prospects. More specifically, there can be no assurance that this product will achieve commercial success or that competing products will not preempt any market opportunity that might exist for the product.
SOURCE Centocor, Inc.
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