Business Services Industry
DepoCyt Scheduled for Nov. 16, 1998 FDA Advisory Committee Meeting
Business Wire, Oct 17, 1998
SAN DIEGO and EMERYVILLE, Calif.--(BW HealthWire)--Oct. 16, 1998--DepoTech Corp. (Nasdaq:DEPO) today announced that the U.S. Food and Drug Administration (FDA) has advised the company that it is currently scheduling its New Drug Application (NDA) for DepoCyt(TM) for the treatment of neoplastic meningitis (NM) from lymphomas for review by the FDA's Oncologic Drugs Advisory Committee (the "Committee") on Nov. 16, 1998.
DepoCyt is an injectable sustained-release formulation of the chemotherapeutic agent cytarabine. DepoCyt is being developed in collaboration with Chiron Corp. (Nasdaq:CHIR) in the U.S. DepoTech submitted the NDA for the lymphoma indication in October 1998.
The final decision regarding marketing approval of new therapeutics resides with FDA officials subsequent to any recommendation of the Committee.
DepoTech is a drug delivery company dedicated to the development and manufacture of innovative, sustained-release therapeutic products based on DepoFoam(TM) technology. Products are being developed to satisfy medical needs in cancer, infectious diseases, pain management and other fields.
Chiron Corp., with headquarters in Emeryville, Calif., is a leading biotechnology company that participates in three global healthcare markets: therapeutics, vaccines and blood testing. Chiron also conducts research and development in the fields of biological proteins, gene therapy and combinatorial chemistry in support of these targeted areas.
This press release may contain forward-looking statements regarding DepoTech Corp. and Chiron Corp. Actual results could differ materially from those described in this press release as a result of a number of factors, including, but not limited to the following: Uncertainties involved in obtaining regulatory approval for DepoCyt or any of the companies' potential products in the U.S. and other markets, including timing of approval, if at all; and uncertainties involved in commercialization of DepoCyt or any of the companies' potential products, and other risks detailed from time to time in the companies' filings with the Securities and Exchange Commission.
For DepoTech, additional risk factors include, but are not limited to, corporate partners' ability to terminate collaborative agreements regarding DepoCyt. The companies undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this release.
Additional written materials and recent releases regarding DepoTech are available on the World Wide Web at http://www.depotech.com.
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