IVAN, <<DEPO>>
Just in case you did not see news. Based on this the cat might still be stalking for a little longer.
Tuesday May 26, 9:14 am Eastern Time
Company Press Release
DepoTech Receives Non-Approvable Letter for DepoCyt
From FDA
SAN DIEGO--(BW HealthWire)--May 26, 1998--DepoTech Corporation (NASDAQ:DEPO -
news) today announced that the U.S. Food and Drug Administration (FDA) has notified the
company that its New Drug Application (NDA) for DepoCyt(TM), an anticancer drug for the
treatment of neoplastic meningitis (NM) from solid tumors, does not contain adequate information to
support approval. DepoTech intends to seek a meeting with the FDA to clarify the reasons for its
decision.
The FDA stated that, in its opinion, the evidence of patient benefit was not persuasive and the
possibility of increased benefit compared to the control drug was deemed to require further
substantiation. However, the FDA determined that the data submitted are sufficiently promising to
support submission of a Treatment Protocol for NM from solid tumors. The FDA also indicated that
data from the completion of the ongoing study of NM from lymphomas plus additional case studies
under the treatment protocol could potentially substantiate the safety and effectiveness of DepoCyt.
''The company believes that it has exceeded the requirements for approval of DepoCyt contained in
written agreements reached with the FDA over five years ago,'' said John P. Longenecker, Ph.D.,
DepoTech's president and chief operating officer. ''We do not understand the agency's decision or
what would be required for approval and intend to request a meeting with the FDA as soon as
possible.''
The solid tumor study for DepoCyt was a multicenter, controlled, non-blinded study in which a total
of 61 patients were randomized to treatment either with DepoCyt or to the control drug,
methotrexate. Primary end points were complete response rate and time to clinical progression.
Secondary end points included survival and quality of life. This study was to enroll 40 patients and
was not designed to show statistical significance for primary end points. In April 1998, the company
filed an amendment to the NDA for DepoCyt which provided interim data for 30 patients from a
Phase IV clinical trial of NM from solid tumors. In addition, the filing included interim data from 28
patients from a Phase III study of NM from lymphomas.
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, pain management and other fields.
This press release may contain forward-looking statements regarding programs for DepoCyt. 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 company's potential products in the U.S. and other markets,
including timing of approval, if at all; corporate partners' ability to terminate collaborative agreements
regarding DepoCyt; and uncertainties involved in commercialization of DepoCyt or any of the
company's potential products. The company 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 depotech.com.
DepoFoam is a trademark of DepoTech Corporation. |
