DepoTech Corp. has filed a partial new drug application (NDA) withthe FDA for DepoCyt, an anti-cancer drug, to be used for patientswith neoplastic meningitis arising from solid tumors.
Under the "rolling NDA" procedure, the chemistry, manufacturingand controls section of the submission is filed first, which allows theFDA more time to review the manufacturing issues. The remainingsections of the NDA must be filed, according to regulation, 120 daysafter the first application.
DepoCyt is a sustained-release form of cytarabine for treatment ofneoplastic meningitis associated with cancer metastasis. Cytarabine, achemotherapy agent, is encapsulated in DepoFoam, DepoTech'slipid-based drug delivery system.
DepoCyt-treated patients were evaluated in a Phase III trial against acontrol group receiving methotrexate. In June of this year, thecompany said findings from the study showed patients receivingDepoCyt experienced a higher complete response rate compared withmethotrexate.
Chiron Corp., of Emeryville, Calif., has partnered with DepoTech onthis project and has marketing rights in North America and Europe.The two companies, Dana McGowan, chief financial officer atDepoTech, told BioWorld Today, are currently working on twoseparate collaborations: the Chiron Proprietary Products program anda generic drug program.
Under the Proprietary Products program, the companies aredeveloping a compound, DepoIGF-1, a protein for two indications:one for rheumatology and another which, McGowan said, has notbeen disclosed.
The generic program is the umbrella under which such drugs asDepoCyt are developed, McGowan said.
DepoTech and Chiron will continue pivotal Phase III studies ofDepoCyt in neoplastic meningitis arising from leukemia andlymphoma. Additionally, a multicenter Phase IV study of DepoCytfor the treatment of neoplastic meningitis arising from solid tumorsis underway in the U.S. and Canada.
Chiron is currently conducting trials of DepoCyt in Europe.
June Phase I results of DepoAmikacin, a sustained release form of theantibiotic, amikacin, for bacterial infections, proved the drug to bewell tolerated at all five dose levels tested. DepoAmikacin is alsobased on DepoFoam, the company's drug delivery technology.
DepoTech, based in San Diego, Calif., grossed $38 million from aninitial public offering of 3 million shares priced at $12 each inSeptember 1995. The company, which went public a year ago,currently has registered for a private placement and is waiting to hearfrom the Securities and Exchange Commission. DepoTech's cash onhand as of Sept. 30, 1996, was $24.2 million. Net losses were $11.2million and the company's burn rate is $1.75 million a month.
DepoTech's stock (NASDAQ: DEPO) on Tuesday was up $0.500 to$14. n
-- Frances Bishopp
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