By Randall Osborne
Almost exactly six months after taking the FDA¿s guidance to shift gears and submit a changed new drug application (NDA) for their chemotherapeutic agent DepoCyt, SkyePharma plc and Chiron Corp. won marketing approval of the drug for lymphomatous meningitis, and the companies expect to make it available in about four weeks.
First developed by DepoTech Corp., of San Diego, DepoCyt ¿ an injectable, sustained-released formulation of cytarabine ¿ was included in the package when London-based SkyePharma disclosed last year its plan to buy DepoTech. Chiron, of Emeryville, Calif., is DepoTech¿s U.S. marketing partner. The merger was completed early last month. (See BioWorld Today, Oct. 20, 1998, p. 1.)
¿There¿s been a lot of activity here,¿ said John Longnecker, president of DepoTech.
The plan for the merger, which made DepoTech a wholly owned subsidiary of SkyePharma, came despite a not-approvable letter from the FDA for DepoCyt earlier in the year. The agency, saying clinical trials of DepoCyt failed to show conclusively that the drug benefits patients with neoplastic meningitis from solid tumors, told DepoTech and Chiron it would consider an altered submission ¿ one seeking approval of the drug for neoplastic meningitis from lymphomas. (See BioWorld Today, May 27, 1998, p. 1, and Sept. 3, 1998, p. 1.)
¿Not everybody believed we¿d been invited [to submit another NDA], but we had been,¿ Longnecker said. ¿The failure the first time around wasn¿t related to the technology, but to the difficulty of this type of clinical study,¿ he added. An FDA panel last November recommended approval of DepoCyt¿s new NDA.
Part of SkyePharma¿s deal with DepoTech was that the purchase price of about $30.6 million, made up of a stock exchange and equity purchase, would increase by about $14 million worth of SkyePharma stock, if DepoCyt is launched in the U.S. by March 31, 2000.
¿We had a lot of people interested in acquiring the technology,¿ said Longnecker, who has been with DepoTech for six and a half years.
DepoCyt is the only treatment approved by the FDA for lymphomatous meningitis. Delivered by a lipid-based encapsulation system, DepoCyt is injected every two weeks directly into the cerebrospinal fluid ¿ rather than twice per week, which is the standard intrathecal chemotherapy dose. Pricing has not been established, Longnecker said.
Studies Of DepoMorphine Ongoing
Another product using the same delivery technology, DepoMorphine for acute post-surgical pain, is in an open-label Phase II study, for which patient accrual was recently completed, and in a controlled Phase II study, which is over halfway accrued, Longnecker said.
DepoTech, which will probably change its name in the next month to reflect new ownership, has six feasibility studies ongoing with other drugs, delivered by way of the same technology, Longnecker said. Among its partners in those studies are St. Louis-based Monsanto Co. and Synthelabo SA, of Montrouge, France.
The FDA¿s approval letter arrived Friday, Longnecker said, but the news was not disclosed until Monday afternoon, after the U.S. stock markets closed.