LIFEQUEST PLANNING MITOLACTOL NDA SUBMISSION BY YEAR END
Executive Summary
LIFEQUEST PLANNING MITOLACTOL NDA SUBMISSION BY YEAR END for treatment of brain tumors. The Vancouver, Canada firm said in a recent press release that it "has hired the Biometric Research Institute, Inc. of Arlington, Virginia, to submit an application to the FDA for final approval on behalf of the company." LifeQuest received licensing rights to Mitolactol (dibromodulcitol) from the Hungarian firm Chinoin in July. Mitolactal is LifeQuest's first pharmaceutical product; the company manufactures wheelchairs and other types of mobility equipment for the disabled. The oral anti-cancer agent has been studied in the U.S. for 10 years, according to the company. "Studies conducted at 26 major cancer institutes in the U.S., including the University of California at San Francisco, the University of Wisconsin, M. D. Anderson, and Columbia University, involving over 2,400 patients have shown Mitolactol to be effective against a variety of cancers, either alone or in combination with other drugs," the news release states. "The most promising, from the standpoint of certification and marketing, is its effects on primary and metastatic brain tumors and breast cancer." According to a study compilation assembled by Chinoin, Mitolactol "seems to be an active agent in various brain tumors because of its ability to cross the blood-brain barrier and to accumulate in brain tissue." In addition, the drug "as a single agent is particularly effective on an intermittent schedule." LifeQuest said it "will receive 90% of the profits until its investment is recovered, after which time profits will be shared on a 50/50 basis with its partner." Furthermore, "the agreement contains an option period, in LifeQuest's favor, until Nov. 21, 1987 during which time the company will be able to establish the market and profit potential of the drug." LifeQuest plans to market Mitolactol directly to oncologists. The company recently announced plans "to develop LifeQuest Mobility Centers, a one-stop shopping concept for the physically impaired." LifeQuest also reported that "sales for the year ending April, 1987 were $4.3 mil. Projected sales in 1988 are $19 mil. excluding the pharmaceutical division."