West Coast Editor
Gearing up to file a new drug application for tetrabenazine in chorea related to Huntington's disease, Prestwick Pharmaceuticals Inc. raised $37 million in a Series B financing that will be used to advance the firm's pipeline of drugs for central nervous system disorders.
"We had participation of all of our insiders," with Pequot Ventures, of New York, stepping in to lead the round, said David Cory, president and chief operating officer of Washington-based Prestwick. The firm's Series A fund raising garnered $23 million in two tranches during the summer of 2003. (See BioWorld Today, June 20, 2003.)
Chorea is "an umbrella term that speaks to hyperkinetic movement disorders," Cory said, noting that they are typically caused by too much dopamine in the basal ganglia.
"It's the exact opposite of Parkinson's disease, where you don't have enough," he noted.
Privately held Prestwick already markets tetrabenazine in Canada under the brand name Nitoman for hyperkinetic disorders, and some of the funds from the Series B will be used to boost that effort. The drug also is sold in some European markets as Xenazine. Cory told BioWorld Today that a new drug application will be filed in the U.S. in "the very near future," probably the first quarter of next year, with approval expected in the third or fourth quarter.
Series B funds also will be used to establish a tetrabenazine sales force, and to push Prestwick's pair of Phase II candidates. One is lisuride, a dopamine agonist developed by Berlin-based Schering AG for Parkinson's disease. Prestwick owns U.S. and Canadian rights to develop and commercialize the drug for subcutaneous and transdermal administration.
The second early Phase II compound is PPI-00410, licensed from Harvard University for schizophrenia. Prestwick owns worldwide rights to the drug, which is described as a selective and full agonist at the N-methyl-D-aspartate glycine site.
Stimulators of the NMDA receptor are expected to work against schizophrenia, but they also might be toxic since the NMDA receptor is coupled with a glycine receptor, and both must be activated. However, stimulation of the glycine site involves no toxicity risk, and studies outside the U.S. have shown PPI-00410, when added to neuroleptics, apparently works on schizophrenics, with excellent tolerability.
Prestwick plans to partner PPI-00410. Meanwhile, eyes are on tetrabenazine, which Cory said "has been available outside the U.S. and used in humans for over 30 years." That it hasn't been approved in the U.S., he said, is due to "the orphan nature of the disease and, actually, no one picked the product up" until Prestwick licensed it from Cambridge Laboratories, of Newcastle, UK.
The FDA has granted fast-track status to the compound - which still isn't approved in France or Germany, Cory said. Cambridge Laboratories is working on that.
"They'll use our dossier," he said. "We trade information."
Prestwick, founded in late 2002, has about 30 employees. Cory came aboard in September 2003, having previously worked as Brisbane, Calif.-based InterMune Inc.'s vice president of sales and marketing.
"I was employee number nine at InterMune and helped take them public," he said.
Participants in Prestwick's Series B included Sofinnova Ventures, of San Francisco; Vivo Ventures, of Palo Alto, Calif.; Atlas Ventures, of Boston; BA Venture Partners, of Foster City, Calif.; and CNF Investments, an arm of Clark Enterprises Inc., of Bethesda, Md.