Shares of Protalix BioTherapeutics surged another 12 percent this morning after the developer announced that the FDA had put its closely-watched therapy for Gaucher disease on the agency's fast track. And Protalix says that it will have late-stage data on prGCD ready to submit to regulators in October.
While the FDA almost always takes a slow, methodical approach to reviewing a marketing application for a new drug, prGCD has taken a radically different path. At the FDA's urging, the Israeli biotech has been making the late-stage experimental drug available to patients hit by a sudden shortage of Genzyme's Cerezyme. Fast track status will set up a rapid review process in which regulators will be able to consider preliminary late-stage data for marketing approval.
Protalix shares have already benefited enormously from the agency's actions. Its stock value has more than tripled overall in the wake of Genzyme's problems. Cerezyme is one of the world's most expensive therapeutics, costing about $250,000 a year.
- here's the Protalix release
- read the Reuters report