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Protalix BioTherapeutics Inc., based in Carmiel, Israel, has announced that the U.S. Food and Drug Administration has approved the company’s treatment protocol for prGCD, a treatment of Gaucher disease. The treatment protocol allows physicians and other care providers to administer the drug before it is approved by the FDA, with the intention of easing the shortage of Genzyme’s Gaucher treatment, Cerezyme.
Protalix’(NYSE-Amex:PLX) stock jumped almost 12 percent on the news, to $6.46 in morning trading Monday, up from $5.77 at the previous close.
Genzyme officials expect the supply to be constrained through the end of the year, due to a six-week plant closure at the Cambridge company’s Allston plant, following the discovery of a virus.
Protalix is continuing its Phase 3 clinical trial for its Gaucher drug. Prior to accepting the treatment protocol, the FDA reviewed available data from the company’s ongoing Phase 3 clinical development programs, according to Protalix. Protalix will provide the drug free of charge to patients enrolled in the protocol.
The company expects to submit the drug to the FDA for approval by the end of the year.
The FDA has also approved a treatment protocol to allow a Gaucher drug made by British firm Shire plc to be administered before it is approved.
Genzyme officials are currently only able to provide Cerezyme to three groups of patients who are considered to be the most vulnerable. Genzyme stopped shipping Cerezyme to other patients on Aug 3.
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