Genzyme’s Next Challenge
Last week, Genzyme’s (Cambridge, MA) Allston Landing, Massachusetts, plant resumed production of Cerezyme, the company’s treatment for Gaucher’s disease. Genzyme presumably found and eliminated the source of contamination that had been reported weeks earlier. You’d think that after putting out this latest fire at the troubled plant, the company would be justified in heaving a sigh of relief.
Its triumph might be fleeting, though. On the same day that Allston Landing began shipping vials of Cerezyme, Pfizer (New York) signed an agreement with Protalix (Karmiel, Israel) to develop a competitor for the drug. Protalix has successfully completed Phase III studies of taliglucerase alfa, a potential treatment for Gaucher’s disease. The company will soon submit a New Drug Application for the medicine, which the US Food and Drug Administration has already granted Orphan-Drug and Fast-Track status. The product could be on the market sometime in 2010.
To create taliglucerase alfa, Protalix uses a plant-cell expression system, which remains a fairly novel technique for the biopharmaceutical industry. Protalix claims that their system is quicker and safer than animal-cell production. They also say that plant-cell expression avoids the risk that cross-contamination would affect a patient.
If FDA can see its way to approving a drug produced through plant-based expression, then Cerezyme’s market position might be in jeopardy. A superior manufacturing method and clever marketing could steal some of Genzyme’s thunder. On the other hand, the Pfizer–Protalix deal could spur Genzyme, and indeed the entire industry, to look more closely at plant-based production. In any case, the availability of several therapeutic options would be good news for patients with Gaucher’s disease.