Genzyme Rival Gets Another FDA Break

Luke Timmerman8/25/09

Protalix BioTherapeutics, the Israel-based biotech company, said today it has received “fast-track” status with the FDA for its experimental drug for Gaucher’s disease. The designation allows the company (AMEX: PLX) to submit pieces of information for its new drug application as they become available, rather than waiting for everything to be finalized, and gives the company the potential for faster-than-usual product approval. The FDA has already allowed patients to get expanded access to the Protalix drug in clinical trials this month, as Genzyme’s market-leading imiglucerase (Cerezyme) suffers from a manufacturing shortfall.

Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle. E-mail him at ltimmerman@xconomy.com or follow him on Twitter at twitter.com/ldtimmerman.