Regulators are not expected to render Protalix decision until May of 2012 Print E-mail
By Staff and Wire Reports   
Tuesday, 06 December 2011 10:00
Shares of Protalix BioTherapeutics, Inc. (NYSE-AMEX: PLX, TASE: PLX), are dropping but could present yet another buying opportunity after the company announced on Tuesday morning aht it had received notification from FDA that regulators have extended the PDUFA decision date.

Regulators are not expected to render a decision on the New Drug Application (NDA) for taliglucerase alfa until May 1, 2012 , a three-month extension from the previous PDUFA date of February 1 , 2012. 

Taliglucerase alfa is the Company's proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD), which is being developed for the treatment of Gaucher disease and delays like these make investors, already jittery about the possibility of approval, run for the hills.

In November 2011 , the Company submitted certain clinical information regarding taliglucerase alfa in response to an FDA request.  This request related mainly to the presentation of select data provided in the NDA.  As this information was requested and provided within 90 days of the February 1, 2012 PDUFA goal date, the agency has the option to extend the PDUFA goal date to provide adequate time for the FDA to complete their review.  A three month extension cycle is the standard period granted.  No additional data were requested by the FDA in the notification, nor was the Company notified of any specific deficiency in the taliglucerase alfa NDA.

"We believe we have addressed the FDA's request," said Dr. David Aviezer, Protalix's President and Chief Executive Officer.  "We look forward to working closely with the agency as it continues its review."

Just days ago, the company had announced that the Irish Medicines Board (IMB) had completed a successful manufacturing practices audit of the firm's manufacturing facility in Carmiel, Israel, and that regulators there had issued a Certificate of GMP Compliance of a Manufacturer for the facility. That IMB Certificate is accepted by all health authorities in the European Union (EU) under the EU's centralized marketing authorization procedure, and by authorities of several other countries that recognize EU Certification. The audit was performed as part of the European Medicines Agency's (EMA) evaluation of the Marketing Authorization Application for taliglucerase alfa for the treatment of Gaucher disease.  Dr. Michal Kahana, Protalix's Vice President of Quality Affairs said that the important achievement helped demonstrate the viability of PLX's proprietary plant-cell based technology platform, which is the engine behind all of the company's pipeline candidates.

Most recently, in November the firm announced that a published research included an investigation of the effect of Protalix's PRX-105 on alternative splicing patterns in the striatum, which may confer protection in Parkinson's disease. PRX-105 is being developed for several indications, including a biodefense program and an organophosphate-based pesticide treatment program. On June 2009, Protalix successfully completed an exploratory Phase I study for PRX-105.



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