SOURCE: BioMedReports


February 24, 2011 10:38 ET

Report: Protalix BioTherapeutics Inches Closer to FDA Approval After Inspection

LOS ANGELES, CA--(Marketwire - February 24, 2011) - BioMedReports has issued a trade alert this morning, based on a 10K that was filed last night after hours by Protalix BioTherapeutics Inc.

Within the 10K, investors will find the answer to the number one open concern going into this week's pending FDA approval PLX/partner Pfizer's Gaucher's disease enzyme replacement therapy Uplyso (taliglucerase alfa). The FDA has set a PDUFA date of 25 February 2011 for the plant-cell expressed therapy drug candidate.

From the 10-k filing: "On February 20, 2011, we received a letter from the FDA notifying us that the FDA had completed its review of the Establishment Inspection Report in connection with the FDA's inspection of our facility in Carmiel, Israel, and that the FDA had classified our facility as acceptable."

As biotech investors know, the acceptance of a firm's manufacturing facilities are a critical step towards FDA approval. The fact that U.S. regulators have signed off on the Israeli facility bodes well.

Analysts actively covering the sector have been very bullish about the drug candidate's chances in the days and weeks leading up to this point.

Cannacord Genuity's Ritu Baral had this to say in her latest report: "We think PLX/partner Pfizer's taliglucerase (tali) for Gaucher's will be approved by its Feb. 25 PDUFA date. We expect a strong US launch in Q2/11 driven by EAP patients and Phase 3b data. We think tali will capture ~15+% of the $1.2B+ Gaucher's market, taking Cerezyme market share through strong marketing and competitive pricing. Our $13 target is based on a pNPV analysis."

In addition, Wells Fargo Market Securities issued this comment along with a $12-$14 "outperform" price target for the company:

"We believe regulatory approval of Protalix's lead drug taliglucerase, an enzyme replacement therapy for Gaucher disease partnered with Pfizer (PFE) is highly likely, potentially catalyzing upside for the shares in H1 2011. We also believe Protalix has a unique profile among small-cap biotechs, which should command a premium: the potential for sustainable profitability from product sales near term, and an underlying technology platform capable of producing other successful candidates longer term. Although recent share appreciation indicates that the company is no longer below investors' radars, we believe the stock remains undervalued based on the potential of taliglucerase and the unique protein production platform."

A full special report complete with analyst report links and charts about the pending FDA decision for Protalix BioTherapeutics is available for premium subscribers at:

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