PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[midastouch017]

Protalix Biotherapeutics (PLX) is the best-performing drug stock this year, with shares 180% higher. (I exclude stocks with market caps lower than $100 million in my ranking.)

The stock's comeback appears related to a renewed investor interest in the company's plant cell-based protein drug manufacturing technology. Most therapeutics proteins (think injectable drugs like monoclonal antibodies) are made from genetically altered mammalian cells. Protalix uses genetically altered plant cells (carrot cells, actually) to do the same thing at lower cost.

Protalix's drug manufacturing platform is capable of making real drugs, but it has not proven adept at selling them. To me, that's the biggest risk factor with the stock.

The company's commercial track record is poor. Elelyso was the first protein replacement therapy developed by Protalix. The drug secured U.S. approval for Gaucher's disease in 2012, but sales through Pfizer are negligible next to its competition, Sanofi's (SNY) Cerezyme/Cerdelga.

The pharma giant doesn't break out Elelyso sales. Sales of "other rare disease drugs" (of which Elelyso is one) totaled $22 million in 2016, according to Pfizer's annual report.

Next up in Protalix's pipeline is a protein replacement therapy for Fabry disease, known as PRX-102. The drug is basically a plant cell-based copy of Sanofi's Fabrazyme. Protalix has two phase III studies of PRX-102 in Fabry disease underway with interim results expected in 2018.

The other two drugs in Protalix's pipeline are a "plant-based" biosimilar of the cystic fibrosis drug Pulmozyme, made by Genentech/Roche, and an oral anti-TNF being studied in ulcerative colitis.

It's going on five years since Elelyso was approved. Under the best circumstances, Protalix is still two years away from the potential approval of a second drug in a disease (Fabry) where it will face entrenched and strong competition. I don't know if Protalix can get it done.

https://www.thestreet.com/story/14006436/1/biotech-stock-mailbag-bulls-love-a-distracted-trump-protalix-acadia-sarepta.html?puc=yahoo&cm_ven=YAHOO