PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[midastouch017]

Protalix's competitor flies 30% because of the understandings with the FDA

(Article from Israeli Bizportal Goog translated)

Amicus (Nasdaq: FOLD) is up 30% in pre-market trading in the United States, in the background of its announcement that it will file a new application for approval of the drug it developed for Fabri after it reached understandings with the FDA. At the end of December 2016, the share of Protalix, which develops a drug for the same disease, surged by a steep 30%, while Amicus crashed 45%, in light of the recent failure in its Phase III trial.

Now, with Amicus's announcement, it appears that competition for initial penetration into the Fabrian market is rising. This is negative news for Protalix since the drug being developed by the Israeli company for Fabry (PRX 102) is considered to be the most advanced product pipeline alongside Cystic Fibrosis.

Yesterday, we had an interview with the company's CEO, Moshe Manor, who referred to the progress of the drug to Fabri when he told Bizportal that "in the Phase II trial, the results were encouraging. In the central polymer (EGFR), which is actually renal function, there was improvement over the competing drugs, Over a period. According to the indications we received. Today we are performing the third phase of the experiment when we look at this central parameter. The experiment is expected to take about two years. After a year we can see the interim results, and then the product can be submitted at the same stage at the same time as the experiment. "

"Regarding Fabri, after the results of the third phase, the future of the product will become clearer and our value will be determined accordingly, and certainly we will need a partner to market the product, but the real step will only come after the results. "These are the catalysts in the near term, which will affect our future path, because the cash flow will probably be reflected in the situation and will help us further develop our products."

It should be noted that the market for Fabri disease, which is a rare hereditary genetic disease, is currently estimated at $ 1 billion when it comes to a growing market (around 10% per year). It is estimated that there are currently between 5,000 and 10,000 people worldwide suffering from this disease.