Protalix Soars on FDA Approval of Gaucher Drug: Tel Aviv Mover

Protalix BioTherapeutics Inc. soared in Tel Aviv trading after the biopharmaceutical company’s first product won approval from the U.S. Food and Drug Administration.

Protalix surged 14 percent to 29.14 shekels at the 4:30 p.m. close in Tel Aviv. The stock gained 13 percent in New York trading, the biggest single-day advance in more than six months. The company developed the drug, Elelyso, with Pfizer Inc. to treat the most common form of Gaucher disease, a rare genetic disorder.

Elelyso will compete with Sanofi’s Cerezyme and Shire Plc’s Vpriv. Type 1 Gaucher, which can lead to spleen and liver enlargement, affects about 6,000 people in the U.S. Pfizer and Protalix will price Elelyso 25 percent less than Cerezyme, the companies said in a statement late yesterday. The approval may help Protalix cement agreements with drugmakers for its medicines in development, Chief Executive Officer David Aviezer said.

“This is a validation of our technology,” Aviezer said in an interview in Tel Aviv. “The approval could be a harbinger for additional agreements with other companies for some of our other drugs in the near future.”

Share Moves

Protalix’s U.S.-listed stock jumped to $7.01 at the close in New York, giving the company a market value of $636.6 million. Biocell Ltd., Protalix’s largest shareholder with a 16 percent stake, jumped 26 percent to close at 34.87 shekels in Tel Aviv. Sanofi rose 1.2 percent to 58.36 euros, and Shire climbed 0.3 percent to 2,022 pence.

Cerezyme brought in 441 million euros ($580 million) in revenue for Sanofi, France’s largest drugmaker, last year, data compiled by Bloomberg show. Manufacturing problems caused contamination of Cerezyme at a Massachusetts plant in 2009 that led to shortages. Shire’s Vpriv had sales of $256.2 million.

Pfizer, the world’s largest drugmaker, paid Protalix $60 million for an exclusive agreement to sell the drug globally except for in Israel, according to the company’s annual report. Pfizer also agreed to pay Protalix $55 million for meeting certain regulatory requirements. The U.S. company will get 60 percent of Elelyso sales while Protalix will keep 40 percent.

Protalix’s shares were downgraded today to hold from buy by Ritu Baral, an analyst at Canaccord Genuity Corp. The price estimate is $8 per share.

Israel Review

Protalix expects approval to sell its Gaucher disease drug in Israel soon, Aviezer said. Israel has at least 500 patients affected with the illness, he said. The company also is awaiting a regulatory decision in the European Union.

“This is a biotechnology milestone as it it the first time the FDA has approved a product that was engineered in plant cells, as opposed to mammalian or bacterial-based systems,” Yoav Kedar, a biotechnology consultant for Clal Finance Brokerage Ltd., said in an interview. “The approval will better position the company to receive approvals in Europe, Israel and Brazil.”

Gaucher disease can cause fat to build up in the liver, spleen, bone marrow and nervous system. About 1 in 14 individuals of Ashkenazi Jewish ancestry carries the mutated gene that can cause the illness, and as many as 1 in 500 present a form of the disorder.

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