The new management of Protalix Biotherapeutics Inc. (NYSE MKT:PLX; TASE: PLX) - chairman Shlomo Yanai and the replacement for outgoing CEO David Aviezer - will be faced with a more competitive market. The US Food and Drug Administration (FDA) yesterday approved for marketing a new drug for the treatment of Gaucher's disease: Cerdelga, made by Sanofi (the drug was developed by Genzyme, which Sanofi acquired a number of years ago).
Protalix's flagship drug is also designed to treat Gaucher's disease, and has been approved for US marketing. The company has a cooperation agreement with pharmaceutical giant Pfizer, under which Pfizer markets Protalix's drug everywhere except for Israel and Brazil.
The Protalix share responded to the news by plunging 6% on the TASE and 7% in pre-market trading on the New York Stock Exchange (NYSE). Protalix, which has developed technology for producing human proteins in plant cells, has a $246 million market cap on the TASE and NYSE.
Did not win a substantial market share
Gaucher's disease is a genetic disease that causes a chronic shortage of a specific enzyme that breaks down fatty material. Without the enzyme, the fatty material accumulates in the body cells, and interferes with its functioning. It is liable to cause liver damage, anemia, and bone problems. The drug approved yesterday is a chemical molecule, in contrast to Protalix's enzyme.
Sanofi's orally administered drug retards the production of the fatty materials. The FDA announcement said that the drug's safety and effectiveness had been tested in two clinical trials with 199 participants. It said that the most common side effects among users of the drug were fatigue, headaches, nausea, diarrhea, and back pain.
Protalix finished the first half of 2014 with a $13.5 million net loss on $9.1 million in revenue. As of now, the company is awaiting expansion of its market through approval of a product designed for children and revenue from the Australian market. On the other hand, it appears that the company's drug has so far not managed to win a substantial global market share. There are other products in Protalix's pipeline scheduled to enter advanced clinical trials in the next year or two. CEO David Aviezer announced that he would resign this year, and the company is looking for a replacement. Several weeks ago, Protalix announced that former Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) CEO Shlomo Yanai was replacing Zeev Bronfeld as chairman.
Published by Globes [online], Israel business news - www.globes-online.com - on August 20, 2014
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