FDA approves Protalix Gaucher treatment

Protalix is to receive a $25 million milestone payment from Pfizer, which developed the treatment with the Israeli company.

The US Food and Drug Administration (FDA) has approved for marketing in the US Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) drug Elelyso for the treatment of Gaucher disease. The approval comes 15 months after the FDA first rejected the company's application because it required more data.

Following the approval, Protalix will receive a $25 million milestone payment from Pfizer Inc., which developed the treatment with the Israeli company. The FDA approval also paves the way for regulatory approval in Europe and distribution in Brazil, which could earn the company tens of millions of dollars in the next few years..

Protalix share price fell 11% to $6.19 in New York last night, giving a market cap of $562.14 million but after news of the FDA approval, the share price rose 22.62% in after-trading to $7.59.

Protalix CEO Dr. David Aviezer said, "The approval of Elelyso is important for patients who depend on available ERT to manage their Gaucher disease.We also believe that this great news is a recognition of our technology, which is a plant cell manufacturing system from Protalix. This technology is the production process behind Elelyso and other Protalix product candidates."

The statement posted last night on the FDA site said, "The US FDA today approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder. Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. The enzyme deficiency causes fatty materials (lipids) to collect in the spleen, liver, kidneys, and other organs. The major signs of Gaucher disease include liver or spleen damage, low red blood cell counts (anemia), low blood platelet counts, and bone problems."

The statement continued, "Elelyso is an injection that replaces the missing enzyme in patients with a confirmed diagnosis of Type 1 (non-neuropathic) Gaucher disease and should be administered by a health care professional every other week. Type 1 Gaucher disease is estimated to affect about 6,000 people in the US."

FDA director of the office of drug evaluation III in the center for drug evaluation and research Dr. Julie Beitz said, “Today’s approval provides for a new enzyme replacement therapy for the select number of patients with Type 1 Gaucher disease. It also demonstrates FDA’s commitment to developing treatments for rare diseases.”

Published by Globes, Israel business news - www.globes-online.com - on May 2, 2012

© Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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