Protalix Signs Deal With Pfizer to Continue Managing Elelyso Trials

   By Saabira Chaudhuri 
 

Protalix BioTherapeutics Inc. (PLX) has struck a deal with Pfizer Inc. (PFE) under which Protalix will continue to manage ongoing clinical trials relating to its Gaucher disease treatment Elelyso.

Shares rose 2.6% to $5.62 in recent premarket trading. The stock has risen 11% so far this year.

Protalix is currently sponsoring adult and pediatric extension studies of Elelyso, also called taliglucerase alfa. It said new clinical trials for the drug will be conducted and sponsored by Pfizer.

Under the terms of the agreement, Protalix is eligible to receive a milestone payment of $8.3 million if it achieves certain near-term clinical development milestones.

In November 2009, Pfizer and Protalix entered into an agreement to develop and commercialize taliglucerase alfa, an enzyme replacement therapy for the treatment of Gaucher disease. Under the terms of the agreement, Pfizer received exclusive world-wide licensing rights for the commercialization of taliglucerase alfa, while Protalix retained the exclusive commercialization rights in Israel.

Elelyso was approved for marketing by the U.S. Food and Drug Administration in May, and by the Israeli Ministry of Health in September. Protalix has partnered with Pfizer for world-wide development and commercialization, excluding Israel, where Protalix retains full rights. In June, the European Medicines Agency recommended against marketing authorization for the drug.

According to the National Institute of Health's National Institute of Neurological Disorders and Stroke, Gaucher disease is the most common of the inherited metabolic disorders known as lipid storage diseases. Gaucher disease is caused by a deficiency of the enzyme glucocerebrosidase. Fatty materials can accumulate in the spleen, liver, lungs, bone marrow, and brain. Symptoms may include skeletal disorders, enlarged spleen and liver, liver malfunction, anemia, and yellow spots in the eyes.

Write to Saabira Chaudhuri at [e-mail]

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