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 saabira.chaudhuri@dowjones.com
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