EU recommends against Pfizer, Protalix drug

Pfizer and Protalix say EU panel recommends against approving Elelyso because of Shire drug

Associated Press

NEW YORK (AP) -- Protalix BioTherapeutics Inc. and Pfizer Inc. said Friday that European Union regulators are recommending their Gaucher disease drug Elelyso not be approved because a competing drug has exclusive marketing rights until 2020.

The recommendation is not binding, but the European Medicines Agency usually follows the advice of its advisory panels. Shares of Protalix dropped 51 cents, or 7.7 percent, to $6.09 in midday trading.

Elelyso, or taliglucerase, is intended to treat a rare genetic disorder called Gaucher disease, which is caused by a deficiency in an important enzyme. The condition can cause liver and neurological problems. EU regulators approved Shire PLC's Vpriv as a treatment for Gaucher disease in August 2010, and the advisory panel said the drug has marketing exclusivity until August 2020 because it was awarded orphan drug status.

Orphan drug status is awarded to treatments for rare diseases that have few or no treatment options. Competing drugs are generally barred from the market for 10 years in Europe and seven years in the U.S.

The companies said Pfizer challenged Vpriv's orphan drug status, but was not successful. They said the panel had a positive view of Elelyso's benefits, and Pfizer will consider its next steps on Elelyso.

The Food and Drug Administration approved the drug on May 1.

Pfizer, of New York, has exclusive rights to market Elelyso in all countries except Israel, where Protalix is based. Pfizer shares rose 14 cents to $22.74 and shares of Shire rose $1.25 to $92.07.

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