FDA Approval Delay Sends Protalix Shares Plunging 20%

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Protalix BioTherapeutics is down nearly 20% after news came out that the FDA rejected its application and asked for more data on a drug used to treat Gaucher’s disease that has sales potential of $225 million.

Gaucher’s disease is a rare genetic disorder in which fat builds up in the liver, bone marrow and nervous system.

The Gaucher’s disease drug market is estimated to be worth $2 billion annually and is slated to reach $4 billion by 2015.

Israel-based Protalix is collaborating on the drug, Taliglucerase, with Pfizer.

In 2009 Pfizer paid $60 million for rights to the drug and agreed to pay $55 million more to Protalix if it passed regulation. Pfizer will be entitled to 60% of revenues.

Pfizer is flat today.

Protalix and Pfizer were aiming to take some sales away from Genzyme’s Cerezyme which cornered the market up until last year. Production contamination issues slowed down manufacturing and Cerezyme revenue dropped to $720 million after earning more than $1 billion in recent years.

Shire’s Vpriv is also a big player in the Gaucher’s disease market. Shire is up over 3% today and Genzyme is flat.

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