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Protalix completes NDA submission for taliglucerase alfa to FDA for treatment of Gaucher's disease.


9 December 2009 - Israeli biopharmaceutical company Protalix BioTherapeutics Inc (AMEX: PLX) said today it has completed its New Drug Application (NDA) submission with the US Food and Drug Administration (FDA) for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD) for the potential treatment of Gaucher's disease.

On 1 December 2009, Pfizer (NYSE: PFE) and Protalix inked an agreement to develop and commercialise taliglucerase alfa for the treatment of Gaucher's disease. The agreement gives Pfizer exclusive worldwide licensing rights to commercialise taliglucerase alfa while Protalix retains commercialisation rights in Israel.

In addition, Protalix today announced the filing of its proposed pediatric investigation plan to the pediatric committee of the European Medicines Agency (EMEA) for a clinical study in patients between the ages of 2 and 18. This event triggers a milestone payment of USD5m (EUR3.4m) by Pfizer to Protalix according to the agreement between the parties. The terms of the agreement calls for USD55m to be paid by Pfizer to Protalix in connection with certain regulatory milestones.

Taliglucerase alfa has been granted Orphan product designation and fast track development status by the FDA. Taliglucerase alfa is currently being provided to Gaucher's patients in the US under an expanded access protocol, as well as to patients in the European Union under a compassionate use protocol, Protalix said.

On 2 December 2009, Protalix held a medical meeting with the principal investigators involved with the company's taliglucerase alfa clinical trial programme. At the event, the company shared the full Phase III trial results that were submitted to FDA in the company's NDA filing. These data will be presented at the Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2010, 10-12 February, in Miami, Florida.

(USD1 = EUR0.677)

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Publication:M2 Pharma
Date:Dec 9, 2009
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