Protalix BioTherapeutics Receives Israel Government Grant

As per the terms of the grant, up to $2.9m of the funds awarded are to be used for the advancement of the Protalix BioTherapeutics’ early-stage pipeline product candidates, including acetylcholinesterase (AChE), PRX-102, pr-antiTNF, and three undisclosed compounds in development.

AChE, an anti-organophosphate nerve agent in development for biodefense applications, which had shown efficacy data in a number of animal studies, is currently the subject of a Phase I clinical trial in healthy volunteers.

Protalix said that PRX-102, in development as an enzyme replacement therapy for Fabry disease, has shown results in the knock-out animal model.

Additionally, pr-antiTNF, a biosimilar version of etanercept (Enbrel) in development for rheumatoid arthritis, also demonstrated results in a well-established collagen induced arthritist animal model.

Protalix anticipates meeting with the FDA for pre-IND meetings in the near-term to discuss next steps for these product candidates.

In addition to the capital being allocated to the its early stage programs, the terms of the grant also provide that up to $1.2m is to be used in connection with the further development of taliglucerase alfa, Protalix’s proprietary plant cell expressed recombinant Glucocerebrosidase enzyme for the treatment of Gaucher disease.

The new drug application (NDA) for taliglucerase alfa is currently being reviewed by the FDA, and similar applications with other comparable regulatory agencies in other countries are expected to be submitted during 2010.

Protalix is making taliglucerase alfa available to Gaucher patients in the US under an Expanded Access protocol, and to patients in the EU, Israel and other countries under Named Patient provisions.

Protalix sais that the grant is available through the end of 2010 and funds are to be made available to the company over the course of the year based on actual expenditures made by the company in connection with the designated programs.

David Aviezer, president and CEO of Protalix, said: “We are enthused by the continued support of the OCS in our development efforts. With the influx of capital the company has received over the past six months, we are focused on developing our pipeline product candidates, all of which are stemming from our proprietary ProCellEx protein expression system.

“We have hired approximately fifty new employees in the areas of R&D, product development, engineering and manufacturing, which will enable us to move multiple programs forward at the same time and prepare for the anticipated launch of our product candidate, taliglucerase alfa.”