Another Catalyst for Protalix Print E-mail
By M.E.Garza   
Thursday, 26 January 2012 07:24
FDA CalendarProtalix BioTherapeutics, Inc. (AMEX:PLX)  gave traders another forward-looking catalyst after they announced that new clinical data on taliglucerase alfa will be presented at the 8th Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2012 being held February 8-10 in San Diego, California.

Protalix Biotherapeutics is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins based on its proprietary ProCellEx(TM) protein expression system. The firm's novel bioreactor plant cell system is based on disposable plastic vials that provides stable, optimized conditions, with manufacturing capabilities for the entire range of proteins, including antibodies, complex enzymes and plant-derived pharmaceuticals. Its patented bioreactor system utilizes sterilized, large flexible plastic containers for culturing and harvesting cells in consecutive cycles, with central unit providing oxygen and nutrients.

Professor Ari Zimran, M.D., Director of the Gaucher Clinic, Shaare Zedek Medical Center, Jerusalem, Israel, will deliver an oral presentation entitled "Long term safety and efficacy data of taliglucerase alfa, a Plant Cell Expressed Recombinant Glucocerebrosidase, in treatment of Naive Gaucher Disease patients", which has been scheduled for Friday, February 10, 2012 at 3:45 PM PT.

Gregory Pastores, M.D., Professor of Neurology and Pediatrics and Director of the Neurogenetics Laboratory at New York University School of Medicine, will deliver an oral presentation entitled "Plant Cell Expressed Recombinant Glucocerebrosidase taliglucerase alfa as Therapy for Gaucher Disease in Patients Previously Treated with Imiglucerase" which has been scheduled for Friday, February 10, 2012 at 4:00 PM PT.

Laura van Dussen, M.D., of the Academic Medical Center, University of Amsterdam, will introduce a poster entitled "Long term bone marrow responses, as measured by Quantitative Chemical Shift Imaging (QCSI) MRI, following treatment with taliglucerase alfa in patients with type 1 Gaucher Disease." The poster will be presented on Wednesday, February 8, 2012 from 5:00-7:00 PM PT and Thursday, February 9, 2012 from 4:00-6:00 PM PT.

Protalix' initial commercial focus has been on complex therapeutic proteins, including proteins for the treatment of genetic disorders, such as Gaucher disease and Fabry disease. Its product candidate, taliglucerase alfa(prGCD), is a plant cell expressed recombinant Glucocerebrosidase enzyme (GCD) for the treatment of Gaucher disease. The company's other products in the pipeline include: PRX-102, a proprietary alpha Galactosidase enzyme for the treatment of Fabry disease; PRX-105, a plant cell expressed PEGylated recombinant human Acetylcholinestrase (AChE) for the use in the biodefense arena for therapeutic and prophylactic indications for nerve agents attack; and ANTI TNF, a plant cell expressed recombinant fusion protein for the treatment of arthritis.

The BioMedReports FDA Calendar shows a major upcoming milestone for the firm which was announced in mid-December. As you may recall, Protalix received notification from the U.S. Food and Drug Administration that the FDA had extended the Prescription Drug User Fee Act goal date of the New Drug Application for taliglucerase alfa to May 1, 2012, a three-month extension from the previous PDUFA date of February 1, 2012. Taliglucerase alfa is the Company's proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD), which is being developed for the treatment of Gaucher disease.

In November 2011, Protalix had submitted  clinical information regarding taliglucerase alfa in response to an FDA request. This request related mainly to the presentation of select data provided in the NDA. As this information was requested and provided within 90 days of the February 1, 2012 PDUFA goal date, the agency has the option to extend the PDUFA goal date to provide adequate time for the FDA to complete their review. A three month extension cycle is the standard period granted. No additional data were requested by the FDA in the notification, nor was the Company notified of any specific deficiency in the taliglucerase alfa NDA.

Canaccord Genuity life sciences analyst Ritu Baral which assigned a "BUY," $8 target to the stock has noted investor concern over the recent weakness in the Euro and, in a note to investors on Thursday, highlighted biotech companies in her coverage universe with the greatest foreign currency exposure. Among them was Protalix, which is an Israel-based company that reports in dollars. She notes an expected CHMP review date around mid-2012 for lead drug taliglucerase, a recombinant enzyme therapy for Gaucher’s disease. Canaccord also notes that the drug could receive approval in Israel and Brazil, both major Gaucher’s markets, shortly after US approval.

Disclosure: None

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