Key Developments: Protalix Biotherapeutics Inc (PLX)
5.20USD
23 May 2013
$-0.01 (-0.19%)
$5.21
$5.19
$5.25
$5.11
145,748
166,913
$6.80
$4.71
Latest Key Developments (Source: Significant Developments)
Protalix BioTherapeutics Inc. Announces New Clinical Data On Taliglucerase Alfa
Protalix BioTherapeutics Inc. announced new clinical data on taliglucerase alfa. Bone marrow fat fractions of eight naive patients from pivotal and extension trials who were treated with taliglucerase alfa for at least 36 months, and 15 untreated Gaucher patients, were evaluated using Quantitative Chemical Shift Imaging (QCSI) MRI. At 36 months, the patients treated with taliglucerase alfa demonstrated improvement in fat fraction from baseline (p-value = 0.012 after 36 months of follow-up). Range of absolute fat fraction values was between 0.19% and 0.42%, which corresponds to a mean change of 92% from baseline of fat fraction, after 36 months. In addition, there was a increase in bone marrow fat fractions of Gaucher patients treated with taliglucerase alfa when compared to untreated Gaucher patients (p-value = 0.004 after 36 months of follow-up). All patients treated with taliglucerase alfa demonstrated sustained improvements in all other disease parameters. Results demonstrate that treatment with taliglucerase alfa significantly increases lumbar spine fat fractions, thereby indicating clearance of Gaucher cells from bone marrow, an important indication of overall bone disease status in Gaucher patients. 11 treatment-naive patients with symptoms and clinical manifestations of Gaucher disease between ages of two and 18 were enrolled in trial. Full Article
European Medicines Agency Committee For Medicinal Products For Human Use Adopts Opinion On Pfizer Inc And Protalix BioTherapeutics, Inc.'s Taliglucerase Alfa Marketing Authorization Application
Pfizer Inc and Protalix BioTherapeutics, Inc. announced that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) has adopted an Opinion recommending against the Marketing Authorization of taliglucerase alfa, an enzyme replacement therapy (ERT) for the treatment of Gaucher disease. As part of Opinion, the CHMP gave a positive risk-benefit assessment for taliglucerase alfa concluding that the benefits of the medicine outweighed risks in the treatment of Type 1 Gaucher disease. Despite the positive risk-benefit assessment, the Committee could not recommend Marketing Authorization due to Shire's velaglucerase alfa, which received prior Marketing Authorization with orphan drug designation for the same condition. Therefore, Shire's treatment has orphan market exclusivity in the European Union (EU) for ten years from the time of authorization in August 2010. Pfizer pursued a request for derogation from Shire's orphan market exclusivity based on a number of factors. This request, however, was denied. Taliglucerase alfa (ELELYSO) was approved by the U.S. Food and Drug Administration on May 1, 2012 for the long term enzyme replacement therapy (ERT) of adults with a confirmed diagnosis of Type 1 Gaucher disease. On November 30, 2009, Pfizer and Protalix BioTherapeutics, Inc. entered into an agreement to develop and commercialize taliglucerase alfa. Full Article
Pfizer Inc And Protalix BioTherapeutics Inc. Announce FDA Approval Of ELELYSO For Treatment Of Gaucher Disease
Pfizer Inc And Protalix BioTherapeutics Inc. announced that the United States (U.S.) Food and Drug Administration (FDA) approved ELELYSO (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease. ELELYSO is the first FDA-approved plant cell-based ERT for Gaucher disease. It is also the first approved plant cell-expressed drug that is derived from ProCellEx, Protalix's proprietary manufacturing system, using genetically engineered carrot cells. ELELYSO is a form of the human lysosomal enzyme, glucocerebrosidase, used to treat Gaucher disease. Full Article
Protalix BioTherapeutics Inc. Announces Proposed Public Offering Of Common Stock
Protalix BioTherapeutics Inc. announced that it intends, subject to market conditions, to offer and sell shares of its common stock in an underwritten public offering. Jefferies & Company, Inc. is acting as the sole book-running manager for the offering and each of Canaccord Genuity Inc. and Oppenheimer & Co. Inc. are acting as co-managers for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. The Company expects to grant the underwriters a 30-day option to purchase additional shares of its common stock to cover over-allotment, if any. The Company expects to use the net proceeds from the sale of the shares primarily to fund clinical trials for the Company's product candidates, to fund the Company's research and development activities, to enhance the Company's manufacturing capacity, for working capital and general corporate purposes. Full Article
FDA Extends Protalix BioTherapeutics Inc.'s Taliglucerase Alfa PDUFA Date To May 1, 2012
Protalix BioTherapeutics, Inc. announced that it received notification from the U.S. Food and Drug Administration (FDA) that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date of the New Drug Application (NDA) 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 plant cell expressed recombinant form of human Glucocerebrosidase (GCD), which is being developed for the treatment of Gaucher disease. In November 2011, the Company submitted certain 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. Full Article
Protalix BioTherapeutics Inc.'s Acetylcholinesterase Demonstrates Potential Role In The Treatment Of Parkinson's Disease
Protalix BioTherapeutics Inc. announced that a paper entitled: "Adaptive alternative splicing correlates with less environmental risk of Parkinsonism," has been published online in the Journal of Neurodegenerative Diseases. The research includes an investigation of the effect of Protalix's PRX-105 on alternative splicing patterns in the striatum, which may confer protection in Parkinson's disease. PRX-105 is a plant derived version of the human soluble acetylcholinesterase splice variant R (AChE-R) that is in development for several indications, including a biodefense program and an organophosphate-based pesticide treatment program. Building on prior research supporting a role for disrupted alternative splicing in several neurodegenerative diseases, scientists from the Hebrew University of Jerusalem, Israel and Protalix BioTherapeutics investigated splicing patterns in pre-clinical models of Parkinson's disease to determine a possible role of AChE-R in the brain's protective mechanisms. The research highlights that a splice shift, either inherited or induced by environmental factors (e.g. neurotoxins), from the more common 'synaptic form' of acetylcholinesterase (AChE-S) to the monomeric 'read-through' variant of AChE (AChE-R), is important in conferring protection against Parkinson-like symptoms. Furthermore, intravenous injection with PRX-105 induced a protective gene expression profile in the striatum of the brain. Full Article
Protalix BioTherapeutics Inc. Announces FDA Accepts For Review Complete Response Resubmission For Taliglucerase Alfa And Assigns PDUFA Date
Protalix BioTherapeutics Inc. announced that the U.S. Food & Drug Administration (FDA) has accepted for review the resubmission of the taliglucerase alfa New Drug Application (NDA) following the Company's receipt of a Complete Response Letter (CRL) in February 2011. The FDA deemed the resubmission a class 2, or six month, response and established February 1, 2012 as the Prescription Drug User Fee Act (PDUFA) date. 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. The Company's submission addresses the questions posed by the FDA in the CRL, including the request for clinical data from the Company's switchover trial and long-term extension trial, and additional information relating to chemistry, manufacturing and controls (CMC). Full Article
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