Up-to-date news on the campaign to Gauchers Association. http://www.gaucher.org.uk Protalix BioTherapeutics, announced today 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. 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 Naïve Gaucher Disease patients". 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". 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." A report of all of these presenations will be included in the next edition of the Gaucher News http://www.gaucher.org.uk/news.php?id=93 Genzyme, a Sanofi company, announced today that the US Food and Drug Administration (FDA) has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme® (agalsidase beta).  Please click here to view the press release. This announcement follows last week’s press release that the EMA also approved the Framingham manufacturing plant for the production of Fabrazyme.   Today’s announcement further supports our ability to return Fabry patients globally to regular dosing in accordance with our previously communicated goal of returning all patients to unconstrained full supply throughout 2012.  Product from Framingham can now support the return of US patients to full doses as planned.  Globally, the complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year as Genzyme works to obtain all global regulatory approvals throughout the year and to build inventory.  We will continue to update the Fabry community at a regional/local level about specific Fabrazyme availability.  As a reminder, despite this positive step towards resuming a stable supply of treatment, we continue to operate with limited inventory, so any change to our manufacturing plans could affect the availability of product to patients.  Please contact your local Genzyme representative or your treating physician with additional questions.   This posting contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2010. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. http://www.gaucher.org.uk/news.php?id=92 CARMIEL, Israel, December 6, 2011 Protalix BioTherapeutics, Inc. announced today 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 proprietary 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.    "We believe we have addressed the FDA's request," said Dr. David Aviezer, Protalix's President and Chief Executive Officer.  "We look forward to working closely with the agency as it continues its review.” http://www.gaucher.org.uk/news.php?id=91 CARMIEL, Israel, Protalix BioTherapeutics, Inc. announced today that the Irish Medicines Board (IMB) has completed a successful GMP (Good Manufacturing Practice) audit of the Company's manufacturing facility in Carmiel, Israel, and has issued a Certificate of GMP Compliance of a Manufacturer for the facility.  The IMB Certificate is accepted by all health authorities in the European Union (EU) under the EU's centralized marketing authorization procedure, and by authorities of several other countries that recognize EU Certification.  The audit was performed as part of the European Medicines Agency's (EMA) evaluation of the Marketing Authorization Application for taliglucerase alfa for the treatment of Gaucher disease. In addition to the EMA, the U.S. Food and Drug Administration (FDA), Israeli Ministry of Health and Brazilian National Health Surveillance Agency have completed audits of the Company's manufacturing facility and deemed the facility acceptable. "We are pleased to accomplish this major regulatory milestone," said Dr. Michal Kahana, Protalix's Vice President of Quality Affairs.  "This important achievement helps demonstrate the viability of our proprietary plant-cell based technology platform, which is the engine behind all our pipeline candidates." To date, marketing applications for taliglucerase alfa have been submitted in the United States, European Union, Brazil, Israel and Australia.  The Prescription Drug User Fee Act (PDUFA) target date for taliglucerase alfa in the United States is February 1, 2012. http://www.gaucher.org.uk/news.php?id=90 We are pleased to announce that as of the 12th September The Gauchers Association moved their office into new premises.  Our new address is:  Evesham House Business Centre, 48/52 Silver Street, Dursley, Gloucestershire, GL11 4ND.  Our telephone remains the same 01453 549231 along with our email address ga@gaucher.org.uk http://www.gaucher.org.uk/news.php?id=89