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MAHWAH, N.J., Feb. 14, 2017 (GLOBE NEWSWIRE) -- Radware® (NASDAQ:RDWR), a leading provider of cyber security and application delivery solutions, today announced that it has secured a multi-million dollar deal to support the network security infrastructure for one of the world’s largest Content Delivery Network (CDN) services providers’ Security-as-a-Service business for the next three years. Radware’s family of DDoS security solutions provides integrated application and network security solutions for a best of breed, multi-layered security architecture and DDoS attack prevention.  The solution provides the highest protection accuracy with patent-protected behavioral based detection to protect legitimate traffic and real-time signature creation for zero-day attack protection.  Radware's DDoS protection offers the highest mitigation capacity in the industry with devices handling up to 400Gbps of traffic at 330M PPS (packets-per-second). “Security as a service is a significant revenue stream for this CDN,” said Igal Toledano, Vice President of global service contracts for Radware. “An operation of its size requires vigilant and ongoing updates to its security infrastructure.  Radware’s security solutions will ensure that the CDN can provide the fastest and highest quality DDoS detection and mitigation to its clients without latency, downtime or slowness.” The agreement provides the CDN with subscription to the Radware Emergency Response Team’s weekly and ad-hoc Security updates, full maintenance of the Radware install base across the world and priority response time and SLA to the Radware ERT team to assist in attack mitigation in real time. Radware® (NASDAQ:RDWR), is a global leader of application delivery and cyber security solutions for virtual, cloud and software defined data centers. Its award-winning solutions portfolio delivers service level assurance for business-critical applications, while maximizing IT efficiency. Radware’s solutions empower more than 10,000 enterprise and carrier customers worldwide to adapt to market challenges quickly, maintain business continuity and achieve maximum productivity while keeping costs down. For more information, please visit www.radware.com. Radware encourages you to join our community and follow us on: Facebook, Google+, LinkedIn, Radware Blog, SlideShare, Twitter, YouTube, Radware Connect app for iPhone® and our security center DDoSWarriors.com that provides a comprehensive analysis on DDoS attack tools, trends and threats. ©2017 Radware Ltd. All rights reserved. Radware and all other Radware product and service names are registered trademarks or trademarks of Radware in the U.S. and other countries. All other trademarks and names are property of their respective owners. The Radware products and solutions mentioned in this press release are protected by trademarks, patents and pending patent applications. For more details please see: https://www.radware.com/LegalNotice/. This press release may contain statements concerning Radware’s future prospects that are “forward-looking statements” under the Private Securities Litigation Reform Act of 1995. Statements preceded by, followed by, or that otherwise include the words "believes", "expects", "anticipates", "intends", "estimates", "plans", and similar expressions or future or conditional verbs such as "will", "should", "would", "may" and "could" are generally forward-looking in nature and not historical facts. For example, we cannot guarantee such deals in the future. Because such statements deal with future events, they are subject to various risks and uncertainties and actual results, expressed or implied by such forward-looking statements, could differ materially from Radware's current forecasts and estimates. Factors that could cause or contribute to such differences include, but are not limited to: the impact of global economic conditions and volatility of the market for our products; changes in the competitive landscape; inability to realize our investment objectives; timely availability and customer acceptance of our new and existing products; risks and uncertainties relating to acquisitions; the impact of economic and political uncertainties and weaknesses in various regions of the world, including the commencement or escalation of hostilities or acts of terrorism; Competition in the market for Application Delivery and Network Security solutions and our industry in general is intense; and other factors and risks on which we may have little or no control. This list is intended to identify only certain of the principal factors that could cause actual results to differ. For a more detailed description of the risks and uncertainties affecting Radware, reference is made to Radware’s Annual Report on Form 20-F which is on file with the Securities and Exchange Commission (SEC) and the other risk factors discussed from time to time by Radware in reports filed with, or furnished to, the SEC. Forward-looking statements speak only as of the date on which they are made and, except as required by applicable law, Radware undertakes no commitment to revise or update any forward-looking statement in order to reflect events or circumstances after the date any such statement is made. Radware’s public filings are available from the SEC’s website at www.sec.gov or may be obtained on Radware’s website at www.radware.com.


News Article | May 24, 2017
Site: www.prnewswire.co.uk

The presentation slides from today's AGM are available on the Company's website. Pharming is a specialty pharmaceutical company developing innovative products for the safe, effective treatment of rare diseases and unmet medical needs. Pharming's lead product, RUCONEST® (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of acute Hereditary Angioedema ("HAE") attacks in patients in Europe, the US, Israel and South Korea. The product is available on a named-patient basis in other territories where it has not yet obtained marketing authorization. RUCONEST® is commercialized by Pharming in Algeria, Andorra, Austria, Bahrain, Belgium, France, Germany, Ireland, Jordan, Kuwait, Lebanon, Luxembourg, Morocco, the Netherlands, Oman, Portugal, Qatar, Syria, Spain, Switzerland, Tunisia, the United Arab Emirates, the United Kingdom, the United States of America and Yemen. RUCONEST® is distributed by Swedish Orphan Biovitrum AB (publ) (SS: SOBI) in the other EU countries, and in Azerbaijan, Belarus, Georgia, Iceland, Kazakhstan, Liechtenstein, Norway, Russia, Serbia and Ukraine. RUCONEST® is distributed in Argentina, Colombia, Costa Rica, the Dominican Republic, Panama, and Venezuela by Cytobioteck, in South Korea by HyupJin Corporation and in Israel by Megapharm. RUCONEST® is also being investigated in a Phase II clinical trial for the treatment of HAE in young children (2-13 years of age) and evaluated for various additional follow-on indications. Pharming's technology platform includes a unique, GMP-compliant, validated process for the production of pure recombinant human proteins that has proven capable of producing industrial quantities of high quality recombinant human proteins in a more economical and less immunogenetic way compared with current cell-line based methods. Leads for enzyme replacement therapy ("ERT") for Pompé and Fabry's diseases are being optimized at present, with additional programs not involving ERT also being explored at an early stage at present. Pharming has a long term partnership with the China State Institute of Pharmaceutical Industry ("CSIPI"), a Sinopharm company, for joint global development of new products, starting with recombinant human Factor VIII for the treatment of Haemophilia A. Pre-clinical development and manufacturing will take place to global standards at CSIPI and are funded by CSIPI. Clinical development will be shared between the partners with each partner taking the costs for their territories under the partnership. Pharming has declared that the Netherlands is its "Home Member State" pursuant to the amended article 5:25a paragraph 2 of the Dutch Financial Supervision Act. Additional information is available on the Pharming website: http://www.pharming.com This press release of Pharming Group N.V. and its subsidiaries ("Pharming", the "Company" or the "Group") may contain forward-looking statements including without limitation those regarding Pharming's financial projections, market expectations, developments, partnerships, plans, strategies and capital expenditures. The Company cautions that such forward-looking statements may involve certain risks and uncertainties, and actual results may differ. Risks and uncertainties include without limitation the effect of competitive, political and economic factors, legal claims, the Company's ability to protect intellectual property, fluctuations in exchange and interest rates, changes in taxation laws or rates, changes in legislation or accountancy practices and the Company's ability to identify, develop and successfully commercialize new products, markets or technologies. As a result, the Company's actual performance, position and financial results and statements may differ materially from the plans, goals and expectations set forth in such forward-looking statements. The Company assumes no obligation to update any forward-looking statements or information, which should be taken as of their respective dates of issue, unless required by laws or regulations.


News Article | May 24, 2017
Site: www.businesswire.com

OVERLAND PARK, Kan.--(BUSINESS WIRE)--On the eve of what’s predicted to be one of the most active tropical storm seasons in three years, wireless customers can be confident in Sprint’s network performance when bad storms strike. Sprint’s experienced Emergency Response Team stands ready, having provided voice, broadband data, cellular, and satellite infrastructure for thousands of weather related crisis and special events. In order to protect its wireless network from the impact of a tropical storm and keep customers connected during a natural disaster, Sprint has taken various preparedness measures including: “Communication during a storm is vital, and our customers and first responders can be confident Sprint is there for them,” said Joe Meyer, Vice President, Sprint Network Performance. “Our extensive planning for hurricane season and other crisis events ensures we can respond quickly to restore any impacted services.” Once an event occurs, Sprint’s Enterprise Incident Management Team moves quickly to: To help wireless consumers prepare for a storm this season, Sprint offers tips such as the importance of sending text messages instead of calling, and keeping mobile devices and batteries fully charged. To learn more, visit Sprint’s Emergency Response Team Facebook page or follow @SprintsERT. Public safety officials seeking information about services from Sprint ERT should call 1-888-639-0020 or email ERTRequests@sprint.com. Sprint (NYSE: S) is a communications services company that creates more and better ways to connect its customers to the things they care about most. Sprint served 59.7 million connections as of March 31, 2017 and is widely recognized for developing, engineering and deploying innovative technologies, including the first wireless 4G service from a national carrier in the United States; leading no-contract brands including Virgin Mobile USA, Boost Mobile, and Assurance Wireless; instant national and international push-to-talk capabilities; and a global Tier 1 Internet backbone. Sprint has been named to the Dow Jones Sustainability Index (DJSI) North America for the past five years. You can learn more and visit Sprint at www.sprint.com or www.facebook.com/sprint and www.twitter.com/sprint. * Contact Sprint’s Emergency Readiness Team for more details and requirements.


News Article | May 24, 2017
Site: www.prnewswire.com

"Over the past twelve years, we have grown Medrio to be a leader in the eClinical market and are excited to partner with Questa as we now embark on the next stage of the company's growth," commented Mike Novotny. "This investment will enable us to expand the adoption of our integrated product offering and invest in the next generation of software applications for our global customer base. We are thrilled to have a partner with such a deep understanding of the healthcare IT space and a great appreciation for our mission to bring greater efficiency to the clinical development process." "Mike and his team have done a remarkable job building Medrio into a vibrant growth company in a capital-efficient manner," said Ryan Drant, Founder and Managing Director of Questa Capital. "Questa's investment approach is to partner with companies that have exceptionally-driven, high-integrity executives who share our passion for improving healthcare. The leadership team at Medrio is a perfect fit for this philosophy." "Over the many years we have known Medrio, we have been impressed with their success in the eClinical market," remarked Brad Sloan, Managing Director of Questa Capital. "Given our deep experience base in healthcare IT and pharma services, we look forward to assisting the company to further its growth and thought leadership, and to enhance the range of solutions it provides to customers." Messrs. Drant and Sloan have joined Medrio's board of directors, which now includes: Mr. Novotny; Richard Scheller, Ph.D., Chief Scientific Officer at 23andMe and former Executive Vice President of Research & Early Development at Genentech; Dave Lipscomb, Co-founder of NetSuite; and Doug Engfer, Founder and Former CEO of invivodata (acquired by ERT). About Medrio Inc. Medrio Inc. is a leading healthcare technology company that provides eClinical solutions including electronic data capture (EDC) for clinical trials. The company's software platform and mobile suite of products deliver simple, fast, and affordable tools for study sponsors and contract research organizations (CROs) to collect clinical trial data. Medrio has extensive experience in all study phases with its software leading the way in early-phase trials. The company serves over 500 customers globally. For more information, please visit www.medrio.com. About Questa Capital Founded in 2016, Questa Capital is a venture capital firm focusing on investments in growth-stage healthcare companies. Questa seeks out disruptive, technology-enabled business models that help improve patient lives and provide better quality and more efficient care. The firm partners with superior management teams to help build innovative market leaders. Questa is led by industry veterans in healthcare investment and operations, Ryan Drant, Brad Sloan and Shawn Conway, who have advised more than 40 growth-stage companies over the past twenty years. More information is available at . To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/medrio-inc-announces-30-million-equity-investment-from-questa-capital-300462905.html


Orbita’s Nathan Treloar will discuss the role of voice-powered healthcare applications during a full-day workshop on Tuesday, May 23, 2017 in San Francisco. Titled Connected Health and IoT: Technology Innovators and Disruption, the workshop is part of Connections: The Premier Connected Home Event hosted by Parks Associates, a market research and consulting firm specializing in emerging consumer technology products and services. Orbita, Inc., a leading provider of voice-first software for connected home healthcare announced today a collaboration with ERT to research innovative new approaches to data procurement and management for pharmaceutical and device customers seeking to streamline clinical trials. The collaboration combines the advanced capabilities of ERT’s EXPERT™ technology platform for clinical trial data collection, processing, and analysis with Orbita Voice™, a first-of-its-kind solution for creating conversational applications using intelligent voice agents such as Amazon Alexa and Google Assistant. “ERT is continually collaborating with clinical trial sponsors and technology experts to ideate and test the application of innovative technologies in clinical development,” said Andrea Valente, executive vice president and chief development officer at ERT. “We’re excited to work with Orbita on this solution and to give patients the power of voice ─ an important, emerging technology ─ to complete surveys, verify completion of care pathway tasks and report health concerns, all of which enables pharmaceutical researchers to move ahead in their clinical development programs quickly, and with confidence.” Orbita Voice is the first healthcare-centric solution designed to easily create and manage intelligent, conversational skills for voice-powered assistants such as Amazon Echo and Google Home. Clinical trial investigators and coordinators use Orbita Voice’s intuitive tools to create interactive voice surveys and collect voice responses, and use built-in analytics to track user engagement and respond to user input. Using the combined ERT and Orbita solution, clincial trial study coordinators can create and manage care plans by setting care goals, tasks, and rules over a specified timeline, including completion of daily pain assessment surveys, wellness tasks, or vitals measurements. Patients and family members can review and manage care tasks via voice as well as in mobile phone and web environments. Nathan Treloar, Orbita president, said, “We are thrilled to be working with ERT to bring next-generation technologies to the forefront for clinical trial sponsors and participants. ERT’s leadership in the clinical trials industry and their creativity in blending Orbita Voice with the advanced capabilities of their own EXPERT™ technology platform make them an ideal partner to deliver transformative solutions to this market.” According to Harry Wang, senior director of research at Parks Associates, “Voice-based UI innovations have huge implications for the healthcare industry, particularly in areas where patient participation, interaction, and engagement is critical to the market success of digital health solutions and services. This collaboration between Orbita and ERT is a clear example of voice recognition technology’s potential in healthcare and we expect many more use cases that incorporate voice UI to emerge.” At the end of 2016, 45% of U.S. smartphone owners reported using a voice-enabled personal assistant through an app or dedicated device and that figure rises to 63% of millennial smartphone owners. About Orbita Orbita is an innovator of connected home healthcare solutions that dramatically increase patient engagement, optimize care coordination, improve outcomes, and reduce costs. Healthcare organizations, device manufacturers and service providers use Orbita’s cloud platform and care journey management solutions to create, deploy and manage secure, connected healthcare applications that combine data from wearables and other connected devices into collaborative care experiences. Orbita’s voice-first solutions enable quick, easy development and management of intelligent voice assistants based on Amazon Alexa, Google Assistant and other voice platforms. http://www.orbita.ai About ERT ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards. Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement, and measure the efficacy of new clinical treatments while ensuring patient safety. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. http://www.ert.com


E4D-RT: Real-Time Four-Dimensional Subsurface Imaging Software is the only commercially available ERT imaging software that can run on distributed memory supercomputing systems—multiprocessor computer systems in which each processor has its own private memory—making it scalable where others are not. E4D-RT’s nimble ability to scale according to the resources of the computing system running the software allows it to continue to produce excellent results on both small and large computing systems, provided the computer processing unit—or CPU—has a minimum of two processor cores, which is currently common even among standard laptops. By linking field data collection hardware to a supercomputing system, E4D-RT can process data fast enough to provide this imaging in real-time—something other commercial ERT programs can’t do. In 2015, the U.S. Department of Energy (DOE) spent about $6 billion on clean-up and remediation; world-wide, the cost of these activities is even larger. Real-time imaging allows scientists to see subsurface processes and solutions as they occur, such as remediation processes that are working to limit the movement of contaminants below the surface and toward water resources. Each year for more than 50 years, R&D Magazine has honored the 100 best innovations in research and development. We are currently accepting applications for the 2017 R&D 100 Awards. Innovators with an exceptional product developed between January 1, 2016 and March 31, 2017 should apply. Submissions close May 12, 2017. For information on the 55th Annual R&D 100 Awards visit the R&D 100 Conference website.


E4D-RT: Real-Time Four-Dimensional Subsurface Imaging Software is the only commercially available ERT imaging software that can run on distributed memory supercomputing systems—multiprocessor computer systems in which each processor has its own private memory—making it scalable where others are not. E4D-RT’s nimble ability to scale according to the resources of the computing system running the software allows it to continue to produce excellent results on both small and large computing systems, provided the computer processing unit—or CPU—has a minimum of two processor cores, which is currently common even among standard laptops. By linking field data collection hardware to a supercomputing system, E4D-RT can process data fast enough to provide this imaging in real-time—something other commercial ERT programs can’t do. In 2015, the U.S. Department of Energy (DOE) spent about $6 billion on clean-up and remediation; world-wide, the cost of these activities is even larger. Real-time imaging allows scientists to see subsurface processes and solutions as they occur, such as remediation processes that are working to limit the movement of contaminants below the surface and toward water resources. Each year for more than 50 years, R&D Magazine has honored the 100 best innovations in research and development. We are currently accepting applications for the 2017 R&D 100 Awards. Innovators with an exceptional product developed between January 1, 2016 and March 31, 2017 should apply. Submissions close May 12, 2017. For information on the 55th Annual R&D 100 Awards visit the R&D 100 Conference website.


News Article | May 2, 2017
Site: www.theguardian.com

The long road to Greece emerging from its worst financial crisis in modern times reached another milestone on Tuesday as the country concluded a crucial compliance review that will allow it to avert default in July. At the cost of yet more painful austerity – in the form of extra pension cuts and tax increases – international creditors agreed to disburse €7.5bn (£6.3bn) in emergency loans to enable Athens to honour maturing debt repayments. More importantly, lenders accepted to set talks in motion on making Greece’s debt mountain more manageable – vital if the country is to gain access to the capital markets from which it has been almost completely exiled since 2009. The breakthrough, after marathon 12-hour talks, became apparent only when the Greek finance minister, Euclid Tsakalotos, announced in the small hours that “white smoke” had been achieved. “There is white smoke … The negotiation is finished with agreement on all the issues,” he said. “We now have a decision that the Greek government will be called to enforce with laws and decisions.” The deal ends more than six months of intense wrangling over the fiscal and structural reforms that Athens must implement in exchange for loans from its third, €86bn bailout programme. Although the programme was outlined in 2015 when Greece came closest to crashing out of the eurozone and reverting to the drachma, the conditions attached to the lifeline remained open to negotiation. Discord most recently had focused on labour reforms and pensions – two issues that Tsakalotos, a British-trained Marxist economics professor, had felt especially strongly about. Under the agreement, the leftist-led government undertook to further slash pensions by 18% as of 2019. Pension payments have now been reduced 12 times since the start of the crisis, and cut by 40% in the past six years. With poorer out-of-work families often depending on them, news of a further drop was met with fury by union leaders, who immediately announced industrial action. The two-party coalition led by the prime minister, Alexis Tsipras, also agreed to broaden the tax-free threshold by effectively dispensing with tax breaks as of 2020. Both measures are expected to produce savings worth €3.6bn or 2% of gross domestic product. “It will be a very hot spring,” Odysseus Trivalas, acting president of the union of public sector employees, told the Guardian. “We have yet to see the details of this agreement but what we know is that it will mean further cuts. There will be a lot of strikes and a general 24-hour lockdown when the measures are brought to parliament for vote.” Greece’s main opposition leader, Kyriakos Mitsotakis, said with better negotiation the painful cutbacks could have been avoided and were tantamount to a “fourth memorandum” or bailout accord. The agreement, which also included opening up the energy market to competitors and liberalising Sunday trade, is likely to be finalised at the next meeting of eurozone finance ministers on 22 May. Legislation is expected no later than 17 May, with the ruling leftist Syriza party anticipating full endorsement from MPs. “The government believes that this road, despite the difficulties, will lead to the country’s exits from bailouts,” interior minister Panos Skourletis told state-run ERT TV. “What’s important after closing the bailout review is to have a roadmap for debt relief.” The International Monetary Fund, which has argued vociferously that Greece’s debt load is unsustainable and has balked at even joining the latest bailout programme, hinted that it could soon sign up to it. IMF participation is viewed as vital by Berlin, the biggest provider of Greece’s rescue funds. Angela Merkel, the German chancellor, faces general elections in September and a crisis-weary electorate that does not want more Greek drama. In a joint statement with Greece’s European lenders, the IMF said: “The Greek authorities have confirmed their intention to swiftly implement this policy package. This preliminary agreement will now be complemented by further discussions in the coming weeks on a credible strategy for ensuring Greece’s debt is sustainable.” Debt relief would come in the form of extended maturities and less punishing interest payments than a one-off write-down. At 180% of GDP, Greece’s debt burden is not only staggering but by far the highest in the 27-member EU. The country’s economy has shrunk by about 27% since the start of the crisis – far greater than the contraction experienced by the US during the Great Depression. Once debt relief was in place, Greece would aim to re-enter markets again, the government said. The European Central Bank has signalled it will include the country in its bond-buying programme if its debt becomes more manageable. “The Greek government is aiming at tapping the markets as soon as possible after wrapping up the second [bailout] review and a comprehensive deal on the medium-term [measures] for the debt,” the government spokesman Dimitris Tzanakopoulos told reporters after the agreement was announced.


News Article | February 15, 2017
Site: globenewswire.com

New Phase 3 Retrospective Analysis Shows Correlation between Reduction in Disease Substrate (Kidney Interstitial Capillary GL-3) and Improved Diarrhea in Fabry Patients with Amenable Mutations treated with Migalastat Supportive Study for Japanese New Drug Application (J-NDA) Demonstrates Migalastat Exposure is Similar in Japanese and non-Japanese Individuals SAN DIEGO and CRANBURY, N.J., Feb. 14, 2017 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biotechnology company at the forefront of therapies for rare and orphan diseases, today announced new positive data analyses for the oral small molecule pharmacological chaperone migalastat HCl (“migalastat”) for Fabry disease at WORLDSymposium™ 2017 in San Diego, California. Jay Barth, Chief Medical Officer of Amicus Therapeutics, Inc., stated, “The new analyses highlighted at this year’s WORLDSymposium add to the already significant body of data which demonstrate the multiple benefits of treatment with migalastat in Fabry patients with amenable mutations. Here, the correlation of the reduction in disease substrate with the reduction in diarrhea symptoms provides further evidence that migalastat is having a positive effect on an important gastrointestinal symptom in Fabry. These findings in diarrhea symptoms support our current Fabry regulatory strategy for migalastat in the U.S., which is based upon improvement in diarrhea in this patient population. Also, we remain on track in Japan with our submission to the Pharmaceuticals and Medical Devices Agency based on completed Phase 1 and Phase 3 studies. We also remain committed to providing access to this important medicine to patients in the EU, where it is already approved, in addition to other major geographies.” Data Highlights for Migalastat for Fabry Disease at WORLDSymposium 2017 Phase 3 Retrospective Analysis - Correlation between Substrate Reduction and Reduction in Diarrhea In a poster1 from Study 011 (FACETS) in Fabry patients who were naïve to ERT, a retrospective analysis from baseline to month 6 demonstrated that migalastat reduces disease substrate (KIC GL-3) and improves diarrhea symptoms (GSRS-D) in patients with Fabry disease with amenable mutations. Key highlights were as follows: To support full approval in the U.S., which represents approximately 25% of the global Fabry market, Amicus plans to confirm the clinical beneficial effects of migalastat in a GI symptom study. The GI study is anticipated to begin in 2017 in approximately 35 Fabry patients who are naïve to treatment and who have an amenable mutation and diarrhea and other GI symptoms. More than 50% of patients with Fabry disease report or show GI signs and symptoms, including diarrhea, abdominal pain, constipation, nausea, and vomiting.2 Supportive Pharmacokinetics (PK) Study for Japanese Regulatory Submission As previously announced, Amicus plans to submit a J-NDA in Japan in the first half of 2017. The J-NDA will be based on data from completed clinical studies with migalastat, including two pivotal Phase 3 studies as well as a Phase 1 study that evaluated the pharmacokinetics (PK) of migalastat in Japanese volunteers. The results from this Phase 1 study are being highlighted in a poster3 at WORLDSymposium 2017 with key highlights as follows: Japan represents the second largest Fabry market in the world by country, with approximately 13% of the $1.2B global Fabry ERT sales generated in Japan in 2015.4 The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan previously confirmed that completed studies of migalastat meet J-NDA submission requirements without the need to conduct an additional clinical study in Japan. The PMDA took into account data from Japanese patients included in the Phase 3 program and the similar PK properties in Japanese and non-Japanese individuals. Migalastat is designed to selectively and reversibly bind with high affinity to the active sites of certain mutant forms of alpha-Gal A, the genotypes of which are referred to as amenable mutations. On May 30, 2016, the European Commission granted full approval for migalastat, under the trade name Galafold™, as a first line therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation. This EU approval may serve as the basis for regulatory approvals in more than two-thirds of the global Fabry market that is outside the U.S. Amicus has commenced the commercial launch of Galafold in Germany and is undergoing the EU country-by-country processes to launch in the majority of EU countries throughout 2016 and 2017. The Company has also initiated expanded access programs (EAP) in the EU and other territories outside the U.S. that provide this mechanism for reimbursed access prior to formal approval. Galafold™ (migalastat) is a first-in-class chaperone therapy approved in the EU as a monotherapy for Fabry disease in patients with amenable mutations. Galafold works by stabilizing the body’s own dysfunctional enzyme, so it can clear the accumulation of disease substrate in patients who have amenable mutations.  A proprietary in vitro assay (Galafold Amenability Assay) was used to classify more than 800 known GLA mutations as “amenable” or “not amenable” to treatment with Galafold. The current EU label includes 313 GLA mutations that have been identified and determined to be amenable based on the Galafold Amenability Assay, which represent between 35% and 50% of the currently diagnosed Fabry population. Healthcare providers in the EU may access the website www.galafoldamenabilitytable.com to quickly and accurately identify which mutations are categorized as “amenable” or “not amenable” to Galafold. Amicus expects to submit updates to the label as additional GLA mutations are identified and tested in the Galafold Amenability Assay. Treatment with GALAFOLD should be initiated and supervised by specialists experienced in the diagnosis and treatment of Fabry disease. GALAFOLD is not recommended for use in patients with a nonamenable mutation. For further important safety information for Galafold, including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European SmPC for Galafold available from the EMA website at www.ema.europa.eu. Fabry disease is an inherited lysosomal storage disorder caused by deficiency of an enzyme called alpha-galactosidase A (alpha-Gal A), which is the result of mutations in the GLA gene. The primary biological function of alpha-Gal A is to degrade specific lipids in lysosomes, including globotriaosylceramide (referred to here as GL-3 and also known as Gb ). Lipids that can be degraded by the action of alpha-Gal A are called "substrates" of the enzyme. Reduced or absent levels of alpha-Gal A activity lead to the accumulation of GL-3 in the affected tissues, including the central nervous system, heart, kidneys, and skin. Progressive accumulation of GL-3 is believed to lead to the morbidity and mortality of Fabry disease, including pain, kidney failure, heart disease, and stroke. The symptoms can be severe, differ from patient to patient, and begin at an early age. All Fabry disease is progressive and may lead to organ damage regardless of the time of symptom onset. Amicus Therapeutics (Nasdaq:FOLD) is a global biotechnology company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of advanced therapies for a broad range of human genetic diseases. Amicus’ lead programs in development include the small molecule pharmacological chaperone migalastat as a monotherapy for Fabry disease, SD-101 for Epidermolysis Bullosa (EB), as well as novel enzyme replacement therapy (ERT) and biologic products for Fabry disease, Pompe disease, and other rare and devastating diseases. 1D. Germain, WORLDSymposium 2017, Effects of Treatment With Migalastat on the Combined Endpoint of Kidney Globotriaosylceramide Accumulation and Diarrhea in Patients With Fabry Disease: Results From the Phase 3 FACETS Study 2Hoffmann B et al. Clin Gastroenterol Hepatol. 2007;5(12):1447-1453. 3F. Johnson, WORLDSymposium 2017, Migalastat exposures in Japanese healthy volunteers and non-Japanese subjects provide evidence that they are similar to Japanese patients with Fabry disease 4Company filings and Amicus estimates Forward Looking Statements This press release contains "forward- looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to data, future studies and ongoing regulatory strategies for migalastat.  Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements.  The forward looking statements included in this press release are based on management's current expectations and belief's which are subject to a number of risks, uncertainties and factors, including that the data reported herein will not be predictive of future results, that later study results will not support  further development of migalastat, or even if such later  results are favorable, that the Company will not be able to successfully complete the development of, obtain regulatory approval for, or successfully commercialize migalastat.  In addition, all forward looking statements are subject to the other risks and uncertainties detailed in our Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on 10-Q for the Quarter ended September 30, 2016.  As a consequence, actual results may differ materially from those set forth in this press release or the accompanying conference call or webcast.  You are cautioned not to place undue reliance on these forward looking statements, which speak only of the date hereof.  All forward looking statements are qualified in their entirety by this cautionary statement and we undertake no obligation to revise this press release to reflect events or circumstances after the date hereof.


CRANBURY, N.J., Feb. 22, 2017 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a global biotechnology company at the forefront of therapies for rare and orphan diseases, today announced a conference call and live audio webcast on Wednesday, March 1, 2017 at 8:30 a.m. ET to discuss financial results for the year ended December 31, 2016. The call will be hosted by John F. Crowley, Chairman and Chief Executive Officer. He will be joined on the call by additional members of the Amicus management team. Interested participants and investors may access the conference call by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international). A live audio webcast can also be accessed via the Investors section of the Amicus Therapeutics corporate website at http://ir.amicusrx.com/, and will be archived for 30 days. Web participants are encouraged to go to the website 15 minutes prior to the start of the call to register, download, and install any necessary software. A telephonic replay of the call will be available for seven days beginning at 11:30 a.m. ET on March 1, 2017. Access numbers for this replay are 855-859-2056 (U.S./Canada) and 404-537-3406 (international); conference ID: 77299407. Amicus Therapeutics (Nasdaq:FOLD) is a global biotechnology company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of advanced therapies for a broad range of human genetic diseases. Amicus’ lead programs in development include the small molecule pharmacological chaperone migalastat as a monotherapy for Fabry disease, SD-101 for Epidermolysis Bullosa (EB), as well as novel enzyme replacement therapy (ERT) and biologic products for Fabry disease, Pompe disease, and other rare and devastating diseases.

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