US DOJ Closes Investigation into Plato UNITED STATES

New Post Public Reply Private Reply Replies (0) Message Board

News Desk 2018

Aug 19, 2014 at 2:15 AM

US DOJ Closes Investigation into Plato

UNITED STATES DEPARTMENT OF JUSTICE CLOSES INVESTIGATION INTO PLATO CLINICAL TRIAL FOR BRILINTA AstraZeneca today announced that it has received confirmation from the United States Department of Justice that it is closing its investigation into PLATO, a clinical trial with Brilinta (ticagrelor). The government is not planning any further action. Pascal Soriot, Chief Executive Officer, said: "We welcome the Department of Justice's decision not to pursue further action. We have always had absolute confidence in the integrity of the PLATO trial and we are proud of the important benefit Brilinta offers to patients around the world suffering from acute coronary syndrome. As one of AstraZeneca's growth platforms, we are committed to delivering the full potential of this important medicine." AstraZeneca recently announced the start of the SOCRATES trial, studying Brilinta for patients with acute ischemic stroke or transient ischemic attack, and the THEMIS study in patients with Type 2 diabetes and coronary atherosclerosis. These studies form part of PARTHENON, AstraZeneca's largest ever clinical trial programme, involving more than 80,000 patients worldwide. The programme also includes two trials that have recently completed recruitment; EUCLID for patients with Peripheral Artery Disease and PEGASUS, studying Brilinta for secondary prevention in patients with previous myocardial infarction. Headline results for PEGASUS are expected in the first quarter of 2015. In 2011, the US Food and Drug Administration approved Brilinta for the treatment of patients with acute coronary syndrome (ACS). Brilinta has been approved by regulatory authorities in over 100 countries and is included in 11 major ACS treatment guidelines globally, including six established US treatment guidelines. The trial manuscript from the PLATO Executive Committee was first published in the New England Journal of Medicine. Following additional rigorous peer-review, over 30 PLATO sub-analyses articles have subsequently been published. The combination of these global reviews makes the PLATO data set one of the most widely analysed clinical trials. About the civil investigative demand On 21 October 2013, AstraZeneca received a civil investigative demand from the US Department of Justice seeking documents and information related to the PLATO trial. AstraZeneca has cooperated with the government enquiry, which focused on questions that have been raised previously in public about the trial. Similar questions have been responded to by the independent PLATO Executive Committee which led the clinical trial. About the PLATO trial PLATO was a large (18,624 patients in 43 countries), head-to-head patient outcomes study of BRILINTA vs. clopidogrel, both given in combination with aspirin and other standard therapy. The trial was designed to establish whether BRILINTA plus aspirin could achieve a clinically meaningful reduction in cardiovascular (CV) events in acute coronary syndrome (ACS) patients, above and beyond that afforded by clopidogrel plus aspirin. Patients were treated for at least 6 months and up to 12 months. BRILINTA plus aspirin has been proven clinically superior to clopidogrel plus aspirin, in reducing thrombotic CV events, including CV death, at 12 months, based on data from the PLATO trial. About AstraZeneca AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com CONTACTS Media Enquiries Esra Erkal-Paler +44 20 7604 8030 (UK/Global) Vanessa Rhodes +44 20 7604 8037 (UK/Global) Ayesha Bharmal +44 20 7604 8034 (UK/Global) Jacob Lund +46 8 553 260 20 (Sweden) Michele Meixell + 1 302 885 6351 (US) Investor Enquiries Karl Hård +44 20 7604 8123 mob: +44 7789 654364 Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729 Anthony Brown +44 20 7604 8067 mob: +44 7585 404943 Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627 19 August 2014 -ENDS-

Newer

Older

Scroll down for more posts ▼

Top 10 Most Recent News Articles

Protecting Teeth: Insights from Endodontist Dr. Joubert

Preserving Our Natural Chompers Digging into the details of endodontic care, you realize how it's the unsung hero in the dental world. And let's face it, teeth don't get happier on their own when there's a problem on the inside. Dr. Christopher Joubert, a wiz on the endodontic front, spills the beans over at HelloNation about how essential these practices are in keeping...

ARTiSTORY's Strategic Advance in Cultural IP Licensing

Call it a seismic shift or call it common sense, but ARTiSTORY's recent haul of accolades makes it clear: they're onto something big in the cultural IP game. Receiving four honors at the 26th International Advertising Institute Awards (IAI Awards), including a Gold for their British Library × CHAGEE collaboration, and jumping into License Global's Top 60, they're staking...

New 2027 Jeep Wrangler JL-2A: A Blast from the Past

Revisiting a Prized Legacy: The 2027 Jeep Wrangler JL-2A Sometimes, what’s new is really just a nod to what’s old—and nowhere is this more so than with the 2027 Jeep Wrangler JL-2A. In the grand parade of automotive history, Jeep's latest creation is more than just a vehicle; it's a time machine that cruises on its historic lineage while strapping on all the modern...

OneOdio Showcases Innovation at IFA 2026 in Berlin

Echoes from Berlin IFA 2026 in Berlin was a cacophony of innovation, as OneOdio wrapped up its showcase with a bang. Boasting interactive activities and live DJ sets, the event echoed OneOdio's drive to meld advanced audio technology with the pulsating needs of music pros and everyday listeners. You couldn’t miss the excitement in the air at Booth 217. Tech Unplugged:...

Countries Eye New Investment Paths at CIFIT 2026

Global Investment Winds Shift at CIFIT In the thick of a world that's being turned on its head, you've got big shots from 129 countries and 30 international organizations talking shop at the 26th China International Fair for Investment and Trade (CIFIT) in Xiamen. Take your pick from the 48 of the world's top 50 GDP powerhouses rubbing shoulders there—this ain't your...

U.S. Green Beret's Mission: Clearing Landmines in Ukraine

The Rise of "Safe Ground" on Prime Video This isn't your typical feel-good story—it’s about grit and the unending fight for 'normalcy' where war left scars. Safe Ground, now streaming on Prime Video, showcases Ryan Hendrickson, a U.S. Army Green Beret whose story takes a sharp turn after stepping on an IED in 2010. The day he almost became just another statistic...

USPS Honors 150 Years of the U.S. Coast Guard Academy

Honoring Tradition and Service The good ol’ U.S. Postal Service is at it again, giving a tip of the hat to a slice of American military heritage. This time, they’re putting out a new stamp to celebrate the 150th anniversary of the U.S. Coast Guard Academy. And you know where they did the honors? Right there on Custom House Pier in New London, Connecticut, a place that...

IASLC Boosts Global Thoracic Cancer Collaboration

Breaking Down Barriers in Thoracic Oncology Picture a world where financial walls don't block innovation and knowledge sharing in cancer treatment. The International Association for the Study of Lung Cancer (IASLC) is leading the charge here. They've just launched a new initiative offering complimentary full membership to qualified healthcare professionals in low- and...

SystImmune's Data on Iza-bren Show Promise for Lung Cancer

Stepping into New Territory with SystImmune Amid the cacophony of biotech whispers and the marketplace hum, SystImmune is trotting out something that might just make the folks in lab coats raise an eyebrow. They’ve got new data for Iza-bren—none of that flashy PR chatter—but it's damn promising if you ask me. At the World Conference on Lung Cancer in Seoul,...

Pizza: The Unlikely Symbol of Universal Togetherness

Why Pizza Is More Than Just Food They say a slice of pizza can tell a story. Whether it's a late-night snack amongst college buddies or the centerpiece of a family's Friday tradition, pizza unites like few others can. It morphs from a study aid into a tool for togetherness without skipping a beat, much like a chameleon of the food world. And no one understands this better...