Marine drive stretch saw the highest maximum noise level being recorded across the three locations reaching 114.1dB opposite Police Gymkhana
Reported by DNA 8 hours ago.
Mumbai witnesses downward trend in noise pollution this year
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Trump dubs California bar shooter 'sick puppy' as community grieves
U.S. President Donald Trump said on Friday the gunman who killed 12 people in a crowded South California bar this week was a "very, very sick guy," as investigators tried to determine what could have motivated the 28-year-old Marine combat veteran.
Reported by Reuters India 7 hours ago.
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UPDATE - Seismic Technologies Business of Fairfield Geotechnologies to be Acquired by Magseis
HOUSTON, Nov. 09, 2018 (GLOBE NEWSWIRE) -- Fairfield Geotechnologies (“Fairfield”) today announced that it has entered into a definitive agreement with Magseis ASA (“Magseis”) whereby Magseis will acquire the Seismic Technologies business from Fairfield comprising data acquisition, nodal and system sale & rental activities, including all shares in Fairfield's wholly owned UK subsidiary WGP Group (jointly the "Business") (the “Transaction”). The name of the new business will be Magseis Fairfield. Fairfield Geotechnologies will remain privately held by the Sugahara family through Fairfield-Maxwell and focus its efforts on data licensing and data processing, as well as imaging, data analytics and data interpretation.
The parties have agreed that the purchase price payable by Magseis shall be based on an enterprise value for the Business of approximately USD 233 million, which comprises a combination of cash and Magseis shares. In addition, Fairfield-Maxwell will receive five year warrants and certain rights under an earn-out payment mechanism related to a project in the Middle East. The final purchase price will be subject to closing working capital adjustments.
The Transaction combines two highly complementary businesses to create a leading provider of marine seismic solutions, including Ocean Bottom Seismic (“OBS”):
· Unmatched global presence through complementary geographical footprints
· Combined client base comprising the world’s largest E&P companies
· Most efficient technologies for all OBS segments and offerings
· Demonstrated track-record and profitability
· Solid combined backlog of more than USD 350m
· Positioned for accelerated growth in the expanding marine seismic industry
Fairfield Seismic Technologies is a leading provider of marine ocean bottom nodal (“OBN”) seismic systems. The Business has performed 45 OBN surveys globally since 2005 and owns an extensive portfolio of intellectual property for both OBS, land and permanent reservoir monitoring solutions. Headquartered in Houston, the Business has approximately 230 full-time employees and 250 contracted personnel.
Byron Sugahara, Chairman of Fairfield-Maxwell Ltd, the owner of Fairfield, says, “Through Fairfield-Maxwell, my family has owned and invested in Fairfield Geotechnologies for more than 40 years. We are excited to become Magseis Fairfield’s largest shareholder given our positive outlook on the seismic services industry and confidence in the combined management team. We are also pleased that the transaction will provide Fairfield-Maxwell additional capital for potential reinvestment in Fairfield Geotechnologies’ remaining data licensing and data processing business.”
“This transformational transaction enables Magseis to take pole position in the development of the marine seismic industry with critical mass, leading technology, modern crews and financial capabilities to capitalize on exciting growth opportunities,” says Jan Pihl Grimnes, Chairman of the Board of Directors of Magseis.
The Chairman, CEO and President of Fairfield, Charles W. (“Chuck”) Davison, has been proposed as the new Chairman of the Board of Directors of Magseis upon completion of the Transaction. Anthony Dowd, President and CEO of Fairfield-Maxwell Ltd, has been proposed as a member of Magseis' nomination committee.
“We are truly excited and look forward to combining with Magseis, creating a leader in the marine seismic industry on a global basis. We believe the multiple value creation opportunities afforded by the Transaction are extremely compelling and in the best long-term interest of all stakeholders, including our customers and employees,” says Chuck Davison.
“Magseis and Fairfield Seismic Technologies combined will have the industry’s largest nodal inventory and be positioned for global operations with substantial scale advantages. The combined entity will have an excellent technology platform providing optimal ability to meet all client requirements regardless of geography, water depth and acquisition methodology,” says Per Christian (“PC”) Grytnes, Chief Executive Officer of Magseis.
Following completion of the Transaction, the combined organization will comprise approximately 430 full-time employees and be structured in three business areas: (i) Eastern Hemisphere Operations (Headquarters in Oslo, Norway), (ii) Western Hemisphere Operations (Headquarters in Houston, USA) and (iii) Technology.
The Transaction does not include the data licensing or data processing business of Fairfield, which will be retained by Fairfield. The Business will be carved out of Fairfield's organization and transferred into a newly incorporated company owned by Fairfield before completion of the Transaction.
Fairfield Geotechnologies will have access to Magseis Fairfield’s equipment and services through a five-year preferred supplier agreement.
*CORPORATE APPROVALS AND CONDITIONS*
Completion of the Transaction is conditional upon, inter alia (i) antitrust approval in the United States, (ii) Magseis being able to raise the required funds, and (iii) the general meeting of Magseis approving the share and warrant issues required for Magseis to complete the Transaction.
Completion of the Transaction is also subject to fulfilment of certain additional conditions, such as Magseis having established, for the benefit of certain officers and employees in the Business, an incentive plan of approximately USD 7 million, Chuck Davison having been elected as Chairman of the Board of Directors of Magseis, completion of a confirmatory due diligence and no material breach of warranties, as well as certain other customary conditions.
Major existing shareholders of Magseis representing more than 50% of the shares outstanding, have communicated their support for the Transaction and undertaken to vote in favor of the issuance of new equity and warrants, and for the election of Chuck Davison as new Chairman, at an extraordinary general meeting of Magseis (the “EGM”).
Financing commitments for the Transaction are expected to be secured (subject to approval by the EGM) as soon as practically possible and at the latest by the end of November 2018.
The Transaction is expected to be completed by the end of the fourth quarter of 2018.
*ADVISORS*
Thompson Hine LLP and Schjødt are acting as legal advisors to Fairfield. Crowe LLP is acting as financial due diligence advisor to Fairfield.
Arctic Securities and DNB Markets are acting as financial advisors and Wiersholm is acting as legal advisor to Magseis. KWC is acting as due diligence advisors to Magseis.
For further information, please contact:
Wes Harris, Communications Advisor to Fairfield
Tel: 281 740 1334
E-mail: wes@alpetrie.com
Per Christian Grytnes, CEO
Tel: +47 48 21 48 21
E-mail: pc.grytnes@magseis.com
Tom Henrik Sundby, CFO
Tel: +47 47 75 44 15
E-mail: tom.sundby@magseis.com
This announcement is not an offer for sale of securities in the United States or any other country. The securities referred to herein have not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), and may not be sold in the United States absent registration or pursuant to an exemption from registration under the U.S. Securities Act. Magseis does not intend to register any portion of the offering of the securities in the United States or to conduct a public offering of the securities in the United States.
Certain statements included within this announcement contain forward-looking information, including, without limitation, those relating to) forecasts, projections and estimates, statements of management's plans, objectives and strategies for Magseis, such as planned expansions, investments or other projects, management, as well as statements preceded by "expected", "scheduled", "targeted", "planned", "proposed", "intended" or similar statements. Although Magseis believes that the expectations reflected in such forward-looking statements are reasonable, these forward-looking statements are based on a number of assumptions and forecasts that, by their nature, involve risk and uncertainty. Various factors could cause actual results to differ materially from those projected in a forward-looking statement or affect the extent to which a particular projection is realized.
No assurance can be given that such expectations will prove to have been correct. Magseis disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
*ABOUT FAIRFIED GEOTECHNOLOGIES*
Privately held Fairfield Geotechnologies, a pioneer and global leader in ocean bottom seismic nodal technology, designs and manufactures a complete range of revolutionary, true cable-free ZLand® and ZMarine® systems and offers expert marine acquisition and data processing services. In addition to its extensive multi-client database in the Gulf of Mexico Shelf and Permian Basin, the Company continues to expand licensing coverage in the Lower 48 through focused investment and strategic acquisition of existing multi-client libraries.
Reported by GlobeNewswire 7 hours ago.
The parties have agreed that the purchase price payable by Magseis shall be based on an enterprise value for the Business of approximately USD 233 million, which comprises a combination of cash and Magseis shares. In addition, Fairfield-Maxwell will receive five year warrants and certain rights under an earn-out payment mechanism related to a project in the Middle East. The final purchase price will be subject to closing working capital adjustments.
The Transaction combines two highly complementary businesses to create a leading provider of marine seismic solutions, including Ocean Bottom Seismic (“OBS”):
· Unmatched global presence through complementary geographical footprints
· Combined client base comprising the world’s largest E&P companies
· Most efficient technologies for all OBS segments and offerings
· Demonstrated track-record and profitability
· Solid combined backlog of more than USD 350m
· Positioned for accelerated growth in the expanding marine seismic industry
Fairfield Seismic Technologies is a leading provider of marine ocean bottom nodal (“OBN”) seismic systems. The Business has performed 45 OBN surveys globally since 2005 and owns an extensive portfolio of intellectual property for both OBS, land and permanent reservoir monitoring solutions. Headquartered in Houston, the Business has approximately 230 full-time employees and 250 contracted personnel.
Byron Sugahara, Chairman of Fairfield-Maxwell Ltd, the owner of Fairfield, says, “Through Fairfield-Maxwell, my family has owned and invested in Fairfield Geotechnologies for more than 40 years. We are excited to become Magseis Fairfield’s largest shareholder given our positive outlook on the seismic services industry and confidence in the combined management team. We are also pleased that the transaction will provide Fairfield-Maxwell additional capital for potential reinvestment in Fairfield Geotechnologies’ remaining data licensing and data processing business.”
“This transformational transaction enables Magseis to take pole position in the development of the marine seismic industry with critical mass, leading technology, modern crews and financial capabilities to capitalize on exciting growth opportunities,” says Jan Pihl Grimnes, Chairman of the Board of Directors of Magseis.
The Chairman, CEO and President of Fairfield, Charles W. (“Chuck”) Davison, has been proposed as the new Chairman of the Board of Directors of Magseis upon completion of the Transaction. Anthony Dowd, President and CEO of Fairfield-Maxwell Ltd, has been proposed as a member of Magseis' nomination committee.
“We are truly excited and look forward to combining with Magseis, creating a leader in the marine seismic industry on a global basis. We believe the multiple value creation opportunities afforded by the Transaction are extremely compelling and in the best long-term interest of all stakeholders, including our customers and employees,” says Chuck Davison.
“Magseis and Fairfield Seismic Technologies combined will have the industry’s largest nodal inventory and be positioned for global operations with substantial scale advantages. The combined entity will have an excellent technology platform providing optimal ability to meet all client requirements regardless of geography, water depth and acquisition methodology,” says Per Christian (“PC”) Grytnes, Chief Executive Officer of Magseis.
Following completion of the Transaction, the combined organization will comprise approximately 430 full-time employees and be structured in three business areas: (i) Eastern Hemisphere Operations (Headquarters in Oslo, Norway), (ii) Western Hemisphere Operations (Headquarters in Houston, USA) and (iii) Technology.
The Transaction does not include the data licensing or data processing business of Fairfield, which will be retained by Fairfield. The Business will be carved out of Fairfield's organization and transferred into a newly incorporated company owned by Fairfield before completion of the Transaction.
Fairfield Geotechnologies will have access to Magseis Fairfield’s equipment and services through a five-year preferred supplier agreement.
*CORPORATE APPROVALS AND CONDITIONS*
Completion of the Transaction is conditional upon, inter alia (i) antitrust approval in the United States, (ii) Magseis being able to raise the required funds, and (iii) the general meeting of Magseis approving the share and warrant issues required for Magseis to complete the Transaction.
Completion of the Transaction is also subject to fulfilment of certain additional conditions, such as Magseis having established, for the benefit of certain officers and employees in the Business, an incentive plan of approximately USD 7 million, Chuck Davison having been elected as Chairman of the Board of Directors of Magseis, completion of a confirmatory due diligence and no material breach of warranties, as well as certain other customary conditions.
Major existing shareholders of Magseis representing more than 50% of the shares outstanding, have communicated their support for the Transaction and undertaken to vote in favor of the issuance of new equity and warrants, and for the election of Chuck Davison as new Chairman, at an extraordinary general meeting of Magseis (the “EGM”).
Financing commitments for the Transaction are expected to be secured (subject to approval by the EGM) as soon as practically possible and at the latest by the end of November 2018.
The Transaction is expected to be completed by the end of the fourth quarter of 2018.
*ADVISORS*
Thompson Hine LLP and Schjødt are acting as legal advisors to Fairfield. Crowe LLP is acting as financial due diligence advisor to Fairfield.
Arctic Securities and DNB Markets are acting as financial advisors and Wiersholm is acting as legal advisor to Magseis. KWC is acting as due diligence advisors to Magseis.
For further information, please contact:
Wes Harris, Communications Advisor to Fairfield
Tel: 281 740 1334
E-mail: wes@alpetrie.com
Per Christian Grytnes, CEO
Tel: +47 48 21 48 21
E-mail: pc.grytnes@magseis.com
Tom Henrik Sundby, CFO
Tel: +47 47 75 44 15
E-mail: tom.sundby@magseis.com
This announcement is not an offer for sale of securities in the United States or any other country. The securities referred to herein have not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), and may not be sold in the United States absent registration or pursuant to an exemption from registration under the U.S. Securities Act. Magseis does not intend to register any portion of the offering of the securities in the United States or to conduct a public offering of the securities in the United States.
Certain statements included within this announcement contain forward-looking information, including, without limitation, those relating to) forecasts, projections and estimates, statements of management's plans, objectives and strategies for Magseis, such as planned expansions, investments or other projects, management, as well as statements preceded by "expected", "scheduled", "targeted", "planned", "proposed", "intended" or similar statements. Although Magseis believes that the expectations reflected in such forward-looking statements are reasonable, these forward-looking statements are based on a number of assumptions and forecasts that, by their nature, involve risk and uncertainty. Various factors could cause actual results to differ materially from those projected in a forward-looking statement or affect the extent to which a particular projection is realized.
No assurance can be given that such expectations will prove to have been correct. Magseis disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
*ABOUT FAIRFIED GEOTECHNOLOGIES*
Privately held Fairfield Geotechnologies, a pioneer and global leader in ocean bottom seismic nodal technology, designs and manufactures a complete range of revolutionary, true cable-free ZLand® and ZMarine® systems and offers expert marine acquisition and data processing services. In addition to its extensive multi-client database in the Gulf of Mexico Shelf and Permian Basin, the Company continues to expand licensing coverage in the Lower 48 through focused investment and strategic acquisition of existing multi-client libraries.
Reported by GlobeNewswire 7 hours ago.
↧
HDFC ERGO Announces the Launch of ‘Cyber Security Awareness Week’
*HDFC ERGO General Insurance Company*, India’s third largest non-life insurance provider in the private sector launched the ‘*Cyber Security Awareness Week*’ starting from October 21, 2018 to October 27, 2018. During the week, HDFC ERGO aims to create awareness about the facets of cybercrime and promote the need of cyber security among individuals under its theme ‘*#**HackSeLado*’.
In order to commence the launch of Cyber Security Week, HDFC ERGO invited esteemed speakers to shed light on the increasing number of cybercrimes in India and discuss the on-going challenges faced by individuals. The panellists for the discussion were as follows:
· Balsingh Rajput, DCP Cyber Crime Maharashtra
· Saket Modi, Ethical Hacker Lucideus Tech
· SuhasTuljapurkar, Managing Partner, Legasis Partners and Founder Director Legasis Services
· Varkha Chulani, Clinical Psychologist & Mental Health Expert
· Anurag Rastogi, Member of Executive Management, HDFC ERGO General Insurance Company
Addressing the panel *Dr. Balsingh Rajput, DCP Cyber Crime Maharashtra *said, “There is an alarming rate of Cyber Crimes in the country with a growth rate of 100% year-on-year. Scams such as Phishing have become an alternate industry, with call centers being set up to defraud unsuspecting victims. Maharashtra Cyber is implementing cyber security and cyber lab project to enable law enforcement to tackle these crimes.”
*Mr. Saket Modi, CEO & Co-founder, Lucideus* added, “There has been a lack of awareness amongst individuals while using technology or the social media. In this digital age most of us haven't been trained to handle a smartphone and hence easily fall prey to basic hacks. Individuals need to realise that anything uploaded on the internet is prone to be hacked and therefore they need to be careful while being online.”
Commenting on the legalities around a cyber-hack, *Mr. Suhas Tuljapurkar, Managing Partner Legasis Partners and Founder Director Legasis Services *said, “Definitely there is a deficiency in current laws relating to Cyber Crime. While there are jurisdictional challenges especially when the Cyber Crime crosses the boundaries, there is legislative requirement to bring out robust laws to outpace the advancements made by the organized Cyber Crime industry.”
Talking about the emotional aspect of a cyber-hack, *Varkha Chulani, Clinical Psychologist and Mental Health Expert *said, “Individuals today suffer from a new condition called ‘*Selfitis*’. Relationships at home nowadays have become more insecure because of extensive use of gadgets. More than financial loses there are emotional losses seen amongst couples and families. Parents should use discipline and keep time limits for their children to avoid the misuse of the Internet.”
Commenting on the launch of cyber security insurance week, *Mr. Anurag Rastogi, Member of Executive Management, HDFC ERGO General Insurance Company *said, “At HDFC ERGO, we are happy to launch the ‘*Cyber Security Awareness Week*’ to promote awareness about the facets of cyber-crime in India. Today, individuals suffer from huge financial loss as well as emotional loss post a cyber-crime which includes the legal fees or the cost of consulting a psychologist. With the launch of HDFC ERGO E@Secure, individual cyber insurance policy, we aim to help individuals overcome any financial loss as a result of any cyber-attack or cyber bulling.”
HDFC ERGO recently launched E@Secure Cyber Insurance Policy. The policy aims at providing comprehensive protection to individuals and their families against any cyber- attacks, cyber frauds or digital threats that could lead to a financial loss and or reputational loss. For more information on the policy and the full range of HDFC ERGO Insurance products please contact HDFC ERGO representative or visit the website www.hdfcergo.com for further details on risk factors, exclusions, terms and conditions please read the sales brochure before concluding a sale.
*About HDFC ERGO*
HDFC ERGO General Insurance Company is a 51:49 joint venture between the Housing Development Finance Corporation Ltd (HDFC), India’s premier Housing Finance Institution, and ERGO International AG, the primary insurance entity of the Munich Re Group of Germany. In August 2017, with IRDAI’s approval for the merger of HDFC ERGO General Insurance Co. Ltd. with HDFC General Insurance Ltd. (formerly Known as L&T General Insurance Co. Ltd.), the Company marked the first merger in the General Insurance sector. The merged entity, known as HDFC ERGO General Insurance Co. Ltd., is the third largest General Insurance provider in the private sector.
HDFC ERGO offers products like Motor, Health, Travel, Home, Personal Accident and Cyber Security Insurance in the retail space and customized products like Property, Marine and Liability Insurance in the corporate space through its vast network of 122 branches spread across 106 cities and a wide distribution network.
Reported by NewsVoir 7 hours ago.
In order to commence the launch of Cyber Security Week, HDFC ERGO invited esteemed speakers to shed light on the increasing number of cybercrimes in India and discuss the on-going challenges faced by individuals. The panellists for the discussion were as follows:
· Balsingh Rajput, DCP Cyber Crime Maharashtra
· Saket Modi, Ethical Hacker Lucideus Tech
· SuhasTuljapurkar, Managing Partner, Legasis Partners and Founder Director Legasis Services
· Varkha Chulani, Clinical Psychologist & Mental Health Expert
· Anurag Rastogi, Member of Executive Management, HDFC ERGO General Insurance Company
Addressing the panel *Dr. Balsingh Rajput, DCP Cyber Crime Maharashtra *said, “There is an alarming rate of Cyber Crimes in the country with a growth rate of 100% year-on-year. Scams such as Phishing have become an alternate industry, with call centers being set up to defraud unsuspecting victims. Maharashtra Cyber is implementing cyber security and cyber lab project to enable law enforcement to tackle these crimes.”
*Mr. Saket Modi, CEO & Co-founder, Lucideus* added, “There has been a lack of awareness amongst individuals while using technology or the social media. In this digital age most of us haven't been trained to handle a smartphone and hence easily fall prey to basic hacks. Individuals need to realise that anything uploaded on the internet is prone to be hacked and therefore they need to be careful while being online.”
Commenting on the legalities around a cyber-hack, *Mr. Suhas Tuljapurkar, Managing Partner Legasis Partners and Founder Director Legasis Services *said, “Definitely there is a deficiency in current laws relating to Cyber Crime. While there are jurisdictional challenges especially when the Cyber Crime crosses the boundaries, there is legislative requirement to bring out robust laws to outpace the advancements made by the organized Cyber Crime industry.”
Talking about the emotional aspect of a cyber-hack, *Varkha Chulani, Clinical Psychologist and Mental Health Expert *said, “Individuals today suffer from a new condition called ‘*Selfitis*’. Relationships at home nowadays have become more insecure because of extensive use of gadgets. More than financial loses there are emotional losses seen amongst couples and families. Parents should use discipline and keep time limits for their children to avoid the misuse of the Internet.”
Commenting on the launch of cyber security insurance week, *Mr. Anurag Rastogi, Member of Executive Management, HDFC ERGO General Insurance Company *said, “At HDFC ERGO, we are happy to launch the ‘*Cyber Security Awareness Week*’ to promote awareness about the facets of cyber-crime in India. Today, individuals suffer from huge financial loss as well as emotional loss post a cyber-crime which includes the legal fees or the cost of consulting a psychologist. With the launch of HDFC ERGO E@Secure, individual cyber insurance policy, we aim to help individuals overcome any financial loss as a result of any cyber-attack or cyber bulling.”
HDFC ERGO recently launched E@Secure Cyber Insurance Policy. The policy aims at providing comprehensive protection to individuals and their families against any cyber- attacks, cyber frauds or digital threats that could lead to a financial loss and or reputational loss. For more information on the policy and the full range of HDFC ERGO Insurance products please contact HDFC ERGO representative or visit the website www.hdfcergo.com for further details on risk factors, exclusions, terms and conditions please read the sales brochure before concluding a sale.
*About HDFC ERGO*
HDFC ERGO General Insurance Company is a 51:49 joint venture between the Housing Development Finance Corporation Ltd (HDFC), India’s premier Housing Finance Institution, and ERGO International AG, the primary insurance entity of the Munich Re Group of Germany. In August 2017, with IRDAI’s approval for the merger of HDFC ERGO General Insurance Co. Ltd. with HDFC General Insurance Ltd. (formerly Known as L&T General Insurance Co. Ltd.), the Company marked the first merger in the General Insurance sector. The merged entity, known as HDFC ERGO General Insurance Co. Ltd., is the third largest General Insurance provider in the private sector.
HDFC ERGO offers products like Motor, Health, Travel, Home, Personal Accident and Cyber Security Insurance in the retail space and customized products like Property, Marine and Liability Insurance in the corporate space through its vast network of 122 branches spread across 106 cities and a wide distribution network.
Reported by NewsVoir 7 hours ago.
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California shooting: Trump dubs bar shooter 'sick puppy' as community grieves
Trump said the 28-year-old Marine combat veteran who killed 12 people in a crowded South California bar this week was a "very, very sick guy."
Reported by DNA 6 hours ago.
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California shooting follows election of gun control advocate as governor
This week's fatal shooting of 12 people in a California bar by a Marine combat veteran came the day after the election of a new Democratic governor who has pushed for tighter gun control in the state, which already has some of the strictest firearms laws in the country.
Reported by Reuters India 3 hours ago.
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'Sky penis' air pattern grounds two Marine Corps pilots, pending investigation
Two Marine Corps pilots have been grounded pending an investigation into a digitally-map flight path over Southern California skies last month that appeared to be the shape of a penis and testicles.
Reported by FOXNews.com 21 hours ago.
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California shooting: Gunman identified as former marine
On November 8, a former Marine shot at killed 12 people in a crowded bar in California, once again raising the debate over gun control.
Reported by Al Jazeera 20 hours ago.
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Veteran Marine Says That Service Never Stops
NPR's Scott Simon speaks with U.S.Marine Corps veteran Scott Cooper about his initiative for veterans to interact at the community level and bridge political divides.
Reported by NPR 20 hours ago.
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T.I. Shares Disturbing Revelation After California Bar Shooter Coverage
Grammy-winning rapper T.I. is way more woke than people realize. The King of the South went to social media this week to share his issues with the way media portrays the person responsible for mass shootings. In light of this week’s shocking California shooting, Tip acknowledged how deceased Marine Ian David Long received an excuse […]The post T.I. Shares Disturbing Revelation After California Bar Shooter Coverage appeared first on SOHH.com. Reported by SOHH 19 hours ago.
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Trip to monument honoring American marines who fought in France cancelled for Trump amid bad weather
President Donald Trump called off a a trip to Aisne-Marne American Cemetery and Memorial on Saturday after a bad weather call grounded Marine One.
Reported by MailOnline 18 hours ago.
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News24.com | Trump blames mental illness in California bar massacres
As investigators work to figure out why an ex-Marine killed 12 people at a country music bar, President Donald Trump is blaming mental illness.
Reported by News24 18 hours ago.
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Larson Electronics Releases 12” x 12” x 6” Hazardous Location Stainless-Steel Junction Box
KEMP, Texas, Nov. 10, 2018 (GLOBE NEWSWIRE) -- Larson Electronics, a Texas-based company with over 40 years of experience spearheading the industrial lighting and equipment sectors, announced the release of a stainless-steel junction box designed for use in hazardous locations. This unit measures 12” by 12” by 6” and is IP66, Class I, Division 2 and ATEX-rated for indoor or outdoor applications where flammable gases, vapors or dust may be present.The EPL-AEH-SS-12.12.6-N4X-BP-2X1S junction box is made of 316 stainless steel with an EPDM rubber seal. This unit is a Type 4X junction box with a hinged cover that conceals and contains removeable pins. The exterior of the box measures 12” by 12” by 6”, while the interior measures 10.93” by 10.93” by 5.74”.
This unit comes equipped with bi-directional mounting lugs for easy mounting on walls or other flat surfaces and contains two, one-inch NPT hubs located on the south side of the enclosure. Suitable applications for this unit include on offshore rigs, at sewage and wastewater treatment plants, coal plants, gas facilities and any other sites where a hazardous location or ATEX-rated enclosure is needed.
*About Larson Electronics LLC: *Larson Electronics LLC is a manufacturer of industrial lighting equipment and accessories. The company offers an extensive catalog of industry-grade lighting and power distribution products for the following sectors: manufacturing, construction, food processing, oil and gas, military, marine and automobile. Customers can benefit from the company’s hands-on, customized approach to lighting solutions. Larson Electronics provides expedited service for quotes, customer support and shipments.
*For further information, please contact:*
Rob Bresnahan, *President and CEO
*Toll-free: 1-800-369-6671
Phone: 214-616-6180
Fax: 903-498-3364
E-mail: sales@larsonelectronics.com
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/e2940274-c81d-443e-ba92-081f448e547b Reported by GlobeNewswire 17 hours ago.
This unit comes equipped with bi-directional mounting lugs for easy mounting on walls or other flat surfaces and contains two, one-inch NPT hubs located on the south side of the enclosure. Suitable applications for this unit include on offshore rigs, at sewage and wastewater treatment plants, coal plants, gas facilities and any other sites where a hazardous location or ATEX-rated enclosure is needed.
*About Larson Electronics LLC: *Larson Electronics LLC is a manufacturer of industrial lighting equipment and accessories. The company offers an extensive catalog of industry-grade lighting and power distribution products for the following sectors: manufacturing, construction, food processing, oil and gas, military, marine and automobile. Customers can benefit from the company’s hands-on, customized approach to lighting solutions. Larson Electronics provides expedited service for quotes, customer support and shipments.
*For further information, please contact:*
Rob Bresnahan, *President and CEO
*Toll-free: 1-800-369-6671
Phone: 214-616-6180
Fax: 903-498-3364
E-mail: sales@larsonelectronics.com
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/e2940274-c81d-443e-ba92-081f448e547b Reported by GlobeNewswire 17 hours ago.
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Happy Birthday To The US Marine Corps — A Daily Caller Salute To Heroes At Home And Abroad
'It's just what we do as Marines'
Reported by Daily Caller 16 hours ago.
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Learfield Licensing Partners Teams With 47’, Operation Hat Trick to Promote Military and Veterans Through Collegiate Market
*INDIANAPOLIS, IN / ACCESSWIRE / November 10, 2018 /* In honor of true American heroes, Learfield Licensing Partners again collaborates with '47 and Operation Hat Trick (OHT), a nonprofit organization supporting the recovery of wounded service members and veterans, to promote local military organizations on college campuses nationwide by honoring veterans in-game, creating a military scholarship and sending veterans prize packs.Twelve collegiate institutions that partner with Learfield Licensing (UAlbany, Army West Point, UC Berkeley, Campbell, Hofstra, Loyola Marymount University, North Dakota State, Northwest Missouri State, UNC Wilmington, Vermont and Western Michigan University) in conjunction with their own military appreciation football or men's basketball games, have aligned with '47 and OHT to honor veterans at games by donating hats to those veterans. Proceeds from the headwear sales will go directly to help dozens of organizations that provide direct services and support to wounded service members and veterans.
"I am so very proud that Learfield Licensing schools have partnered with Operation Hat Trick to promote OHT on their campuses, in retail and through their advertising and social media channels," said Dot Sheehan, founder, and CEO of Operation Hat Trick. "By making a commitment to support the recovery of wounded service members and veterans, together we are making a difference, one veteran at a time. This year is very special for OHT. We honor Navy SEALs Nate Hardy and Mike Koch, to whom we've dedicated OHT to on the 10th anniversary of their deaths in 2008. We also celebrate $1 million in donations since 2014. Thanks to all who helped make this possible, we are honored."
To help further support and raise awareness of OHT, Learfield Licensing, in partnership with Western Michigan University (WMU) and its Office of Military and Veteran Affairs, established an annual OHT Scholarship. A portion of the proceeds of all OHT merchandise sold at WMU will help fund the OHT Military Scholarship, awarded each fall to a WMU student veteran. The winner of the first annual OHT scholarship was Paul Kidd, a Marine Combat Veteran and WMU student. He was recognized during WMU’s Salute to Heroes Football game on Thursday, November 1.
"It was a pleasure and an honor to work with Learfield Licensing Partners, Operation Hat Trick, the WMU Office of Military and Veterans Affairs and Follett in order to generate a scholarship for a Western Michigan University student veteran," said Bob D'Amelio, Associate AD, Marketing, Licensing & Ticketing at Western Michigan University. "This is one of the most rewarding endeavors I have been involved with during my time at WMU. This program could easily be replicated across all campuses in the United States. To active and retired military personnel around the world, thank you for your service."
Additionally, The University of New Mexico will deliver 20 OHT Hero Boxes, filled with OHT hats and other gifts, to patients at the Raymond G. Murphy VA Medical Center in Albuquerque, N.M.
Learfield Licensing assisted in the promotion of these events and products with customized in-store signage and social media graphics and videos. Social media giveaways involved tagging veterans who deserved to be gifted with an OHT Hero Box, a specially branded box with athletic tickets and the OHT hats inside. Schools using an OHT Hero Box include Army, Hofstra, New Mexico, Sam Houston State, UC Irvine, UTSA and Vermont.
*About Learfield Licensing Partners*
Learfield Licensing Partners, a trademark management agency specializing in licensing and branding, is a world-class licensing firm aligned with Learfield's history, strength and reputation. With industry-leading technology and a dynamic team of licensing and branding experts, we provide best practices and strategies to properly protect and promote our clients' brands and build partnerships that help our clients succeed, with resources and strategies for growth from Learfield.
Learfield, which has a deep presence in the college athletics landscape, manages the multimedia and sponsorship rights for nearly 130 collegiate institutions, conferences, and arenas, and supports athletic departments at all competitive levels as title sponsor of the Learfield Directors' Cup. For more than four decades, Learfield has connected brands to the excitement, passion, tradition, fun and fans of college sports and now leverages multiple platforms and partnerships through distinct offerings through its affiliated companies.
*About Operation Hat Trick*
First established in 2008 at the University of New Hampshire (UNH), OHT started as a program that delivered free hats to wounded veterans in Veterans hospitals. The name Operation Hat Trick comes from the initial focus of hats, with a nod to the University's rich hockey history. The program was started by Dot Sheehan, the then Senior Athletics Director for External Relations, at UNH, as a way to honor local veterans. When tragedy shook UNH with the death of Navy SEAL Nate Hardy, son of a UNH professor and his wife, and Mike Koch, Nate's teammate and fellow SEAL, who died while serving in Iraq, Sheehan was inspired by the sacrifices made between the two friends and OHT launched itself onto the national scene with a business model that addressed a social need and the critical gaps and care that were not covered by the government or other agencies. OHT has an exclusive partnership with global sports lifestyle brand, '47, and other select licensees, academic institutions, sport leagues, retailers and corporations. A portion of every sale, "A Purchase with a Purpose," comes back to OHT who then makes donations to selected organizations that fulfill OHT's mission.
To learn more about the story behind the cause, visit operationhattrick.com.
*About '47*
'47 is a privately held sports lifestyle brand founded in Boston, MA, by twin brothers, Arthur and Henry D'Angelo in 1947. The D'Angelos were entrepreneurial pioneers who were quick to see the future of sports licensing by selling pennants and other sports memorabilia on the streets around Fenway Park. Through a combination of hard work, sound instincts and incredible passion, the brothers were able to grow their business from a single street cart to a premier sports lifestyle brand that uniquely melds sport and style. Previously known as Twins Enterprises, '47 is currently managed by Arthur's four sons, Bobby, David, Mark, and Steven. '47 is a proud partner of Major League Baseball, the National Football League, the National Hockey League, the National Basketball Association and over 900 collegiate programs and owner of Old Time Sports. '47 employs over 250 corporate and retail associates around the world and is headquartered in Boston and Westwood, MA. For more information, please visit www.47brand.com.
*SOURCE: *Learfield Licensing Partners
View source version on accesswire.com:
https://www.accesswire.com/527725/Learfield-Licensing-Partners-Teams-With-47-Operation-Hat-Trick-to-Promote-Military-and-Veterans-Through-Collegiate-Market Reported by Accesswire 16 hours ago.
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Vascepa® (icosapent ethyl) 26% Reduction in Key Secondary Composite Endpoint of Cardiovascular Death, Heart Attacks and Stroke Demonstrated in REDUCE-IT™ Supports 25% Overall Reduction in Five-Point Major Adverse Cardiovascular Event Primary Composit
*Landmark Cardiovascular Risk Reduction Benefits Demonstrated in REDUCE-IT Are Largest of Any Major Cardiovascular Outcomes Study of a Drug Intended to Address Residual Cardiovascular Risk Remaining After Cholesterol Management*
*Cardiovascular Death Reduced by 20%
**Fatal or Nonfatal Heart Attacks Reduced by 31%
**Fatal or Nonfatal Stroke Reduced by 28%
**Urgent or Emergent Coronary Revascularization* *Reduced by 35%
**Hospitalization for Unstable Angina* *Reduced by 32%*
*Number Needed to Treat for Primary Composite Endpoint: 21*
*Patient Years of Study Support Favorable Benefit/Risk Profile in REDUCE-IT*
*Affordably Priced Vascepa Positions Amarin with Potential to Help Millions of Patients *
*Conference Call Scheduled for Today, Saturday, November 10, 2018 at 7:15 pm CT/8:15 pm ET*
CHICAGO, Nov. 10, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) announced today the primary results from the Vascepa® (icosapent ethyl) cardiovascular (CV) outcomes trial, REDUCE-IT™, following presentation of the late-breaking clinical trial results at the 2018 Scientific Sessions of the American Heart Association (AHA) in Chicago, Illinois. REDUCE-IT primary results confirmed 25% relative risk reduction (RRR) for the topline primary endpoint result with multiple robust demonstrations of efficacy, including 20% reduction in cardiovascular death.
Cardiovascular benefits appeared not to be influenced significantly by triglyceride (TG) levels at baseline (135 mg/dL to 499 mg/dL baseline range) or as achieved at one year, suggesting mechanisms at work with use of Vascepa that are independent of triglyceride reduction. Results were robust across multiple subgroups, including in patients with and without diabetes at baseline. REDUCE-IT study results were simultaneously published in The New England Journal of Medicine and are available at nejm.org/doi/full/10.1056/NEJMoa1812792.
REDUCE-IT was a global study of 8,179 statin-treated adults with elevated CV risk. Many patients with well-managed LDL-C remain at high risk for cardiovascular events. No therapy is currently approved to treat the residual risk in REDUCE-IT patients and no other therapy has demonstrated a 25% risk reduction on top of statin therapy in a major cardiovascular outcomes trial. REDUCE-IT studied Vascepa 4 grams/day as compared to placebo over a median follow-up time of 4.9 years.
Efficacy results for Vascepa as presented today from REDUCE-IT are as follows:
Primary endpoint achieved: *25%* relative risk reduction (RRR) (hazard ratio (HR), 0.75; 95% confidence interval CI, 0.68-0.83; p
· Number needed to treat (NNT) was *21* for the first occurrence of MACE in the 5-point primary composite endpoint.
· For perspective, NNTs for cholesterol-managing drugs atorvastatin (Lipitor®)^1 and evolocumab (Repatha®)^2 were reported to be 45 and 67, respectively. These drugs are not competitors with Vascepa as Vascepa is not a therapy for cholesterol (LDL-C) management nor has Vascepa been evaluated in a head-to-head study with these drugs.
Key secondary endpoint achieved: *26%* RRR (HR, 0.74; 95% CI, 0.65-0.83; p
Additional secondary endpoints achieved: Seven secondary endpoints were achieved below the key secondary endpoint, as follows (in order of sequential statistical testing within the prespecified hierarchy):
· Cardiovascular death or nonfatal heart attack: *25%* RRR (HR, 0.75; 95% CI, 0.66-0.86; p · Fatal or nonfatal heart attack: *31%* RRR (HR, 0.69; 95% CI, 0.58-0.81; p · Urgent or emergent revascularization: *35%* RRR (HR, 0.65; 95% CI, 0.55-0.78; p · Cardiovascular death: *20%* RRR (HR, 0.80; 95% CI, 0.66-0.98; p=0.03)
· Hospitalization for unstable angina: *32%* RRR (HR, 0.68; 95% CI, 0.53-0.87; p=0.002)
· Fatal or nonfatal stroke: *28%* RRR (HR, 0.72; 95% CI, 0.55-0.93; p=0.01)
· Total mortality, nonfatal heart attack or nonfatal stroke: *23%* RRR (HR, 0.77; 95% CI, 0.69-0.86; p
The next prespecified secondary endpoint in the hierarchy, and the only such endpoint that did not achieve statistical significance, is as follows:
· Total mortality, which includes mortality from non-cardiovascular and cardiovascular events: 13% RRR (HR, 0.87; 95% CI, 0.74-1.02; p=0.09)
Baseline demographics: Patients qualified to enroll in REDUCE-IT had LDL-C between 41-100 mg/dL (median baseline LDL-C 75 mg/dL) controlled by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides (TGs) between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or age 50 or more with diabetes mellitus and at least one other CV risk factor (primary prevention cohort). Approximately 59% of the patients had diabetes at baseline and approximately 71% of the patients had established cardiovascular disease at time of enrollment.
Safety: Excluding the major adverse CV events (MACE) results described above, overall adverse event rates in REDUCE-IT were similar across the statin plus Vascepa and the statin plus placebo treatment groups. There were no significant differences between treatments in the overall rate of treatment emergent adverse events or serious adverse events leading to withdrawal of study drug. The one serious adverse event occurring at a frequency of >2% was pneumonia which occurred at a numerically higher rate in the statin plus placebo treatment group (2.9%) than in the statin plus Vascepa treatment group (2.6%). Adverse events occurring in 5% or greater of patients and more frequently with Vascepa than placebo were peripheral edema (6.5% Vascepa patients versus 5.0% placebo patients), constipation (5.4% Vascepa patients versus 3.6% placebo patients), and atrial fibrillation (5.3% Vascepa patients versus 3.9% placebo patients). There were numerically more serious adverse events related to bleeding in the statin plus Vascepa treatment group although overall rates were low with no fatal bleeding observed in either group and no significant difference in adjudicated hemorrhagic stroke or serious central nervous system or gastrointestinal bleeding events between treatments. In summary, Vascepa was well tolerated with a safety profile generally consistent with clinical experience associated with omega-3 fatty acids and current FDA-approved labeling of such products.
Subgroups and other REDUCE-IT information: Positive REDUCE-IT results were consistent across various patient subgroups, including female/male, diabetic/non-diabetic and secondary/primary prevention. At baseline, approximately 59% and 71% of the patients had diabetes and established cardiovascular disease, respectively. Approximately 71% of the patients studied were classified as Westernized with the largest cohort from the United States. Vital status was obtained for 99.8% of the patients randomized supporting robust trial results.
Differentiated result and mechanism of action: The success of REDUCE-IT is distinct from past failures to show significant benefit of other agents that lower triglyceride levels when studied on top of statin therapy, including mixtures of omega-3 fatty acids, fenofibrates, niacin and CETP inhibitors. In REDUCE-IT, the median change in triglyceride levels from baseline to year one was -18.3% (-39 mg/dL) for Vascepa and +2.2% (4.5 mg/dL) for placebo; placebo-corrected median change from baseline of -19.7% (-44.5 mg/dL; p=
The active pharmaceutical ingredient in Vascepa has a unique molecular structure. Vascepa has demonstrated clinical effects that have not been shown for any other product. The clinical effects of Vascepa demonstrated in REDUCE-IT cannot be generalized to any other product.
Mechanisms responsible for Vascepa’s effects in the REDUCE-IT study were not directly evaluated in the outcomes study. Independent of REDUCE-IT, Amarin has worked to further support the REDUCE-IT hypothesis with published scientific findings based on various degrees of evidence that show that icosapent ethyl may interrupt the atherosclerotic process (e.g., plaque formation and instability) by beneficially affecting cellular functions thought to contribute to atherosclerosis and cardiovascular events and by beneficially affecting lipid, lipoprotein and inflammation biomarkers.^4, 5, 6, 7, 8
Scientific presentation: Presentation of the REDUCE-IT results at AHA were made by the Global Principal Investigator and Steering Committee Chair for the study, Deepak L. Bhatt, MD, MPH, Professor of Medicine at Harvard Medical School, Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital Heart and Vascular Center.
Dr. Bhatt stated, “REDUCE-IT establishes a new paradigm for the prevention of important cardiovascular events in statin-treated patients at elevated risk with increased triglycerides. I believe that the results of this study may represent the most significant breakthrough in preventative cardiovascular care since the introduction of statin therapy decades ago.”
Amarin perspective: Commenting on these results from Amarin:
“The robustness and consistency of these clinical results are exciting. Extensive scientific evaluation led to the design and conduct of this study; but the degree of benefit shown with Vascepa nevertheless exceeded our expectation,” stated Steven Ketchum, president of research and development and chief scientific officer of Amarin. “We believe that these positive results identify an important new treatment option to help lower cardiovascular risk in appropriate patients. Cholesterol management lowers cardiovascular risk by 25-35%. REDUCE-IT suggests that the residual 65-75% cardiovascular risk beyond cholesterol management can be significantly lowered with Vascepa in studied patients. We again thank all of the patients, investigators and others involved in this landmark study.”
“Amarin has spent over $500 million developing Vascepa. We are intently focused on improving patient care. Our priorities are now shifting to educate the world regarding these results so that the pain, loss of productivity and high costs of cardiovascular events can be reduced,” stated John F. Thero, president and CEO of Amarin.
*Regulatory Pathway*
The REDUCE-IT study was designed under a special protocol assessment agreement with the U.S. Food and Drug Administration (FDA). Amarin intends to submit an sNDA to the FDA in early 2019 seeking approval to expand the label for Vascepa based on the cardioprotective effect of Vascepa demonstrated in the REDUCE-IT study. FDA's determination of standard or priority review will be made when the sNDA is submitted. At this time, Amarin is planning for a standard review with potential approval anticipated in late 2019.
*Vascepa is Affordably Priced*
Vascepa is a low-cost drug. The majority of patients covered by insurance who obtain prescriptions for Vascepa pay a monthly co-pay charge of $9.99 or less. A patient with commercial insurance can pay as little as $9.00 for a 90-day supply prescription of Vascepa.
*Commercial Expansion and Next Steps*
As previously described, Amarin is in the process of increasing the number of company sales representatives promoting Vascepa to over 400 people in the United States. Amarin’s plans provide for greater concentration of coverage in current sales territories and new coverage where Amarin currently does not have sales representatives. With numerous experienced applicants for these new positions, the company is well on its way towards having these new sales representatives hired and trained heading into 2019. The company is also planning to support various medical education forums covering preventative solutions in cardiovascular care. Amarin anticipates making the published results of REDUCE-IT available to healthcare professionals. Following potential label expansion, Amarin will consider other initiatives to expand Vascepa promotion including more extensive consumer promotion focused on cardiovascular risk reduction.
*Financial Disclosure *
Funding from Amarin was provided to Brigham and Women’s Hospital for Dr. Deepak L. Bhatt’s work as the REDUCE-IT study chair and global principal investigator.
*Conference Call and Webcast Information*
Amarin will host a conference call at 7:15 p.m. CT/ 8:15 p.m. ET, November 10, 2018 to discuss this information. The call will be accessible through the investor relations section of the company’s website at www.amarincorp.com. The call can also be heard via telephone by dialing 877-407-8033. A replay of the call will be made available for a period of two weeks following the conference call. To hear a replay of the call, dial 877-481-4010 (inside the United States) or 919-882-2331 (outside the United States). A replay of the call will also be available through the company's website shortly after the call. For both dial-in numbers please use conference ID 39894.
*About Amarin*
Amarin Corporation plc. is a rapidly growing, innovative pharmaceutical company focused on developing therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa (icosapent ethyl) is Amarin's first FDA-approved drug and is available by prescription in the United States, Lebanon and the United Arab Emirates. Amarin’s commercial partners are pursuing additional regulatory approvals for Vascepa in Canada, China and the Middle East. For more information about Amarin, visit www.amarincorp.com.
*About Cardiovascular Disease *
Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and women. In the United States CVD leads to one in every three deaths – one death approximately every 38 seconds – with annual treatment cost in excess of $500 billion.^9, 10
Multiple primary and secondary prevention trials have shown a significant reduction of 25% to 35% in the risk of cardiovascular events with statin therapy, leaving significant persistent residual risk despite the achievement of target LDL-C levels.^4
Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiologic, clinical and real-world data suggest that patients with elevated triglycerides (TG) (fats in the blood), and TG-rich lipoproteins, are at increased risk for cardiovascular disease.^ 11, 12, 13, 14
*About VASCEPA^® (icosapent ethyl) Capsules*
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient from degradation. Vascepa, known in scientific literature as AMR101, has been designated a new chemical entity by the FDA. Amarin has been issued multiple patents internationally based on the unique clinical profile of Vascepa, including the drug’s ability to lower triglyceride levels in relevant patient populations without raising LDL-cholesterol levels.
Indication and Usage Based on Current FDA-Approved Label (not including REDUCE-IT results)
· Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
· The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa Based on Current FDA-Approved Label (not including REDUCE-IT results) (Includes Data from Two 12-Week Studies (n=622) (MARINE and ANCHOR) of Patients with Triglycerides Values of 200 to 2000 mg/dL)
· Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
· In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
· Use with caution in patients with known hypersensitivity to fish and/or shellfish.
· The most common reported adverse reaction (incidence >2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction >3% and greater than placebo.
· Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
· Patients receiving treatment with Vascepa and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
· Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.
*Important Cautionary Information About REDUCE-IT Primary Results*
Further REDUCE-IT data assessment and data release could yield additional useful information to inform greater understanding of the trial outcome. Further detailed data assessment by Amarin and regulatory authorities will continue and take several months to complete and record. The final evaluation of the totality of the efficacy and safety data from REDUCE-IT may include some or all of the following, as well as other considerations: new information affecting the degree of treatment benefit on studied endpoints; study conduct and data robustness, quality, integrity and consistency; additional safety data considerations and risk/benefit considerations; consideration of REDUCE-IT results in the context of other clinical studies.
*Forward-Looking Statements *
This press release contains forward-looking statements, including expectations regarding planned regulatory filings and the nature of FDA’s review and related timing thereof; expectations that REDUCE-IT results could lead to a new treatment paradigm in the patient population studied; and plans for sales force, international and insurance coverage expansion. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In addition, Amarin's ability to effectively commercialize Vascepa will depend in part on its ability to continue to effectively finance its business, efforts of third parties, its ability to create market demand for Vascepa through education, marketing and sales activities, to achieve market acceptance of Vascepa, to receive adequate levels of reimbursement from third-party payers, to develop and maintain a consistent source of commercial supply at a competitive price, to comply with legal and regulatory requirements in connection with the sale and promotion of Vascepa and to maintain patent protection for Vascepa. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that sales may not meet expectations and related cost may increase beyond expectations; the risk that patents may not be upheld in patent litigation and applications may not result in issued patents sufficient to protect the Vascepa franchise. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
*Availability of Other Information About Amarin*
Investors and others should note that Amarin communicates with its investors and the public using the company website (http://www.amarincorp.com/), the investor relations website (http://investor.amarincorp.com/), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
*References*
^1 LaRosa JC, Grundy SM, Waters DD, et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005; 352: 1425–35.
^2 Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713.
^3 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. DOI: 10.1056/NEJMoa1812792.
^4 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.
^5 Borow KM, Nelson JR, Mason RP. Biologic plausibility, cellular effects, and molecular mechanisms of eicosapentaenoic acid (EPA) in atherosclerosis. Atherosclerosis. 2015;242(1):357-366.
^6 Nelson JR, Wani O, May HT, et al. Potential benefits of eicosapentaenoic acid on atherosclerotic plaques. Vascul Pharmacol. 2017;91:1–9.
^7 Mason RP, Dawoud H, Jacob RF, et al. Eicosapentaenoic acid improves endothelial function and nitric oxide bioavailability in a manner that is enhanced in combination with a statin. Biomed Pharmacother. 2018;103:1231-1237.
^8 Takamura M, Kurokawa K, Ootsuji H, et al. Long-term administration of eicosapentaenoic acid improves post-myocardial infarction cardiac remodeling in mice by regulating macrophage polarization. J Am Heart Assoc. 2017;6(2). pii: e004560.
^9 American Heart Association. 2018. Disease and Stroke Statistics-2018 Update.
^10 American Heart Association. 2017. Cardiovascular disease: A costly burden for America projections through 2035.
^11 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
^12 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.
^13 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
^14 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014;384:626–635.
*Amarin Contact Information*
Investor Relations:
Elisabeth Schwartz
Investor Relations and Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. Stern
Trout Group
In U.S.: +1 (646) 378-2992
lstern@troutgroup.com
Media Inquiries:
Christy Maginn
Burson-Marsteller
In U.S.: +1 (646) 280-5210
Christy.Maginn@bm.com Reported by GlobeNewswire 13 hours ago.
*Cardiovascular Death Reduced by 20%
**Fatal or Nonfatal Heart Attacks Reduced by 31%
**Fatal or Nonfatal Stroke Reduced by 28%
**Urgent or Emergent Coronary Revascularization* *Reduced by 35%
**Hospitalization for Unstable Angina* *Reduced by 32%*
*Number Needed to Treat for Primary Composite Endpoint: 21*
*Patient Years of Study Support Favorable Benefit/Risk Profile in REDUCE-IT*
*Affordably Priced Vascepa Positions Amarin with Potential to Help Millions of Patients *
*Conference Call Scheduled for Today, Saturday, November 10, 2018 at 7:15 pm CT/8:15 pm ET*
CHICAGO, Nov. 10, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) announced today the primary results from the Vascepa® (icosapent ethyl) cardiovascular (CV) outcomes trial, REDUCE-IT™, following presentation of the late-breaking clinical trial results at the 2018 Scientific Sessions of the American Heart Association (AHA) in Chicago, Illinois. REDUCE-IT primary results confirmed 25% relative risk reduction (RRR) for the topline primary endpoint result with multiple robust demonstrations of efficacy, including 20% reduction in cardiovascular death.
Cardiovascular benefits appeared not to be influenced significantly by triglyceride (TG) levels at baseline (135 mg/dL to 499 mg/dL baseline range) or as achieved at one year, suggesting mechanisms at work with use of Vascepa that are independent of triglyceride reduction. Results were robust across multiple subgroups, including in patients with and without diabetes at baseline. REDUCE-IT study results were simultaneously published in The New England Journal of Medicine and are available at nejm.org/doi/full/10.1056/NEJMoa1812792.
REDUCE-IT was a global study of 8,179 statin-treated adults with elevated CV risk. Many patients with well-managed LDL-C remain at high risk for cardiovascular events. No therapy is currently approved to treat the residual risk in REDUCE-IT patients and no other therapy has demonstrated a 25% risk reduction on top of statin therapy in a major cardiovascular outcomes trial. REDUCE-IT studied Vascepa 4 grams/day as compared to placebo over a median follow-up time of 4.9 years.
Efficacy results for Vascepa as presented today from REDUCE-IT are as follows:
Primary endpoint achieved: *25%* relative risk reduction (RRR) (hazard ratio (HR), 0.75; 95% confidence interval CI, 0.68-0.83; p
· Number needed to treat (NNT) was *21* for the first occurrence of MACE in the 5-point primary composite endpoint.
· For perspective, NNTs for cholesterol-managing drugs atorvastatin (Lipitor®)^1 and evolocumab (Repatha®)^2 were reported to be 45 and 67, respectively. These drugs are not competitors with Vascepa as Vascepa is not a therapy for cholesterol (LDL-C) management nor has Vascepa been evaluated in a head-to-head study with these drugs.
Key secondary endpoint achieved: *26%* RRR (HR, 0.74; 95% CI, 0.65-0.83; p
Additional secondary endpoints achieved: Seven secondary endpoints were achieved below the key secondary endpoint, as follows (in order of sequential statistical testing within the prespecified hierarchy):
· Cardiovascular death or nonfatal heart attack: *25%* RRR (HR, 0.75; 95% CI, 0.66-0.86; p · Fatal or nonfatal heart attack: *31%* RRR (HR, 0.69; 95% CI, 0.58-0.81; p · Urgent or emergent revascularization: *35%* RRR (HR, 0.65; 95% CI, 0.55-0.78; p · Cardiovascular death: *20%* RRR (HR, 0.80; 95% CI, 0.66-0.98; p=0.03)
· Hospitalization for unstable angina: *32%* RRR (HR, 0.68; 95% CI, 0.53-0.87; p=0.002)
· Fatal or nonfatal stroke: *28%* RRR (HR, 0.72; 95% CI, 0.55-0.93; p=0.01)
· Total mortality, nonfatal heart attack or nonfatal stroke: *23%* RRR (HR, 0.77; 95% CI, 0.69-0.86; p
The next prespecified secondary endpoint in the hierarchy, and the only such endpoint that did not achieve statistical significance, is as follows:
· Total mortality, which includes mortality from non-cardiovascular and cardiovascular events: 13% RRR (HR, 0.87; 95% CI, 0.74-1.02; p=0.09)
Baseline demographics: Patients qualified to enroll in REDUCE-IT had LDL-C between 41-100 mg/dL (median baseline LDL-C 75 mg/dL) controlled by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides (TGs) between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or age 50 or more with diabetes mellitus and at least one other CV risk factor (primary prevention cohort). Approximately 59% of the patients had diabetes at baseline and approximately 71% of the patients had established cardiovascular disease at time of enrollment.
Safety: Excluding the major adverse CV events (MACE) results described above, overall adverse event rates in REDUCE-IT were similar across the statin plus Vascepa and the statin plus placebo treatment groups. There were no significant differences between treatments in the overall rate of treatment emergent adverse events or serious adverse events leading to withdrawal of study drug. The one serious adverse event occurring at a frequency of >2% was pneumonia which occurred at a numerically higher rate in the statin plus placebo treatment group (2.9%) than in the statin plus Vascepa treatment group (2.6%). Adverse events occurring in 5% or greater of patients and more frequently with Vascepa than placebo were peripheral edema (6.5% Vascepa patients versus 5.0% placebo patients), constipation (5.4% Vascepa patients versus 3.6% placebo patients), and atrial fibrillation (5.3% Vascepa patients versus 3.9% placebo patients). There were numerically more serious adverse events related to bleeding in the statin plus Vascepa treatment group although overall rates were low with no fatal bleeding observed in either group and no significant difference in adjudicated hemorrhagic stroke or serious central nervous system or gastrointestinal bleeding events between treatments. In summary, Vascepa was well tolerated with a safety profile generally consistent with clinical experience associated with omega-3 fatty acids and current FDA-approved labeling of such products.
Subgroups and other REDUCE-IT information: Positive REDUCE-IT results were consistent across various patient subgroups, including female/male, diabetic/non-diabetic and secondary/primary prevention. At baseline, approximately 59% and 71% of the patients had diabetes and established cardiovascular disease, respectively. Approximately 71% of the patients studied were classified as Westernized with the largest cohort from the United States. Vital status was obtained for 99.8% of the patients randomized supporting robust trial results.
Differentiated result and mechanism of action: The success of REDUCE-IT is distinct from past failures to show significant benefit of other agents that lower triglyceride levels when studied on top of statin therapy, including mixtures of omega-3 fatty acids, fenofibrates, niacin and CETP inhibitors. In REDUCE-IT, the median change in triglyceride levels from baseline to year one was -18.3% (-39 mg/dL) for Vascepa and +2.2% (4.5 mg/dL) for placebo; placebo-corrected median change from baseline of -19.7% (-44.5 mg/dL; p=
The active pharmaceutical ingredient in Vascepa has a unique molecular structure. Vascepa has demonstrated clinical effects that have not been shown for any other product. The clinical effects of Vascepa demonstrated in REDUCE-IT cannot be generalized to any other product.
Mechanisms responsible for Vascepa’s effects in the REDUCE-IT study were not directly evaluated in the outcomes study. Independent of REDUCE-IT, Amarin has worked to further support the REDUCE-IT hypothesis with published scientific findings based on various degrees of evidence that show that icosapent ethyl may interrupt the atherosclerotic process (e.g., plaque formation and instability) by beneficially affecting cellular functions thought to contribute to atherosclerosis and cardiovascular events and by beneficially affecting lipid, lipoprotein and inflammation biomarkers.^4, 5, 6, 7, 8
Scientific presentation: Presentation of the REDUCE-IT results at AHA were made by the Global Principal Investigator and Steering Committee Chair for the study, Deepak L. Bhatt, MD, MPH, Professor of Medicine at Harvard Medical School, Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital Heart and Vascular Center.
Dr. Bhatt stated, “REDUCE-IT establishes a new paradigm for the prevention of important cardiovascular events in statin-treated patients at elevated risk with increased triglycerides. I believe that the results of this study may represent the most significant breakthrough in preventative cardiovascular care since the introduction of statin therapy decades ago.”
Amarin perspective: Commenting on these results from Amarin:
“The robustness and consistency of these clinical results are exciting. Extensive scientific evaluation led to the design and conduct of this study; but the degree of benefit shown with Vascepa nevertheless exceeded our expectation,” stated Steven Ketchum, president of research and development and chief scientific officer of Amarin. “We believe that these positive results identify an important new treatment option to help lower cardiovascular risk in appropriate patients. Cholesterol management lowers cardiovascular risk by 25-35%. REDUCE-IT suggests that the residual 65-75% cardiovascular risk beyond cholesterol management can be significantly lowered with Vascepa in studied patients. We again thank all of the patients, investigators and others involved in this landmark study.”
“Amarin has spent over $500 million developing Vascepa. We are intently focused on improving patient care. Our priorities are now shifting to educate the world regarding these results so that the pain, loss of productivity and high costs of cardiovascular events can be reduced,” stated John F. Thero, president and CEO of Amarin.
*Regulatory Pathway*
The REDUCE-IT study was designed under a special protocol assessment agreement with the U.S. Food and Drug Administration (FDA). Amarin intends to submit an sNDA to the FDA in early 2019 seeking approval to expand the label for Vascepa based on the cardioprotective effect of Vascepa demonstrated in the REDUCE-IT study. FDA's determination of standard or priority review will be made when the sNDA is submitted. At this time, Amarin is planning for a standard review with potential approval anticipated in late 2019.
*Vascepa is Affordably Priced*
Vascepa is a low-cost drug. The majority of patients covered by insurance who obtain prescriptions for Vascepa pay a monthly co-pay charge of $9.99 or less. A patient with commercial insurance can pay as little as $9.00 for a 90-day supply prescription of Vascepa.
*Commercial Expansion and Next Steps*
As previously described, Amarin is in the process of increasing the number of company sales representatives promoting Vascepa to over 400 people in the United States. Amarin’s plans provide for greater concentration of coverage in current sales territories and new coverage where Amarin currently does not have sales representatives. With numerous experienced applicants for these new positions, the company is well on its way towards having these new sales representatives hired and trained heading into 2019. The company is also planning to support various medical education forums covering preventative solutions in cardiovascular care. Amarin anticipates making the published results of REDUCE-IT available to healthcare professionals. Following potential label expansion, Amarin will consider other initiatives to expand Vascepa promotion including more extensive consumer promotion focused on cardiovascular risk reduction.
*Financial Disclosure *
Funding from Amarin was provided to Brigham and Women’s Hospital for Dr. Deepak L. Bhatt’s work as the REDUCE-IT study chair and global principal investigator.
*Conference Call and Webcast Information*
Amarin will host a conference call at 7:15 p.m. CT/ 8:15 p.m. ET, November 10, 2018 to discuss this information. The call will be accessible through the investor relations section of the company’s website at www.amarincorp.com. The call can also be heard via telephone by dialing 877-407-8033. A replay of the call will be made available for a period of two weeks following the conference call. To hear a replay of the call, dial 877-481-4010 (inside the United States) or 919-882-2331 (outside the United States). A replay of the call will also be available through the company's website shortly after the call. For both dial-in numbers please use conference ID 39894.
*About Amarin*
Amarin Corporation plc. is a rapidly growing, innovative pharmaceutical company focused on developing therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa (icosapent ethyl) is Amarin's first FDA-approved drug and is available by prescription in the United States, Lebanon and the United Arab Emirates. Amarin’s commercial partners are pursuing additional regulatory approvals for Vascepa in Canada, China and the Middle East. For more information about Amarin, visit www.amarincorp.com.
*About Cardiovascular Disease *
Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and women. In the United States CVD leads to one in every three deaths – one death approximately every 38 seconds – with annual treatment cost in excess of $500 billion.^9, 10
Multiple primary and secondary prevention trials have shown a significant reduction of 25% to 35% in the risk of cardiovascular events with statin therapy, leaving significant persistent residual risk despite the achievement of target LDL-C levels.^4
Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiologic, clinical and real-world data suggest that patients with elevated triglycerides (TG) (fats in the blood), and TG-rich lipoproteins, are at increased risk for cardiovascular disease.^ 11, 12, 13, 14
*About VASCEPA^® (icosapent ethyl) Capsules*
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient from degradation. Vascepa, known in scientific literature as AMR101, has been designated a new chemical entity by the FDA. Amarin has been issued multiple patents internationally based on the unique clinical profile of Vascepa, including the drug’s ability to lower triglyceride levels in relevant patient populations without raising LDL-cholesterol levels.
Indication and Usage Based on Current FDA-Approved Label (not including REDUCE-IT results)
· Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
· The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa Based on Current FDA-Approved Label (not including REDUCE-IT results) (Includes Data from Two 12-Week Studies (n=622) (MARINE and ANCHOR) of Patients with Triglycerides Values of 200 to 2000 mg/dL)
· Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
· In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
· Use with caution in patients with known hypersensitivity to fish and/or shellfish.
· The most common reported adverse reaction (incidence >2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction >3% and greater than placebo.
· Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
· Patients receiving treatment with Vascepa and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
· Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.
*Important Cautionary Information About REDUCE-IT Primary Results*
Further REDUCE-IT data assessment and data release could yield additional useful information to inform greater understanding of the trial outcome. Further detailed data assessment by Amarin and regulatory authorities will continue and take several months to complete and record. The final evaluation of the totality of the efficacy and safety data from REDUCE-IT may include some or all of the following, as well as other considerations: new information affecting the degree of treatment benefit on studied endpoints; study conduct and data robustness, quality, integrity and consistency; additional safety data considerations and risk/benefit considerations; consideration of REDUCE-IT results in the context of other clinical studies.
*Forward-Looking Statements *
This press release contains forward-looking statements, including expectations regarding planned regulatory filings and the nature of FDA’s review and related timing thereof; expectations that REDUCE-IT results could lead to a new treatment paradigm in the patient population studied; and plans for sales force, international and insurance coverage expansion. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In addition, Amarin's ability to effectively commercialize Vascepa will depend in part on its ability to continue to effectively finance its business, efforts of third parties, its ability to create market demand for Vascepa through education, marketing and sales activities, to achieve market acceptance of Vascepa, to receive adequate levels of reimbursement from third-party payers, to develop and maintain a consistent source of commercial supply at a competitive price, to comply with legal and regulatory requirements in connection with the sale and promotion of Vascepa and to maintain patent protection for Vascepa. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that sales may not meet expectations and related cost may increase beyond expectations; the risk that patents may not be upheld in patent litigation and applications may not result in issued patents sufficient to protect the Vascepa franchise. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
*Availability of Other Information About Amarin*
Investors and others should note that Amarin communicates with its investors and the public using the company website (http://www.amarincorp.com/), the investor relations website (http://investor.amarincorp.com/), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
*References*
^1 LaRosa JC, Grundy SM, Waters DD, et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005; 352: 1425–35.
^2 Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713.
^3 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. DOI: 10.1056/NEJMoa1812792.
^4 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.
^5 Borow KM, Nelson JR, Mason RP. Biologic plausibility, cellular effects, and molecular mechanisms of eicosapentaenoic acid (EPA) in atherosclerosis. Atherosclerosis. 2015;242(1):357-366.
^6 Nelson JR, Wani O, May HT, et al. Potential benefits of eicosapentaenoic acid on atherosclerotic plaques. Vascul Pharmacol. 2017;91:1–9.
^7 Mason RP, Dawoud H, Jacob RF, et al. Eicosapentaenoic acid improves endothelial function and nitric oxide bioavailability in a manner that is enhanced in combination with a statin. Biomed Pharmacother. 2018;103:1231-1237.
^8 Takamura M, Kurokawa K, Ootsuji H, et al. Long-term administration of eicosapentaenoic acid improves post-myocardial infarction cardiac remodeling in mice by regulating macrophage polarization. J Am Heart Assoc. 2017;6(2). pii: e004560.
^9 American Heart Association. 2018. Disease and Stroke Statistics-2018 Update.
^10 American Heart Association. 2017. Cardiovascular disease: A costly burden for America projections through 2035.
^11 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
^12 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.
^13 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
^14 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014;384:626–635.
*Amarin Contact Information*
Investor Relations:
Elisabeth Schwartz
Investor Relations and Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. Stern
Trout Group
In U.S.: +1 (646) 378-2992
lstern@troutgroup.com
Media Inquiries:
Christy Maginn
Burson-Marsteller
In U.S.: +1 (646) 280-5210
Christy.Maginn@bm.com Reported by GlobeNewswire 13 hours ago.
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Mumbai: 100 cases filed against locals for flouting Supreme Courts guidelines on firecrackers
The city police have registered a total of 53 cases against firecracker sellers and 100 cases against people flouting Supreme Courts guidelines regarding bursting of crackers beyond permissible time limits.
The numbers have been made available by the cops two days after the festival of Diwali and according to the cops, the numbers vary in different zones, across the city.
According to the police, along with locals, who violated the guidelines of the apex court, taking actions on illegal sellers and manufacturers of firecrackers was equally necessary as those held continued to sell crackers without proper and required permissions. The SC had in October perimitted sale and manufacture of low emission "green firecracker" countrywide and had allowed bursting of the same for a fixed span of two hours (8pm-10pm) during Diwali and New year. Before the arrival of the festival, cops had ensured that the guidelines are followed rigorously and no loopholes are left in executing the same.
"The action taken by the police comes for violating the guidelines issued by the court and different police station across the city have different numbers of the defaulters against both locals and dealers, sellers and manufacturers of firecrackers. Those booked under the provision for violation not the rule shall face action under relevant sections of the Indian Penal Code and The Bombay Police Act."said Deputy Commissioner of Police, Operations, Manjunath Shinge.
In the first case of violation the Trombay police had booked two persons for bursting firecrackers at midnight. Later, the Marine Drive police also detained seven people for flouting the orders of SC. Similar such cases were reported at Bandra and Nirmal Nagar police stations respectively.
To address the flurry of complaints in huge number, the Mumbai police showed alertness via social media and also the police control room managed to reach out to those areas where crackers were set off after permissible time limits.
Article Type:
Report
Sections:
Mumbai
India
Authors:
dna Correspondent
Agencies:
DNA
Tags:
Mumbai Police
Supreme Court
firecrackers
crackers
cracker ban
Diwali
Manjunath Shinge
Marine Drive Police
Trombay Police
Social Media
Sun, 11 Nov 2018-06:10am
Date updated:
Sunday, 11 November 2018 - 6:10am
Article Images:
Photo for representation
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Short URL:
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From Print Edition:
Highlights: Reported by DNA 8 hours ago.
The numbers have been made available by the cops two days after the festival of Diwali and according to the cops, the numbers vary in different zones, across the city.
According to the police, along with locals, who violated the guidelines of the apex court, taking actions on illegal sellers and manufacturers of firecrackers was equally necessary as those held continued to sell crackers without proper and required permissions. The SC had in October perimitted sale and manufacture of low emission "green firecracker" countrywide and had allowed bursting of the same for a fixed span of two hours (8pm-10pm) during Diwali and New year. Before the arrival of the festival, cops had ensured that the guidelines are followed rigorously and no loopholes are left in executing the same.
"The action taken by the police comes for violating the guidelines issued by the court and different police station across the city have different numbers of the defaulters against both locals and dealers, sellers and manufacturers of firecrackers. Those booked under the provision for violation not the rule shall face action under relevant sections of the Indian Penal Code and The Bombay Police Act."said Deputy Commissioner of Police, Operations, Manjunath Shinge.
In the first case of violation the Trombay police had booked two persons for bursting firecrackers at midnight. Later, the Marine Drive police also detained seven people for flouting the orders of SC. Similar such cases were reported at Bandra and Nirmal Nagar police stations respectively.
To address the flurry of complaints in huge number, the Mumbai police showed alertness via social media and also the police control room managed to reach out to those areas where crackers were set off after permissible time limits.
Article Type:
Report
Sections:
Mumbai
India
Authors:
dna Correspondent
Agencies:
DNA
Tags:
Mumbai Police
Supreme Court
firecrackers
crackers
cracker ban
Diwali
Manjunath Shinge
Marine Drive Police
Trombay Police
Social Media
Sun, 11 Nov 2018-06:10am
Date updated:
Sunday, 11 November 2018 - 6:10am
Article Images:
Photo for representation
File Photo
Short URL:
dnai.in/fKZx
Embargo:
Syndicate:
Hide lead image:
Page views:
1
From Print Edition:
Highlights: Reported by DNA 8 hours ago.
↧
↧
Larson Electronics Releases 25W Handheld LED Hunting Spotlight with 1000’ Light Beam
KEMP, Texas, Nov. 10, 2018 (GLOBE NEWSWIRE) -- Larson Electronics, a Texas-based company with over 40 years of experience spearheading the industrial and recreational lighting sectors, announced the release of a 25-watt handheld LED hunting spotlight. This IP65-rated unit offers powerful Cree^® LED illumination that generates a total of 2,000 lumens of light with 70% lumen retention at 50,000 hours of use.The HUL-LED25WRE-CPR-TRP-9 handheld LED hunting spotlight features a 120mm parabolic reflector and projects a focused light beam up to 1,000 feet. The body of this light is made of ultra-durable ABS polymer with an aluminum alloy light head housing and an impact resistant polycarbonate lens. This ergonomically designed and compact unit is waterproof, dust proof and shock proof for demanding outdoor conditions and applications.
This hunting spotlight features an articulated light head that can be tilted up or down independently of the handle for more precise positioning of the beam. This unit features a no-slip textured nylon handle that ensures a firm grip in wet conditions and a booted push-button that adds protection from water and dust.
This hunting spotlight comes with a 16-foot detachable cord and a 9-pin round trailer hitch plug. The cord is detached with a weatherproof 2-pin Deutsch connector that attaches and detaches the coil cord from the spotlight easily and securely. Suitable applications for this spotlight include hunting, marine and boating, camping, emergency services and first responders.
“This LED spotlight is a lightweight, yet ultra-rugged spotlight, perfect for outdoor uses in rough environments,” said Rob Bresnahan, CEO of Larson Electronics LLC. “It’s powerful illumination and far reaching beam is also ideal for emergency and first responder services.”
*About Larson Electronics LLC: *Larson Electronics LLC is a manufacturer of industrial lighting equipment and accessories. The company offers an extensive catalog of industry-grade lighting and power distribution products for the following sectors: manufacturing, construction, food processing, oil and gas, military, marine and automobile. Customers can benefit from the company’s hands-on, customized approach to lighting solutions. Larson Electronics provides expedited service for quotes, customer support and shipments.
*For further information, please contact:*
Rob Bresnahan, *President and CEO
*Toll-free: 1-800-369-6671
Phone: 214-616-6180
Fax: 903-498-3364
E-mail: sales@larsonelectronics.com Reported by GlobeNewswire 12 hours ago.
This hunting spotlight features an articulated light head that can be tilted up or down independently of the handle for more precise positioning of the beam. This unit features a no-slip textured nylon handle that ensures a firm grip in wet conditions and a booted push-button that adds protection from water and dust.
This hunting spotlight comes with a 16-foot detachable cord and a 9-pin round trailer hitch plug. The cord is detached with a weatherproof 2-pin Deutsch connector that attaches and detaches the coil cord from the spotlight easily and securely. Suitable applications for this spotlight include hunting, marine and boating, camping, emergency services and first responders.
“This LED spotlight is a lightweight, yet ultra-rugged spotlight, perfect for outdoor uses in rough environments,” said Rob Bresnahan, CEO of Larson Electronics LLC. “It’s powerful illumination and far reaching beam is also ideal for emergency and first responder services.”
*About Larson Electronics LLC: *Larson Electronics LLC is a manufacturer of industrial lighting equipment and accessories. The company offers an extensive catalog of industry-grade lighting and power distribution products for the following sectors: manufacturing, construction, food processing, oil and gas, military, marine and automobile. Customers can benefit from the company’s hands-on, customized approach to lighting solutions. Larson Electronics provides expedited service for quotes, customer support and shipments.
*For further information, please contact:*
Rob Bresnahan, *President and CEO
*Toll-free: 1-800-369-6671
Phone: 214-616-6180
Fax: 903-498-3364
E-mail: sales@larsonelectronics.com Reported by GlobeNewswire 12 hours ago.
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Rob Norris smashes hat-trick as rampant Lincoln United see off Spalding United
Boston United were beaten while Trinity were held by Marine
Reported by Sleaford Target 10 hours ago.
↧
Marine's Helmet Saves His Life After Being Shot by an Enemy Sniper
A soldier's life flashes before his eyes when he is hit by a sniper's bullet.
Reported by eBaums World 8 hours ago.
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