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Tuesday, June 30, 2015

Alcohol and Fireworks Just Don't Mix, Chubb Warns Boaters

From Chubb:


Alcohol and Fireworks Just Don't Mix, Chubb Warns Boaters

WARREN, NJ, June 29, 2015—Many boat owners are looking forward to heading out onto the waterways this July 4th to watch the fireworks. But what starts off as just another fun experience can end in tragedy.
“Crowded waterways, alcohol and fireworks are a recipe for disaster,” said John Villas, vice president and worldwide marine claim manager for the Chubb Group of Insurance Companies. “We’ve seen too many lives and too much property unnecessarily lost when boats collide, capsize or catch fire under these circumstances.”  
The U.S. Coast Guard Auxiliary reports that more than one-third of all boating-related accidents and fatalities occur between Memorial Day and Labor Day.
That’s why Villas is encouraging boat owners to:
• ensure that passengers and crew members remain sober;
• appoint a designated boat operator in the event someone else needs to take control of the steering wheel;
• prohibit fireworks from being brought onboard;
• comply with their vessels’ maximum weight and passenger capacities;
• provide a readily-accessible approved life vest to every passenger and crew member;
• obey speed, zone and other waterway restrictions;
• refrain from turning off boat safety lights; and
• watch attentively for other boats and swimmers.
Villas also recommended that boat owners be mindful of water and weather conditions before and after they leave the dock. “Winds can whip up suddenly, and even the most experienced boater shouldn’t mess around with Mother Nature,” he said.
A leading insurer of yachts and other watercraft and a sponsor of U.S. Sailing, Chubb has been helping protect customers from maritime risks since its founding on the docks of New York City in 1882. Today, owners of small and large boats alike can obtain coverages from Chubb that typically are excluded in other policies. Depending on the coverage they have purchased, Chubb policies can include broad navigational limits on a year-round basis and coverage for full-time paid crew member liability, personal effects and fishing tackle for crew and guests, mechanical breakdown due to faulty repair, ice or freezing, and emergency towing and repair.
About Chubb
Since 1882, members of the Chubb Group of Insurance Companies have provided property and casualty insurance products to customers around the globe. These products are offered through a worldwide network of independent agents and brokers. The Chubb Group of Insurance Companies is known for financial strength, underwriting and loss-control expertise, tailoring products for the needs of high-net-worth individuals and commercial customers in niche markets and select industry segments, and outstanding claim service.
The Chubb Group of Insurance Companies is the marketing term used to describe several separately incorporated insurance companies under the common ownership of The Chubb Corporation. The Chubb Corporation is listed on the New York Stock Exchange (NYSE: CB) and, together with its subsidiaries, employs approximately 10,000 people throughout North America, Europe, Latin America, Asia and Australia. For more information regarding The Chubb Corporation, including a listing of the insurers in the Chubb Group of Insurance Companies, visit www.chubb.com.

Big Data for Small Producers - USDA Market News Now Covers 85 Farmers Markets

From the #USDA:


The Des Moines Farmers Market
As local and regional food systems continue to expand, so does the need for reliable market data. USDA Market News now captures data on over 85 farmers markets in the U.S. Pictured here is the Des Moines Farmers Market, which draws an average of 20,000 visitors a weekend. Photo courtesy of Des Moines, Iowa Farmers Market.
Farmers markets are an important part of local and regional food systems.  Nationwide, 150,000 farmers and ranchers are selling their products directly to consumers to meet the growing demand for local food.  Many sell their products at farmers markets, which can be a catalyst for future growth. 
According to USDA’s National Farmers Market Directory, there are over 8,400 farmers markets across the country serving as community gathering places where America’s food producers are building successful businesses and bringing fresh, local food to their communities.  As local and regional food systems continue to expand, so does the need for reliable market data.
In response, and thanks to support from the 2014 Farm BillUSDA Market News created a series of market reports on local products.  USDA Market News – administered by USDA’s Agricultural Marketing Service (AMS) – provides data that serves as the information lifeline for America’s agricultural economy.  The reports for local and regional food outlets – available on the Local & Regional Food Marketing Information webpage – provide a one-stop-shop for market and pricing information.  One component of the local and regional market data are reports on farmers markets. 
Currently, AMS works with 15 states to develop local and regional price reporting.  Thanks to this collaborative federal-state partnership, USDA Market News captures data on over 85 farmers markets from Colorado to Maryland. 
A great example of our farmers market coverage includes two reports capturing Iowa markets.  The Iowa Farmers Market Report covers farmers markets located in Ames, Cedar Rapids, Clinton, Des Moines, Dubuque, Mason City, and Spencer, Iowa.  The report provides prices of locally produced fruits, vegetables, herbs, cheese, eggs, maple syrup, mushrooms, starter plants, and various meat products.
There is also a stand-alone report for the Des Moines Farmers Market.  Entering into its 40th year, and considered to be one of the best farmers markets in the country, the Des Moines Farmers Market takes place on Saturdays from May to October – and a few winter markets too. Over the course of the market season, the market offers products from 58 Iowa counties by over 300 local entrepreneurs.  A key gathering place for the community, the market draws an average of 20,000 visitors every weekend. Vendors and patrons can also participate in Meals from the Market program, which acts as a fresh food collector to distribute food from the market to local pantries.  
As consumer demand for local foods has grown, USDA Market News strives to deliver up-to-date information.  In the future, we plan to include more states, more markets, and more historic analysis to help local and regional food producers get the market data they need to improve their businesses.
USDA Market News makes our nation’s commodity markets one of the most transparent in the world and provides critical market intelligence. This year marks the 100th anniversary of USDA Market News. Our farmers market reports are one example of how Market News works to ensure that everyone in the agricultural supply chain has the information they need when they need it.  We encourage you to take a look at our websiteinfographic, and video to see why for 100 years USDA Market News has been a trusted source then, now, and always.
    

Mexico pulls out of Trump's Miss Universe pageant - Jun. 30, 2015

Donald Trump warned earlier this month that unsavory individuals are crossing the border from Mexico. Now the country won't be sending anyone to Trump's beauty pageant.



The Mexican media company Televisa said it will not have a representative in the next Miss Universe pageant. Trump is a partial owner of the Miss Universe Organization, which oversees both the Miss Universe and Miss USA pageants.



Mexico pulls out of Trump's Miss Universe pageant - Jun. 30, 2015

The first American-made Kalashnikovs are now for sale - Jun. 30, 2015

They're not just Russian anymore.



Kalashnikov USA announced on Tuesday that it is now selling AK-47 assault rifles and shotguns that have been manufactured at a U.S. factory.



The first American-made Kalashnikovs are now for sale - Jun. 30, 2015

ESET Shares First Analysis of Dino Spying Malware, Created by Animal Farm

ESET®, a global leader in proactive digital protection, has today published in-depth research on a technically complex, backdoor Trojan called Dino. The malware has ties to the French espiognage group, Animal Farm



ESET Shares First Analysis of Dino Spying Malware, Created by Animal Farm

AgiltyWorks partners with Dell Boomi for Europe's First Managed Service of iPaaS | Dell

Tweet this: Together @AgilityWorks and Dell @Boomi provide first managed service for iPaaS in Europehttp://dell.to/1Iozaca


Dell Software today announced that AgilityWorks is partnering exclusively with Dell Boomi to power its newConnected Cloud Enterprise™, Europe’s first managed service for integration platform as a service (iPaaS).Providing flexible integration packages at a fixed monthly cost, Connected Cloud Enterprise eliminates application integration barriers without the need for an in-house resource, reducing costs and accelerating time to value. AgilityWorks selected Dell Boomi AtomSphere® to power Connected Cloud Enterprise™ because of Dell Boomi’s domain expertise and AtomSphere’s proven reliability and support for the widest range of integration patterns, including application, enterprise, B2B, mobile, social and API management.


AgiltyWorks partners with Dell Boomi for Europe's First Managed Service of iPaaS | Dell

Distinguished Duke Energy leader, Paul Newton, to retire in August - Duke Energy

RALEIGH, N.C. -
Paul Newton, Duke Energy state president - North Carolina, will retire from the company on Aug. 31, 2015.


Distinguished Duke Energy leader, Paul Newton, to retire in August - Duke Energy

Duke Energy to upgrade its Notrees Energy Storage System - Duke Energy

CHARLOTTE, NC -
Duke Energy, Samsung SDI and Younicos will team up to update Duke Energy’s 36-megawatt (MW) energy storage and power management system at the company’s Notrees Windpower Project in west Texas.
The system, one of the nation’s largest, has been operating since 2012 with lead acid batteries. Over the course of 2016, these batteries will be gradually replaced with lithium-ion technology.


Duke Energy to upgrade its Notrees Energy Storage System - Duke Energy

Johnson Controls honored by United Way of Greater Toledo

From Johnson Controls:


Johnson Controls honored by United Way of Greater Toledo
Employee inducted into hall of fame
TOLEDO, OHIO—June 30, 2015— Johnson Controls was recently awarded the 2014 Pillar Award by the United Way of Greater Toledo.
Employees at the company’s Toledo battery manufacturing facility and Northwood automotive seating plant raised more than $52,000 for the 2014 United Way campaign. Johnson Controls matched that amount for a total donation of $104,000. The funds raised support United Way of Greater Toledo’s community programs focused on education, health and financial stability of the clients they serve.
“Johnson Controls is extremely committed to strengthening the communities where we live and work,” said Tracy Breeding, Toledo plant manager, Johnson Controls. “Our employees have supported the United Way of Greater Toledo for more than 20 years.”
Toledo plant human resources coordinator, Kathy Brown, who has been with Johnson Controls for 34 years, was also inducted into the United Way Campaign Managers Hall of Fame. She joins 21 other present and past volunteer campaign managers in the Greater Toledo area.
“Kathy is passionate about helping our community and has employed several best practices to drive Johnson Controls campaign,” said Scott Schultz, Director, Major Firms, United Way of Greater Toledo. “I have worked with her for many years and truly appreciate her support and passion for United Way.”
“United Way is an amazing resource for the Toledo community,” said Brown. “The organization offers many great services for those in need.”
The United Way also recognized Johnson Controls in the following categories:
  • Top Campaign Committee: awarded to a team of United Way advocates coordinating a successful campaign that generates excitement in the workplace
  • Top Labor/Management Campaign Partner: awarded to a company whose United Way support is demonstrated by labor and management working together
Nationwide, Johnson Controls employee donations and company match for the 2014 United Way campaign totaled $8.9 million. Funding supports the arts, education, health and social services, the environment, and leadership development.
CONTACT:
Gretchen Miller
Global Media Relations Manager, Johnson Controls Power Solutions
Gretchen.A.Miller@jci.com
414-630-6723
About Johnson Controls
Johnson Controls is a global diversified technology and industrial leader serving customers in more than 150 countries. The company’s 170,000 employees create quality products, services and solutions to optimize energy and operational efficiencies of buildings; lead-acid automotive batteries and advanced batteries for hybrid and electric vehicles; and interior systems for automobiles. Johnson Controls’ commitment to sustainability dates back to its roots in 1885, with the invention of the first electric room thermostat. Through its growth strategies and by increasing market share, Johnson Controls is committed to delivering value to shareholders and making its customers successful. In 2015, Corporate Responsibility Magazine recognized Johnson Controls as the #14 company in its annual “100 Best Corporate Citizens” list. For additional information, please visit http://www.johnsoncontrols.com or follow @johnsoncontrols on Twitter.  

CNET On Cars - On the road: 2015 Volkswagen Golf R

Alcoa to Close Poços Smelter in Brazil

From #Alcoa:


June 30, 2015
Alcoa to Close Poços Smelter in Brazil
NEW YORK--(BUSINESS WIRE)--Lightweight metals leader Alcoa (NYSE:AA) today announced that it will permanently close its Poços de Caldas primary aluminum smelter in Brazil on June 30, 2015. The smelter has been curtailed since May 2014 and the underlying market conditions that led to the curtailment have not improved.

“The closure of the Poços smelter permanently removes a high-cost smelting facility from the Alcoa system and is another step in creating a more profitable Primary Metals business,” said Alcoa Global Primary Products President Bob Wilt.

Once the Poços smelter is closed, Alcoa’s total global smelting capacity will be reduced by 96,000 metric tons, to 3.4 million metric tons. The Poços mine, refinery, aluminum powder plant and casthouse will continue normal operations.

As a result of the closure, Alcoa expects to record restructuring-related charges in second quarter 2015 between $100 million and $110 million after-tax, or $.08 to $.09 per share, of which approximately 60 percent is non-cash.

About Alcoa

A global leader in lightweight metals technology, engineering and manufacturing, Alcoa innovates multi-material solutions that advance our world. Our technologies enhance transportation, from automotive and commercial transport to air and space travel, and improve industrial and consumer electronics products. We enable smart buildings, sustainable food and beverage packaging, high-performance defense vehicles across air, land and sea, deeper oil and gas drilling and more efficient power generation. We pioneered the aluminum industry over 125 years ago, and today, our approximately 59,000 people in 30 countries deliver value-add products made of titanium, nickel and aluminum, and produce best-in-class bauxite, alumina and primary aluminum products. For more information, visit www.alcoa.com, follow @Alcoa on Twitter atwww.twitter.com/Alcoa and follow us on Facebook atwww.facebook.com/Alcoa.

Forward-Looking Statements

This release contains statements that relate to future events and expectations and, as such, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include those containing such words as “estimates,” “expects,” “goal,” “plans,” “will,” or other words of similar meaning. All statements that reflect Alcoa’s expectations, assumptions, or projections about the future other than statements of historical fact are forward-looking statements, including, without limitation, statements about Alcoa’s goal to create a globally competitive commodity business, the expected timing for closing the Poços de Caldas primary aluminum smelter, and other statements about Alcoa’s strategies, outlook, and business and financial prospects. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and changes in circumstances that are difficult to predict. Important factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements include: (a) material adverse changes in aluminum industry conditions, including global supply and demand conditions and fluctuations in London Metal Exchange-based prices and premiums, as applicable, for primary aluminum, alumina, and other products, and fluctuations in indexed-based and spot prices for alumina; (b) changes in preliminary accounting estimates due to the significant judgments and assumptions required; and (c) the other risk factors discussed in Alcoa’s Form 10-K for the year ended December 31, 2014, and other reports filed with the Securities and Exchange Commission. Alcoa disclaims any obligation to update publicly any forward-looking statements, whether in response to new information, future events or otherwise, except as required by applicable law.

Trump not backing down: 'Mexico is not our friend' - Jun. 30, 2015

His incendiary comments about Mexican immigrants may have cost him a longstanding business partnership, but Donald Trump isn't exactly chastened.



A day after NBC severed ties with him, the reality television star and Republican presidential candidate offered more fighting words on the subject of illegal immigration and border security.



Trump not backing down: 'Mexico is not our friend' - Jun. 30, 2015

Eugenio Derbez dedica mensaje a Donald Trump durante NALIP | Variety Latino

Eugenio Derbez no desaprovechó la oportunidad de dedicarle algunas palabras a Donald Trumpdurante el discurso que dio en la conferencia de la Asociación Nacional de Productores Independientes Latinos (NALIP, por sus siglas en inglés) el 27 de junio.



Eugenio Derbez dedica mensaje a Donald Trump durante NALIP | Variety Latino

Puerto Rican debt crisis could hit South Florida, say business leaders | Miami Herald Miami Herald

As Puerto Rico’s government looms on the edge of a $72 billion default, local business and community leaders with ties to the island territory voiced concerns that a prolonged crisis on the island could hurt South Florida’s economy.


Read more here: http://www.miamiherald.com/news/business/article25791211.html#storylink=cpy


Puerto Rican debt crisis could hit South Florida, say business leaders | Miami Herald Miami Herald

Greece confirms it will default to IMF - Jun. 30, 2015

Greece won't pay the International Monetary Fund the 1.5 billion euros it owes Tuesday.



A spokesman for Finance Minister Yanis Varoufakis told CNN the payment would not be made. Greece thus becomes the first developed economy to default to the IMF.



Greece confirms it will default to IMF - Jun. 30, 2015

Window of opportunity opens this fall for dock modifications to reach deeper water - Duke Energy

SENECA, S.C. -
Eligible property owners on Lake Keowee and Lake Jocassee will have a one-year timeframe to apply for dock modifications to reach deeper water beginning September 1, 2015 through August 31, 2016. The program allows dock owners to proactively make permanent modifications to ensure a dock’s usability when lake levels may be lower, such as during an extended drought. 

Eligibility is based on requirements outlined in Duke Energy’s 2014 Keowee-Toxaway Shoreline Management Plan (SMP). Property owners may qualify for the dock modifications program if they had an existing Duke Energy-approved boat dock by the December 1, 2013 effective date of the Relicensing Agreement; or they had a Duke Energy-approved permit for a not-yet-installed dock issued less than 12 months prior to December 1, 2013 and installed prior to the permit expiring. In addition, an eligible dock must meet all other requirements of the SMP. 


Window of opportunity opens this fall for dock modifications to reach deeper water - Duke Energy

Take control of summer cooling costs with these tips from Duke Energy Florida - Duke Energy

ST. PETERSBURG, FLA. -
A sweltering hot Florida summer can cause your electric bill to jump as your air conditioning battles high humidity and temperatures consistently north of 90 degrees. But, you can survive the heat and your summer energy bills by following these simple tips from Duke Energy Florida. 

Try these money-saving tips to help reduce your electric use and save as the temperature rises:


Take control of summer cooling costs with these tips from Duke Energy Florida - Duke Energy

Greeks are rushing to Bitcoin - Jun. 29, 2015

With bank doors slammed shut, frantic Greeks are turning to online trading platforms to see if the digital money Bitcoin is a better bet than the euro.



The world's largest Bitcoin exchanges tell CNNMoney they've seen a surge of business from Greece.



Greeks are rushing to Bitcoin - Jun. 29, 2015

UPS Applauds Signing of Historic Bipartisan Trade Promotion Authority

UPS CEO David Abney Says Legislation Enhances U.S. Leadership Role on Global Trade



UPS Applauds Signing of Historic Bipartisan Trade Promotion Authority

NBCUniversal cuts ties with Donald Trump - Jun. 29, 2015

NBCUniversal, under pressure from an array of Hispanic groups, is severing its business ties to presidential candidate Donald Trump.



The Miss USA pageant, scheduled for July 12, will no longer air on the network. Nor will the Miss Universe pageant, scheduled for next January. Both pageants were, until now, jointly owned by NBC and Trump.



NBCUniversal cuts ties with Donald Trump - Jun. 29, 2015

Alcoa to Host Webcast of Second Quarter 2015 Results

From #Alcoa:


June 29, 2015
Alcoa to Host Webcast of Second Quarter 2015 Results
NEW YORK--(BUSINESS WIRE)--Alcoa (NYSE:AA) will hold a conference call on Wednesday, July 8 beginning at 5:00 p.m. EDT to discuss second quarter 2015 results and business developments. The conference call will be webcast live via Alcoa's website,www.alcoa.com, with presentation materials available online at 4:15 p.m. EDT.

Conference Call Information

Time: 5:00 – 6:00 p.m. EDT
 
Hosts:Klaus Kleinfeld, Chairman and Chief Executive Officer
William Oplinger, Executive Vice President and Chief Financial Officer
 
Call:(855) 252-9433
+ 1 (484) 487-2715 (International)
Conference ID: 71123428
To avoid a delay in start time, please dial-in beginning at 4:45 p.m. EDT
 
Webcast:
Invest section of the Alcoa website to listen and view slides only.
Note: Adobe Flash 9 or higher is required. Please refer to the system check to verify that your computer meets the system requirements. Click here if you need the latest version of Adobe Flash.

Replay Information

A replay of the call will be available from 8:15 p.m. EDT on July 8 until July 22 at 11:59 p.m. EDT.

Replay: (855) 859 2056
+ 1 (404) 537 3406 (International)
Conference ID: 71123428 or Quarterly Earnings Presentations on our website.
About Alcoa

A global leader in lightweight metals technology, engineering and manufacturing, Alcoa innovates multi-material solutions that advance our world. Our technologies enhance transportation, from automotive and commercial transport to air and space travel, and improve industrial and consumer electronics products. We enable smart buildings, sustainable food and beverage packaging, high performance defense vehicles across air, land and sea, deeper oil and gas drilling and more efficient power generation. We pioneered the aluminum industry over 125 years ago, and today, our approximately 59,000 people in 30 countries deliver value-add products made of titanium, nickel and aluminum, and produce best-in-class bauxite, alumina and primary aluminum products. For more information, visit www.alcoa.com, follow @Alcoa on Twitter atwww.twitter.com/Alcoa and follow us on Facebook at www.facebook.com/Alcoa.

Check Out These Business Travel Horror Stories!

Each month SurePayroll produces its SurePayroll Small Business Score Card. And this month the company was kind enough to allow Small Business Trends to add some questions posed to small business owners and managers about their practices and policies for business travel.
One of the questions was:


Check Out These Business Travel Horror Stories!

Lilly and Immunocore Announce Immunotherapy-based Clinical Trial Collaboration in Melanoma (NYSE:LLY)

INDIANAPOLIS and OXFORD, EnglandJune 29, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Immunocore Limited today announced that they have entered into an immunotherapy-based clinical trial collaboration to explore the utility of Immunocore's lead T cell receptor-based investigational therapeutic, IMCgp100, in combination with Lilly's galunisertib (LY2157299) and merestinib (LY2801653) for the treatment of melanoma. The goal of the collaboration is to identify combination regimens that provide synergies in efficacy and durability in patients with metastatic cutaneous and uveal melanomas.



Lilly and Immunocore Announce Immunotherapy-based Clinical Trial Collaboration in Melanoma (NYSE:LLY)

Perpetually Plugged In: America’s Smartphone Obsession Continues as Many Admit to Constant Connectivity | Bank of America Newsroom

Bank of America Survey Reveals Reluctance to Disconnect; Growing Reliance on Mobile Extends to Banking, Payments



Perpetually Plugged In: America’s Smartphone Obsession Continues as Many Admit to Constant Connectivity | Bank of America Newsroom

Merck Announces Phase 3 Study of Single-Dose EMEND® (fosaprepitant dimeglumine) for Injection Regimen Met Primary Endpoint in Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy

From #Merck:


Merck Announces Phase 3 Study of Single-Dose EMEND® (fosaprepitant dimeglumine) for Injection Regimen Met Primary Endpoint in Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy

Monday, June 29, 2015 8:30 am EDT
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from a Phase 3 study investigating the safety and efficacy of single-dose EMEND® (fosaprepitant dimeglumine) for Injection, Merck’s substance P/neurokinin (NK-1) receptor antagonist, in combination with other anti-vomiting medicines, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adult cancer patients receiving moderately emetogenic (vomit-inducing) chemotherapy (MEC). In the study, the first to evaluate an intravenous NK-1 receptor antagonist for the prevention of CINV associated with MEC, the single-dose EMEND for Injection regimen provided greater protection from nausea and vomiting following administration of chemotherapy versus an active control of placebo with other anti-vomiting medicines. These data were presented in an oral session at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) Annual Meeting on Supportive Care in Cancer (Abstract #27-02-O) in Copenhagen (June 25-27, 2015).
“The results from this important Phase 3 trial are very encouraging as they are the first study to evaluate EMEND for Injection in a combination regimen for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy – and show the potential to use a single day antiemetic regimen,” said Dr. Bernardo L. Rapoport, principal investigator for the study and chief medical oncologist, Medical Oncology Centre of Rosebank, Johannesburg, South Africa.
"Nausea and vomiting remain a significant burden for patients receiving chemotherapy and we look forward to submitting these data for EMEND for Injection to the U.S. Food and Drug Administration,” said Stuart Green, vice president, clinical research, Merck Research Laboratories. “This study builds on our decade of research for EMEND and Merck’s overall commitment to help people with cancer.”
EMEND for Injection, a substance P/Neurokinin-1 (NK1) receptor antagonist approved for use in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer (HEC) chemotherapy, including high-dose cisplatin; and for prevention of nausea and vomiting associated with initial and repeat courses of MEC. EMEND has not been studied for treatment of established nausea and vomiting. Chronic continuous administration of EMEND is not recommended.
In the U.S., the single-dose regimen of EMEND for Injection is approved for use associated with HEC. Merck plans to submit these recent data to the Food and Drug Administration in the second half of 2015 to seek approval for a regimen containing single-dose EMEND for Injection for the prevention of CINV associated with MEC.
About Phase 3 Study for Single-Dose EMEND for Injection in MEC
In this global randomized, Phase 3, double-blind study, more than 1,000 patients receiving MEC were randomly assigned to receive either single-dose EMEND for Injection (150 mg) in combination with ondansetron capsules (16 mg) and dexamethasone capsules (12 mg) (n=504) on day one (followed by oral placebo for ondansetron on days two and three) or an active control regimen consisting of placebo (saline IV) in combination with ondansetron (16 mg) and dexamethasone (20 mg) (n=497) on day one (followed by 8 mg ondansetron on days two and three). The primary endpoint of the study was complete response (CR) (as measured by no vomiting and no use of rescue medication for nausea or vomiting) in the delayed phase (25 to 120 hours following initiation of chemotherapy). The secondary endpoints were CR after the first dose of chemotherapy in the acute phase (0 to 24 hours) and in the overall phase (0-120 hours), as well as no vomiting in the overall phase.
Single-Dose EMEND for Injection Regimen Achieved Superior Control of CINV
For the primary study endpoint, EMEND for Injection regimen provided higher incidence of CR in days 2 through 5 – with CR observed in 78.9 percent of patients receiving the EMEND for Injection regimen versus 68.5 percent in the active control group (p <0.001). For the secondary endpoints, in the acute phase, CR was observed in 93.2 percent of patients receiving the EMEND for Injection regimen versus 91 percent in the active control group (p = 0.184). In the overall phase, the incidence of CR was observed in 77.1 percent of patients receiving the EMEND for Injection regimen versus 66.9 percent in the active control group (p <0.001). Additionally, a significantly greater proportion of patients receiving the EMEND for Injection regimen experienced no vomiting in the overall phase (82.7 percent with EMEND vs 72.9 percent in the active control group) and delayed phase (83.9 percent with EMEND vs 75.1 percent in the active control group) (both p <0.001) – with a favorable trend in the acute phase (94.8 percent with EMEND vs 92 percent in the active control group).
The most common adverse events (across all grades) in the EMEND for Injection regimen and active control group included fatigue (15.1 percent and 12.9 percent), diarrhea (12.7 percent and 11.3 percent), and constipation (9.3 percent and 10.5 percent). Treatment-related adverse events were observed in 8.5 percent of patients receiving the EMEND for Injection regimen and in 9.1 percent of patients in the active control group. Serious treatment-related adverse events were observed in 0.2 percent of patients receiving the EMEND for Injection regimen and in 0.4 percent of patients in the active control group.
Selected Important Safety Information for EMEND (fosaprepitant dimeglumine) For Injection
EMEND for Injection is contraindicated in patients who are hypersensitive to EMEND for Injection, aprepitant, polysorbate 80, or any other components of the product. Known hypersensitivity reactions include flushing, erythema, dyspnea, and anaphylactic reactions.
Aprepitant, when administered orally, is a moderate cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitor. Because fosaprepitant is rapidly converted to aprepitant, neither drug should be used concurrently with pimozide or cisapride. Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions.
EMEND for Injection should be used with caution in patients receiving concomitant medications, including chemotherapy agents that are primarily metabolized through CYP3A4. Inhibition of CYP3A4 by EMEND for Injection could result in elevated plasma concentrations of these concomitant medications. Conversely, when EMEND for Injection is used concomitantly with another CYP3A4 inhibitor, aprepitant plasma concentrations could be elevated. When EMEND for Injection is used concomitantly with medications that induce CYP3A4 activity, aprepitant plasma concentrations could be reduced, and this may result in decreased efficacy of aprepitant.
Chemotherapy agents that are known to be metabolized by CYP3A4 include docetaxel, paclitaxel, etoposide, irinotecan, ifosfamide, imatinib, vinorelbine, vinblastine, and vincristine. In clinical studies, EMEND was administered commonly with etoposide, vinorelbine, or paclitaxel. The doses of these agents were not adjusted to account for potential drug interactions. In separate pharmacokinetic studies, EMEND did not influence the pharmacokinetics of docetaxel or vinorelbine.
Because a small number of patients in clinical studies received the CYP3A4 substrates vinblastine, vincristine, or ifosfamide, particular caution and careful monitoring are advised in patients receiving these agents or other chemotherapy agents metabolized primarily by CYP3A4 that were not studied.
There have been isolated reports of immediate hypersensitivity reactions, including flushing, erythema, dyspnea, and anaphylaxis, during infusion of fosaprepitant. These hypersensitivity reactions have generally responded to discontinuation of the infusion and administration of appropriate therapy. It is not recommended to reinitiate the infusion in patients who have experienced these symptoms during first-time use.
Coadministration of EMEND for Injection with warfarin (a CYP2C9 substrate) may result in a clinically significant decrease in international normalized ratio (INR) of prothrombin time. In patients on chronic warfarin therapy, the INR should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of EMEND for Injection with each chemotherapy cycle.
The efficacy of hormonal contraceptives (including birth control pills, skin patches, implants, and certain IUDs) may be reduced during coadministration with and for 28 days after the last dose of EMEND for Injection. Alternative or backup methods of contraception should be used during treatment with and for 1 month after the last dose of EMEND for Injection.
Chronic continuous use of EMEND for Injection for prevention of nausea and vomiting is not recommended because it has not been studied and because the drug interaction profile may change during chronic continuous use.
In clinical trials of EMEND in patients receiving HEC, the most common adverse events reported at a frequency greater than with standard therapy, and at an incidence of 1% or greater, were hiccups (4.6% EMEND vs 2.9% standard therapy), asthenia/fatigue (2.9% vs 1.6%), increased ALT (2.8% vs 1.5%), increased AST (1.1% vs 0.9%), constipation (2.2% vs 2.0%), dyspepsia (1.5% vs 0.7%), diarrhea (1.1% vs 0.9%), headache (2.2% vs 1.8%), and anorexia (2.0% vs 0.5%).
In a clinical trial evaluating safety of the 1-day regimen of EMEND for Injection compared with the 3-day regimen of EMEND, the safety profile was generally similar to that seen in prior HEC studies with aprepitant. However, infusion-site reactions occurred at a higher incidence in patients who received fosaprepitant (3.0%) than in those who received aprepitant (0.5%). Those infusion-site reactions included infusion-site erythema, infusion-site pruritus, infusion-site pain, infusion-site induration, and infusion-site thrombophlebitis.
About Chemotherapy Induced Nausea and Vomiting (CINV)
Chemotherapy Induced Nausea and Vomiting (CINV) is a common side effect of chemotherapy caused by injured stomach cells that start the process of nausea and vomiting and can directly activate the area of the brain responsible for producing nausea and vomiting. The two main types of CINV are acute and delayed. Acute happens within the first 24 hours of receiving chemotherapy. Delayed happens from day 2 to day 5 after chemotherapy. The amount and timing of CINV can vary. Some chemotherapies cause acute nausea and vomiting. Others cause acute nausea and vomiting followed by another period of delayed nausea and vomiting.
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Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck Oncology, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology, and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
About Merck
Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on TwitterFacebook and YouTube.
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Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information for EMEND (aprepitant) athttp://www.merck.com/product/usa/pi_circulars/e/emend/emend_pi.pdf and Patient Information for EMEND (aprepitant) at http://www.merck.com/product/usa/pi_circulars/e/emend/emend_ppi.pdf
Please see Prescribing Information for EMEND (fosaprepitant dimeglumine) for Injection athttp://www.merck.com/product/usa/pi_circulars/e/emend_iv/emend_iv_pi.pdf and Patient Information for EMEND (fosaprepitant dimeglumine) for Injection athttp://www.merck.com/product/usa/pi_circulars/e/emend_iv/emend_iv_ppi.pdf.