Disruption in the Commercial Mortgage Business Continues!

Top-ten commercial mortgage brokerage firm Eastern Union Funding, one of the fastest growing in the nation and a pioneer of capped-fee loan origination, announced today that it will be adjusting its fee cap to $135,000 on loans for stabilized properties, effective immediately on new originations.
The decision results from the firm’s success in the year since its president, Ira Zlotowitz, sent shock waves through the industry by rolling out a fee cap of $250,000 per transaction—making Eastern Union the first debt brokerage to offer a solution to the problem of exorbitant industry fees.
In the 12 months since the rollout of the $250,000 cap, business has more than doubled, with Eastern Union Funding closing 100 deals above $10 million.
“Not only did we pick up deals above $25 million, which directly benefited from the cap because the industry typically pays one percent of $25 million, but we also saw a surge in the $10 million to north of $50 million loans,” said Eastern Union President Ira Zlotowitz. “Clients are choosing to grow with Eastern, knowing that not only are they receiving best-in-class service; but as they get bigger, the fees on their larger loans will be capped.”
“We grew to $3 billion a year based on being trusted advisors, coupled with our certainty of execution,” said Michael Muller, Eastern Union Senior Managing Director and the top originator at Eastern Union Funding for the last decade. “We are now taking that trust to a new level. We truly feel that, in today’s market, advances in technology and data points warrant a new fee structure. We are now able to offer a cap of $135K, which we feel is in line with the progression of the market.
The company’s top producer also alluded to further changes in the company’s fee structure: “We are continuing to innovate, and are in the process of developing another industry-revolutionizing refinancing product to be rolled out by the end of the third quarter that will truly transform the CRE financing arena.”
“Our goal from the start has always been to foster efficiency in the marketplace. Borrowers have questioned for years why a $100 million deal warrants a fee five times the size of a $20 million deaI, and why a $20 million deal carries a fee four times that of a $5 million dollar transaction,” Zlotowitz said. “It doesn’t make sense. If anything, it’s easier for large deals. They are more appealing to lenders. We are confronting this issue directly and offering a value-added, fair fee for a service we know is top quality and inspires loyalty. It’s a win-win.” Reported by PR Newswire.

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Carnival Corporation Granted U.S. Approval for Travel to Cuba

Carnival Corporation & plc (NYSE/LSE: CCL; NYSE: CUK), the world’s largest travel and leisure company, today announced that the U.S. Department of the Treasury and the U.S. Department of Commerce granted approval for the company to begin travel to Cuba. Carnival Corporation intends to take travelers to Cuba beginning in May 2016 via its newly launched fathom brand – a new social impact travel brand providing purpose-oriented, social impact experiences, initially in the Dominican Republic.
Carnival Corporation intends to operate fathom travel itineraries directly to Cuba for the purpose of providing cultural, artistic, faith-based and humanitarian exchanges between American and Cuban citizens. Authorized under current U.S.-to-Cuba travel guidelines, the new Cuban itineraries on fathom will strictly comply with U.S. Department of Treasury rules that allow licensed travel companies to transport approved travelers to Cuba to engage in activities that support the Cuban people. Carnival Corporation is in active discussions and plans to work with the appropriate authorities in Cuba so that Cuban approval is granted.
Launched June 4th as Carnival Corporation’s 10th global brand, fathom is designed as a purpose-driven brand to enrich the lives of its travelers and in the case of the Dominican Republic, drive sustainable social impact on a significant scale. The brand expects to attract 37,000 annual travelers who collectively could spend a total of more than 100,000 days a year either volunteering or immersing in educational and cultural exchanges in local communities.
Beginning in April 2016, fathom will embark on weekly seven-day voyages from Port Miami aboard the MV Adonia, a 710-passenger vessel redeployed from Carnival Corporation’s P&O Cruises (UK) brand. fathom’s first impact destination will be the northern region of the Dominican Republic, where Carnival Corporation’s new port of call, Amber Cove, will serve as home base.
Following the inaugural April month of voyages to the Dominican Republic, fathom intends to offer both Dominican and Cuban itineraries on a systematic and regular basis, giving travelers the opportunity to choose from two destinations and a range of activities from social impact in the Dominican Republic and educational and cultural exchanges in both countries designed to have a positive, transformative effect on the lives of the travelers.
“We are excited about receiving U.S. approval as the very important first step to ultimately take travelers to Cuba under the existing 12 criteria for authorized travel. We look forward to working with the Cuban authorities for their approval to help make the social, cultural and humanitarian exchanges between U.S. citizens and the people of Cuba a reality,” said Arnold Donald, President and CEO of Carnival Corporation. “We know there is strong demand from travelers who want to immerse themselves in Cuban culture, so this is a historic opportunity for us to enable more people to experience Cuban society. It is also an important opportunity for our new fathom brand to expand its positive influence in the world with this potential to add full-week immersion sailings to Cuba to its already planned full-week social-impact itineraries to the Dominican Republic beginning in the spring of 2016.”
Tara Russell, president of fathom and global impact lead for Carnival Corporation, added: “We’re incredibly excited and humbled by this potential opportunity to help travelers experience the amazing beauty and culture of Cuba, while being able to provide educational and cultural exchange activities that will benefit both the traveler and the Cuban people. After establishing the Dominican Republic as our first partner destination, Cuba represents an important step for us to expand our ability to offer meaningful and enriching experiences to purpose-driven travelers. Our goal remains the same for both destinations – to enable travelers to immerse, learn, serve and flourish while making enduring, sustainable contributions on a scalable and systematic basis. We are looking forward to building what we intend to be a beautiful and lasting friendship with the Cuban people.”
Led by Russell’s strong background in social entrepreneurship, fathom seeks to develop lasting social impact partnerships that allow for meaningful personal enrichment of the traveler, while providing systematic, long-term educational, environmental and economic development benefits in its partner countries.
“We’re very interested in exploring the prospects of expanding our partnership with fathom to include Cuba, building new impact programs and lending our assistance to strengthen existing initiatives that will help educational, cultural and humanitarian efforts already going on in Cuba,” said David Luther, founder and executive director of IDDI, a non-profit organization with the mission to help alleviate poverty in rural and urban areas in the Caribbean. “IDDI has long-standing relationships in Cuba and more than a decade of experience working on the ground side-by-side with local officials to make a positive impact in Cuban communities. Nothing else like fathom exists to bring hundreds of like-minded travelers a week to communities of people who need ongoing support. With fathom and its travelers, the potential for making a lasting impact in people’s lives is tremendous. We look forward to partnering closely with fathom to take our programs to the next level, and support growth and prosperity for the citizens of Cuba.”
Travelers may reserve travel on future fathom voyages
Prices for the seven-day trip to the Dominican Republic start at $1,540 per person, which includes an exterior cabin with a view, all meals on the ship, onboard social impact immersion experiences, three on-shore social impact activities and related supplies, taxes, fees, and port expenses. Prices will vary by season.
Prices for seven-day itineraries to Cuba start at $2,990 per person, excluding taxes, port and other government and related fees, and including all meals on the ship, onboard social impact immersion experiences and certain on-the-ground cultural immersion activities.
About Carnival Corporation & plc
Carnival Corporation & plc is the largest cruise company in the world, with a portfolio of 10 cruise brands in North America, Europe, Australia and Asia, comprised of Carnival Cruise Lines, Holland America Line, Princess Cruises, Seabourn, AIDA Cruises, Costa Cruises, Cunard, P&O Cruises (Australia), P&O Cruises (UK) and fathom.
Together, these brands will operate 100 ships in 2015 totaling 219,000 lower berths with eight new ships scheduled to be delivered between 2016 and 2018. Carnival Corporation & plc also operates Holland America Princess Alaska Tours, the leading tour companies in Alaska and the Canadian Yukon. Traded on both the New York and London Stock Exchanges, Carnival Corporation & plc is the only group in the world to be included in both the S&P 500 and the FTSE 100 indices. Reported by PR Newswire
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Former U.S. Attorney General Eric Holder Returns to Covington

Former U.S. Attorney General Eric Holder Returns to Covington (PRNewsFoto/Covington & Burling LLP)
Former U.S. Attorney General Eric Holder Returns to Covington (PRNewsFoto/Covington & Burling LLP)

Former U.S. Attorney General Eric H. Holder, Jr. is returning to Covington as a partner after more than six years of service as the nation’s top law enforcement officer.
Mr. Holder will be resident in the firm’s Washington office and focus on complex investigations and litigation matters, including matters that are international in scope and raise significant regulatory enforcement issues and substantial reputational concerns.
“It is a source of great pride to welcome Eric back to the firm after his distinguished service as attorney general,” said Timothy Hester, chair of the firm’s management committee. “Eric’s entire private practice career has been as a Covington partner, and we look forward to the role he will again play as a colleague, leader, client adviser and advocate.”
Mr. Holder is the third longest serving attorney general in U.S. history and the first African American to hold the office. As a member of President Obama’s cabinet and head of the Department of Justice, he oversaw the government’s efforts to address many critically important issues arising at the intersection of law and public policy, including national security investigations and prosecutions; landmark antitrust, environmental, fraud, and tax cases; the defense of voting rights and marriage equality; and reform of the federal criminal justice system. In 2014, Time magazine named Mr. Holder to its list of 100 Most Influential People, stating that he “worked tirelessly to ensure equal justice.”
Mr. Holder’s service as attorney general marks the most recent chapter in a remarkable career in public service. Prior to joining Covington in 2001, he served during the Clinton Administration as Deputy Attorney General and United States Attorney for the District of Columbia. Earlier, Mr. Holder served as Associate Judge of the Superior Court of the District of Columbia, having been appointed by President Reagan in 1988. Before becoming a judge, he served for many years as a public corruption prosecutor in the Justice Department’s Public Integrity Section, which he had joined in 1976 upon his graduation from Columbia Law School.
Mr. Holder was a partner at Covington from 2001 until February 2009, when President Obama appointed and the Senate confirmed him as the nation’s 82nd Attorney General. Reported by PR NewsWire.

San Antonio’s Historic Missions Receive UNESCO World Heritage Status

Mission San Jose is one of five San Antonio Missions just named to the UNESCO World Heritage list. (PRNewsFoto/San Antonio Convention & Visitor)
Mission San Jose is one of five San Antonio Missions just named to the UNESCO World Heritage list. (PRNewsFoto/San Antonio Convention & Visitor)

The wait is finally over: The San Antonio Missions have officially been designated a UNESCO World Heritage Site. The decision was announced on July 5th at the annual UNESCO World Heritage committee meeting in Bonn, Germany. An elite list with just 22 existing U.S. landmarks included, the five Missions (including The Alamo) are taking their place among other great American historic and cultural institutions like the Statue of Liberty and Independence Hall, in addition to natural treasures such as the Grand Canyon and world wonders like the Great Wall of China. The Missions, which are the largest collection of the Spanish colonial architecture in the U.S., are the third designation in the country in the last 20 years.
San Antonio’s Missions symbolize an era when the world was expanding, cultures were intertwining, and the global landscape was forever changed. It’s time now to “Remember the Alamo,” the first San Antonio Mission.
“The United States has a powerful and valuable history that encompasses a wide range of peoples, creeds and experiences,” said Crystal Nix-Hines, U.S. ambassador and permanent representative to UNESCO. “The San Antonio Missions represent an important element of our story, and a World Heritage designation allows them to be shared not only within the U.S. but also the wider global community.”
Susan Snow, archeologist for San Antonio Missions National Historical Park who has been coordinating the community efforts to secure UNESCO World Heritage status since 2007, said, “The San Antonio Missions are a tangible representation of everything required for a functioning Spanish colonial mission system, all within a short trek along the San Antonio River. These Missions are a living example of the interchange of cultures bringing together the indigenous, Spanish, Mexican, and other influences that form South Texas today. The resulting cross-cultural exchange is the very essence of the great melting pot of the United States.”
“San Antonio has grown to become the nation’s seventh-largest city while preserving the iconic history upon which it was built,” said Casandra Matej, Executive Director of the San Antonio Convention & Visitors Bureau. “Treasures like The Missions set us apart as an authentic destination, and now with World Heritage status, we are provided a tremendous opportunity to bring even more awareness, visitors and business to our city.”
Major Economic Impact
A UNESCO designation is a catalyst for socio-economic change, with increased visitation and tourist spending. According to the U.S. Travel Association, $928 billion was generated by domestic and international travelers in 2014, placing tourism as one of our nation’s largest economic generators and spurring an additional $1.2 trillion in other industries.
For San Antonio, the impact will be even more significant, as tourism is one of the city’s top five industries, providing one in eight jobs and more than $12 billion annually. By 2025, the World Heritage Site economic impact on San Antonio and Bexar County is expected to generate an additional $44 million -$105 million in economic activity, with over 1,100 newly created jobs.
History of the Missions
As the largest collection of Spanish colonial architecture in the U.S., Mission Concepcion, Mission San Jose, Mission San Juan, Mission Espada and Mission San Antonio de Valero (The Alamo) were built in the early 1700s to convert Native Americans to Christianity and help settle this region under the flag of Spain. Reported by PR Newswire.

First Aid Summer Survival Tips from Nyack Hospital

Before you head outdoors with your family to enjoy the summer weather, plan ahead so you can stay safe and healthy. Take steps to protect yourself from the sun, bugs and poisonous plants #summersafety. Infographic http://nyackhospital.org/summersafety
Protect Your Skin From the Sun
Exposure to ultraviolet (UV) rays from the sun can increase your risk of skin cancer. To protect your skin from UV radiation, stay in the shade as much as possible, especially during midday hours. Wear a hat with a wide brim to shade your face, head, ears and neck, and wraparound sunglasses. Use sunscreen with a sun protection factor (SPF) of 30 or higher, which offers protection from both UVA and UVB rays.
Apply at least one ounce of sunscreen (about the amount you can hold in your palm) at least 20 minutes before sun exposure, and reapply every two hours, and each time you get out of the water or perspire heavily.
Stay Hydrated
When you’re outdoors, make sure everyone in the family drinks plenty of liquids. Don’t wait until a child says they are thirsty before giving them something to drink. Provide fluids before going outside, while outdoors and when they get back inside.
Avoid Mosquito Bites
Using insect repellent can help you avoid mosquito bites when you’re outside. Most insect repellents applied to the skin contain either DEET, picaridin or oil of lemon eucalyptus. The higher the concentration of DEET or picaridin, the longer it will provide protection against mosquitoes. Don’t use products that contain DEET on infants younger than six months, and don’t use picaridin or oil of lemon eucalyptus on children under age three.
Other tips for safe insect repellent use:
• Don’t let young children get products containing DEET or picaridin on their hands or faces.
• Apply repellent only to exposed areas of skin — not under clothing.
• When you head back indoors, remove any remaining repellent by washing with soap and water.
If you know you’ll be in an area with many mosquitoes, wear long sleeves, long pants tucked into the tops of your socks, light colors and a wide-brimmed hat to help protect your ears and the back of your neck. Taking these steps can also help protect against ticks that carry Lyme disease.
Learn to Spot…and Treat…Poison Ivy
The best way to deal with poison ivy, oak and sumac is to learn to recognize it, so you can avoid it. Avoid bushy, overgrown areas that may contain these plants. When hiking, try to stay on paths, and wear protective clothing to reduce the amount of skin that’s exposed.
If you do come into contact with one of these plants, wash exposed areas with soap and water within 5 to 10 minutes of contact if possible to prevent a breakout. If you do develop a rash, soak in a cool bath sprinkled with oatmeal or baking soda to rinse the oil from the plants that spreads the rash. After the bath, apply calamine lotion to help reduce itching. Wash all of your clothes—even your sneakers—and sheets to get rid of the plant oil. The oil can even cling to your dog’s fur. Call your doctor if the rash starts oozing or your skin swells.
Pack a summer first aid kit and keep it in the car. Infographic: Pack a Summer First Aid Kit
• Thermometer
• Bug spray
• Sunscreen
• Hydrocortisone cream for rashes and bug bites
• Bottle of water to clean a wound or scrape
• Tea tree oil to treat poison ivy
• Aloe vera gel to help soothe a sunburn
• Sanitizing wipes to clean your hands
• Antiseptic towelettes to clean out scrapes and cuts
• Antibiotic ointment to prevent infection
• Bandages, Band-aids, gauze and tape
• Tweezers and a sterile needle for splinters
• Instant ice packs for inflammation
• Cotton balls and cotton swabs
• Saline solution to clean out eyes
• Small doses of over-the-counter medications such as Tylenol, Advil, Pepto-Bismol tablets, Dramamine, and Benadryl for allergic reactions
Keep a list of emergency numbers handy:
• Emergency medical services (911)
• Your family doctor
• Pediatrician
• Dentist
• Poison control

Reported by PR Newswire.

Safe at School: Diabetes Forecast Celebrates Triumphs for Students with Diabetes

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Diabetes Forecast, the Healthy Living Magazine from the American Diabetes Association, has released its annual Safe at School feature in the July/August 2015 issue. As students, parents and staff gear up for another school year, State of Safety reviews progress that has been made in ensuring schools are a safe and inclusive place for students living with diabetes.
Arkansas’ recent journey in passing a Safe at School bill illustrates the need for advocacy so that students with diabetes receive fair treatment and safe care at school while being able to participate in all school activities. Arkansas’ bill allows staff volunteers to be trained to give insulin and glucagon, and treatment for low blood glucose emergencies, as needed. The bill also allows kids who are able to do diabetes self-care tasks – such as using a blood glucose meter and giving insulin – to do so. The article also outlines steps that family members can take to advocate for fair treatment and equal educational opportunities if they feel a child is being discriminated against because of diabetes.
Believing Without Seeing: Prepare to be inspired! Matthew Weed, PhD, is a bioethics scholar at Yale and an avid skier, Rollerblader and hiker. He is also blind and lives with type 1 diabetes. Weed enlists the help of his willing students, neighbors and volunteers on campus to help monitor his blood glucose and give insulin several times a day. Read more about Weed’s motivational story and his mission to lead a life of action.
Stripped Down Savings: Diabetes management can be expensive. Even smaller costs, such as test strips, can add up over time; however, there are resources available that offer qualifying patients assistance with costs. Check out this compilation of cost-saving tips for strips, plus resources for saving on prescriptions.
Insulin Innovations: How far has insulin come since the American Diabetes Association’s founding 75 years ago, and what’s on the horizon at your pharmacy? Read about breakthroughs in creating and delivering insulin (one kind can be inhaled) and check out what insulins are available now, coming soon and expected down the road for diabetes management. Reported by PR Newswire.

New Analysis Reveals High-Priced Hepatitis C Drugs Could Have Costly Impact on State

A new analysis and infographic released today estimate California’s exposure to high-priced Hepatitis C medications could range from hundreds of millions of dollars, even if only 5 percent of Californians infected with Hepatitis C receive treatment through state programs. The analysis, which looks at the costly impact of new Hepatitis C treatments on public programs, comes at a time when state and federal agencies grapple with hefty price tags for drugs like Gilead Sciences’ Harvoni and Sovaldi.
California’s state agencies have already acknowledged the impact of high-priced Hepatitis C drugs by setting aside hundreds of millions in the state budget and establishing workgroups to address the high-cost drug trend. The analysis released today supports the need for these proactive actions as these highly-effective, but costly, treatments pose a significant threat to the stability of our health care system at a time when health care reform has expanded coverage to millions of Americans.
“With a host of potentially six-figure priced drugs due to hit the market this year, this report shows how just one new treatment can blow a hole in state and federal budgets,” said Charles Bacchi, President and CEO of the California Association of Health Plans. “These findings illustrate that this pricing trend is not sustainable for our state, its taxpayers and our public programs.”
The introduction of Hepatitis C drugs with prices as high as $94,000 per treatment caused prescription spending for the disease to increase 750 percent in just the last year. And, with the state paying the health care tab for one-third of Californians through Medi-Cal, the state and taxpayer liability for these increased costs has risen significantly. The report estimates that if just 5 percent of those with Hepatitis C in state programs receive discounted treatment, costs could range from $512 million to $921 million. If the percentage of those receiving treatments increases, costs could run into the billions, even with steep discounts.
The report estimates the number of people receiving health coverage/services in state programs (Medi-Cal, CalPERS, prisons, state hospitals and the AIDS Drug Assistance Program) who are infected with Hepatitis C. It then offers a range of cost estimates based on different scenarios for price discounts and those obtaining treatment.
The report illustrates the state’s vulnerability to high-priced Hepatitis C drugs. The Governor’s 2015-16 budget recognized this exposure, calling for $228 million in supplemental funding for high-priced Hepatitis C treatments. The numbers revealed in the report support the state’s efforts, while illustrating the need to prepare for future impacts as the costs seen to-date are only the tip of the iceberg.
“We look forward to working with the Administration and the Legislature — both of which have acknowledged the challenges posed by high-priced drugs — to ensure we have greater transparency around the cost of these drugs and to identify additional strategies that will sustain the long term affordability of our health care system,” added Bacchi.
The analysis, produced by the Taylor Feldman Group for the California Association of Health Plans, uses a linear model based on prevalence of Hepatitis C in state-funded health programs, Hepatitis C treatment prices, and percentage of patients seeking treatment in a given year to determine how California may be impacted by high-priced Hepatitis C drugs. The findings provide a range of cost estimates for the entire state population as well as sub-populations covered by public programs and illustrate a significant burden to the state across the board.
A variety of Hepatitis C specialty drugs and drug combinations are available, but the market is currently dominated by Gilead Sciences’ Harvoni and Sovaldi, which hold more than 90 percent of the market share. While new drugs – like AbbVie’s Viekira Pak – have recently hit the market, the pricing of these drugs is similar to Harvoni and Sovaldi, allowing the Gilead products used in the study to serve as a good proxy for the impacts of new drugs, like Viekira Pak, as market share grows.
The introduction of high-priced drugs that treat widespread diseases like Hepatitis C is an unsustainable trend that runs counter to efforts to make quality health care affordable and accessible. California is already seeing the impact of these high prices, and the analysis released today underscores additional strains to come. These new drugs have great potential as effective treatments, but their price tags strain state budgets and stand in the way of patients’ ability to access treatments. Reported by PR Newswire.

New Survey Finds 4 out of 10 Pregnant Women in United States Skipping Crucial Health Step

Oral health may not be top of mind when preparing for a new baby, but it should be. A new survey out today from Delta Dental finds that 42.5 percent of expecting moms in the United States aren’t visiting their dentist, a step that can help identify key health issues appearing specifically during pregnancy.
On the heels of Pregnancy Awareness Month, Delta Dental is reminding women who are pregnant or planning to become pregnant to visit a dentist for routine examination, cleanings and guidance about specific oral health issues that may occur during pregnancy. When visiting the dentist, expecting women should ask about the following issues and concerns:
• Why do my gums bleed more easily?
• “Pregnancy gingivitis” may affect women during pregnancy due to increased hormones.
• To help prevent a build-up of plaque, brush twice a day with a fluoride toothpaste and floss at least daily, paying special attention to cleaning along and just below the gum line.
• What is the red lump that has developed along my gumline?
• “Pregnancy tumors” are somewhat rare red growths of gum tissue that can form on the gums between the teeth as a result of excess plaque, usually during the second trimester of pregnancy.
• Don’t worry too much, although they may bleed when irritated, these are benign and harmless, and usually subside on their own after the baby is born.
• Can I receive routine or emergency dental care during my pregnancy?
• Yes, be sure to get an examination and cleaning, but try to avoid routine dental care during the first trimester and later part of the third trimester.
• If a dental emergency arises, be sure to let your dentist know that you are pregnant. He or she will know what precautions need to be taken to resolve your dental problem.
• If you need cavities filled or other necessary procedures, the second trimester is the best time. Elective procedures like tooth whitening or other cosmetic work should be delayed until after the baby is delivered.
“We know expecting mothers have a lot going on during this exciting time in their lives, making a routine trip to the dentist is one step that shouldn’t be skipped,” said Dr. Bill Kohn, Delta Dental Plans Association’s vice president of dental science and policy. “There are oral health issues that have a heightened risk of occurring during pregnancy, being aware and on top of these is key.” Reported by PR Newswire.

People With Thyroid Cancer in The Nordic Region Now Able to Benefit From New Advanced Thyroid Cancer Treatment Lenvima® (Lenvatinib)

Lenvima® (Lenvatinib), a treatment for people with radioactive iodine refractory differentiated thyroid cancer (RAI refractory DTC), launches in in the Nordic region. Advanced thyroid cancer is a difficult to treat condition with a poor prognosis and Lenvima represents a significant advance for patients in the Nordic countries. Lenvatinib is indicated for the treatment of adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC) refractory to radioactive iodine (RAI).[1]
Lenvatinib shows a significant median 18.3 months progression free survival versus 3.6 months for placebo (hazard ratio [HR] 0.21; 99% confidence interval 0.14-0.31, p<0.0001). The response rate was 64.8% in the lenvatinib group (4 complete responses, 1.5%) and 1.5% in the placebo (P,0.001). 70.4% of patients had a complete or partial response to lenvatinib within 30 days on the 24mg dose. Lenvatinib was associated with a median time to objective response of 2 months (95% CI, 1.9-3.5). Median duration of treatment was 13.8 months with lenvatinib versus 3.9 months for placebo. SELECT is a randomised, double-blind, multicentre trial for people with progressive RIA DTC (n=392).[2] For lenvatinib, the most common treatment related adverse events were hypertension, diarrhoea, fatigue, decreased appetite, decreased weight, and nausea.
“It is a challenge to treat advanced thyroid cancer, when the possibility to offer an effective therapy is limited. The progression free survival benefit of lenvatinib represents an important milestone in the treatment of radioiodine-refractory advanced thyroid cancer (of papillary and follicular types) and is welcomed by doctors and patients alike,” commented Dr Lars Bastholt, Department of Oncology, University Hospital of Odense.
“For patients who no longer respond to radioactive iodine treatment, there are limited options. This makes the launch of lenvatinib in the Nordics countries particularly pertinent as it means patients have an effective treatment option to help fill this unmet medical need. Lenvatinib has been proven to extend progression free survival by approximately 15 months when compared to placebo,” comments Anna Wallin, Eisai Nordic Marketing Manager.
Lenvatinib, discovered and developed by Eisai, is an oral molecular tri-specific targeted therapy that possesses a potent selectivity and a binding mode different to other tyrosine kinase inhibitors (TKI). Lenvatinib simultaneously inhibits the activities of several different molecules including vascular endothelial growth factor receptors (VEGFR), fibroblast growth factor receptors (FGFR), RET, KIT and platelet-derived growth factor receptors (PDGFR). This potentially makes lenvatinib the first TKI that simultaneously inhibits the kinase activities of FGFR 1-4 as well as VEGFR 1-3.[3],[4] In addition, lenvatinib was found to have a new Type V binding mode of kinase inhibition that is distinct from existing compounds.[5]
While thyroid cancer is relatively rare, over the past few decades the incidence of the disease is rising rapidly across the whole of Europe.[6],[7] In 2012 there were approximately 1,300 new cases of thyroid cancer in Nordic countries.[7] More prevalent in women than men, at a ratio of 2 to 1, thyroid cancer is the most common endocrine malignancy.[8]
Lenvatinib has been approved for the treatment of refractory thyroid cancer in the United States, Europe and Japan, and has been submitted for regulatory approval in Switzerland, South Korea, Canada, Singapore, Russia, Australia and Brazil. Lenvima was granted Orphan Drug Designation in Japan for thyroid cancer, in the United States for treatment of follicular, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer and in Europe for follicular and papillary thyroid cancer.
The development of lenvatinib underscores Eisai’s human health care (hhc) mission, the company’s commitment to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. Eisai is committed to the therapeutic area of oncology and to address the unmet medical needs of patients and their families.
Notes to Editors
Lenvatinib (E7080)
Eisai is currently conducting clinical studies of Lenvima in several types of cancer including hepatocellular carcinoma (Phase III), renal cell carcinoma (Phase II), non-small cell lung cancer (Phase II) and endometrial cancer (Phase II).
About Lenvatinib’s Novel Binding Mode (Type V)[6]
Kinase inhibitors are categorized into several types (Type I to Type V) depending on the binding site and the conformation of the targeted kinase in complex with them. Most of the currently approved tyrosine kinase inhibitors are either Type I or Type II, however according to X-ray crystal structural analysis, lenvatinib was found to possess a new Type V binding mode of kinase inhibition that is distinct from existing compounds. In addition, lenvatinib was confirmed via kinetic analysis to exhibit rapid and potent inhibition of kinase activity, and it is suggested that this may be attributed to its novel binding mode.
About SELECT[3]
The SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) study was a multicentre, randomised, double-blind, placebo-controlled Phase III study to compare the PFS of patients with RR- radioiodine-refractory differentiated thyroid cancer and radiographic evidence of disease progression within the prior 13 months, treated with once-daily, oral lenvatinib (24mg) versus placebo. The study enrolled 392 patients in over 100 sites in Europe, North and South America and Asia and was conducted by Eisai in collaboration with the SFJ Pharmaceuticals Group.
Participants were stratified by age (≤65, >65 years), region and ≤1 prior VEGFR-targeted therapies and randomised 2:1 to either lenvatinib or placebo therapy (24mg/d, 28-d cycle). The primary endpoint was PFS assessed by independent radiologic review. The secondary endpoints of the study included overall response rate (ORR), overall survival (OS) and safety. Rates of complete response were 1.5% (4 patients) for the lenvatinib group and zero in the placebo group. The results for partial response were 63.2% (165 patients) in the lenvatinib group and 1.5% (2 patients) in the placebo arm. The median exposure duration was 13.8 months for lenvatinib and 3.9 months for placebo and the median time to response for lenvatinib was 2.0 months. Median OS has not yet been reached.
The six most common lenvatinib treatment-related adverse events (TRAEs) of any grade were hypertension (67.8%), diarrhea (59.4%), fatigue (59.0%), decreased appetite (50.2%), weight loss (46.4%) and nausea (41.0%). TRAEs of Grade 3 or higher (Common Terminology Criteria for Adverse Events) included hypertension (41.8%), proteinuria (10.0%), weight loss (9.6%), diarrhoea (8.0%), and decreased appetite (5.4%).
Subgroup analyses presented at the European Thyroid Association Annual Meeting in September 2014 showed that lenvatinib maintained a PFS benefit in all pre-defined subgroups of people with progressive radioiodine-refractory differentiated thyroid cancer. In particular, the PFS benefit observed in 195 people with progressive radioiodine-refractory differentiated thyroid cancer in Europe (lenvatinib n=131 and placebo n=64) was similar to the PFS of overall study population (HR=0.24, [95% CI, 0.16-0.35]).[9] The median PFS with lenvatinib and placebo were 18.7 months and 3.7 months respectively.
Two recent subanalyses from the SELECT study have been presented at the Endocrine Society Congress 2015 (ENDO). The first reports the results of the open-label extension phase of SELECT and aims to assess the crossover of patients in the placebo arm to the optional open-label lenvatinib treatment period. The results highlight that patients who crossed over from the placebo arm achieved a median PFS of 12.4 months with open-label lenvatinib treatment. Although toxicities were substantial, these were generally managed with medications, dose interruption, and dose reductions.
The second abstract examines the relationship between thyroid abnormalities and their effect on the safety and efficacy outcomes in SELECT. The analysis shows that although an increase in thyroid-stimulating hormone (TSH) levels was a frequent complication, its direct relationship to lenvatinib therapy has not been established and there is no evidence TSH levels affect tumour responses to lenvatinib treatment.
About Thyroid Cancer
Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea.[10] It is more common in women than in men and most are in their 40s or 50s at time of diagnosis.[11]
Thyroid cancer affects more than 52,000 people in Europe each year.[7] The incidence of thyroid cancer has increased significantly in the last decade by 69% and 65% in men and women, respectively.[12] The most common types of thyroid cancer, papillary and follicular (including Hurthle cell), are classified as differentiated thyroid cancer (DTC) and account for approximately 85-90% of all cases.[13],[14],[15] The remaining cases are classified as either medullary (3-4% of cases)[16] or anaplastic (1-2% of cases).Reported by PR Newswire.

Understanding Payer Decision-Making is Key for Future Growth in Pharmaceutical Industry

The U.S. Supreme Court’s ruling this week in support of the Affordable Care Act was good news for the health insurance industry. If the court had ruled against the government, insurers were at risk of losing millions of customers.
Instead, payers will continue to grow as the number of insured Americans increases. For the pharmaceutical industry, this means more of its top-line growth will flow from payers and it will be critical for organizations to understand not only the different payer segments but also what drives payer decision-making.
To help pharma leaders navigate this new landscape, research and consulting leader Best Practices, LLC conducted a research project to identify what market research approaches are most effective and innovative for understanding payer needs and decision-making. The wide-ranging study also identifies what market research approaches are most effective for understanding payer contracting activities & timing as well as formulary activities & timing.
The 95-page study, “Increasing Market Access through Innovative Payer Market Research: Assessing New Tools & Technologies to Gain Insight into Payer Decision Making,” includes more than 200 metrics and 20+ narratives from payer research leaders.
Some of the questions addressed in this study include:
• What research techniques work best during different product lifecycle stages to ensure national, regional and government payer access for therapies?
• What drives national, regional and government payer decisions?
• What drives the decision-making of Accountable Care Organizations and Integrated Delivery Networks?
• How are companies communicating and coordinating payer research efforts?
• What are resource and investment levels for payer-focused research?
Thirty-eight payer research leaders participated in this study. More than half of the participants represent pharma or biotech companies, and another quarter come from medical device companies. Five selected participants were interviewed to add qualitative depth to the study.
Among the insights uncovered in the study was that payer landscape research is well used and highly valued:
• Up to 86% use payer landscape research tactics to understand payer decision making
• Value-proposition testing with payers is the most heavily used and most effective tactic
• Mock P&T committees are used to explore parameters that could change payer thinking Reported by PR Newswire.