Author: Michelle Dryden

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Healthcare

Bristol Myers Squibb provides update on Phase 3 IDHENTIFY trial in patients with relapsed or refractory acute myeloid leukemia

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #AML—Bristol Myers Squibb (NYSE:BMY) today announced that the Phase 3 IDHENTIFY study evaluating IDHIFA® (enasidenib) plus best supportive care (BSC) versus conventional care regimens, which include best supportive care (BSC) only, azacitidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC, did not meet the primary endpoint of overall survival (OS) in patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. The safety profile of IDHIFA was consistent with previously reported findings. The company will complete a full evaluation of the IDHENTIFY data and work with investigators to present detailed results at a future medical meeting.

“While we are disappointed by the outcome of the IDHENTIFY study, we remain confident in IDHIFA’s established role as a treatment option for patients with relapsed or refractory AML with an IDH2 mutation and are grateful to all those who participated in the study,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. “AML is one of the most difficult-to-treat blood cancers, and we’re committed to furthering our research and improving on the standards of care for patients living with this aggressive disease.”

In August 2017, Bristol Myers Squibb received full approval in the U.S. for IDHIFA for the treatment of adult patients with R/R AML with an IDH2 mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is the first and only FDA-approved therapy for patients with R/R AML and positive for an IDH2 mutation, which represents up to 19 percent of AML patients. IDHIFA is also approved in Australia and Canada.

About IDHENTIFY

IDHENTIFY (NCT02577406) is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs), which include continuous 28-day cycles of best supportive care (BSC) only, azacitidine subcutaneously (SC) plus BSC, low-dose cytarabine SC plus BSC, or intermediate-dose cytarabine intravenously plus BSC, in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation. The primary endpoint of the study was overall survival. Key secondary endpoints included overall response rate, event-free survival, duration of response and time to response.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is the most common type of acute leukemia. AML starts in the bone marrow but moves quickly into the blood. Unlike in normal blood cell development, in AML, the rapid buildup of abnormal white blood cells in the bone marrow may interfere with the production of normal blood cells, resulting in decreased healthy white blood cells, red blood cells and platelets. AML is a complex, diverse disease associated with multiple genetic mutations, such as the isocitrate dehydrogenase-2 (IDH2) mutation, and usually worsens quickly and can lead to death if not treated. IDH2 mutations are present in up to 19 percent of AML cases. AML has a high relapse rate, meaning following patients’ initial response to treatment, their disease is likely to return, signifying an unmet need for targeted therapy options. The worldwide incidence of AML is estimated to be over 350,000 cases. In the United States, there will be an estimated 21,450 new cases of AML this year, with an estimated 10,920 deaths resulting from the disease.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational chimeric antigen receptor (CAR) T-cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

About IDHIFA

IDHIFA (enasidenib) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation as detected by an FDA-approved test. IDHIFA is also approved in Australia and Canada.

Important Safety Information

BOXED WARNING: DIFFERENTIATION SYNDROME

Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome: See Boxed WARNING. In the AG221-C-001 Phase 2 clinical trial, 14% of patients treated with IDHIFA experienced differentiation syndrome, which may be life-threatening or fatal if not treated. Differentiation syndrome has been observed with and without concomitant hyperleukocytosis, as early as 1 day and at up to 5 months after IDHIFA initiation. Symptoms in patients treated with IDHIFA included acute respiratory distress represented by dyspnea and/or hypoxia and need for supplemental oxygen; pulmonary infiltrates and pleural effusion; renal impairment; fever; lymphadenopathy; bone pain; peripheral edema with rapid weight gain; and pericardial effusion. Hepatic, renal, and multi-organ dysfunction have also been observed. If differentiation syndrome is suspected, initiate systemic corticosteroids and hemodynamic monitoring until improvement. Taper corticosteroids only after resolution of symptoms. Differentiation syndrome symptoms may recur with premature discontinuation of corticosteroids. If severe pulmonary symptoms requiring intubation or ventilator support and/or renal dysfunction persist for more than 48 hours after initiation of corticosteroids, interrupt IDHIFA until signs and symptoms are no longer severe. Hospitalization for close observation and monitoring of patients with pulmonary and/or renal manifestation is recommended.

Embryo-Fetal Toxicity: Based on animal embryo-fetal toxicity studies, IDHIFA can cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with IDHIFA and for at least 2 months after the last dose. Pregnant women, patients becoming pregnant while receiving IDHIFA, or male patients with pregnant female partners should be apprised of the potential risk to the fetus.

ADVERSE REACTIONS

  • The most common adverse reactions (≥20%) included total bilirubin increased (81%), calcium decreased (74%), nausea (50%), diarrhea (43%), potassium decreased (41%), vomiting (34%), decreased appetite (34%), and phosphorus decreased (27%)
  • The most frequently reported ≥Grade 3 adverse reactions (≥5%) included total bilirubin increased (15%), potassium decreased (15%), phosphorus decreased (8%), calcium decreased (8%), diarrhea (8%), differentiation syndrome (7%), non-infectious leukocytosis (6%), tumor lysis syndrome (6%), and nausea (5%)
  • Serious adverse reactions were reported in 77.1% of patients. The most frequent serious adverse reactions (≥2%) were leukocytosis (10%), diarrhea (6%), nausea (5%), vomiting (3%), decreased appetite (3%), tumor lysis syndrome (5%), and differentiation syndrome (8%). Differentiation syndrome events characterized as serious included pyrexia, renal failure acute, hypoxia, respiratory failure, and multi-organ failure

LACTATION

Many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants, advise women not to breastfeed during treatment with IDHIFA and for at least 2 months after the last dose.

Please see full Prescribing Information, including Boxed WARNING

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol-Myers Squibb company and Juno Therapeutics, a Bristol-Myers Squibb company.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, the possibility of unfavorable results from further clinical trials involving IDHIFA (enasidenib). No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

Contacts

Media Inquiries:
media@bms.com
609-252-3345

Rose Weldon

rose.weldon@bms.com

Investors:
Tim Power

609-252-7509

timothy.power@bms.com

Nina Goworek

908-673-9711

nina.goworek@bms.com

Categories
Business

Mercury Insurance offers contactless home inspections to policyholders in New York and New Jersey through Flyreel

Mercury’s home inspection app minimizes health risks by eliminating the need for outsiders to make an in-person home visit

LOS ANGELES–(BUSINESS WIRE)–Today, Mercury Insurance announced that the company is offering New York and New Jersey homeowners policyholders DIY inspection services using an advanced Artificial Intelligence (AI) assistant. Created by Flyreel, the app guides homeowners through a self-inspection of their property and gives them the option for a contactless experience, helping policyholders maintain their physical distance from those outside of the household during the COVID-19 pandemic. The AI assistant is available to download as a mobile app from the Apple App Store and Google Play.

“We do so much with smartphones now that giving our insureds the ability to use photos and video to capture and verify the characteristics of their property made so much sense,” said Holly Sacks, Mercury Insurance portfolio underwriter. “The AI in our app is top-class, making it super simple to complete a self-inspection. The step-by-step instructions are easy to follow and fun to use!”

New Mercury homeowner policyholders will be emailed a link to download the app and activate it. Then, they can complete the self-inspection at their leisure with no appointment needed. The virtual inspection is conducted with state-of-the-art AI, high fidelity video and a conversation feature to streamline the experience while capturing everything Mercury needs to accurately underwrite a policy. It also helps catalog belongings and building materials in the event the customer needs to file a claim. On average, the self-inspection process takes less than 30 minutes.

Flyreel, Mercury’s home inspection app technology partner, is the pioneer in developing advanced AI to help insurance providers protect policyholders and their property using AI-assisted, self-service inspections.

“We’re grateful for the opportunity to support Mercury Insurance as they push the envelope of innovation, deploying the best of today’s technology to better serve their customers,” said Cole Winans, CEO of Flyreel. “Their relentless commitment to protecting homeowners while delivering an industry-leading customer experience makes us proud to be their partner.”

Visit https://www.mercuryinsurance.com/insurance/homeowners/ to learn more about Mercury’s products and services.

About Mercury Insurance

Mercury Insurance (MCY) is a multiple-line insurance organization predominantly offering personal automobile, homeowners and business insurance through a network of independent agents in Arizona, California, Florida, Georgia, Illinois, Nevada, New Jersey, New York, Oklahoma, Texas and Virginia. Since 1962, Mercury has specialized in offering quality insurance at affordable prices. For more information, visit www.mercuryinsurance.com or Facebook and follow the company on Twitter.

About Flyreel

Flyreel provides Total Property UnderstandingTM for underwriting, loss control and claims. Flyreel’s advanced AI assistant guides users through fully configurable workflows. As users scan their property with their smartphone camera, Flyreel’s proprietary computer vision technology automatically documents critical property data like hazards, risks, features, materials and more. Flyreel’s AI Assistant can “react and respond” to data collected by the policyholder, adapting and customizing conversational workflows based on the unique attributes that it “sees” in near real-time. To learn more about Flyreel, visit https://www.flyreel.co/.

Contacts

PCG – Kyle Reuter (424) 903-3657

kreuter@pacificcommunicationsgroup.com

Flyreel, Inc. – Alyson Austin (949) 403-0484

alyson@gaffneyaustin.com

Categories
Business

Many U.S. cities including New York, San Francisco, LA and major metros throughout Florida utilize Everbridge to mitigate the compounding threat from overlapping crises: COVID-19 pandemic, wildfires and hurricanes

Serving Eight of the Ten Largest U.S. Cities, and Over 3,700 Municipalities and Counties Across the Country, Everbridge Enables Local Governments to Execute Best Practices to Keep Citizens Safe and Informed Amid Critical Events

BURLINGTON, Mass.–(BUSINESS WIRE)–Everbridge, Inc. (NASDAQ: EVBG), the global leader in critical event management (CEM), today announced a number of major U.S. cities relying on the company’s platform to coordinate emergency response and safeguard the public from the combined threats posed by COVID-19, as well as wildfires in the western part of the country and hurricanes along the Atlantic, Pacific and Gulf Coasts.


State and local governments need to be proactive in their response and recovery to events impacting the public that range from severe weather, active shooter, and hazmat situations to occurrences such as heat advisories, rolling blackouts, large-scale gatherings, protests and construction projects. These events require information to be shared with residents, visitors and emergency personnel, over any device, providing the confidence that critical information like evacuation routes, lockdowns, or road closures reach recipients immediately.

“A critical part of any emergency response is the ability to disseminate accurate information in a timely manner. Our dedication to public messaging is at the forefront of our mission to connect with every individual we serve, providing them life-saving information before, during, and after an emergency,” said NYC Emergency Management Commissioner Deanne Criswell.

“Our partnership with Everbridge allows us to communicate effectively with New Yorkers during difficult times. This held true during COVID-19, where our Notify NYC team developed a text alert short code in both English and Spanish to provide individuals with a streamlined method of receiving critical information about the pandemic. This crucial messaging continued through heat emergencies and Tropical Storm Isaias. We are grateful for the opportunity to work with Everbridge’s first-class team and remain committed to providing New Yorkers with the essential information they need no matter the challenge or emergency.”

In Hoboken, New Jersey, Isaias’s heavy winds downed trees and power lines, leaving more than one million people statewide without power. “Preparing for the summer hurricane season is challenging under normal conditions, but during a pandemic, it calls for unique measures,” said Ravi Bhalla, Mayor of Hoboken. “Throughout the COVID-19 outbreak, we have reminded our residents of our commitment to sharing potentially life-saving information.”

Continued Mayor Bhalla, “With an unusually active hurricane season ahead of us, we’ve renewed that commitment. Our number one priority is keeping our people safe by providing them access to real-time public information when they need it most. Our partnership with Everbridge allows Hoboken to disseminate this information quickly and accurately, ensuring residents have access to vital data, whether it be about the ongoing coronavirus pandemic, impending storms, or other threats to the city.”

Cities, counties and municipalities across the U.S. leverage the Everbridge Platform to execute the following six best practices for effectively communicating with citizens during a crisis:

  1. Deploy a population-wide opt-in means for the public to receive critical updates and information via their mobile device – provide communities with a quick and easy-to-implement, opt-in solution for citizens to text a keyword or zip-code to an established SMS short-code.
  2. Contribute to a risk data sharing network that connects the public sector with the private sector – enable government agencies, hospitals, universities, airports, and local businesses to share life-saving information to respond quicker to emergency situations.
  3. Leverage pre-established communications templates – empower government agencies to send more complex emergency notifications quickly and at scale to over 100 different modalities.
  4. Execute special/functional needs registries – identify at-risk citizens during an emergency to ensure high-priority individuals (i.e. nursing homes, hospitals) receive specialized care.
  5. Create incident zones by geographic location – trigger mobile emergency alerts from government authorities when an individual travels into, or returns back to, an area designated as an active critical event.
  6. Maximize outreach with robust database of contacts – to complement opt-in databases, emergency officials turn to the Everbridge Resident Connection database – a robust database of landline, voice over Internet protocol (VoIP) and cellular business and residential contacts to reach the greater population with more confidence.

As the coronavirus pandemic continues to impact how municipalities navigate the public’s return to work, return to school, and return to public spaces, many cities now face the impact of an extremely active hurricane and wildfire season.

Current wildfires in areas grappling with the COVID-19 virus present unprecedented threats for firefighters, emergency managers and the public, particularly when it comes to evacuations. Cities such as Los Angeles and San Francisco, and counties including Sonoma and Lake, turn to the Everbridge Platform to warn residents of fire dangers and poor air quality. In Napa County, where the Hennessy Fire continues to threaten residents, the Office of Emergency Services relies on Everbridge to alert at-risk residents to evacuate their homes and take shelter, all while adhering to social distancing guidelines.

“As we head into wildfire season, we are focused on prepping the public to create an emergency plan and listen to authorities,” explained Soraya Sutherlin, Joint Information Center Manager for Alert SouthBay, an Everbridge customer and regional communications system shared by 13 California cities including Inglewood, El Segundo, Hermosa Beach, Redondo Beach, and Torrance. “People are reluctant to leave their homes to go to a shelter because of COVID-19 concerns, which are likely to increase. We encourage residents to find a trusted source for information; plan where they will go if they are afraid of staying in a shelter; and identify at least two ways to get out of their neighborhood and leave when they feel unsafe. Finally, ensure masks are part of any emergency kit, including hand sanitizers, wipes, and first aid supplies.”

As hurricane season continues, dozens of cities from Florida to Massachusetts rely on Everbridge to keep citizens informed and their employees updated on internal preparations, response, and recovery activities. Among the cities deploying Everbridge are Jacksonville FL; Charleston and Myrtle Beach, SC; Charlotte, NC; Norfolk, VA; Washington, DC; Philadelphia, PA; Hoboken, NJ; and New York City, NY.

“Emergency Management and Public Health officials are working tirelessly around the clock since this pandemic broke out,” said Brian Toolan, Head of Government Strategy at Everbridge. “Everbridge salutes our first responder community and supports their daily mission with a global platform for cities to protect residents and mitigate the impact of multiple crises through the most comprehensive and scalable notification system, reaching diverse populations in multiple languages.”

To bolster Florida’s ongoing hurricane preparedness efforts, the Florida Division of Emergency Management (FDEM) uses Everbridge to power AlertFlorida, distributing critical information to residents, businesses and visitors across the state. Video interviews with six Florida counties, as well as the city of Miami, document best practices for ensuring hurricane readiness, the benefits of mutual aid assistance across counties, coordinating safe evacuations for all residents, as well as the many use cases for a scalable mass notification platform.

Everbridge supports population-wide alerting in 11 countries across Europe, Asia, Oceania, The Middle East, Africa, and South America including Australia, Greece, Iceland, the Netherlands, New Zealand, Norway, Peru, Singapore and Sweden. Everbridge’s population alerting capabilities also power the entire states of California, Massachusetts, Vermont, New York, Connecticut, and Florida, as well as municipalities, counties and cities within 49 of the 50 United States, within all of Canada’s provinces, and throughout Europe and Asia, including deployments within multiple populous states in India.

About Everbridge

Everbridge, Inc. (NASDAQ: EVBG) is a global software company that provides enterprise software applications that automate and accelerate organizations’ operational response to critical events in order to Keep People Safe and Businesses Running™. During public safety threats such as active shooter situations, terrorist attacks or severe weather conditions, as well as critical business events including IT outages, cyber-attacks or other incidents such as product recalls or supply-chain interruptions, over 5,300 global customers rely on the company’s Critical Event Management Platform to quickly and reliably aggregate and assess threat data, locate people at risk and responders able to assist, automate the execution of pre-defined communications processes through the secure delivery to over 100 different communication devices, and track progress on executing response plans. The company’s platform sent over 3.5 billion messages in 2019 and offers the ability to reach over 550 million people in more than 200 countries and territories, including the entire mobile populations on a country-wide scale in Australia, Greece, Iceland, the Netherlands, New Zealand, Peru, Singapore, Sweden, and a number of the largest states in India. The company’s critical communications and enterprise safety applications include Mass Notification, Incident Management, Safety Connection™, IT Alerting, Visual Command Center®, Public Warning, Crisis Management, Community Engagement™ and Secure Messaging. Everbridge serves 8 of the 10 largest U.S. cities, 9 of the 10 largest U.S.-based investment banks, 47 of the 50 busiest North American airports, 9 of the 10 largest global consulting firms, 8 of the 10 largest global auto makers, all 4 of the largest global accounting firms, 9 of the 10 largest U.S.-based health care providers, and 7 of the 10 largest technology companies in the world. Everbridge is based in Boston and Los Angeles with additional offices in Lansing, San Francisco, Abu Dhabi, Beijing, Bangalore, Kolkata, London, Munich, New York, Oslo, Singapore, Stockholm and Tilburg. For more information, visit www.everbridge.com, read the company blog, and follow on LinkedIn, Twitter, and Facebook.

Cautionary Language Concerning Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements regarding the anticipated opportunity and trends for growth in our critical communications and enterprise safety applications and our overall business, our market opportunity, our expectations regarding sales of our products, our goal to maintain market leadership and extend the markets in which we compete for customers, and anticipated impact on financial results. These forward-looking statements are made as of the date of this press release and were based on current expectations, estimates, forecasts and projections as well as the beliefs and assumptions of management. Words such as “expect,” “anticipate,” “should,” “believe,” “target,” “project,” “goals,” “estimate,” “potential,” “predict,” “may,” “will,” “could,” “intend,” variations of these terms or the negative of these terms and similar expressions are intended to identify these forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond our control. Our actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: the ability of our products and services to perform as intended and meet our customers’ expectations; our ability to successfully integrate businesses and assets that we may acquire; our ability to attract new customers and retain and increase sales to existing customers; our ability to increase sales of our Mass Notification application and/or ability to increase sales of our other applications; developments in the market for targeted and contextually relevant critical communications or the associated regulatory environment; our estimates of market opportunity and forecasts of market growth may prove to be inaccurate; we have not been profitable on a consistent basis historically and may not achieve or maintain profitability in the future; the lengthy and unpredictable sales cycles for new customers; nature of our business exposes us to inherent liability risks; our ability to attract, integrate and retain qualified personnel; our ability to maintain successful relationships with our channel partners and technology partners; our ability to manage our growth effectively; our ability to respond to competitive pressures; potential liability related to privacy and security of personally identifiable information; our ability to protect our intellectual property rights, and the other risks detailed in our risk factors discussed in filings with the U.S. Securities and Exchange Commission (“SEC”), including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on February 28, 2020. The forward-looking statements included in this press release represent our views as of the date of this press release. We undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

All Everbridge products are trademarks of Everbridge, Inc. in the USA and other countries. All other product or company names mentioned are the property of their respective owners.

Contacts

Everbridge:
Jim Gatta

Media Relations

jim.gatta@everbridge.com
215-290-3799

Joshua Young

Investor Relations

joshua.young@everbridge.com
781-236-3695

Categories
Healthcare

Merck’s KEYTRUDA® (pembrolizumab) receives two new approvals in Japan

KEYTRUDA Now Approved for Patients With PD-L1-Positive Esophageal Squamous Cell Carcinoma Who Have Progressed After Chemotherapy and for a Six-Week Dosing Schedule Across All Adult Indications

Six-Week Dosing Schedule for KEYTRUDA Now Approved in Japan, US and Europe

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA). KEYTRUDA monotherapy is now approved for the treatment of patients whose tumors are PD-L1-positive, and have radically unresectable, advanced or recurrent esophageal squamous cell carcinoma (ESCC) who have progressed after chemotherapy. Additionally, KEYTRUDA was approved for use at an additional recommended dosage of 400 mg every six weeks (Q6W) administered as an intravenous infusion over 30 minutes across all adult indications, including KEYTRUDA monotherapy and combination therapy. This new dosage option will be available in addition to the current dose of 200 mg every three weeks (Q3W). With these approvals, KEYTRUDA has 13 indications across seven tumor types plus MSI-H tumors in Japan.

“We remain committed to improving outcomes for as many patients with cancer as possible, including those with esophageal squamous cell carcinoma, which is a leading cause of cancer-related death in Japan,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “With today’s approvals, specific patients with esophageal cancer can receive a much-needed new treatment option, and adult patients receiving KEYTRUDA will now have the option of a dosing schedule that reduces how often they are at the clinic for treatment.”

The approval for KEYTRUDA for the treatment of certain patients with ESCC is based on results from the global Phase 3 KEYNOTE-181 trial, in which an improvement in overall survival (OS) was observed for KEYTRUDA monotherapy compared with chemotherapy (paclitaxel, docetaxel or irinotecan) in patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10) (HR=0.64 [95% CI, 0.46-0.90]). The median OS was 10.3 months (95% CI, 7.0-13.5) for KEYTRUDA compared with 6.7 months (95% CI, 4.8-8.6) for chemotherapy.

The approval of KEYTRUDA for a Q6W dosing regimen is based on pharmacokinetic modeling and exposure-response analyses. The pharmacokinetic modeling data was supported by an interim analysis of pharmacokinetic, efficacy and safety data from KEYNOTE-555 from a cohort of patients (Cohort B) treated with KEYTRUDA 400 mg Q6W.

“In Japan, more than 90% of esophageal cancers are squamous cell carcinomas. Patients with advanced disease face a poor prognosis and are in critical need of new treatment options,” said Jannie Oosthuizen, president, MSD Japan. “These approvals reinforce our commitment to innovative research that will continue to help more patients with cancer in Japan.”

About Esophageal Cancer in Japan

Esophageal cancer, a type of cancer that is particularly difficult to treat, begins in the inner layer (mucosa) of the esophagus and grows outward. There are two main types of esophageal cancer: squamous cell carcinoma and adenocarcinoma. In Japan, more than 90% of all esophageal cancers are squamous cell carcinomas. Globally, esophageal cancer is the seventh most commonly diagnosed cancer, and it is estimated there were more than 572,000 new esophageal cancer cases and nearly 509,000 deaths resulting from the disease in 2018.

About KEYTRUDA® (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) ≥10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

  • solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
  • colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Adult Indications: Additional Dosing Regimen of 400 mg Every 6 Weeks

KEYTRUDA is indicated for use at an additional recommended dosage of 400 mg every 6 weeks for all approved adult indications. This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety. Continued approval for this dosing may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor–blocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality.

Contacts

Media:

Pamela Eisele

(267) 305-3558

Ayn Wisler

(908) 740-5590

Investors:

Peter Dannenbaum

(908) 740-1037

Courtney Ronaldo

(908) 740-6132

Read full story here

Categories
Business

AM Best affirms credit ratings of American Federated Insurance Company and American Federated Life Insurance Company

OLDWICK, N.J.–(BUSINESS WIRE)–AM Best has affirmed the Financial Strength Rating of B (Fair) and the Long-Term Issuer Credit Ratings of “bb” of American Federated Insurance Company (AFIC) and American Federated Life Insurance Company (AFLIC). The outlook of these Credit Ratings (ratings) is stable. Both companies are known collectively as American Federated Insurance Companies and are domiciled in Flowood, MS.

The ratings of AFIC reflect its balance sheet strength, which AM Best categorizes as very strong, as well as its strong operating performance, limited business profile and marginal enterprise risk management (ERM). The ratings also reflect drag from the parent holding company, First Tower Finance Company LLC (First Tower Finance).

The ratings of AFLIC reflect its balance sheet strength, which AM Best categorizes as very strong, as well as its adequate operating performance, limited business profile and marginal ERM. The ratings also reflect drag from the parent holding company, First Tower Finance.

The American Federated Insurance Companies are indirect, wholly owned subsidiaries of First Tower Finance, a multiline specialty finance company. Prospect Capital Corporation [NASDAQ: PSEC], a publicly traded closed-end investment company, indirectly owns an 80.1% majority interest in First Tower Finance and its subsidiaries.

AFIC provides credit insurance coverage on collateralized personal loans originated by the consumer finance subsidiaries of First Tower Finance, and involuntary unemployment insurance.

AFLIC provides credit life and credit accident and health insurance coverages for individuals that have personal loans originated by the consumer finance subsidiaries of First Tower Finance. Given the products offered by the two companies, AM Best will continue to monitor the potential effects of COVID-19 and the macroeconomic environment on the business profiles and operations of AFIC and AFLIC.

The drag to the ratings of AFIC and AFLIC reflects the considerable financial leverage with a deficit in members’ equity at First Tower Finance, stemming from a 2014 transaction involving the return of First Tower Finance’s capital to its members.

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper media use of Best’s Credit Ratings and AM Best press releases, please view Guide for Media – Proper Use of Best’s Credit Ratings and AM Best Rating Action Press Releases.

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in New York, London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2020 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Jeffrey Stary

Financial Analyst
+1 908 439 2200, ext. 5689
jeffrey.stary@ambest.com

Raymond Thompson, CPCU, ARe, ARM
Director
+1 908 439 2200, ext. 5621
raymond.thompson@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Jim Peavy
Director, Public Relations
+1 908 439 2200, ext. 5644
james.peavy@ambest.com

Categories
Business

AM Best: Pandemic, economic issues dampen Chile insurance market (AM BestTV)

OLDWICK, N.J.–(BUSINESS WIRE)–In this episode of AMBestTV, Eli Sanchez, associate director, AM Best, said the rating agency’s negative market segment outlook on Chile’s insurance sector is based on declines in insurance activity, tied to the pandemic and longer-running economic issues. Click on http://www.ambest.com/v.asp?v=chileoutlook_english720 to view the entire program.

Sanchez addressed to what extent COVID-19 is affecting insurers in Chile.

“As of March 2020, there has been a 10% contraction in the overall insurance industry,” said Sanchez. “There was a contraction of around 1.8% last year. AM Best has seen declines, especially in the life side, related to annuities, some accident and health, as well as the property/casualty segment. Additionally, there has been lower economic activity. As of May, the monthly economic indicator contracted by approximately 15%. That puts a lot of pressure on underlying industries that use insurance as a way of protecting its relative assets.”

Chile is having economic problems that the pandemic has exacerbated. Sanchez spoke about how COVID-19 has affected insurers’ ability to grow.

“With lower global economic activity, there have been tensions, specifically commercial tensions between China and the United States. These countries are important partners for Chile. These tensions have created a lot of flight to quality, which have threaten the Chilean peso. In addition, with the tensions in trade, copper prices have come down. That limits a lot of the growth that could happen in the country, which in turn affects a lot that could happen in the demand for insurance.”

To view this video in Spanish, please go to http://www.ambest.com/v.asp?v=chileoutlook_spanish720.

To access the related market segment report, titled, “Market Segment Outlook: Chile Insurance,” please visit http://www3.ambest.com/bestweek/purchase.asp?record_code=532765.

Recent AMBestTV coverage includes:

  • AM Best: Cyber Insurance Profitability Challenged by New Risks: AM Best analysts say standalone cyber insurance premiums are growing as companies reduce silent cyber risk: http://www.ambest.com/v.asp?v=ambcyber720.
  • BDO Director: Companies Should Review Hurricane Response Plans: The COVID-19 pandemic adds a layer of complexity to hurricane response plans, said James MacDonnell, director of crisis management/ business continuity at BDO, an advisory firm: http://www.ambest.com/v.asp?v=macdonnell820.
  • ITC Conference Expands to Month Long ‘Celebration of Insurtech Innovation’: InsureTech Connect is launching ‘ITC September to Remember’ leading up to its flagship global conference, said Mee-Jung Jang, president, InsureTech Connect: http://www.ambest.com/v.asp?v=itc820.
  • Allianz: Docked Cruise Ships in Hurricane-Prone Areas Are ‘Hot Spots’ to Watch: Cruise ships grounded due to the pandemic are among risks requiring “constant vigilance,” said Andrew Kinsey, senior marine risk consultant, Allianz Global Corporate & Specialty: http://www.ambest.com/v.asp?v=covidshipping820.

AM BestTV covers exclusive AM Best and insurance industry information and reports, targeted topics and key developments in the insurance, reinsurance and related sectors daily. Sign up for alerts of episodes at www.ambest.com/multimedia/ambtvsignup.html. View AM BestTV episodes at www.ambest.tv.

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in New York, London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2020 by A.M. Best Company, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Lee McDonald
Group Vice President, Publication and News Services
+1 908 439 2200, ext. 5561
lee.mcdonald@ambest.com

Categories
Sports & Gaming

FanDuel expands fantasy sports offerings with the addition of Best Ball and Daily Snake Drafts

NEW YORK–(BUSINESS WIRE)–#FanDuelBestBall–Today, FanDuel announced the expansion of its industry-leading fantasy sports products with the launch of Best Ball and Daily Snake Drafts ahead of the football season.


Best Ball contests are the simplest way to play fantasy football, bringing the popular season-long fantasy game on to FanDuel’s fantasy platform. The Pro Football Best Ball slates are small, single-entry contests with a shared player pool. Users draft a 20 player fantasy team before or during the football season, then keep that team for the remainder of the season. Unlike other FanDuel contests, there is no salary cap and one player per team. There are also no trades or waiver claims like other season long fantasy football products. Every week, FanDuel automatically combines the scores of your best players at each position (9 players in total) to generate your score for that week. There are only 2-12 users in each contest, and the user with the highest cumulative score at the end of the season wins. As of today, Best Ball contests are available on FanDuel.com or via the FanDuel DFS app, and you can choose from a variety of contest sizes and entry fees starting at $1.

“Best Ball games are perfect for sports fans looking to play fantasy for the first time, or who love the season-long fantasy format,” said John Griffin, General Manager Fantasy, FanDuel Group. “These contests are a hybrid of season-long and daily fantasy, and users can draft a team once and never have to set their lineups again or watch waiver wires, which is incredibly appealing to fans of all levels.”

To celebrate the launch of Best Ball, FanDuel will debut a new commercial featuring former NFL Head Football Coach, Jeff Fisher. The new spot from BBH NY, highlights the fact that FanDuel’s new fantasy sports addition is simple and easy to play. In the hilarious spot, Coach Fisher helps a fan with his Best Ball picks, while multitasking in the kitchen. Only 15 wins shy of being in the top-10 winningest coaches of all time, Coach Fisher is not only a world class talent evaluator, he also cooks a mean paella.

FanDuel will also offer daily Snake Draft contests for select NBA, NHL, golf and MLB games. Snake Draft contests for the football season will be available in early September. Daily Snake Drafts are single-entry, easy-to-enter, small contests with a shared player pool, letting you draft a team for each game day or week. Unlike other FanDuel contests, there’s no salary cap. In addition, the player pool is shared so players can only be drafted by one user. Everyone in the contest picks players one after another in real-time, with 30 seconds to pick, until your rosters for that week are full.

About FanDuel Group

FanDuel Group is an innovative sports-tech entertainment company that is changing the way consumers engage with their favorite sports, teams, and leagues. The premier gaming destination in the United States, FanDuel Group consists of a portfolio of leading brands across gaming, sports betting, daily fantasy sports, advance-deposit wagering, and TV/media, including FanDuel, Betfair US, and TVG. FanDuel Group has a presence across 45 states and 8.5 million customers. The company is based in New York with offices in California, New Jersey, Florida, Oregon, and Scotland. FanDuel Group is a subsidiary of Flutter Entertainment plc, a leading international sports betting and gaming operator and a constituent of the FTSE 100 index of the London Stock Exchange.

Contacts

FanDuel

Emily Bass

press@fanduel.com

Categories
Art & Life

Local owner partners with Life Hospitality to transform the BeachWalk at Sea Bright into a locally-rooted boutique hotel

The BeachWalk at Sea Bright – nestled between the Navesink River and the Atlantic Ocean in Sea Bright, NJ – will be rebranded to a one-of-a-kind independent hotel in partnership with Life Hospitality, marking the tech-enabled operator’s entrance to the New Jersey hotel market.

NEW YORK–(BUSINESS WIRE)–#hotelindustry—Life Hospitality, the tech-enabled hotel brand and management arm of Life House focused exclusively on independent hotels, announces the addition of 76-key BeachWalk Hotel to its growing portfolio. The property, owned by Sunil Nayak of Innzen Hospitality, is nearing completion of a comprehensive renovation to reposition the asset into a locally-rooted boutique hotel – the first of its kind in the beachside town of Sea Bright, NJ.

Located less than an hour away from Manhattan and tucked between the Atlantic Ocean and the Navesink River, the BeachWalk at Sea Bright is located in the heart of the picturesque three-mile coastal town in Monmouth County, NJ. Innzen Hospitality is nearing completion of an expansion of the existing 37-key property into a boutique hotel that will feature a grand total of 76-keys under a to-be-announced brand upon completion this fall. The new guest rooms will feature panoramic views of the Atlantic Ocean along with access to the property’s private beach, swimming pool, and the hotel’s popular waterfront Tiki Bar, in addition to the property’s 40 dock slips and 80 parking spots.

“After studying the landscape for management of independent hotels in seasonal resort environments, I was impressed by Life Hospitality and their impressive case studies in markets that feature similar seasonal demand patterns as Sea Bright,” said Sunil Nayak. “We look forward to starting a fruitful partnership with Life Hospitality, which we hope to expand to new properties in New Jersey as opportunities arise to acquire similar independent hotels throughout the region”.

Life House was founded by luxury boutique hotel veterans in 2017 and is backed by leading travel and technology investors, such as Thayer Ventures, Tiger Global, JLL Spark, and Ashton Kutcher & Guy Oseary’s Sound Ventures, among others. Life House has rebuilt the complex hotel technology stack from the ground up to create a completely new operational model that allows for a robust, lean operation to hotel owners and a great hospitality service to travelers. Life Hospitality, launched in response to the need for tech-enabled management services from the independent hotel ownership community, leverages a proprietary technology stack that enables its teams to efficiently drive incremental revenue and risk-free cost savings to the bottom line, supporting owners in a tepid demand environment post Covid-19.

“We are excited to support Sunil and the partners with positioning this asset to optimize revenues and achieve outsized bottom line performance as a result of our lean & technology-enabled management platform,” said John Basting, VP Acquisitions at Life House. “Considering the market’s proximity to Manhattan and the greater New York City Metropolitan population, we feel strongly that long-term supply/demand dynamics in the region are favorable and are actively seeking additional projects to collaborate on together across the Jersey Shore”.

About Life Hospitality

Life Hospitality is a New York-based, venture-backed & vertically-integrated hotel management company. The company has built a proprietary technology stack to power a platform that makes hotels more seamless and more profitable for hotel owners and travel more meaningful and more accessible for travelers. In 2018, the company launched its first brand, Life House, which features contextual hotels with narrative, substance, and locally-rooted restaurants and bars.

About Innzen Hospitality

Innzen Hospitality, LLC, headquartered in Monmouth Junction, NJ, has been active in hotel acquisitions and development of franchised and boutique hotels for over 25 years.

Contacts

Bryan Dunn

Head of Growth

Bryan@lifehousehotels.com

Categories
Business

Cross River announces completion of $106 million subordinated debt offering

Additional Proceeds From Private Placement Transaction Will Provide The Company With Opportunistic Capital

FORT LEE, N.J.–(BUSINESS WIRE)–CRB Group, Inc., the parent company of Cross River Bank, today announced the closing of its $106 million private placement of subordinated notes (the “Notes”).

“We are pleased to announce the successful completion of our subordinated debt offering, which will provide us with opportunistic capital to continue our strategic growth plans and to fuel our commitment to our employees, partners, businesses and consumers,” said Gilles Gade, Founder, President and CEO of Cross River. “This offering was oversubscribed, and we appreciate the strong support and positive response of the investment community.”

The Notes have a maturity date of September 1, 2030 and carry a fixed rate of interest of 6.50% for the first five years. Thereafter, the Notes will pay interest at 3-month SOFR plus 638 basis points, payable quarterly in arrears. The Notes include a right of prepayment without penalty on or after September 1, 2025. The subordinated notes have been structured to qualify as Tier 2 capital for regulatory purposes. Kroll Bond Rating Agency assigned an investment rating of BBB- to the Notes.

The net proceeds from the offering will be used for general corporate purposes, including to support the growth of the company. Cross River’s current offerings include marketplace lending, payments and strategic financing, as well as small business and commercial real estate lending.

Piper Sandler & Co. served as the lead-placement agent and Keefe, Bruyette & Woods and Jefferies LLC. acted as co-placement agents for the private offering. The Company was advised by Hunton Andrews Kurth LLP and the placement agents were advised by Holland & Knight LLP.

About Cross River

Cross River Bank is a fast-growing financial services organization that merges the established expertise and traditional services of a bank with the forward-thinking offerings of a technology company. Cross River combines a comprehensive suite of products into a unique banking-as-a-platform solution, encompassing lending, payments and risk management. Cross River partners with leading marketplace lenders and technology companies enabling them to focus on their own growth without hindering innovation, while maintaining a strong focus on compliance. In December 2018, Cross River secured $100 million in a funding round led by KKR. This was on top of the $28 million VC funding round in 2016 from Battery Ventures, Andreessen Horowitz, and Ribbit Capital. Founded in 2008, Cross River is a New Jersey state-chartered FDIC insured bank. For more information, please visit Cross River’s website at www.crossriver.com or on Twitter @crossriverbank.

Contacts

Cross River

Eden Hoffman

201 808 7000 x538

ehoffman@crossriver.com

Categories
Business

AM Best downgrades credit ratings of Armed Forces Insurance Exchange

OLDWICK, N.J.–(BUSINESS WIRE)–AM Best has downgraded the Financial Strength Rating to B+ (Good) from B++ (Good) and the Long-Term Issuer Credit Rating to “bbb-” from “bbb” of Armed Forces Insurance Exchange (AFIE) (Leavenworth, KS). The outlooks of these Credit Ratings (ratings) has been revised to stable from negative.

The ratings reflect AFIE’s balance sheet strength, which AM Best categorizes as strong, as well as its marginal operating performance, limited business profile and marginal enterprise risk management (ERM).

AFIE historically had an appropriate ERM program, but AM Best has called the effectiveness of this program into question due to significant volatility in operating results and declining surplus. The further surplus deterioration into 2019 and 2020 as a result of negative operating results supports AM Best’s assessment of AFIE’s ERM as marginal.

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper media use of Best’s Credit Ratings and AM Best press releases, please view Guide for Media – Proper Use of Best’s Credit Ratings and AM Best Rating Action Press Releases.

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in New York, London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2020 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

David Braisted
Financial Analyst
+1 908 439 2200, ext. 5120
david.braisted@ambest.com

Christopher Sharkey

Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Joseph Burtone
Director
+1 908 439 2200, ext. 5125
joseph.burtone@ambest.com

Jim Peavy

Director, Public Relations

+1 908 439 2200, ext. 5644

james.peavy@ambest.com