Category: Regulations & Security

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AM Best affirms Credit Ratings of Symetra Financial Corporation and its subsidiaries

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has affirmed the Financial Strength Rating of A (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICR) of “a+” (Excellent) of Symetra Life Insurance Company and its subsidiary, First Symetra National Life Insurance Company of New York (New York, NY), together referred to as Symetra Life Group. Concurrently, AM Best has affirmed the Long-Term ICR of “bbb+” (Good) and the Long-Term Issue Credit Rating of “bbb+” (Good) on $250 million 4.25% senior unsecured notes, due 2024 of Symetra Financial Corporation (Symetra). The outlook of these Credit Ratings (ratings) is stable. All companies are headquartered in Bellevue, WA, unless otherwise specified.

 

The ratings reflect Symetra Life Group’s balance sheet strength, which AM Best assesses as very strong, as well as its adequate operating performance, favorable business profile and appropriate enterprise risk management (ERM).

 

AM Best views Symetra Life Group’s balance sheet as strong, as measured by quantitative Best’s Capital Adequacy Ratio (BCAR), and qualitative measures with financial support afforded by the ultimate parent, Sumitomo Life Insurance Company, which supports the group’s strategic initiatives. Through past debt capital investments, the parent has enabled the group to execute on key new product development projects and enhanced distribution efforts and current conditions. In 2023, Symetra Life Group paid $207 million in dividends to Symetra to provide capital for new annuities business that the life company ceded to Symetra Bermuda Re, a subsidiary of Symetra. Future dividends are expected to be dependent on operating results.

 

An early trend of profitability has returned to the group, which is expected to help contribute organically to future business growth efforts. AM Best views the group’s ERM as being matched to the scope of its operation, while adjusting through changing and challenging market conditions. Continued organic capital growth through profitable operations has been factored into the current ratings, which is expected to continue.

 

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 use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

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 London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2024 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Anthony McSwieney
Senior Financial Analyst
+1 908 882 2113

anthony.mcswieney@ambest.com

Jacqalene Lentz
Director
+1 908 882 2011
jacqalene.lentz@ambest.com

Christopher Sharkey
Associate Director, Public Relations
+1 908 882 2310
christopher.sharkey@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 882 2318
al.slavin@ambest.com

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Business Culture Economics Lifestyle Perspectives Regulations & Security

AM Best downgrades Credit Ratings of Farm Bureau County Mutual Insurance Company of Texas and Texas Farm Bureau Casualty Insurance Company; removes affiliates from under review

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has downgraded the Financial Strength Rating (FSR) to A- (Excellent) from A (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICR) to “a-” (Excellent) from “a” (Excellent) of Farm Bureau County Mutual Insurance Company of Texas and Texas Farm Bureau Casualty Insurance Company (together known as Texas Farm Bureau Casualty Group).

 

The outlook of these Credit Ratings (ratings) is negative. At the same time, AM Best has removed from under review with negative implications and affirmed the FSR of A- (Excellent) and the Long-Term ICRs of “a-” (Excellent) of Texas Farm Bureau Mutual Insurance Company and Texas Farm Bureau Underwriters (together known as Texas Farm Bureau Mutual Group). The outlook assigned to these ratings is negative. All companies are domiciled in Waco, TX, and are collectively referred to as Texas Farm Bureau Insurance Group (the group).

The ratings reflect Texas Farm Bureau Insurance Group’s balance sheet strength, which AM Best assesses as very strong, as well as its marginal operating performance, neutral business profile and appropriate enterprise risk management.

 

Following a year of material surplus deterioration, the group implemented a pooling agreement between its property affiliates (Texas Farm Bureau Mutual Insurance Company) and the casualty operations (Texas Farm Bureau Casualty Insurance Company), consisting primarily of personal auto, effective Jan. 1, 2024, which will allow the group to manage capital more effectively. Under the pooling agreement, premiums, losses and expenses are combined and pro-rated, with participation percentages based on the individual members’ policyholder surplus.

 

The group’s balance sheet strength assessment of very strong reflects of its very strong overall risk-adjusted capitalization, as measured by Best’s Capital Adequacy Ratio (BCAR), as well as moderate levels of leverage, adequate liquidity, favorable calendar-year reserve development and a comprehensive reinsurance program.

 

The group’s marginal operating performance assessment reflects the most-recent three consecutive years of operating losses and a high degree of volatility. As a result, most of the key profitability metrics fall short of the private passenger standard auto and homeowner composite. Like most of its peers, net underwriting losses were driven by the extraordinary weather-related events in 2023. These weather-related events resulted in 13 catastrophe losses, as classified by the group, four of which exceeded its occurrence catastrophe retention level. Further driving elevated losses is the impact of increased loss cost trends across the group’s core lines of business.

 

Texas Farm Bureau Insurance Group’s business profile is neutral, supported by the group’s market penetration as a leading personal lines writer in Texas, along with their broad product offering. In addition, the assessment takes into account the group’s relationship with the Texas Farm Bureau, which enhances customer loyalty and affinity.

 

In response to these adverse trends, management has put in place a series of initiatives to return to profitability and improve balance sheet strength metrics, including significant rate increases, increased segmentation on the auto line of business and more-refined underwriting guidelines. However, the negative outlooks reflect the uncertainty and execution risks associated with these efforts. Should key balance sheet or operating performance metrics not stabilize as a result of these actions, the ratings may be downgraded.

 

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 use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

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 London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2024 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Brinda Modi Shah
Senior Financial Analyst
+1 908 882 1767
brinda.shah@ambest.com

Christopher Sharkey
Associate Director, Public Relations
+1 908 882 2310
christopher.sharkey@ambest.com

Richard Attanasio
Senior Director
+1 908 882 1638
richard.attanasio@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 882 2318
al.slavin@ambest.com

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How TikTok has influenced US culture: shaped Hollywood, privacy, shopping, news, music, mental health, national security, and more

— TikTok has changed America

 

New York Times:

 

 

—  Has there ever been an app more American seeming than TikTok, with its messy democratic creativity, exhibitionism, utter lack of limits and vast variety of hustlers?

 

And yet, of course, TikTok is not American, which is the whole reason that in March, the House of Representatives passed a bill with broad bipartisan support that would force the Chinese owners of the video-app juggernaut to either sell to a non-Chinese owner or face a ban. Lawmakers say it’s a national security threat, and that the Chinese government could lean on its owner, ByteDance, to obtain sensitive U.S. user data or influence content on the app to serve its interests.

 

There’s a long road of legislation, deal making and legal challenges ahead before TikTok could be forced to change ownership or even be banned. The Senate would need to pass the legislation — which it may do as soon, now that the House has bundled it into a foreign aid package. It would have to survive lawsuits from TikTok and creators. Buyers would have to clear regulatory approval. And after all that, Beijing could simply block a deal.

 

But imagining what a United States without TikTok would look like throws into sharp relief just how much the app has worked its way into American culture.

 

TikTok, which officially landed in the United States in 2018, was the most downloaded app in the country, and the world, in 2020, 2021 and 2022. It wasn’t that the elements of it were so new — compelling videos from randos had long been a staple of American pop culture — but TikTok put the pieces together in a new way.

 

Unlike Instagram, Facebook or Snapchat, TikTok didn’t build itself around social connections. Its goal is pure, uncut entertainment. The algorithm ingested every data point it could from what users skipped, liked or shared — and spat it directly into the maddeningly habit-forming For You Page. Fans whispered reverently that it knew them better than they knew themselves.

 

Here are 19 ways of understanding how TikTok became part of American life. The music America listens to, the movies it sees, what conspiracies it believes, how it can make or break a product’s success, who it defines as a celebrity — all of it has been influenced by TikTok, for good and bad. Even if you’ve never opened the app, you’ve lived in a culture that exists downstream of what happens there.

 

Read More

 

 

— Techmeme

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Parents who need to reach their kids at all times, have become unexpected, forceful opponents of schools’ attempts to ban phones

—  Students’ phone use is disruptive, but teachers and administrators seeking a fix face an unlikely opponent

 

Julie Jargon / Wall Street Journal:

 

 

—  A rural school district in Colorado tried to ban smartphones. Parents stood in the way.

 

Phones were at the center of more than half the schools’ disciplinary issues by 2022—not just kids watching TikTok and YouTube in class, but cyberbullying, spying in bathrooms and recording fights.

Teachers and administrators say gadget bans are the only way to regain student focus and tamp down on misbehavior. Parents complain that they need to be able to reach their kids at all times, both for emergencies and routine scheduling issues. Parents are turning out to be unexpected but forceful opponents of schools’ attempts to keep kids off their smartphones.

 

In Brush, Colo., teachers and administrators settled on a compromise for the 2022-23 school year. Students could keep their phones, provided they were out of sight. To reach their parents, they needed a teacher’s permission and had to use the phone in the office. If a student was busted, the phone was confiscated and a parent needed to pick it up.

The policy, which is still in effect, was too much for some parents, says Brush School District superintendent Bill Wilson. Several parents transferred their students.

Administrators say they are trying to do what’s best for students. Experts often blame smartphones for fueling the youth mental-health crisis, through social media and its most angst-amplifying features. Teachers say they spend too much time policing phone use. And even school systems that are so far reluctant to ban phones know the fights are just beginning.

‘A disconnect with parents’

About a quarter of notifications hitting teens’ phones daily come during school hours, according to a recent Common Sense Media report. Teens use smartphones for a median of 43 minutes during the school day, said the report, the primary time-suck being social-media and messaging apps.

 

Parents are often the ones texting their kids, teachers say.

“There seems to be a disconnect with parents,” says Liz Shulman, an English teacher at Evanston Township High School in Illinois, where phones are expected to be put away during class. “They often sound very supportive of cellphone policies and they want their kids to learn, but they also want access to them at all times.”

Dozens of parents told me they support school cellphone bans.

But in a recent poll from the nonprofit National Parents Union, most parents who supported banning phones in class said they should be allowed at other times, such as passing periods, lunch and recess.

 

“Parents want a direct line to their kids during the school day,” says Ariel Taylor Smith, senior director of policy and action for the National Parents Union.

She, too, likes being able to reach her 8-year-old son by phone during the school day. “We should be teaching students how to use cellphones responsibly, not banning them,” says Taylor Smith, a former high-school teacher.

School shootings have raised parents’ anxiety. As a mother of three, I’m certainly as worried as any other parent about school violence. School-safety experts say that using phones during an emergency can endanger kids. Ringing or buzzing phones can give away the location of a kid who is trying to hide from an intruder, and parents on the line can distract students from following lifesaving instructions from school personnel.

Day to day, parents are mostly texting kids things that can wait til the dismissal bell, teachers tell me—practice reminders, pickup changes and other such minutiae.

Students comprehend more and have less anxiety when phones aren’t present, some studies show. A Massachusetts boarding school I wrote aboutfound that students became more engaged in class after it banned smartphones.

Even the partial ban at the Brush school district in Colorado last year was effective: Visits to the principal’s office fell sharply among high-schoolers compared with the year before, Wilson says.

Normalizing no phones

Mark Daniel, superintendent of Fort Wayne Community Schools in Indiana, told parents earlier this year that the district would test a cellphone ban, to run through the end of the school year.

The district began locking up students’ phones at two middle schools and two high schools in mid-March. The exercise would help determine whether discipline and classroom engagement improved in the absence of phones.

 

 

Read More

 

 

— Techmeme

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Mercer County to present 3 ways to safely vote in NJ for upcoming Primary, General Elections

Mercer County Board of Elections will have a presentation at the County Library in Lawrence on May 21 to educate the public about the three ways to vote in N.J. for the upcoming Primary and General Elections, and to demonstrate  the safeguards that are  in place to protect county elections.

They will also  provide a demonstration of the Dominion Voting Machines.

With a Presidential Election year underway, Mercer County Clerk Paula Sollami Covello, Superintendent of Elections Walker M. Worthy, Jr., and Board of Elections Chair Jill Moyer invite constituents to a comprehensive presentation aimed at educating the community on the various voting methods available in New Jersey and the ballot design changes for the upcoming Primary Election. The event will feature a live demonstration of the Dominion Voting Machines, which will be utilized during Election Day. The event will be held at the Lawrence Branch of Mercer County Library System on May 21st at 6pm.

“We are dedicated to fostering an informed electorate,” stated County Clerk Sollami Covello. “This presentation serves as an invaluable opportunity for constituents to familiarize themselves with the voting methods available to them, as well as the new ballot design for the Primary Election.”  “They will also gain hands-on experience with the Dominion Voting Machines,” added Superintendent Worthy. Chairwoman Moyer added, “Many people are still not aware that early voting is a great way to cast your vote and to avoid lines at the polls. We will explain how convenient it is as well.”

For more information on this event contact the Mercer County Clerk’s Office at 609-989-6820. For more Election related information, visit the Clerk’s election page, or New Jersey Department of State – Division of Elections – NJ Voter Information Portal, call the County Clerk’s Election Office at 609-989-6495. For polling location questions, or to become a poll worker, you may contact the Mercer County Board of Elections Office at 609-989-6522 or visit their website at Board of Elections

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TimberTech® sets new industry standard with top-rated fire resistance for composite decking; best choice for fire zones

TimberTech Advanced PVC collections feature exceptional flame spread resistance, now with an Ignition Resistant designation from California’s State Fire Marshal

CHICAGO–(BUSINESS WIRE)–The AZEK Company Inc. (NYSE: AZEK) (“AZEK” or the “Company”), the industry-leading manufacturer of beautiful, low-maintenance and environmentally sustainable outdoor living products, including TimberTech® decking and railing, Versatex® and AZEK® Trim, and StruXure® pergolas, is proud to announce that its TimberTech Advanced PVC Vintage Collection® and Landmark Collection® are the first in the composite decking industry to receive an Ignition Resistant designation from California’s State Fire Marshal.

 

Ignition Resistance, as defined by the California State Fire Marshal, and by the surrounding states that have adopted its standards, refers to building materials that resist catching fire or burning easily and that may slow the spread of flames. The new Ignition Resistant designation for these Advanced PVC Collections underscores TimberTech’s commitment to providing homeowners with not only beautiful and durable outdoor living solutions but also products that help enhance the safety of their outdoor spaces by adding an extra layer of protection against fire hazards.

“TimberTech is not just leading but revolutionizing the decking industry through innovation,” said Jonathan Skelly, President of Residential and Commercial for AZEK. “These fire designations underscore our relentless pursuit to not only meet but to exceed fire safety standards. Considering the staggering number of over 46 million homes across 70,000 U.S. communities at risk from the impacts of wildfire, our comprehensive portfolio can help consumers harden their homes to reduce risk and increase resistance to heat, flames, and embers typical of most wildfires.”

 

In addition to the new Ignition Resistant designation, TimberTech’s Vintage and Landmark Collections hold a Class A Flame Spread Rating. Class A is the best rating available and indicates a material is in the highest range of resistance to flames. This means that in a fire, flames will spread slower across the deck surface. Class A Flame Spread Rated decking will resist catching fire and will not readily contribute to the spread of flames. TimberTech’s Advanced PVC Decking also meets Wildland Urban Interface (WUI) compliance standards. Local building codes in WUI zones mandate fire-resistant materials for construction projects, including decks. WUI-Compliant materials resist flame spread and catching fire due to flying embers.

 

“The significance of these ratings cannot be overstated, especially for homeowners like me living in California and those living in other areas prone to wildfires or those simply seeking to enhance the safety of their homes,” said Sam Toole, Chief Marketing Officer for AZEK. “No other decking matches the beauty or performance of our Vintage and Landmark Collections and features top-rated fire resistance.”

 

TimberTech’s recently introduced Aluminum Framing product pairs perfectly with Advanced PVC decking. Because it is made of aluminum, it is particularly well-suited for areas prone to fires as compared to wood, enabling TimberTech to provide homeowners with a comprehensive wood alternative decking and framing solution.

 

To learn more about TimberTech’s innovative decking solutions and their flame spread ratings, visit https://www.timbertech.com/about/fire-resistant-decking/.

 

About The AZEK® Company

The AZEK Company Inc. (NYSE: AZEK) is the industry-leading designer and manufacturer of beautiful, low maintenance and environmentally sustainable outdoor living products, including TimberTech® decking and railing, Versatex® and AZEK® Trim, and StruXure® pergolas. Consistently awarded and recognized as the market leader in innovation, quality, aesthetics and sustainability, our products are made from up to 85% recycled material and primarily replace wood on the outside of homes, providing a long-lasting, eco-friendly, and stylish solution to consumers. Leveraging the talents of its approximately 2,000 employees and the strength of relationships across its value chain, The AZEK Company is committed to accelerating the use of recycled material in the manufacturing of its innovative products, keeping hundreds of millions of pounds of waste and scrap out of landfills each year, and revolutionizing the industry to create a more sustainable future. The AZEK Company has recently been named one of America’s Climate Leaders by USA Today, a Top Workplace by the Chicago Tribune and U.S. News and World Report, and a winner of the 2024 Real Leaders® Impact Awards. Headquartered in Chicago, Illinois, the company operates manufacturing and recycling facilities in Ohio, Pennsylvania, Idaho, Georgia, Nevada, New Jersey, Michigan and Minnesota. For additional information, please visit azekco.com.

Contacts

Amanda Cimaglia

312-809-1093

media@azekco.com

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Mercer County Exec Benson announces ‘Mercer Path Forward’ initiative

MERCER COUNTY — Mercer County is proud to announce a new initiative, Mercer Path Forward. This initiative underscores Mercer County Exec. Dan Benson’s dedication to supporting the well-being of county residents who were previously incarcerated.

Recognizing the importance of providing opportunities for its residents to thrive, Mercer County has taken a proactive step by collaborating with The Glory Firm and Morph Mentoring to provide expungement services and workforce development assistance to residents impacted by the justice system.

“Our Path Forward program will reduce barriers for individuals in search of employment, public assistance, education, housing, parental rights, and voting,” said County Executive Benson. “These are members of our community who have completed their sentences, and deserve the opportunity to rebuild their lives.”

The Glory Firm, a minority and woman-owned law firm, brings expertise and a commitment to justice to this partnership. Led by Managing Partner Valisha Desir, Esq., an esteemed alumna of The College of New Jersey, the Glory Firm is well-equipped to provide compassionate and effective legal support to Mercer County residents seeking to have their record expunged.

“Mercer Path Forward exemplifies Mercer County’s dedication to fostering a supportive community where everyone has the opportunity to thrive. Both Mercer County and The Glory Firm are enthusiastic about the opportunity to serve county residents and assist them in moving forward,” said Valisha Desir, Esq.

Morph mentoring’s curriculum is meticulously designed to equip participants with the skills and knowledge sought by employers in today’s competitive job market. Courses cover a wide range of topics from basic computer literacy to advanced job readiness skills.

“Through the Mercer Path Forward program, Morph mentoring embodies a fusion of compassion and mission-driven purpose. We are dedicated to transforming lives by offering a second chance at success through holistic career development, fostering professionalism, and creating pathways to prosperity,” said Dr. Chelsey Brunson.

Mercer Path Forward exemplifies Mercer County’s dedication to fostering a supportive community where everyone has the opportunity to thrive. Mercer County is enthusiastic about the opportunity to serve county residents and assist them in moving forward.

Path Forward services are free to the public. You must apply to be accepted. Mercer County representatives will be on site to assist interested residents at three public events.

Application and Participant Screening on:

  • Tuesday, April 16, 2024 from 1pm to 7pm at the Mercer County Connection located at 957 Highway 33, Hamilton, NJ 08690 (Hamilton Square Shopping Center)
  • Monday, June 10, 2024 from 1pm to 7pm at the Mercer County Community College 102 N. Broad Street, Trenton, NJ 08608 (James Kerney Campus, 2nd Fl.)
  • Monday, June 17, 2024 from 1pm to 7pm at the Mercer County Office Park at 1440 Parkside Ave., Ewing, NJ 08638 (Kitchen Teaching Room)

For inquiries, email to mercerpathforward@mercercounty.org.

Mercer County strives to enhance community services and resources, creating an environment where every individual can thrive. Through collaborative efforts and a dedication to serving its diverse population, Mercer County is working to be an example for the entire State.

These services are made possible through funds from the American Rescue Plan Act (ARPA).

For additional information, please reach out to Theo Siggelakis at TSiggelakis@Mercercounty.org

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Alvotech and Teva announce US FDA approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab)

  • SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
  • SELARSDI is expected to be marketed in the U.S. on or after February 21, 2025, following a settlement agreement with Johnson & Johnson, the manufacturer of Stelara
  • SELARSDI was developed and is manufactured by Alvotech using murine cell (Sp2/0) and a continuous perfusion process, which are the same type of cells and process used for the production of Stelara

 

 

REYKJAVIK, Iceland & PARSIPPANY, N.J. — (BUSINESS WIRE) — Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), on Wednesday announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older. Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of SELARSDI in the United States.

 

“The approval of SELARSDI – which is our second biosimilar approval this year – underscores Teva’s commitment to expanding the availability, access and uptake of this important treatment option to patients in the U.S.,” said Thomas Rainey, Senior Vice President, U.S. Market Access at Teva. “The biosimilars market is growing, both globally and in the U.S., and biosimilars are a key component of delivering on Teva’s Pivot to Growth strategy. The partnership model that we’ve established enables us to leverage our commercial presence and experiences globally as we move to bring additional biosimilars to market.”

 

Robert Wessman, Chairman and CEO of Alvotech, added, “We are delighted to announce our second biosimilar approval in the U.S., which is the thirty-eighth approved market for our biosimilar to Stelara globally. Bringing SELARSDI to market in the U.S. early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs. The development of SELARSDI leveraged our purpose-built end-to-end development and manufacturing platform for biosimilars. Being able to develop the biosimilar in the same cell type and continuous perfusion process as was used for the reference product, facilitated the development program’s success.”

 

Ustekinumab is a human monoclonal antibody (mAb) that selectively targets the p40 protein, a component common to both interleukin (IL)-12 and IL-23 cytokines, which play crucial roles in treating immune-mediated diseases like psoriasis and psoriatic arthritis. Alvotech developed and produces SELARSDI using Sp2/0 cells and a continuous perfusion process, which are the same type of host cell line and process used in the production of Stelara.

 

Sales of the reference product Stelara in the U.S. were nearly $7 billion in 2023.1 The availability of a Stelara biosimilar will create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients. In the U.S., plaque psoriasis is the most common form of psoriasis while psoriatic arthritis accounts for approximately six percent of all cases of juvenile arthritis.2,3

 

In June 2023, Alvotech and Teva announced that they had reached a settlement and license agreement with the manufacturer of the reference biologic, Johnson & Johnson, granting a license entry date for SELARSDI in the United States no later than Feb. 21, 2025.

 

In August 2020, Alvotech and Teva entered into a strategic partnership for the exclusive commercialization of five of Alvotech’s biosimilar product candidates, and in August 2023, the collaboration was extended to include two additional biosimilars and new presentations of two previously partnered products. Alvotech handles development and manufacturing, while Teva is responsible for the exclusive commercialization in the U.S., which leverages Teva’s experience and extensive sales and marketing infrastructure. SELARSDI is the second biosimilar approved under the strategic partnership: in Feb. 2024, the FDA approved SIMLANDI®, the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA.

 

The FDA approval of SELARSDI, referred to as AVT04 during development, was based on a totality of evidence, including analytical and clinical data. The clinical development program included data from: 1) Study AVT04-GL-301, a randomized, double blind, multicenter, 52-week study to demonstrate equivalent efficacy and to compare safety and immunogenicity between SELARSDI and the reference product Stelara in patients with moderate to severe chronic plaque-type psoriasis. The study was conducted in four countries in Europe and enrolled 581 patients. The primary efficacy endpoint was Psoriasis Area and Severity Index (PASI) percent improvement from Baseline to Week 12; 2) Study AVT04-GL-101, a Phase I, randomized, double-blind, single-dose, parallel-group, 3-arm study to compare the pharmacokinetic, safety, tolerability, and immunogenicity profiles of SELARSDI, administered as a single 45mg/0.5mL subcutaneous injection with that of the US-licensed Stelara as well as EU-approved Stelara. The study was conducted in Australia and New Zealand and enrolled 294 healthy adult volunteers.

 

Use of Trademarks

Stelara® is a registered trademark of Johnson & Johnson.

Humira® is a registered trademark of AbbVie Biotechnology Ltd.

 

About Alvotech

Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

 

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com.

 

INDICATIONS FOR SELARSDI (ustekinumab-aekn)

SELARSDI is a human interleukin-12 and -23 antagonist indicated for:

  • the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis.

 

IMPORTANT SAFETY INFORMATION

SELARSDI injection is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in SELARSDI.

Infections

Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following:

  • Plague psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections.
  • Psoriatic arthritis: cholecystitis.

Avoid initiating treatment with SELARSDI in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of SELARSDI in patients with a chronic infection or a history of recurrent infection.

Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with SELARSDI and discontinue SELARSDI for serious or clinically significant infections until the infection resolves or is adequately treated.

 

Theoretical Risk for Vulnerability to Particular Infections

Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including non typhi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients.

It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing, (e.g., tissue culture, stool culture as dictated by clinical circumstances).

 

Pre-Treatment Evaluation of Tuberculosis (TB)

Evaluate patients for tuberculosis prior to initiating treatment with SELARSDI.

Avoid administering SELARSDI to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis before administering SELARSDI. Consider anti-tuberculosis therapy prior to initiation of SELARSDI in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving SELARSDI for signs and symptoms of active tuberculosis during and after treatment.

 

Malignancies

Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among patients who received ustekinumab in clinical trials. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy.

The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy.

There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving SELARSDI should be monitored for the appearance of non-melanoma skin cancer. Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment.

 

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SELARSDI.

 

Posterior Reversible Encephalopathy Syndrome (PRES)

Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis and psoriatic arthritis. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products.

Monitor all patients treated with SELARSDI for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue SELARSDI.

 

Immunizations

Prior to initiating therapy with SELARSDI, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with SELARSDI should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with SELARSDI or for one year prior to initiating treatment or for one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving SELARSDI because of the potential risk for shedding from the household contact and transmission to patient.

Non-live vaccinations received during a course of SELARSDI may not elicit an immune response sufficient to prevent disease.

 

Noninfectious Pneumonia

Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue SELARSDI and institute appropriate treatment.

 

ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in the label:

  • Infections
  • Malignancies
  • Hypersensitivity Reactions
  • Posterior Reversible Encephalopathy Syndrome (PRES)
  • Noninfectious Pneumonia

 

To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information for SELARSDI.

 

ALVOTECH Forward Looking Statements

Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential”, “aim” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech’s estimates of expenses and profitability; (6) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (13) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (17) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, on the Company’s business, financial position, strategy and anticipated milestones; and (18) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication.

 

TEVA Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our strategic partnership with Alvotech; our ability to successfully commercialize SELARSDI in the U.S.; our ability to successfully commercialize SIMLANDI in the U.S; our ability to commercialize the additional biosimilar product candidates under the strategic partnership with Alvotech once U.S. regulatory approval is obtained; our ability to successfully compete in the marketplace including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines; and other factors discussed in this press release, and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the sections captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.i

 

1 Johnson and Johnson Full-Year and Fourth Quarter 2023 Financial Results: https://www.investor.jnj.com/news/news-details/2024/Johnson–Johnson-Reports-Q4-and-Full-Year-2023-Results/default.aspx.

2 Psoriasis in Children: Your FAQs. (2021, June 29). Healthline.

3 Philadelphia, T. C. H. of. (2014, August 23). Psoriatic Arthritis in Children.

 

Contacts

ALVOTECH
Investor Relations and Global Communications
Benedikt Stefansson, Senior Director

alvotech.ir@alvotech.com

TEVA

IR Contacts

Ran Meir

+1 (267) 468-4475

Yael Ashman

+972 (3) 914 8262

Sanjeev Sharma

+1 (973) 658 2700

Media Contacts

Kelley Dougherty

+1 (973) 832-2810

Yonatan Beker

+1 (973) 264-7378

Eden Klein

+972 (3) 906 2645

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National Gambling Voluntary Self-Exclusion Program takes first step to increase access to help

MORRISTOWN, N.J. — (BUSINESS WIRE) — idPair, Inc., an award-winning provider of safer gaming technology, is pleased to announce the upcoming launch of The National Voluntary Self-Exclusion Program (NVSEP). Pending all regulatory and other necessary approvals, the program will launch in New England in summer 2024 and expand west and south in the following months.

 

This initiative is guided by two concepts: (1) Individuals needing seamless access to a National Voluntary Self-Exclusion list irrespective of geographical location; and (2) alignment of data sets for a single portal of current regulatory information and evolving public health resources.

 

Marlene Warner, CEO of the Massachusetts Council on Gaming and Health (MACGH), commended this collaborative effort, stating: “A national program has been needed for a long time, and I am thrilled that New England has the potential to lead the way with this remarkable step forward to a more seamless approach to Voluntary Self-Exclusion. With the National VSE Program, individuals will soon have a unified platform for seeking help and support across the entire United States and receiving up to date information as it’s needed. I encourage all state gaming regulators to join this initiative to provide a stronger safety net for consumers.”

 

Dr. Michelle Malkin, Director of the Gambling Research and Policy Initiative (GRPI) at East Carolina University said, “Conducting research on voluntary-self exclusion (VSE) has shown that the process can be confusing for those seeking help, especially if they are looking to VSE across multiple jurisdictions. Having an opportunity to engage with the tool using a single process across states will assist those using VSE as a deterrent to gamble and will help make VSE easier to understand which may increase engagement.”

 

“States do not have to change the terms of their individual programs to join NVSEP, a key detail that solves a problem that had held back this advancement in player protection for so long,” added Jonathan Aiwazian, CEO of idPair. “The current state programs will coexist with the new option, giving consumers the flexibility to exclude from as many or as few states and products as they choose, including both land-based and online gambling. While current self-exclusion protections don’t travel, people do, and we look forward to working with more states to use technology to provide a more comprehensive level of protection for those who need it most.”

 

As idPair continues to expand NVSEP, the company encourages gaming regulators from additional states to engage in this initiative. State regulatory bodies interested in joining the National VSE Program are encouraged to get in touch with idPair for more information on how their state-specific programs can be included in the national program. The program will be discussed in more detail at several upcoming industry events, including the East Coast Gaming Congress in Atlantic City on April 18.

 

For more information about NVSEP, please visit www.nvsep.com, or to learn about idPair’s other safer gaming initiatives, please visit www.idpair.com.

 

About idPair:

idPair is an award-winning safer gaming data anonymization and analytics company dedicated to enhancing consumer protection through research and the creation of innovative technology. Through a comprehensive view of gambling behaviors, idPair helps minimize related harm, generates new knowledge through research, and single customer, cross-operator deposit limits and cool-off periods to keep play recreational. Using sophisticated analysis rooted in science, idPair identifies high risk behaviors from transactional data across multiple operators, allowing for early intervention, risk mitigation, and the promotion of player health practices.

Contacts

Media:

media@idpair.com

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Business Energy Environment Lifestyle Regulations & Security Science Weather & Environment

SageSure to Acquire GeoVera MGA, Including GeoVera’s Industry-Leading Underwriting Franchise in Residential Earthquake Risk

Transaction and track record of underwriting outperformance solidify SageSure as the leader in catastrophe-exposed property insurance.

 

JERSEY CITY, N.J. — (BUSINESS WIRE) — SageSure, one of the largest managing general agents focused on catastrophe-exposed markets, today announced that it has entered into a definitive agreement to acquire GeoVera Advantage Insurance Services, Inc. (“GeoVera MGA”), an existing managing general agent within the specialty property insurance provider GeoVera Insurance Holdings, Ltd. (“GeoVera”).

 

Upon the transaction’s completion, SageSure will assume the underwriting operations of GeoVera MGA’s best-in-class residential earthquake franchise.

With the addition of the GeoVera MGA’s deep earthquake expertise, the transaction will further enhance SageSure’s robust catastrophe risk underwriting capabilities and accelerate its entrance into new markets, including Oregon and Washington.

 

“We are excited to enter into an agreement that solidifies SageSure as one of the leading underwriters of catastrophe-exposed property risk in the US. This transaction is a rare opportunity to create significant value for employees and investors of both companies,” said Terrence McLean, President and CEO of SageSure. “The addition of Nesrin Basoz and the GeoVera MGA team will ensure continuity in GeoVera’s product offerings and a seamless experience for GeoVera distributors and policyholders.”

 

Both SageSure and GeoVera MGA teams will continue to drive their respective areas of expertise with the common goal of delivering underwriting outperformance.

 

The transaction will also establish SageSure’s partnership with GeoVera’s insurance carriers, which will provide residential earthquake capacity in California, Oregon, and Washington, and E&S homeowners, commercial habitational, and residential wind capacity in Florida. SageSure’s existing carrier partner SafePort Insurance Company will join GeoVera’s insurance carriers, enhancing an already strong, well-capitalized, and diversified AM Best-rated carrier group.

 

“We are proud to partner with SageSure on this innovative transaction,” said John Forney, President and CEO of GeoVera. “Our MGA team will provide SageSure with additional underwriting expertise and product diversity, while our new carrier partnership will ensure stability and continuity for GeoVera agents and policyholders. We look forward to the exciting opportunities this partnership will bring.”

 

To support the transaction, credit funds managed by Ares Management, SageSure’s long-standing capital provider, will provide an expansion to SageSure’s existing debt facility.

 

Howden Capital Markets & Advisory is serving as exclusive financial advisor to SageSure on the transaction, with Willkie Farr & Gallagher LLP serving as SageSure’s legal counsel.

 

The transaction is expected to close in the fourth quarter of 2024, subject to the receipt of required regulatory approvals and other customary closing conditions.

 

About SageSure

SageSure is the managing general agent specializing in coastal residential and commercial property insurance. SageSure offers more than 50 competitively priced insurance products in 14 coastal states on behalf of its carrier partners, serves more than 550,000 policyholders, and has more than $1.6 billion of inforce premium. Since its launch in 2009, SageSure has been pioneering property insurance through its market-leading online quoting and binding platform and its sophisticated risk modeling and scoring technology. For more information, visit sagesure.com.

 

About GeoVera Insurance Holdings, Ltd.

GeoVera Insurance Holdings, Ltd. is a provider of specialty property insurance products focused on catastrophe-exposed properties in the earthquake and wind markets, operating on both an admitted and surplus lines basis. GeoVera is headquartered in Fairfield, CA with offices in Sheboygan, WI, Jacksonville, FL and Tampa, FL. GeoVera and its subsidiaries maintain a Financial Strength Rating of A (Excellent) from AM Best. For more information, visit GeoVera.com.

Contacts

Walker Sands

sagesure@walkersands.com