Category: Business

Eagle Pharmaceuticals granted additional patent for Bendamustine Franchise

Post author By Michelle Dryden
Post date August 31, 2021
No Comments on Eagle Pharmaceuticals granted additional patent for Bendamustine Franchise

WOODCLIFF LAKE, N.J. — (BUSINESS WIRE) — Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that the U.S. Patent and Trademark Office has granted the Company U.S. Patent No. 11,103,483, entitled “Formulations of Bendamustine.” Eagle is submitting the ‘483 patent for listing in the U.S. Food and Drug Administration’s Orange Book for both BENDEKA^® and BELRAPZO^®.

Eagle had asserted several Orange Book-listed patents against Slayback Pharma LLC, Apotex Inc. et al, Mylan Laboratories Limited, and Fresenius Kabi USA, LLC, related to their respective abbreviated new drug applications referencing BENDEKA. On July 6, 2020, the District Court for the District of Delaware had held these asserted patents both valid and infringed. Apotex, Mylan, and Fresenius appealed this ruling. Previous to the appellate hearing, Eagle settled the Fresenius litigation. On August 13, 2021, the United States Court of Appeals for the Federal Circuit affirmed that the asserted patents were both valid and infringed. Both the asserted patents and the ‘483 patent expire in 2031.

“We are pleased that this appellate decision, as well as the newly issued patent, continue to strengthen Eagle’s intellectual property rights for both BENDEKA and BELRAPZO,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

About Eagle Pharmaceuticals, Inc.

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include RYANODEX^®, BENDEKA^®, BELRAPZO^®, and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle’s website at www.eagleus.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other securities law. Forward-looking statements are statements that are not historical facts. Words and phrases such as “anticipated,” “forward,” “will,” “would,” “may,” “remain,” “potential,” “prepare,” “expected,” “believe,” “plan,” “near future,” “belief,” “guidance,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements concerning the submission of U.S. Patent No. 11,103,483 for listing in the U.S. Food and Drug Administration’s Orange Book for both BENDEKA and BELRAPZO; and statements regarding the strength of the Company’s intellectual property rights for BENDEKA and BELRAPZO. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the Company’s control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks and uncertainties include, but are not limited to: the impacts of the ongoing COVID-19 pandemic, including interruptions or other adverse effects on clinical trials and delays in regulatory review or further disruption or delay of any pending or future litigation; delay in or failure to obtain regulatory approval of the Company’s product candidates and successful compliance with FDA, EMA and other governmental regulations applicable to product approvals; the outcome of litigation involving any of its products or that may have an impact on any of its products; the strength and enforceability of the Company’s intellectual property rights or the rights of third parties; the risks inherent in drug development and in conducting clinical trials; and those risks and uncertainties identified in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission (the “SEC”) on March 5, 2021, as updated by the Company’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2021 and June 30, 2021, filed with the SEC on May 10, 2021 and August 9, 2021, respectively, and its other subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contacts

Investor Relations for Eagle Pharmaceuticals, Inc.:
Lisa M. Wilson

In-Site Communications, Inc.

T: 212-452-2793

E: lwilson@insitecony.com

Tags Business, New Jersey

Business Entertainment News

Actress/Activist Rosario Dawson joins the 2021 New Jersey Auto Retailers Unite campaign

Post author By Michelle Dryden
Post date August 30, 2021
No Comments on Actress/Activist Rosario Dawson joins the 2021 New Jersey Auto Retailers Unite campaign

MAPLEWOOD, N.J. — (BUSINESS WIRE) — More than 200 franchised New Jersey new car and truck dealerships have participated in a variety of New Jersey Auto Retailers Unite fundraising campaigns since 2014. Raising over $2,250,000 since 2014, their generosity has made an extraordinary impact on the lives of more than 6,000 brave children with cancer, sickle cell disease and other blood disorders treated by The Valerie Fund each year.

The 2021 New Jersey Auto Retailers Unite Campaign has set an ambitious goal of raising $500,000. Already, nearly 80 dealers have contributed more than $270,000, before the two-month campaign official launches on September 1, 2021.

Rosario Dawson has also joined the campaign as the celebrity spokesperson and will be featured in a public service announcement expected to be launched in mid-September. Known for her roles in projects such as THE MANDALORIAN, TOP FIVE, RENT and SIN CITY, she can next be seen in the upcoming Hulu limited series DOPESICK which will air in October. In addition to her many acting credits, Ms. Dawson is also a well-respected activist, designer, businesswoman and community volunteer.

The September 1, 2021 campaign launch date coincides with the month’s national recognition of Pediatric Cancer Awareness and Sickle Cell Awareness. This year’s campaign will focus on educating the public about Sickle Cell Disease, in particular. The Valerie Fund Children’s Center at Newark Beth Israel treats more sickle cell patients than any other hospital in New Jersey and is recognized as a Comprehensive Sickle Cell Center.

“New Jersey’s 500+ franchised neighborhood new car and truck dealerships are the backbone of their communities and support local organizations in hundreds of different ways,” said Jim Appleton, President of the New Jersey Coalition of Automotive Retailers. “These entrepreneurs compete for customers every day, but they can also unite behind a worthwhile cause.”

“New Jersey’s dealerships are coming together, across all brands, to pay it forward and support the thousands of brave children treated by The Valerie Fund each year, and their families,” said Judith Schumacher- Tilton, NJ CAR Chairwoman and owner of the Schumacher Auto Group. “It is especially important to support the hundreds of children with Sickle Cell disease treated at Valerie Fund Centers. This is an incurable disease that effects an underserved population.”

For more information about the New Jersey Auto Retailers Unite campaign, The Valerie Fund or the services provided at The Valerie Fund Children’s Centers, please contact Randi Zamkotowicz, Valerie Fund Assistant Director of Development for Philanthropy at (201) 993-3787 or randiz@thevaleriefund.org or Brian Hughes, NJ CAR Director of Communications at bhughes@njcar.org.

About The Valerie Fund

Since 1977, tens of thousands of critically ill children have received state of the art medical treatment and customized health care services at one of seven Valerie Fund Children’s Centers located close to their homes. The Valerie Fund is committed to fully funding psychosocial services that are not reimbursed by insurance but enable kids with life-threatening diseases to live life to the fullest. And now that COVID-19 is a serious threat to our families, The Valerie Fund plays a doubly important role keeping our children safe medically and emotionally.

Contacts

Bunny Flanders

bflanders@thevaleriefund.org
973.202.1992

Brian Hughes

bhughes@njcar.org
609.883.5056, x315

Tags Business, New Jersey

Business

American Water’s Valoria Armstrong named by Philadelphia ‘Business Journal’ as a diversity leader in business

Post author By Michelle Dryden
Post date August 29, 2021
No Comments on American Water’s Valoria Armstrong named by Philadelphia ‘Business Journal’ as a diversity leader in business

CAMDEN, N.J. — (BUSINESS WIRE) — American Water (NYSE: AWK), the largest publicly-traded U.S. water and wastewater utility company, announced that Valoria Armstrong, Chief Inclusion Officer and Vice President, External Affairs, was recognized by the Philadelphia Business Journal as a Diversity Leader in Business. The award recognizes diverse leaders that have demonstrated success in their respective fields and through philanthropic endeavors.

“I want to congratulate Valoria on this well-deserved recognition,” said Walter Lynch, president and CEO of American Water. “Creating an inclusive and diverse work environment is not something a company can achieve by checking off a series of boxes. It requires honest self-examination and a commitment to deep fundamental change. Val has dedicated herself to helping American Water create an environment where differences are embraced and where every person feels engaged and valued.”

American Water is committed to developing an inclusive and diverse workforce reflecting the communities it serves. Armstrong has helped strengthen this commitment through a comprehensive and integrated strategy to drive diversity, equity, mutual respect, and inclusiveness across the organization.

She is also responsible for government and regulatory affairs across American Water’s regulated businesses. Armstrong engages with key external stakeholders like the National Association of Regulatory Utility Commissioners, the U.S. Conference of Mayors, and the National Utilities Diversity Council.

Armstrong has a bachelor’s degree in business administration from Georgia Southern University and a master’s degree in human resource development from Villanova University.

Honorees represent a range of industries, from biotechnology and health care to government and law to higher education and nonprofits. Renamed this year, the Diversity Leaders in Business Awards showcase those who have made an indelible impact over the past 12 to 18 months.

This year’s honorees were celebrated at a live virtual event on Aug. 26 and were profiled in a special edition of the Philadelphia Business Journal on Aug. 27.

About American Water

With a history dating back to 1886, American Water is the largest and most geographically diverse U.S. publicly traded water and wastewater utility company. The company employs more than 7,000 dedicated professionals who provide regulated and market-based drinking water, wastewater and other related services to 15 million people in 46 states. American Water provides safe, clean, affordable and reliable water services to our customers to help make sure we keep their lives flowing. For more information, visit amwater.com and follow American Water on Twitter, Facebook and LinkedIn.

Contacts

Media:
Joseph Szafran

External Affairs Manager

856-955-4304

joseph.szafran@amwater.com

Tags Business, New Jersey

Business

AM Best revises outlooks to negative for American Federated Insurance Company and American Federated Life Insurance Company

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance—AM Best has revised the outlooks to negative from stable and affirmed the Financial Strength Rating of B (Fair) and the Long-Term Issuer Credit Ratings of “bb” (Fair) of American Federated Insurance Company (AFIC) and American Federated Life Insurance Company (AFLIC). Both companies are known collectively as American Federated Insurance Companies and are domiciled in Flowood, MS.

These Credit Ratings (ratings) reflect AFIC’s balance sheet strength, which AM Best assesses as very strong, as well as its adequate 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 the same individuals.

The drag on 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.

The outlook revisions to negative reflect AM Best’s concern that high financial leverage, high interest expenses and growing negative equity at First Tower Finance, the intermediate holding company, may place further pressure on AFIC and AFLIC for additional dividends or increased expense sharing.

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 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.

Contacts

Jeffrey Stary

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

Raymond Thomson, CPCU, ARe, ARM
Associate Director
+1 908 439 2200, ext. 5621
raymond.thomson@ambest.com

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

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

Tags Business, New Jersey

Business Technology

U.S. LPGA Championship & Olympic Golfer Lexi Thompson endorses Aetrex Orthotics

Post author By Michelle Dryden
Post date August 27, 2021
No Comments on U.S. LPGA Championship & Olympic Golfer Lexi Thompson endorses Aetrex Orthotics

Elite athlete and longtime Aetrex customer advocates the use of orthotics for enhanced performance

TEANECK, N.J. — (BUSINESS WIRE) — Aetrex Worldwide, Inc. (“Aetrex”), the global market leader in foot scanning technology, orthotics and comfort & wellness footwear, today announced its first athletic partnership with Lexi Thompson, an LPGA Championship and Tokyo 2020 Olympic athlete, one of the most-credentialed players at a young age. As a longtime customer, Thompson has been leveraging Aetrex Orthotics to enhance her performance during training and tournaments.

Thompson became the youngest golfer to ever qualify to play in the U.S. Women’s Open at the age of 12, turned professional at age 15 and won her first major championship at the age of 19. In the summer of 2018, Thompson made the decision to seek out orthotics that could help alleviate frequent foot pain she had been experiencing due to low arches. After exploring and testing options from various brands, she found Aetrex Orthotics were the best fit for her, providing the comfort, support, and alignment she needed to perform at her best.

“Before using Aetrex Orthotics, I was suffering through a lot of foot pain, especially after a long day of training or while playing four rounds at a tournament,” said Thompson. “Three years ago, I decided to test a few orthotics and found that Aetrex’s Compete Orthotics worked best for me because they helped compensate for the low arch of my feet. They instantly made my golf shoes more comfortable and supportive, which has helped optimize my power transfer on the field and my overall stability. I can now regularly walk over 35 miles a week, as is common during training or when playing in a multi-round tournament, with no pain at all. I even wear them in my regular day-to-day shoes!”

For 75 years, Aetrex has been dedicated to the advancement of foot health and comfort solutions and is today recognized as the World’s Number 1 Foot Orthotics System and approved by the American Podiatric Association for better foot health.

“We’re very excited to be partnering with Lexi, a true golf champion who has an incredible background being one of the youngest LPGA golfers to win a Major,” said Larry Schwartz, CEO at Aetrex. “We’re excited to bring more awareness of our orthotics into the golfing arena. Lexi has been wearing our orthotics authentically for years to help improve her game, so we feel this partnership is a natural next step.”

Aetrex’s Compete product is the preferred choice of golfers throughout the world. Aetrex Orthotics are designed with their proprietary, strategically placed arch support and feature high-tech, lightweight, premium shock-absorbing materials, enhancing the user’s overall foot health. Designed to address various causes of foot pain, including plantar fasciitis, flat feet, ball of foot discomfort, and heel pain, Aetrex Orthotics provide biomechanical alignment, keeping the foot closer to the neutral position throughout the gait cycle. Proper alignment helps minimize overpronation and reduces stress on the plantar fascia, knees, hips and back.

For more information about Aetrex and Aetrex Orthotics, please visit www.aetrex.com.

About Aetrex

Aetrex Worldwide, Inc. is widely recognized as the global leader in foot scanning technology, orthotics, and comfort and wellness footwear. Aetrex has developed state-of-the-art foot scanning devices, including Albert, Albert 2 and iStep, designed to accurately measure feet and determine foot type and pressure points. Since 2002, Aetrex has placed over 10,000 scanners worldwide that have performed more than 40 million unique customer foot scans, currently averaging more than 2.5 million scans a year.

The company is renowned for its over-the-counter orthotics – the worlds #1 foot orthotic. With fashion, function and quality at the forefront, Aetrex also designs and manufactures stylish, performance footwear. Based in New Jersey, Aetrex is consistently named one of New Jersey’s Top 100 Privately Held Companies and was also included in NJBIZ’s Top 30 Manufacturing Companies. It has remained privately owned by the Schwartz family for three generations. For additional information, visit www.aetrex.com.

Contacts

Rajira Hernandez

Matter Communications

978-225-8082

aetrex@matternow.com

Tags Business, New Jersey

Business Technology

Semtech’s BlueRiver® Platform delivers 4K AV content to 200+ displays with SDVoE™ for destination venue, American Dream

In collaboration with SNA Displays, NETGEAR and Aurora Multimedia, the combined Pro AV technology is utilized throughout the venue

CAMARILLO, Calif. — (BUSINESS WIRE) — #AV—Semtech Corporation (Nasdaq: SMTC), a leading supplier of high performance analog and mixed-signal semiconductors and advanced algorithms, announced that its BlueRiver® platform for Software Defined Video over Ethernet (SDVoE™) has been implemented to drive content to 200+ displays at American Dream, a New Jersey destination venue for premier entertainment, retail and dining. The multimedia solution was developed in collaboration with:

SNA Displays, a New York-based LED display manufacturer who provided more than 40,000 square feet of digital display technology
NETGEAR, the leading provider of networking products that power businesses both large and small, who supplied the M4500 series AV network switches and other data network switches
Aurora Multimedia, a global provider of state-of-the-art technology for IP-based AV distribution, who provided its SDVoE endpoints, the Aurora IPX-TC3 Pro devices. The solution supports PoE over 10G links, eliminating the need for local power supply to endpoints as they are powered directly via network link.

The inclusion of Semtech’s BlueRiver platform allowed for full high quality 4K60P, 4:4:4, near-zero latency SDVoE video across all American Dream displays as well as 10Gb data throughout the facility for information-sharing, wayfinding and interactive entertainment – from impressive LED walls to hundreds of digital signage kiosks.

“The BlueRiver chipset and software API comprise the technology at the core of hundreds of interoperable SDVoE products being widely adopted in the Pro AV industry. Accommodating the massive scale of a venue such as American Dream was a challenge, but the flexibility of the BlueRiver platform was able to deliver 4K media from any one of the hundreds of sources in one of the largest retail and entertainment environments in North America,” said Don Shaver, vice president of video products for Semtech’s Signal Integrity Products Group. “Semtech’s participation alongside SNA Displays, NETGEAR and Aurora Multimedia for American Dream illustrates how high quality video displays are a critical aspect of creating a destination experience for the consumer and business alike.”

As a result of the combined effort from Semtech, SNA Displays, NETGEAR, and Aurora Multimedia, delivering a high quality AV experience for the American Dream multi-million-square foot site was made possible. All displays across the venue are connected to Aurora’s TC3 endpoints which use the BlueRiver platform to flawlessly deliver content from any source to any destination. Notably, the solution includes the massive ground-level screen, known as the Grand Staircase, which measures approximately 12 feet tall by 107 feet long, about the size of two and a half highway billboards end to end, and includes 2.7 million pixels.

For further information on Semtech’s BlueRiver platform for SDVoE, please visit here.

About Aurora Multimedia

Aurora Multimedia products incorporate state-of-the-art technologies that surpass typical specifications and features. From the introduction of the industry’s first non-proprietary, Web-standards-based IP control systems and touch panels, to today’s advanced HDBaseT™, SDVoE™, and IPBaseT^® video distribution solutions – has made Aurora a dominant force in the AV industry. Advanced AV processors with scaling, multi-image rotation, and dual/quad display processing only add to our highly adaptive, diversified product line. Aurora provides solutions for a variety of global markets, including government, education, security, hospitality, corporate, and house of worship. www.auroramm.com

About NETGEAR, Inc.

NETGEAR® has pioneered advanced networking technologies for homes, businesses, and service providers around the world since 1996 and leads the industry with a broad range of award-winning products designed to simplify and improve people’s lives. By enabling people to collaborate and connect to a world of information and entertainment, NETGEAR is dedicated to delivering innovative and advanced connected solutions ranging from mobile and cloud-based services for enhanced control and security, to smart networking products, video over Ethernet for Pro AV applications, easy-to-use WiFi solutions and performance gaming routers to enhance online game play. The company is headquartered out of San Jose, Calif. with offices located around the globe. More information is available from the NETGEAR Investor Page or by calling (408) 907-8000. Connect with NETGEAR: Twitter, Facebook, Facebook for NETGEAR Business, Instagram and our blog at NETGEAR.com.

About SNA Displays

SNA Displays brings creative visions to life by building high-end digital displays as vivid and dynamic as the imagination. SNA Displays employs a team of SNAPros™—engineers, skilled project managers, systems experts, installation managers, and support staff—whose mission is total project satisfaction. SNA Displays is headquartered in Times Square and has worked with clients to design and build some of the largest and most recognizable digital spectaculars in the world. Discover how Dreams Live Digitally® at snadisplays.com.

About Semtech

Semtech Corporation is a leading supplier of high performance analog and mixed-signal semiconductors and advanced algorithms for infrastructure, high-end consumer and industrial equipment. Products are designed to benefit the engineering community as well as the global community. The Company is dedicated to reducing the impact it, and its products, have on the environment. Internal green programs seek to reduce waste through material and manufacturing control, use of green technology and designing for resource reduction. Publicly traded since 1967, Semtech is listed on the NASDAQ Global Select Market under the symbol SMTC. For more information, visit www.semtech.com.

Forward-Looking and Cautionary Statements

All statements contained herein that are not statements of historical fact, including statements that use the words “designed to” or other similar words or expressions, that describe Semtech Corporation’s or its management’s future plans, objectives or goals are “forward-looking statements” and are made pursuant to the Safe-Harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of Semtech Corporation to be materially different from the historical results and/or from any future results or outcomes expressed or implied by such forward-looking statements. Such factors are further addressed in Semtech Corporation’s annual and quarterly reports, and in other documents or reports, filed with the Securities and Exchange Commission (www.sec.gov) including, without limitation, information under the captions “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors.” Semtech Corporation assumes no obligation to update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this release, except as required by law.

Semtech, the Semtech logo and BlueRiver are registered trademarks or service marks of Semtech Corporation or its affiliates. SDVoE is a trademark or service mark of the SDVoE Alliance.

SMTC-P

Contacts

Linh Dinh

Semtech Corporation

(408) 510-2704

ldinh@semtech.com

Tags Business, New Jersey

Business

AM Best downgrades credit ratings of Kansas City Life Insurance Company and its subsidiaries

Post author By Michelle Dryden
Post date August 27, 2021
No Comments on AM Best downgrades credit ratings of Kansas City Life Insurance Company and its subsidiaries

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 Rating (Long-Term ICR) to “a-” (Excellent) from “a” (Excellent) of Kansas City Life Insurance Company (Kansas City Life). The outlook of these Credit Ratings (ratings) is negative. Concurrently, AM Best has downgraded the FSR to B++ (Good) from A- (Excellent) and the Long-Term ICR to “bbb+” (Good) from “a-” (Excellent) of Grange Life Insurance Company (Grange Life) (Columbus, OH). The outlook of the FSR has been revised to stable from negative while the outlook of the Long-Term ICR is negative.

AM Best also has downgraded the FSR to B++ (Good) from A- (Excellent) and the Long-Term ICR to “bbb+” (Good) from “a-” (Excellent) of Old American Insurance Company (Old American). Additionally, AM Best has downgraded the FSR to B++ (Good) from A- (Excellent) and the Long-Term ICR to “bbb+” (Good) from “a-” (Excellent) of Sunset Life Insurance Company of America (Sunset Life). The outlook of the Long-Term ICRs has been revised to negative from stable while the outlook of the FSR is stable. All companies are domiciled in Kansas City, MO, unless otherwise specified. All companies are wholly owned subsidiaries of Kansas City Life.

The ratings of Kansas City Life reflect its 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 (ERM).

The rating downgrades of Kansas City Life reflect a revision in its operating performance assessment to marginal from adequate. Return metrics for Kansas City Life on a one-year, three-year and five-year basis are lower than that of its peers and the overall industry. Kansas City Life’s earnings have declined and its investment income has fallen at a higher pace than that of the industry, which has negatively affected surplus growth. Kansas City Life has maintained its dividend as earnings have declined in recent years. The negative outlooks of Kansas City Life reflect the declining balance sheet metrics that have come as the result of negative operating trends.

The ratings of Old American reflect its balance sheet, which AM Best assesses as strong, as well as its marginal operating performance, limited business profile, and appropriate ERM.

The rating downgrades of Old American reflect a revision in its operating performance assessment to marginal from adequate. Old American has been experiencing strain on capital and surplus due to high sales of its final expense product. Return metrics on a one-year, three-year and five-year basis are negative, and net income is negative three of the past five years. Net losses and significant dividends taken out of Old American, even in loss-making years, have led to a material decrease in its risk-adjusted capitalization. The negative Long-Term ICR outlook reflects AM Best’s uncertainty of the profitability of the maturing final expense business and the continued strain that Old American’s risk-adjusted capitalization will experience.

The ratings of Grange Life reflect its balance sheet strength, which AM Best assesses as strong, as well as its marginal operating performance, limited business profile, and appropriate ERM.

The rating downgrades of Grange Life reflect the rating downgrades of Kansas City Life and the decrease in lift that is provided from the ultimate parent.

The ratings of Sunset Life reflect its balance sheet strength, which AM Best assesses as very strong, as well as adequate operating performance, limited business profile, and appropriate ERM.

The rating downgrades of Sunset Life reflect the rating downgrades of Kansas City Life and the decrease in lift that is provided from the ultimate parent.

Contacts

Matthew Dachowski

Financial Analyst
+1 908 439 2200, ext. 5357

matthew.dachowski@ambest.com

Michael Porcelli
Director
+1 908 439 2200, ext. 5548

michael.porcelli@ambest.com

Christopher Sharkey

Manager, Public Relations
+1 908 439 2200, ext. 5159

christopher.sharkey@ambest.com

Jim Peavy
Director, Communications
+1 908 439 2200, ext. 5644

james.peavy@ambest.com

Tags Business, New Jersey

Business

AM Best places credit ratings of Guggenheim Life and Annuity Company under review with developing implications

Post author By Michelle Dryden
Post date August 27, 2021
No Comments on AM Best places credit ratings of Guggenheim Life and Annuity Company under review with developing implications

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance—AM Best has placed under review with developing implications the Financial Strength Rating of B++ (Good) and the Long-Term Issuer Credit Rating of “bbb+” (Good) of Guggenheim Life and Annuity Company (GLAC) (Wilmington, DE).

The Credit Rating (rating) actions reflect GLAC’s decline in surplus and weakening in its risk-adjusted capital position during the first half of 2021, driven in large part by the payment of stockholder dividends to its ultimate parent, Sammons Enterprises, Inc. GLAC’s management is working on a capital plan to increase its capital and surplus and strengthen its risk-adjusted capital position.

The ratings are expected to remain under review while GLAC management finalizes its capital plans and AM Best can fully assess the impact this has on the company’s capital and surplus position and risk-adjusted capitalization.

Contacts

Erik Miller, CFA
Associate Director
+1 908 439 2200, ext.5187
erik.miller@ambest.com

Michael Lagomarsino, CFA, FRM
Senior Director
+1 908 439 2200, ext. 5810
michael.lagomarsino@ambest.com

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

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

Tags Business, New Jersey

Business Technology

Buckle appoints Cheryl Sinclair to newly created position of chief people officer

Post author By Michelle Dryden
Post date August 26, 2021
No Comments on Buckle appoints Cheryl Sinclair to newly created position of chief people officer

Cheryl Sinclair’s 20 years of experience to support Buckle as it continues building team to deliver comprehensive insurance to U.S. gig economy workers

JERSEY CITY, N.J. — (BUSINESS WIRE) — #CPO—Buckle, an inclusive, tech-enabled financial services company, appointed Cheryl Sinclair to the company’s newly created position of Chief People Officer. Cheryl spent nearly 20 years in various human resources roles at Farmers Insurance, most recently as Assistant Vice President, Human Resources. Cheryl is responsible for developing Buckle’s human resources strategy, including talent and performance management as Buckle’s growing team continues to support the new emerging middle class and providers to the gig economy.

“Cheryl has extensive leadership expertise driving HR programs to support the strategic objectives of multi-billion-dollar organizations, while leading diverse teams through complex transformation and growth,” said Kristi Matus, CFO and COO of Buckle. “Building the right talent while shaping a thriving culture is critical to Buckle’s mission and purpose. We are confident Cheryl will ensure diversity, equity, and inclusion at Buckle as she implements HR systems and initiatives to support our growing team in ways that will advance the gig economy.”

While at Farmers Insurance, Cheryl designed a business-based HR model still in place today, leading a team of 50+ regional HR partners across multiple states and lines of business for over 20,000 employees. Most recently, she was Head of Talent Management for Holland America Group, serving Princess Cruises, Holland America Line, Seabourn and P & O Australia. She has a bachelor’s degree in business administration and management from Texas Tech University.

“I’m thrilled to join Buckle at a time when the company is positioning itself for growth and bringing in top industry talent to complement an already strong group of founding members,” said Cheryl Sinclair. “Buckle’s core values are firmly rooted in helping people, and I look forward to doing my part to enhance our employee experience and creating an environment where everyone thrives.”

In addition to Kristi Matus, Cheryl joins Buckle’s stellar executive team that includes Marty Young, co-founder and CEO; Dustin Walsey, co-founder and President; Sharon Fernandez, Head of Insurance; William Breslin, President, Buckle TPA; Adam Landau, CIO; and James Camerino, Head of Strategic Partnerships.

About Buckle

Buckle is the inclusive, digital financial services company serving the emerging middle class and providers to the gig economy. Using a portfolio of technologies and data sources, Buckle provides insurance and credit products to those who earn less than the average American wage and are subsequently penalized for having poor or no credit. Connect with Buckle on Facebook, Twitter and LinkedIn. Visit www.buckleup.com.

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Media Contact:

Tracy Wemett

BroadPR

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tracy@broadpr.com

Tags Business, New Jersey

Business Healthcare

BridgeBio Pharma and LianBio announce first patient treated in phase 2a trial of infigratinib in patients with gastric cancer and other advanced solid tumors

PALO ALTO, Calif. & SHANGHAI & PRINCETON, N.J. — (BUSINESS WIRE) — LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets, and BridgeBio Pharma, Inc. (Nasdaq: BBIO) today announced the first patient has been treated in a Phase 2a clinical trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification and other advanced solid tumors with FGFR genomic alterations.

“Infigratinib is a potent and selective FGFR inhibitor that has demonstrated compelling clinical activity across multiple tumor types with FGFR alterations,” said Yizhe Wang, Ph.D., chief executive officer of LianBio. “Given the disproportionately high prevalence rate of gastric cancer in China, LianBio is pursuing a region-specific development strategy focused on this area of great unmet need. This study marks LianBio’s first trial initiation and demonstrates our continued progress in delivering potentially transformational medicines to patients in Asia.”

TRUSELTIQ™ (infigratinib) is an oral selective inhibitor of FGFR1-3 that is approved in the United States for the treatment of patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by an FDA-approved test. It is also being further evaluated in clinical trials based on demonstration of clinical activity in patients with advanced urothelial carcinoma with FGFR3 genomic alterations. LianBio in-licensed rights from BridgeBio for infigratinib for development and commercialization in Mainland China, Hong Kong and Macau.

The Phase 2a trial is a multicenter, open-label, single-arm study in China designed to evaluate the safety and efficacy of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR alterations. The primary endpoint is objective response rate (ORR). Secondary endpoints include duration of response, safety, disease control rate, progression-free survival and overall survival.

Preclinical data have demonstrated the potential infigratinib may have for patients with gastric cancer. These results, published in Cancer Discovery, demonstrated tumor regression in multiple in vivo FGFR2 amplified gastric models.¹

“We believe that infigratinib could have a meaningful impact for people living with gastric cancer as well as many other cancers with FGFR alterations, and are pleased LianBio is initiating this clinical trial in China where more therapeutic options are needed to match the growing diagnosis rate,” said BridgeBio founder and chief executive officer Neil Kumar, Ph.D. “On the heels of TRUSELTIQ recently obtaining accelerated approval in the United States, we are hopeful that this trial will yield pivotal results in another subset of cancer patients as we continue to build our portfolio of oncology indications with the aim of reaching as many people in need as possible.”

About TRUSELTIQ™ (infigratinib)

TRUSELTIQ (infigratinib) is an orally administered, ATP-competitive, tyrosine kinase inhibitor of fibroblast growth factor receptor (FGFR) that received accelerated approval from the FDA in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. TRUSELTIQ targets the FGFR protein, blocking downstream activity. In clinical studies, TRUSELTIQ demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response. TRUSELTIQ is not FDA-approved for any other indication in the United States and is not approved for use by any other health authority, including any Chinese or other Asian health authority. It is currently being evaluated in clinical studies for first-line cholangiocarcinoma, urothelial carcinoma (bladder cancer), locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma, and other advanced solid tumors with FGFR genomic alterations.

About BridgeBio Pharma, Inc.

BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company’s first two approved therapies. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

About LianBio

LianBio’s mission is to catalyze the development and accelerate availability of paradigm-shifting medicines to patients in China and other major Asian markets, through partnerships that provide access to innovative therapeutic discoveries with a strong scientific basis and compelling clinical data. LianBio collaborates with world-class partners across a diverse array of therapeutic and geographic areas to build out a broad and clinically validated pipeline with the potential to impact patients with unmet medical needs. For more information, please visit www.lianbio.com.

About the LianBio and BridgeBio Pharma, Inc. Strategic Alliance

In August 2020, LianBio entered into a strategic alliance with BridgeBio, a commercial-stage biopharmaceutical company focused on genetic diseases and cancers with clear genetic drivers, to develop and commercialize BridgeBio’s programs in China and other major Asian markets. This strategic relationship initially focuses on two of BridgeBio’s targeted oncology drug candidates: FGFR inhibitor infigratinib, for the treatment of FGFR-driven tumors, and SHP2 inhibitor BBP-398, in development for tumors driven by MAPK pathway mutations. The agreement also provides LianBio with preferential future access in China and certain other major Asian markets to more than 20 drug development candidates currently owned or controlled by BridgeBio. This collaboration is designed to advance and accelerate BridgeBio’s programs in China and other major Asian markets, allowing BridgeBio and LianBio to potentially bring innovation to large numbers of patients with high unmet need.

BridgeBio Pharma, Inc. Forward-Looking Statements

This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act, and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to: the timing and success of the Phase 2a clinical trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification, and other advanced solid tumors with FGFR genomic alterations; the planned approval of infigratinib by foreign regulatory authorities in China and the necessary clinical trial results, and timing and completion of regulatory submissions related thereto; and the competitive environment and clinical and therapeutic potential of infigratinib; reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation: the safety, tolerability and efficacy profile of infigratinib observed to date may change adversely in ex-U.S. clinical trials, ongoing analyses of trial data or subsequent to commercialization; foreign regulatory agencies may not agree with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the continuing success of the BridgeBio and LianBio strategic alliance; and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; as well as those set forth in the Risk Factors section of BridgeBio Pharma, Inc.’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent SEC filings, which are available on the SEC’s website at www.sec.gov. Except as required by law, each of BridgeBio and QED disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. Moreover, BridgeBio and QED operate in a very competitive environment in which new risks emerge from time to time. These forward-looking statements are based on each of BridgeBio’s and QED’s current expectations, and speak only as of the date hereof.

¹Guagnano, V., Kauffman, A., Wörle, S., et al. “FGFR Genetic Alterations Predict for Sensitivity to NVP-BGJ398, a Selective Pan-FGFR Inhibitor.” Cancer Discovery 2 (2012): 1118-1133.