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Patritumab deruxtecan demonstrated clinically meaningful and durable responses in patients with EGFR-mutated metastatic non-small cell lung cancer in HERTHENA-Lung01 phase 2 trial

  • An objective response rate of 29.8% was observed with patritumab deruxtecan in heavily pretreated patients
  • BLA submission in U.S. planned for the second half of fiscal year 2023

 

 

TOKYO & BASKING RIDGE, N.J. — (BUSINESS WIRE) — Results from the HERTHENA-Lung01 phase 2 trial showed that patritumab deruxtecan (HER3-DXd) demonstrated clinically meaningful and durable responses in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) following disease progression with an EGFR TKI and platinum-based chemotherapy. These data were presented Sunday during an oral presentation (OA05.03) at the 2023 World Conference on Lung Cancer (#WCLC23) and simultaneously published in the Journal of Clinical Oncology.

 

Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo’s (TSE: 4568) proprietary DXd ADC technology.

 

NSCLC accounts for approximately 85% of all lung cancers – 55% having distant spread at diagnosis – with EGFR-activating mutations occurring in 14% to 38% of all NSCLC tumors worldwide.1,2,3 After disease progression following treatment with an EGFR TKI and platinum-based chemotherapy, currently available therapies offer limited efficacy, highlighting the need for new approaches to improve outcomes.3,4

 

A confirmed objective response rate (ORR) of 29.8% (95% CI: 23.9-36.2) was observed with patritumab deruxtecan (5.6 mg/kg) in 225 patients with EGFR-mutated NSCLC as assessed by blinded independent central review (BICR). One complete response (CR), 66 partial responses (PRs) and 99 cases of stable disease (SD) were seen. A median duration of response (DOR) of 6.4 months (95% CI: 4.9-7.8) and a disease control rate (DCR) of 73.8% (95% CI: 67.5-79.4) were observed. Median progression-free survival (PFS) was 5.5 months (95% CI: 5.1-5.9) and median overall survival (OS) was 11.9 months (95% CI: 11.2-13.1) as of snapshot data cutoff of May 18, 2023.

 

Efficacy outcomes were consistent across subgroups including a subset of 209 patients previously treated with a third-generation EGFR TKI and platinum-based chemotherapy. Anti-tumor activity with patritumab deruxtecan was observed across diverse mechanisms of EGFR TKI resistance and across a broad range of pretreatment tumor HER3 membrane expression.

 

In a subset of 30 patients with brain metastases at baseline and no prior radiotherapy treatment, an intracranial ORR of 33.3% (95% CI: 17.3-52.8%) was observed as assessed by central nervous system (CNS) BICR. In these patients, nine intracranial CRs, one intracranial PR and 13 cases of SD were seen. A CNS DOR of 8.4 months (95% CI: 5.8-9.2) was observed.

 

“The results from HERTHENA-Lung01 provide compelling evidence of efficacy of patritumab deruxtecan in heavily pretreated patients with advanced EGFR-mutated non-small cell lung cancer,” said Helena Yu, MD, Associate Attending Physician, Memorial Sloan Kettering Cancer Center. “The clinically meaningful efficacy observed across a broad range of HER3 expression and diverse mechanisms of EGFR TKI resistance as well as the anti-tumor activity seen in patients with brain metastases, underscore the potential of patritumab deruxtecan to become an important treatment option for a population of patients with lung cancer who have limited treatment options.”

 

“Disease progression is inevitable in patients with previously treated and relapsed metastatic EGFR-mutated non-small cell lung cancer, reinforcing the need for new and innovative treatments across diverse mechanisms of resistance,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “The results from HERTHENA-Lung01, coupled with early trial results, show that patritumab deruxtecan demonstrates clinically meaningful and durable responses, illustrating the potential of this HER3 directed antibody drug conjugate to become a new standard of care for this patient population with high unmet medical need. These data will support our ongoing discussions with health authorities including our planned submission in the U.S.”

 

The safety profile of patritumab deruxtecan observed in HERTHENA-Lung01 was consistent with previous clinical trials with a low rate (7.1%) of treatment discontinuation due to treatment-emergent adverse events (TEAEs) at the time of primary data cutoff of November 21, 2022. Grade 3 or higher TEAEs occurred in 64.9% of patients. The most common (>5%) grade 3 or higher TEAEs were thrombocytopenia (21%), neutropenia (19%), anemia (14%), leukopenia (10%), fatigue (6%), hypokalemia (5%) and asthenia (5%). Twelve patients (5.3%) had confirmed treatment-related interstitial lung disease (ILD) as determined by an independent adjudication committee. The majority of ILD events were low grade with one grade 1 event and eight grade 2 events. Two grade 3, zero grade 4 and one grade 5 ILD event were observed.

 

In HERTHENA-Lung01, 51% of patients (n=115) had a history of CNS metastases; 32% (n=72) and 33% of patients (n=75) had brain or liver metastases at baseline by BICR, respectively. In the trial, 63% (n=142) and 36% (n=82) of patients had either an EGFR exon 19 deletion or exon 21 L858R mutation detected at baseline, respectively, and one patient had both.

 

Patients were heavily pretreated receiving a median of three prior lines of systemic therapy in the locally advanced/metastatic setting (range, 1-11), including platinum-based chemotherapy (100%), third generation EFGR TKI (93%) and immunotherapy (40%). As of the snapshot data cutoff of May 18, 2023, the median trial duration was 18.9 (14.9-27.5) months, and 13 patients were continuing to receive patritumab deruxtecan.

 

Summary of HERTHENA-Lung01 Results

Efficacy Measure

Prior treatment with any EGFR TKI and platinum-based chemotherapy

n=225

Subset with prior treatment with third-generation EGFR

TKI and platinum-based chemotherapy

n=209

Confirmed ORR, % (95% CI)

29.8% (23.9-36.2)

29.2.% (23.1-35.9)

CR, n (%)

1 (0.4%)

1 (0.5%)

PR, n (%)

66 (29.3%)

60 (28.7%)

SD, n (%)

99 (44.0%)

91 (43.5%)

PD, n (%)

43 (19.1%)

41 (19.6%)

NE, n (%)

16 (7.1%)

16 (7.7%)

DCR (95% CI), %

73.8% (67.5-79.4)

72.7% (66.2-78.6)

DOR, median (95% CI), months

6.4 months (4.9-7.8)

6.4 months (5.2-7.8)

PFS, median (95% CI), months

5.5 months (5.1-5.9)

5.5 months (5.1-6.4)

OS, median (95% CI), months

11.9 months (11.2-13.1)

11.9 months (10.9-13.1)

CR, complete response; DCR, disease control rate; DOR, duration of response; NE, not evaluable; ORR, objective response rate; OS, overall survival; PR, partial response; PFS, progression-free survival; PD, progressive disease; SD, stable disease.

 

About HERTHENA-Lung01

HERTHENA-Lung01 is a global, multicenter, open-label, two-arm phase 2 trial evaluating the safety and efficacy of patritumab deruxtecan in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR TKI and platinum-based chemotherapy. Patients were randomized 1:1 to receive 5.6 mg/kg (n=225) or an uptitration regimen (n=50). The uptitration arm was discontinued as the dose of 5.6 mg/kg of patritumab deruxtecan was selected following a risk-benefit analysis conducted from the phase 1 trial assessing the doses in a similar patient population.

 

The primary endpoint of HERTHENA-Lung01 was ORR as assessed by BICR. Secondary endpoints included duration of response, PFS, disease control rate, and time to response – all assessed by both BICR and investigator assessment – as well as investigator-assessed ORR, OS, safety and tolerability.

 

The data presented at WCLC is from the first arm and based on the fixed-dose (5.6 mg/kg) regimen.

 

HERTHENA-Lung01 enrolled patients in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

 

About EGFR-Mutated Non-Small Cell Lung Cancer

Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide.5 NSCLC accounts for approximately 85% of all lung cancers – 55% having distant spread at diagnosis – with EGFR mutations occurring in 14% to 38% of all NSCLC tumors worldwide.1,2,3

 

The introduction of targeted therapies has improved the treatment landscape for patients with EGFR-mutated locally advanced or metastatic NSCLC. Targeted therapy with EGFR TKIs offers higher response rates, PFS and potential OS advantage, compared to chemotherapy, with third generation EGFR TKIs demonstrating superior efficacy compared to earlier generation inhibitors.1 However, disease progression from resistance to EGFR TKIs inevitably occurs one to two years following initial treatment.6

 

After failure of EGFR TKI and platinum-based chemotherapy, currently available therapies offer limited efficacy.3,4 A recent real-world analysis of the treatment of patients in this setting showed that the median PFS in this setting is 3.3 months (95% CI: 2.8-4.4) and median OS is 8.6 months (95% CI: 7.4-9.8). An estimated real-world ORR of 14.1% (95% CI: 3.7%-33.1%) also has been observed.7,8 New treatment approaches are needed to help improve clinical outcomes in patients with EGFR-mutated NSCLC.

 

About HER3

HER3 is a member of the EGFR family of receptor tyrosine kinases.9 It is estimated that about 83% of primary NSCLC tumors and 90% of advanced EGFR-mutated tumors express HER3 after prior EGFR TKI treatment.10,11 There is currently no HER3 directed therapy approved for the treatment of any cancer.

 

About Patritumab Deruxtecan

Patritumab deruxtecan (HER3-DXd) is an investigational HER3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, patritumab deruxtecan is composed of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

 

Patritumab deruxtecan was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in December 2021 for the treatment of patients with EGFR-mutated locally advanced or metastatic NSCLC with disease progression on or after treatment with a third-generation TKI and platinum-based therapies.

 

Patritumab deruxtecan is currently being evaluated as both a monotherapy and in combination with other therapies in a global development program, which includes HERTHENA-Lung02, a phase 3 trial versus platinum-based chemotherapy in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression on or after treatment with a third-generation EGFR TKI; a phase 1 trial in combination with osimertinib in EGFR-mutated locally advanced or metastatic NSCLC; and a phase 1 trial in previously treated patients with advanced NSCLC. A phase 1/2 trial in HER3 expressing metastatic breast cancer also has been completed.

 

About the DXd ADC Portfolio of Daiichi Sankyo

The DXd ADC portfolio of Daiichi Sankyo currently consists of six ADCs in clinical development across multiple types of cancer. ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, are being jointly developed and commercialized globally with AstraZeneca. Four additional Daiichi Sankyo DXd ADCs include patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd; DS-7300), a B7-H3 directed ADC, raludotatug deruxtecan (R-DXd; DS-6000), a CDH6 directed ADC, and DS-3939, a TA-MUC1 directed ADC.

 

Designed using Daiichi Sankyo’s proprietary DXd ADC technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

 

Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan and DS-3939 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

 

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com.

 

Disclosure: Dr. Yu has a consulting relationship with Daiichi Sankyo.

______________________

References:

1 Economopoulou P, et al. Ann Transl Med. 2018; 6(8):138.

2 Chen R, et al. J Hematol Oncol. 2020; 13(1):58.

3 Zhang Y-L, et al. Oncotarget. 2016; 7(48):78985-78993.

4 Janne PA, et al. Cancer Discov. 2022; 12(1):74-89.

5 World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Accessed January 2023.

6 Janne PA, et al. N Engl J Med 2015; 372:1689-1699.

7 Patel JD, et al. AACR 2023. Poster 6754.

8 Patel JD, et al. IASLC 2023 WCLC. Abstract 2201.

9 Mishra R, et al. Oncol Rev. 2018; 12(355):45-62.

10 Scharpenseel H, et al. Scientific Reports. 2019; 9:7406.

11 Yonesaka K, et al. Clin Cancer Res. 2022; 15:28(2):390-403.

Contacts

Global/US:
Jennifer Brennan

Daiichi Sankyo, Inc.

jbrennan2@dsi.com
+1 908 900 3183 (mobile)

Japan:
Koji Ogiwara

Daiichi Sankyo Co., Ltd.

ogiwara.koji.ay@daiichisankyo.co.jp
+81 3 6225 1126 (office)

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

Categories
Business Culture

Optimum announces Vic Pascarelli as Vice President, General Manager of Northeast Area

Pascarelli now leads local sales, operations, and engagement efforts across Optimum’s New York, New Jersey, and Connecticut footprint

 

BETHPAGE, N.Y. — (BUSINESS WIRE) — Optimum, the local provider of internet, mobile, TV, and phone services, today announces the appointment of Vic Pascarelli as Vice President, General Manager of the company’s Northeast Area serving New York, New Jersey, and Connecticut.

As Vice President, General Manager, Pascarelli is responsible for overseeing local sales, operations, and engagement efforts across the area, ensuring best-in-class service and support to the more than 240 communities Optimum serves across the Northeast Area.

 

“It’s an honor to join Optimum at this exciting time in the company’s history,” said Vic Pascarelli, Vice President, General Manager of Optimum Northeast. “I’m looking forward to leaning into the unique needs of customers throughout Optimum’s footprint in the Northeast and guiding local teams in our efforts to deliver the very best in service and support as we cement Optimum as the connectivity provider of choice across every community we serve.”

 

Pascarelli joins Optimum after a 20-year career with Comcast, where he held a variety of senior sales, marketing, and operations leadership roles in markets across the company’s footprint. Prior to his time with Comcast, Pascarelli was the Director of Marketing for the Au Bon Pain Corporation, and earlier in his career, spent time at Continental Cablevision and American Cablesystems in various GM, sales, and marketing positions.

 

“I’m thrilled to welcome Vic to Optimum as Vice President, General Manager of our Northeast Area,” said William Sweeney, Senior Vice President, Optimum. “Vic is an industry veteran and a skilled and experienced leader who brings with him decades of knowledge and expertise that will be invaluable to Optimum as the company takes on a renewed regional, local, and hyperlocal approach to bringing the best connectivity solutions to customers throughout the Northeast Area.”

 

Pascarelli is based out of the company’s Bethpage, New York offices.

 

About Optimum

Optimum is a brand of Altice USA, one of the largest broadband communications and video services providers in the United States, delivering broadband, video, and mobile services to approximately 4.8 million residential and business customers across 21 states. The company operates a4, an advanced advertising and data business, which provides audience-based, multiscreen advertising solutions to local, regional and national businesses and advertising clients. Altice USA also offers hyper-local, national, international and business news through its News 12, Cheddar News and i24NEWS networks.

Contacts

Raffaella Mazzella: +1 561-817-5813

Raffaella.mazzella@alticeusa.com

Erin Smyth: +1 917-565-2480

Erin.smyth@alticeusa.com

Categories
Business Economics Lifestyle Regulations & Security

AM Best upgrades credit ratings of Assurant, Inc. and its property/casualty subsidiaries; affirms credit ratings of its life/health subsidiaries

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has upgraded the Financial Strength Rating (FSR) to A+ (Superior) from A (Excellent) and the Long-Term Issuer Credit Ratings (Long Term ICR) to “aa-” (Superior) from “a+” (Excellent) of the U.S. property/casualty (P/C) subsidiaries of Assurant, Inc. (Assurant) (headquartered in Atlanta, GA) [NYSE: AIZ].

 

These companies are collectively referred to as Assurant P&C Group (Assurant P&C). At the same time, AM Best has upgraded the Long-Term ICR to “a-” (Excellent) from “bbb+” (Good) and all associated Long-Term Issue Credit Ratings (Long-Term IR), indicative Long-Term IRs and the Short-Term IR of Assurant. The outlooks of all the above Credit Ratings (ratings) have been revised to stable from positive. (See below for a detailed list of the companies and Long- and Short-Term IRs.)

 

Concurrently, AM Best has affirmed the FSR of A (Excellent) and the Long-Term ICRs of “a” (Excellent) of Assurant’s credit and life/health (L/H) subsidiaries: American Bankers Life Assurance Company of Florida (Miami, FL) and Caribbean American Life Assurance Company (San Juan, PR) collectedly known as Assurant Lifestyle. The outlook of these ratings is stable.

 

The ratings of Assurant P&C’s reflect balance sheet strength, which AM Best assesses as very strong, as well as its strong operating performance, favorable business profile and appropriate enterprise risk management (ERM).

 

The rating upgrades of Assurant P&C reflect an improved assessment of the group’s balance sheet strength, which is currently assessed at very strong and is supported by risk-adjusted capitalization at the strongest level. This enhanced view of balance sheet strength also considers the group’s very strong earnings power, strong positive cash flows and new capital formation–the majority of which is derived from low-risk businesses, with limited volatility. Assurant’s property catastrophe exposure, which stems mostly from its lender placed homeowners’ business in global housing, is well-managed and adequately reinsured. Assurant’s operating performance has also benefited from earnings diversification and management’s strategy to partner with market leaders. As a result, Assurant P&C consistently outperformed its peers and generated superior returns on capital.

 

The ratings of Assurant Lifestyle reflect its balance sheet strength, which AM Best assesses as very strong, as well as its strong operating performance, limited business profile and appropriate ERM. Assurant Lifestyle also receives one level of rating enhancement from its affiliate, Assurant P&C, as it is considered important to the Assurant brand as a licensed credit life and credit accident & health insurer business.

 

The FSR has been upgraded to A+ (Superior) from A (Excellent) and the Long-Term ICRs to “aa-” (Superior) from “a+” (Excellent) with outlooks revised to stable from positive for the following P/C subsidiaries of Assurant, Inc.:

  • American Bankers Insurance Company of Florida
  • American Security Insurance Company
  • Standard Guaranty Insurance Company
  • Caribbean American Property Insurance Company
  • Voyager Indemnity Insurance Company
  • Virginia Surety Company, Inc.
  • Reliable Lloyds Insurance Company

 

The following Short-Term IR has been upgraded:

Assurant, Inc.—

— to AMB-1+ (Strongest) from AMB-1 (Outstanding) on commercial paper

The following Long-Term IRs have been upgraded, with outlooks revised to stable from positive:

Assurant, Inc.—

— to “a-” (Excellent) from “bbb+” (Good) on USD 300 million 4.90% senior unsecured bonds, due 2028

— to “a-” (Excellent) from “bbb+” (Good) on USD 300 million 4.20% senior unsecured bonds, due 2023 (USD $50 million outstanding)

— to “a-” (Excellent) from “bbb+” (Good) on USD 350 million 3.70% senior unsecured bonds, due 2030

— to “a-” (Excellent) from “bbb+” (Good) on USD 475 million 6.75% senior unsecured bonds, due 2034 (USD 275 million outstanding)

— to “bbb+” (Good) from “bbb” (Good) on USD 400 million 7.00% subordinated bonds, due 2048

— to “bbb+” (Good) from “bbb” (Good) on USD 250 million 5.25% subordinated bonds, due 2061

The following indicative Long-Term IRs on securities available under the shelf registration have been upgraded, with outlooks revised to stable from positive:

Assurant, Inc.—

— to “a-” (Excellent) from “bbb+” (Good) on senior unsecured

— to “bbb+” (Good) from “bbb” (Good) on subordinated debt

— to “bbb” (Good) from “bbb-” (Good) on preferred stock

 

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 © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Jieqiu Fan
Associate Director
+1 908 882 1762
jieqiu.fan@ambest.com

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

Daniel J. Ryan
Senior Director
+1 908 882 2290
daniel.ryan@ambest.com

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

Jeffrey Lane
Senior Financial Analyst
+1 908 882 1994
jeffrey.lane@ambest.com

Categories
Business Culture Economics International & World Lifestyle Regulations & Security Technology

Agam Capital advises PFI in its formation and launch of Prismic Life Reinsurance, Ltd.

TEANECK, N.J. & NEWARK, N.J. & HAMILTON, Bermuda — (BUSINESS WIRE) — Agam Capital “(Agam),” an analytics driven platform strategically partnering with insurance companies to explore opportunities to enhance their financial flexibility, is advising Prudential Financial, Inc. “(PFI),” a US-based global financial services leader and premier active global investment manager, in the formation and launch of Prismic Life Reinsurance, Ltd. “(Prismic),” a Bermuda-domiciled Class E life and annuity reinsurer.

 

This strategic engagement leveraged Agam’s unique pALM analytical platform and differentiated capabilities to support PFI in the development and establishment of a differentiated new entrant to the vibrant and fast-growing market for life and retirement reinsurance solutions in Bermuda.

 

Separately, Agam and Prismic have entered into a long-term Management Services Agreement “(MSA)” whereby Agam will continue to leverage its industry-leading asset and liability management and enterprise risk management expertise to support Prismic and its future growth.

 

Agam’s Co-Founders, Chak Raghunathan and Avi Katz, said, “The launch of Prismic is a milestone event in the continued growth of the Bermuda reinsurance market. We are thrilled to have been a key part of PFI’s strategic process in the exploration, diligence and launch of Prismic and are excited for our future engagement working with Prismic CEO Amy Kessler and her team to continue to build Prismic into one of the leading Bermuda-based reinsurance platforms.”

 

Robert Falzon, vice chair of PFI, said: “Agam played a critically important role in the creation of Prismic, providing third-party integrated asset, liability, capital, and risk analytical tools that greatly facilitated decision-making throughout the process. We are excited that Agam will partner with Prismic going forward to enable the platform to grow, and in support of PFI’s vision to be a global leader in expanding access to investing, insurance, and retirement security.”

 

About Agam Capital

Agam was founded in 2016 by Avi Katz and Chak Raghunathan with the vision to create a cutting edge differentiated analytical platform. The execution towards this vision continued with the development of pALM, Agam’s proprietary asset and liability management (ALM) system. Offering the only end-to-end enterprise wide risk and capital analytic solution, Agam empowers strategic decision makers towards their capital optimization goals. With a fully embedded dynamic strategic asset allocation (SAA) and enterprise risk management (ERM) infrastructure, pALM supports Agam’s ability to offer one stop, turnkey insurance solutions.

 

Agam’s team of experts have a global reach with offices in the USA, Canada, Bermuda and India. In addition, Agam ISAC Bermuda, which offers a comprehensive suite of operational, management and governance services to Bermuda based reinsurers, is fully licensed as a Class E insurer by the Bermuda Monetary Authority (BMA).

 

About PFI

Prudential Financial, Inc. (NYSE:PRU), a US-based global financial services leader and premier active global investment manager with approximately $1.4 trillion in assets under management as of June 30, 2023, has operations in the United States, Asia, Europe and Latin America. PFI’s diverse and talented employees help makes lives better and create financial opportunity for more people by expanding access to investing, insurance, and retirement security. PFI’s iconic Rock symbol has stood for strength, stability, expertise, and innovation for nearly 150 years. For more information, please visit news.prudential.com.

 

PFI Forward-Looking Statements

Certain of the statements included in this release, such as those regarding the launch of Prismic, reinsurance transactions involving Prismic, the provision of asset management services to Prismic, the anticipated increase in PFI’s underwriting capabilities, equity investments in Prismic by global investors and other institutions, the leadership and operation of Prismic following its launch, and the impact of Prismic on PFI’s business and strategy, constitute forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Words such as “expects,” “believes,” “anticipates,” “includes,” “plans,” “assumes,” “estimates,” “projects,” “intends,” “should,” “will,” “shall” or variations of such words are generally part of forward-looking statements. PFI’s forward-looking statements are made based on management’s current expectations and beliefs concerning future developments and their potential effects upon PFI and its subsidiaries. There can be no assurance that future developments affecting PFI and its subsidiaries will be those anticipated by management. These forward-looking statements are not a guarantee of future performance and involve risks and uncertainties, and there are certain important factors that could cause actual results to differ, possibly materially, from expectations or estimates reflected in such forward-looking statements. Certain important factors that could cause actual results to differ, possibly materially, from expectations or estimates reflected in such forward-looking statements can be found in the “Risk Factors” and “Forward-Looking Statements” sections included in PFI’s Annual Report on Form 10-K. PFI does not undertake to update any particular forward-looking statement included in this document.

 

Prudential Financial, Inc. of the United States is not affiliated in any manner with Prudential plc, headquartered in the United Kingdom, or the Prudential Assurance Company, a subsidiary of M&G plc, headquartered in the United Kingdom.

Contacts

Chak Raghunathan | Co-Founder, Managing Partner

Agam Capital Management, LLC

craghunathan@agamcapital.com

Laura Edling | Director, Financial Communications

PFI

laura.edling@prudential.com

Categories
Business

AM Best Downgrades Credit Ratings of Dentegra Seguros Dentales, S.A. and Places Credit Ratings Under Review With Negative Implications

MEXICO CITY–(BUSINESS WIRE)–AM Best has downgraded the Financial Strength Rating to B++ (Good) from A (Excellent), the Long-Term Issuer Credit Rating to “bbb+” (Good) from “a+” (Excellent) and the Mexico National Scale Rating to “aa+.MX” (Superior) from “aaa.MX” (Exceptional) of Dentegra Seguros Dentales, S.A. (DSD) (Mexico). Concurrently, AM Best has placed these Credit Ratings (ratings) under review with negative implications. These rating actions follow the recent announcement of the acquisition of DSD by Auna S.A.A. (Auna), a Peruvian health-focused company.

Prior to these rating actions, DSD was a member of Dentegra Group, Inc.’s association with Delta Dental companies (Dentegra Group) and deemed by AM Best to be a strategically important subsidiary. On Feb. 1, 2023, Auna announced that it had acquired 100% ownership of DSD. Due to this event, DSD is no longer affiliated with Dentegra Group; therefore, AM Best has removed its group status.

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

DSD’s risk-adjusted capitalization stands at the strongest level, as measured by Best’s Capital Adequacy Ratio (BCAR). The company has a conservative investment strategy in place, paired with strong underwriting practices, which have allowed it to historically report positive bottom-line results. DSD is a market leader in the relatively small dental segment within Mexico’s insurance industry and is concentrated in two products, dental and vision insurance.

With the change in ownership, the company no longer benefits from being integrated with Dentegra Group, Inc., which brought operational leverage through common systems, procedures and ERM practices. AM Best requires further information regarding DSD ‘s new shareholders to fully assess the impact that the change in ownership could potentially have in DSD ratings.

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 © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Inger Rodriguez
Associate Financial Analyst
+52 55 1102 2720, ext. 108
inger.rodriguez@ambest.com

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

Elí Sánchez
Associate Director, Analytics
+52 55 1102 2720, ext. 122
eli.sanchez@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

Categories
Business Culture Economics

DLA, LLC announces hiring of managing director, Maria Golenkov

FAIRFIELD, N.J. — (BUSINESS WIRE) — DLA, LLC (DLA), a leading provider of internal audit and accounting advisory services, is delighted to announce the addition of Maria Golenkov as Managing Director, Internal Audit.

 

With a career of successes performing operational consulting, IPO readiness, SOX implementations, and enterprise risk assessments for Business Development Companies (BDCs) and Financial Services companies. Maria brings a wealth of expertise to fortify DLA’s impactful portfolio.

 

Maria’s niche lies in her strategic focus on BDCs, private equity, credit, real estate investment trusts, hedge funds, and global alternative asset management. Her seasoned background has consistently propelled her clients toward excellence in a dynamic landscape.

 

Before joining DLA, Maria held the position of Director at a prominent Big Four Accounting firm. In this role, she navigated clients through the terrain of public company corporate governance requirements for NYSE and NASDAQ. Her guidance allowed asset managers’ seamless transition from private to public, ensuring adherence to the standards of SOX 404. Maria’s experience extended to the streamlining of business processes and systems, accomplished through innovative automation and the expansion of existing applications.

 

“Maria is an exemplary audit and risk management leader, celebrated for her transformative initiatives and the orchestration of high-performing teams,” commented Phil Ramacca, President & CFO at DLA. “Her exceptional experience perfectly equips her for the role of Managing Director, Internal Audit.”

 

Maria’s arrival underscores the firm’s commitment to excellence and growth. Maria’s alignment with DLA’s values and her capacity to steer transformational change make her an invaluable asset to the firm and its clients alike. As Managing Director, Internal Audit, Maria is set to elevate DLA’s impact and reinforce its reputation for excellence in the realm of audit and advisory services.

 

About DLA, LLC

Founded in 2001, DLA provides internal audit and accounting advisory services to hundreds of clients. DLA’s leadership team averages 30+ years of experience and is led by Big Four veterans with deep industry expertise. DLA specializes in internal audit, accounting advisory, forensic accounting, valuation and litigation support, tax, risk management, and IT advisory services. The company is headquartered in Fairfield, New Jersey.

 

For further information about DLA, LLC, please visit us at www.dlallc.com.

 

Contacts

Danielle Dietrich, Managing Director of Human Resources & Administration, 973.575.1565

Categories
Healthcare Lifestyle Programs & Events Science

MTF Biologics receives Mission Plasticos’ Annual Humanitarian Award for its work in reconstructive surgery

Emmy-Winning Producer Lorna Luft joins the event to share her story right before Breast Cancer Awareness Month

 

EDISON, N.J. — (BUSINESS WIRE) — MTF Biologics will receive the 2023 Corporate Humanitarian Award at Mission Plasticos’ annual Celebration of Global Friendships: Emerald City event on Sept. 9, 2023, in Newport Beach, Calif.

 

Mission Plasticos has been transforming lives on a global and local scale in communities in need over the last 24 years – providing reconstructive surgery, training local medical professionals, and supporting ongoing research focused on improving standards of care.

 

All of this is made possible by the goodwill of its medical volunteers and longtime philanthropic supporters such as MTF Biologics which provides allograft tissue free of charge to support Mission Plasticos’ efforts ensuring all women have access to reconstructive surgery regardless of their economic situation.

 

“At MTF Biologics, we are committed to advancing healthcare through innovative solutions and impactful collaborations, and are proud of our work with Mission Plasticos, an organization that shares our vision of making a positive difference in the world,” said Joe Yaccarino, CEO of MTF Biologics.

 

“As the 2023 Corporate Humanitarian Honoree, we are truly honored to be recognized for our efforts. Together we are addressing the challenges to improve the lives of women during their difficult journey with breast cancer, empowering them to lead healthier, happier, and more fulfilling lives.”

 

This year, Emmy-winning TV producer, Broadway Star, and daughter of legendary actress Judy Garland, Lorna Luft, will be in attendance and share her breast cancer journey. Lorna is thrilled to participate in this celebration as she was diagnosed in 2012 with Stage 2 breast cancer. She is honored to share her story and be an advocate for equity in women’s healthcare.

 

“Mission Plasticos is thrilled to honor MTF Biologics at our upcoming gala for their unwavering support of our mission and our patients,” said Susan Williamson, Executive Director at Mission Plasticos. “Without corporations like MTF Biologics and their philanthropic investments, we would not be able to provide treatment to as many patients as we currently do. Their dedication to ensuring that every woman receives a full journey of care is a quality that we at Mission Plasticos deeply appreciate and for which we are immensely grateful.”

 

About Mission Plasticos

Founded in 1999 by renowned plastic surgeon Dr. Larry Nichter, Mission Plasticos is a 501-c3 non-profit organization dedicated to providing reconstructive surgery to those in need. It provides training to local medical professionals, and supports ongoing research focused on improving standards of care. The group’s board-certified, volunteer surgeons and medical teams provide reconstructive breast surgery for post-mastectomy women, burn contracture surgery, as well as post traumatic, congenital deformity, and other reconstructive surgical care at no cost to patients. Over the last two decades, Mission Plasticos has completed more than 100 missions in 15 countries, trained more than 5,000 doctors, and treated more than 16,000 patients.

 

In 2022 Mission Plasticos launched Reshaping Lives: Full Circle—the first large-scale nationwide program providing no-cost breast reconstruction surgery for post-mastectomy women in the U.S. who are uninsured or underinsured. Mission Plasticos provides this care using volunteer board-certified plastic surgeons across the country who are experts in breast reconstruction. Part of Mission Plasticos broader Reshaping Lives America program, Reshaping Lives: Full Circle is based on the success of Mission Plasticos global work over the last 23 years and its pioneering domestic work in California since 2016. For more information, visit https://missionplasticos.org.

 

About MTF Biologics

MTF Biologics is a global nonprofit organization that saves and heals lives by honoring donated gifts, serving patients and advancing science. It provides exceptional service, resources, and expertise to donors and their loved ones who give the gift of donation; patients who depend on tissue and organ transplants; healthcare providers who care for donors and recipients; and clinicians and scientists advancing medicine through transplantation science and research.

 

The International Institute for the Advancement of Medicine (IIAM), a Division of MTF Biologics, honors donors of non-transplantable organs by providing their gifts to the medical research community to combat and cure diseases. Statline, also a Division of MTF Biologics, provides specialized communications and technology expertise to organ, tissue, and eye procurement organizations, as well as the hospitals and patients that they serve. Its sister organization, Deutsches Institute for Zell-und Gewebeersatz – DIZG (The German Institute for Cell and Tissue Transplantation) expands its reach to patients across the globe. For more information, visit www.mtfbiologics.org.

Contacts

Aleksa Loch, 847-345-1348 or aleksa.loch@finnpartners.com

Categories
Business Economics Lifestyle Regulations & Security

AM Best affirms credit ratings of British Caribbean Insurance Company Limited

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has affirmed the Financial Strength Rating of B++ (Good) and the Long-Term Issuer Credit Rating of “bbb” (Good) of British Caribbean Insurance Company Limited (BCIC) (Jamaica). The outlook of these Credit Ratings (ratings) is stable.

 

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

 

BCIC’s balance sheet strength assessment is derived from the company’s risk-adjusted capitalization being at the strongest level, as measured by Best’s Capital Adequacy Ratio (BCAR), partially offset by the company’s high reinsurance dependence to protect its surplus and earnings in the event of major catastrophe events. The balance sheet strength assessment also reflects BCIC’s strategically liquid investment portfolio, which is primarily composed of government of Jamaica short-term repurchase agreements, fixed-income securities, and cash and cash equivalents.

 

BCIC has a history of consistent earnings supported by underwriting gains, fee income and investment income, resulting in solid profitability metrics as demonstrated by its five-year average return results. Overall earnings in 2022 were primarily driven by reinsurance commissions, as well as strong investment income, which offset a net underwriting loss for the year. Effective Jan. 1, 2022, BCIC entered into a new motor quota share treaty, which resulted in increased operating expenses driven by one-off costs; however, this was offset by the related ceding commissions associated with the treaty.

 

AM Best views the company’s business profile as limited. The company generates the bulk of its business in its domicile of Jamaica, while also operating in Turks and Caicos, and Barbados. BCIC operates in highly competitive markets and offers an array of insurance products through its branches and agents, including commercial and residential property, as well as automobile coverages. Given BCIC’s geographic concentration in the Caribbean, the company has significant exposure to weather-related events. Like many property/casualty insurers operating in the Caribbean, BCIC cedes a significant portion of its written premiums to reinsurers under its reinsurance treaties.

 

BCIC’s ERM is considered appropriate. The company has an established risk management framework that supports the achievement of the organization’s objectives by addressing the full spectrum of its risks and managing the combined impact of those. AM Best anticipates that the company’s risk management capabilities and comprehensive reinsurance program will continue to support BCIC’s overall rating assessment.

 

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 © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

 

Contacts

Anthony Molinaro
Senior Financial Analyst

+1 908 882 2129
anthony.molinaro@ambest.com

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

Ricardo Longchallon
Senior Financial Analyst
+1 908 882 2019
ricardo.longchallon@ambest.com

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

Categories
Business Healthcare Lifestyle Local News Science

Church & Dwight webcasts presentation at the 2023 Barclays Global Consumer Staples Conference

EWING, N.J. — (BUSINESS WIRE) — Church & Dwight Co., Inc. (NYSE: CHD) will present at the 2023 Barclays Global Consumer Staples Conference on Tuesday, Sept. 5, 2023 at 11:15 a.m. ET. A link to the broadcast will be provided through the Investors section of Church & Dwight’s website at http://investor.churchdwight.com/investors/news-events.

 

Church & Dwight Co., Inc. manufactures and markets a wide range of personal care, household and specialty products under the ARM & HAMMER brand name and other well-known trademarks.

 

Church & Dwight Co., Inc. (NYSE: CHD) founded in 1846, is the leading U.S. producer of sodium bicarbonate, popularly known as baking soda. The Company manufactures and markets a wide range of personal care, household, and specialty products under recognized brand names such as ARM & HAMMER®, TROJAN®, OXICLEAN®, SPINBRUSH®, FIRST RESPONSE®, NAIR®, ORAJEL®, XTRA®, L’IL CRITTERS® and VITAFUSION®, BATISTE®, WATERPIK®, ZICAM®, THERABREATH® and HERO®. These fourteen key brands represent approximately 85% of the Company’s products sales. For more information, visit the Company’s website.

 

Contacts

Rick Dierker

609-806-1900

Categories
Business Lifestyle Regulations & Security

AM Best to participate at 2023 Casualty Loss Reserve Seminar

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best Director Steven Chirico will speak on a panel, titled, “Rating Agency & Investor Views of Insurer Financial Condition” on Tuesday, Sept. 12, at 10:00 a.m. (EDT) at the 2023 Casualty Loss Reserve Seminar, which will take place Sept. 11-13, 2023, in Orlando, FL.

 

During the presentation, Chirico will discuss AM Best’s views on insurance company financial strength. The session will introduce approaches to assessing and assigning a value to the financial condition of insurance companies in today’s marketplace, as well as provide participants an opportunity to ask questions. Chirico is a licensed certified public accountant and is responsible for managing a team of AM Best analysts with portfolios of commercial and alternative risk insurers and reinsurers.

 

The seminar is hosted by the Casualty Actuarial Society and the American Academy of Actuaries. The Casualty Actuarial Society is a credentialing and professional education organization focused on property/casualty risks. The American Academy of Actuaries advocates for public policy positions and sets professional standards for actuaries. For more about the seminar, please visit the event page.

 

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 © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

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