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

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

 

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Use of Trademarks

Stelara® is a registered trademark of Johnson & Johnson.

Humira® is a registered trademark of AbbVie Biotechnology Ltd.

 

About Alvotech

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

 

About Teva

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

 

INDICATIONS FOR SELARSDI (ustekinumab-aekn)

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

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

 

IMPORTANT SAFETY INFORMATION

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

Infections

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

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

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

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

 

Theoretical Risk for Vulnerability to Particular Infections

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

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

 

Pre-Treatment Evaluation of Tuberculosis (TB)

Evaluate patients for tuberculosis prior to initiating treatment with SELARSDI.

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

 

Malignancies

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

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

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

 

Hypersensitivity Reactions

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

 

Posterior Reversible Encephalopathy Syndrome (PRES)

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

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

 

Immunizations

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

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

 

Noninfectious Pneumonia

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

 

ADVERSE REACTIONS

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

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

 

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

Please click here for full Prescribing Information for SELARSDI.

 

ALVOTECH Forward Looking Statements

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

 

TEVA Cautionary Note Regarding Forward Looking Statements

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

 

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

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

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

 

Contacts

ALVOTECH
Investor Relations and Global Communications
Benedikt Stefansson, Senior Director

alvotech.ir@alvotech.com

TEVA

IR Contacts

Ran Meir

+1 (267) 468-4475

Yael Ashman

+972 (3) 914 8262

Sanjeev Sharma

+1 (973) 658 2700

Media Contacts

Kelley Dougherty

+1 (973) 832-2810

Yonatan Beker

+1 (973) 264-7378

Eden Klein

+972 (3) 906 2645

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

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

 

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

 

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

 

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

 

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

 

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

 

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

 

About idPair:

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

Contacts

Media:

media@idpair.com

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Applications now open for Mercer County Student Internship Program

MERCER COUNTY — Applications are now open for the 2024 Mercer County Student Internship Program.

High school and college students who live, or attend school, in Mercer County may apply to a wide range of full-time and part-time internship positions. Internship opportunities are available over the summer from June through Labor Day, with a limited number of spots also available over the Winter Break and Spring Break periods.

“I’m excited for the Mercer County Student Internship Program to return this year,” said County Executive Dan Benson. “These positions offer us an opportunity to engage our next generation of leaders in the important work of county government. We all benefit from the energy and enthusiasm that they bring to the work.”

Students in the program will have the opportunity to serve the public by assisting the core day-to-day work of a department or division within the Mercer County government, while acquiring valuable experience for their future careers. Participants will also benefit from a series of activities planned by the Office of Personnel, curated to teach valuable skills, enhance workforce preparedness, and provide information about career paths in public service.

Interested students can visit the Mercer County website to apply, find information on the program, and read details on available positions.

College students will be paid $17/hour and high school students will earn $15.14/hour. All applicants must be at least 15 years of age. Students seeking to earn credits for their college or university have the option of working without pay.

The application deadline for Summer Student Internships is May 3

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

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TD Bank announces Matt Boss as head of US Consumer Banking

CHERRY HILL, N.J. — (BUSINESS WIRE) — $TD #banking—TD Bank, America’s Most Convenient Bank®, recently elevated Matthew (Matt) Boss to Head of U.S. Consumer Banking. In his expanded role, Boss is responsible for TD’s more than 1,100 store locations, contact centers, digital sales and capabilities, retail operations, U.S. Wealth, and TD Auto Finance, while continuing to oversee all consumer product teams, including deposit products, credit cards and unsecured lending and residential lending.

 

“Matt is a strong, forward-thinking leader with a keen focus on delivering results through a culture based on performance and accountability,” said Leo Salom, President and CEO, TD Bank, AMCB. “His customer-centric approach, ability to drive best-in-class products and services from development to delivery, and deep commitment to fortifying our governance risk and controls will serve him well in his new role and position TD Bank for continued success here in the U.S.”

 

With nearly 25 years of banking experience, Boss joined TD Bank in 2017 to lead its Credit Cards and Unsecured Lending portfolios before being promoted to Head of Consumer Product Management in the U.S. Under his leadership, the bank scaled its deposit business while overhauling its overdraft policy, transformed the cards franchise, and optimized its mortgage operations. Boss has also made significant progress in attracting and retaining top talent across his teams and currently oversees the bank’s diversity and inclusion strategy as Chair of the Diversity Leadership Team.

 

“I’m excited about the path ahead for TD and the U.S. Consumer Bank,” said Boss. “We’ve built a strong franchise over the past few decades and have recently introduced a number of product innovations and capability enhancements, but we have so much more to do. It’s as important as ever that we continue to evolve our strategic approach to the business to ensure we’re well-positioned to provide even more value to our customers and communities in the years to come.”

 

Prior to TD, Boss served as the Managing Director of Products and Marketing for Melbourne-based Australia & New Zealand Banking Group (ANZ). In that role, he led the product functions for the retail and commercial bank, including responsibility for digital channels and assets, end-to-end marketing, data and analytics. Boss also spent more than a decade at Bank of America leading teams in the U.S. and England in roles of increasing responsibility across product, marketing, credit cards, and strategy.

 

Outside of TD, Boss serves as a board member of the National Forest Foundation and the Consumer Bankers Association. He earned a Bachelor’s degree in business administration and finance from the University of Massachusetts – Amherst.

 

About TD Bank, America’s Most Convenient Bank®

TD Bank, America’s Most Convenient Bank, is one of the 10 largest banks in the U.S. by assets, providing over 10 million customers with a full range of retail, small business and commercial banking products and services at more than 1,100 convenient locations throughout the Northeast, Mid-Atlantic, Metro D.C., the Carolinas and Florida. In addition, TD Auto Finance, a division of TD Bank, N.A., offers vehicle financing and dealer commercial services. TD Bank and its subsidiaries also offer customized private banking and wealth management services through TD Wealth®. TD Bank is headquartered in Cherry Hill, N.J. To learn more, visit www.td.com/us. Find TD Bank on Facebook at www.facebook.com/TDBank and on Instagram at www.instagram.com/TDBank_US/.

 

TD Bank is a subsidiary of The Toronto-Dominion Bank, a top 10 North American bank. The Toronto-Dominion Bank trades on the New York and Toronto stock exchanges under the ticker symbol “TD”. To learn more, visit www.td.com/us.

Contacts

Miranda Garrison

Miranda.Garrison@td.com

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The AACCNJ announces Malcolm Jenkins as Juneteenth Black Business 2024 Expo speaker

Retired NFL Veteran, Entrepreneur, and Philanthropist Malcolm Jenkins will join John Harmon in a conversation about his career and professional journey as an entrepreneur.

 

 

TRENTON, N.J. – The African American Chamber of Commerce of New Jersey (AACCNJ) announced Malcolm Jenkins as the Keynote Speaker, for the Juneteenth Black Business 2024 Expo, which will be held at Fairleigh Dickinson University – Metropolitan Campus Teaneck, N.J., on June 13, 2024, from 9 a.m. to  4 p.m.

New Jersey native Malcolm Jenkin is a 13-year NFL veteran, two-time Super Bowl champion, three-time Pro-Bowl honoree, NFLPA Executive Committee Board Member, entrepreneur, philanthropist, executive director, published author, an Ohio State Athletics Hall of Fame Inductee, CNN Contributor, and advocate for social justice.

Jenkins created MALCOLM INC., a holding company for the various business verticals he co-founded; LISTEN UP MEDIA, a multimedia production company with the mission to showcase and distribute content that creates social awareness around systemic issues in society; BROAD STREET VENTURES, a $10 million investment vehicle funded entirely by Black and Brown investors including a group of fellow NFL players; DISRUPT FOODS, a multi-unit franchise developer and operator of 20+ quick service restaurants aiming to level the economic playing field for Blacks and Hispanics through Franchise Ownership; and DAMARI, a custom clothing company which includes ready-to-wear and made-to-measure men and women suits. As a philanthropist Jenkins strives to make a positive difference in the lives of youth in underserved communities through his non-profit, public charity, THE MALCOLM JENKINS FOUNDATION, who are proud members of the AACCNJ.

“I am humbled to stand alongside the African American Chamber of Commerce of New Jersey for their Second Annual Black Business Expo. As we honor Juneteenth and delve into “The Journey Continues,” I am eager to share my journey in entrepreneurship and what it’s taught me about the enduring spirit of our community. In spaces like these, we chart a course forward, fueled by innovation, collaboration, and unwavering determination,” said Malcolm Jenkins.

“We are extremely excited to have Malcolm Jenkins share his full portfolio of experience and commitment to demonstrating Black Excellence every day, said John E. Harmon, Sr., IOM, Founder, President & CEO, AACCNJ. “His voice is critical today and beyond as we drive our mission of an equitable coexistence in New Jersey and America,” said Harmon.

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Mercer County announces Tennis Hall of Fame Class of 2024 Awards Dinner

MERCER COUNTY — The Mercer County Park Commission is proud to announce the Mercer County Tennis Hall of Fame Class of 2024. This year’s honorees have made extraordinary achievements in the field of tennis and expanded the popularity of the sport.

The Class of 2024 includes Jim Cryan, Co-Director of the Cryan Memorial Tennis Tournament; Mike Ehrenberg, longtime Director of the G. Nelson Green Memorial Tournament; Ginny Mason, a founding member and continuous supporter of National Junior Tennis and Learning of Trenton (NJTL); Glenn Michibata, a Wimbledon Doubles Semifinalist and Princeton Tennis Program Teaching Professional; and Betty Sander Thompson, who is receiving a posthumous honor and had received a USTA Umpire Emeritus Award for 32 years of service.

The Hall of Fame dinner will be held on Friday, June 14 at 6 p.m. at the Boathouse at Mercer Lake in Mercer County Park, West Windsor.

“I’m pleased to announce this year’s Mercer County Tennis Hall of Fame honorees,” said County Executive Dan Benson.

“Mercer County produces incredible talent in every field imaginable and I’m always thrilled for an opportunity to highlight the leaders in our community. Thanks to the work of the Mercer County Park Commission, the Mercer County Tennis Center isn’t just a place where people can play the sport, it is a center for the tennis community in our region.”

Marc Vecchiolla, Director of the Mercer County Tennis Center, has been the Hall of Fame Chair for 12 years. Throughout his tenure, he has found each year’s honorees to be incredibly inspirational.

“Their shared love of tennis has made each inductee monumentally influential to thousands within Mercer County and beyond,” said Mr. Vecchiolla. “The Park Commission is proud to recognize the indelible contributions the inductees have made to our tennis community.”

The Mercer County Tennis Hall of Fame was initiated in 1992 by the Mercer County Tennis Council to recognize people with ties to the County who have made outstanding contributions to the sport. Since the dissolution of the Tennis Council, the Mercer County Park Commission has overseen the nominating committee, voting process and dinner committee. The Hall of Fame honors individuals for their involvement in competition, education, officiating, recreation, media, industry, or in the advancement of tennis.

Induction ceremonies are held every four years, with the honorees selected by 50 leaders in the area’s tennis community. Criteria for induction stipulate that “the record of achievement must be balanced by a reputation that can be admired and respected. Membership is intended to represent a highly selective group.”

Tickets for the Hall of Fame dinner are $100 per person. For more information or to receive an electronic invitation, please contact Marc Vecchiolla at mvecchiolla@mercercounty.org or by phone at (609) 448-2088.

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

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Mercer County announces second phase of zero-interest rate loans to businesses through a partnership with the UCEDC

MERCER COUNTY — Mercer County Exec. Dan Benson and the Board of County Commissioners are excited to announce that the County will partner for a second phase with UCEDC to establish a 0% Interest Loan Program for small businesses in Mercer County.

Dedicating an additional $240,000 in American Rescue Plan Act (ARPA) dollars, to be administered through the Mercer County Office of Economic Development, the program will allow Mercer County businesses to apply for affordable access to capital. The UCEDC will provide loans on a first-come, first-served basis utilizing current lending products and capital.

“Small businesses represent the life-blood of our local economy here in Mercer County, “said Mercer County Exec. Benson.

“In extending our interest-free loan program we are excited to give our Mercer County small businesses a meaningful jolt to spur economic development.”

“We are thrilled that Mercer County is extending UCEDC’s contract, leveraging another $500K in interest-free loans. This will provide more assistance to entrepreneurs, building on the $750K we’ve already distributed through our partnership. It’s a privilege to contribute to the success of Mercer County small businesses and make a positive impact on local communities in New Jersey,” said UCEDC President Adam Farrah.

The program will require the following:

  • Businesses must be located in Mercer County, registered with the State of New Jersey and must have been formed on or before September 1, 2019.
  • Businesses must have 30 full-time equivalent employees or less at time of application and have less than $10 million in annual gross revenue based on most recent tax return.
  • Loans will range from $10,000 to $20,000.
  • Loans will be offered at 0% interest, with a five-year repayment term.
  • Funds can be used for working capital, inventory, or purchases of furniture and equipment.
  • No collateral requirements, pre-payment penalties, processing, closing, or application fees will be required.
  • Personal guarantees of the significant owners of the business (10% or greater) are required.
  • Applicants must not have had a bankruptcy or significant charge-offs within the most recent 3-year period.

Based on the maximum loan amount of $20,000 and the parameters above, Mercer County will provide funding to approximately 26 businesses in the target market.

Please click here to see the flyer for the Mercer County Zero-Interest Loan Program or here to apply.

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

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Art & Life Culture Lifestyle Perspectives

Mercer County selects Artworks to install community-themed public mural on Cass Street

TRENTON, N.J. — Mercer County and the Mercer County Division of Culture & Heritage (MCDC&H) announced that Artworks, the Trenton-based visual arts center, has been selected to design and install a public mural. The mural to-come, entitled “Breaking Barriers,” will visualize the power art has to connect a community.

“Artworks has been a valued community partner for many years, and I’m excited to see work begin on the project,” said Mercer County Executive Dan Benson.

“Public art provides an opportunity for a community to express its values, its passions, and its hopes. This mural will serve as a lasting testament to the incredible creative talent in our Capital City.

In a ‘Call for Artists,’ the MCDC&H opened submissions for the Mercer County Cass Street Prison Mural Project (MCCSPMP) to professional, practicing artists and artist teams living or working within the tri-state area (N.J., N.Y., Conn. and Pa.). Qualified artists were asked to propose an original design to be installed on the exterior 319 ft (w) x 19 ft (h) wall of the New Jersey State Prison located at 600 Cass St, Trenton, N.J.

The County received over 50 proposals. All qualifying proposals were then reviewed by a committee composed of public art experts, an arts administrator, a NJ State Prison representative and the MCDC&H. The committee narrowed the proposals down to six finalists, who then presented their proposals live in Phase II of the process.

After a thorough deliberation, Artworks came out on top.

“Artworks Trenton’s proposal stood out for its ability to capture the essence of what the grant aims to achieve,” Samuel Kanig, Program Coordinator at The Center for Community Engagement at The College of New Jersey (TCNJ) and a MCCSPMP Committee member said.

“I’m excited about the collective of artists that will be working on the mural and the creativity they individually bring to the project. The Cass Street Mural is sure to be an inspiring community landmark.”

A team of seven artists will be working together to represent Artworks on this project. Artists collaborating on this design are Jonathan “LANK” Conner (Project Manager), Leon Rainbow and Jose “Busta” Bustamente (Lead Artists), Dean “Ras” Innocenzi, Dave “Mek” Klama, Alia Bensliman and April Cooper.

“Artworks is thrilled to have been selected for this project and is proud to be working with an amazing group of local artists led by Leon Rainbow and Jose Bustamente,” Conner said. “We look forward to creating a beautiful mural that represents the city and can be enjoyed by Trentonians for many years to come.”

Artwork’s concept for the mural is a celebration of arts and culture in the City of Trenton. In their proposal, the team described the upcoming mural design as a representation of the power that art has to “break down barriers: mental, cultural, spiritual, financial, and institutional.”

Each of the seven artists involved in the creation of this mural plans to bring a different perspective to their design, both through different artistic styles and through their individual cultural backgrounds. Together, the artists plan to make a connection between the diverse artistic styles and backgrounds of the group and the diverse community of the capital city.

“I was delighted to serve on the Art Selection Committee with our colleagues at Mercer County Division of Culture & Heritage,” said Stephanie Nerbak, Artist Services Manager at the New Jersey State Council on the Arts.

“This project was a perfect fit for the team at Artworks Trenton. Their knowledge of the city, engagement of community members and local artists, combined with their strong design will make a terrific contribution to the neighborhood of South Trenton.”

Artworks will spend the Spring and Summer months workshopping and installing this mural, with an anticipated completion date in the Fall of 2024. To follow along with its development, follow MCDC&H on Facebook (Mercer County Culture and Heritage Commission) or on Instagram (@MercerCountyCultureHeritage).

“The Mercer County Division of Culture & Heritage is looking forward to seeing Artworks’ mural design come to life,” Idamis Pérez Margicin, Division Chief of Mercer County’s Division of Culture & Heritage and MCCSPMP Committee member said.

The MCCSPMP is made possible by funds from the New Jersey State Council on the Arts, a partner agency of the National Endowment for the Arts, and is being administered by the Mercer County Division of Culture & Heritage on behalf of County Executive Dan Benson and the Mercer County Board of Commissioners.

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

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Culture Lifestyle Local News Perspectives Programs & Events

Passage Theatre 2024 Gala: Our biggest and best yet!

On Saturday, April 6, Passage Theatre held its Annual Gala at the Trenton Country Club, where it was a great success, with over 175 guests.

 

They say this year’s Gala was the biggest event in Passage history, and that they thank their patrons and donors.

 

“You have been with us throughout the years as we have brought great storytelling to our Trenton communities.”

 

Passage honored Trenton’s own Phillip McConnell with the Artisan Emerging Award, Maria Richardson with the Patron of the Arts Excellence Award, and the Poor Righteous Teachers with the Cultural Leader Award.

 

The evening’s highlight was a live performance by Wise Intelligent & Culture Freedom, of the Poor Righteous Teachers. It was an epic and incredible night, celebrating the large and supportive community around Passage Theatre.

 

“We want to thank each one of you for your outstanding love, passion and support of Passage. If you would like to contribute to the success of this event and help propel Passage into the future of professional theatre in Trenton, it isn’t too late to donate,” states Passage Theatre management.

 

They plan to continue with their next production, Word On Front: A Spoken Word Festival, on May 3 and 4, and they ask that you continue to support the work they do.

 

“Your donation  will greatly impact not only Passage, but also the communities who need and enjoy the arts in and around Trenton.”

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Innophos upgrades production facility for EC grade calcium phosphates

CRANBURY, N.J. — (BUSINESS WIRE) — Innophos, a leader in the food and nutritional ingredient industry, is excited to announce a significant upgrade in its production facility for EC (European Commission) grade calcium phosphates. This capital investment is a strategic move to meet the growing demand in the EU food and dietary supplement markets.

 

This investment at Innophos’ Chicago Heights, IL production facility will result in greater manufacturing flexibility and is set to enhance the company’s ability to supply high-quality, EC grade calcium phosphates, long known for their purity, consistency, and compliance with stringent European regulatory standards.

 

Migue DeJong, Commercial Director, stated, “This investment reflects our commitment to providing our European customers with top-tier products and services. We recognize the growing need for high-quality calcium phosphates in the food, health, and wellness industry, and we are poised to meet this demand with our enhanced production capabilities.”

 

Calcium phosphates are essential ingredients in dietary supplements, food and beverage products, and infant food and formula contributing to bone health and overall well-being. Innophos’ EC grade calcium phosphates are specifically designed to blend seamlessly into various formulations, offering excellent bioavailability and stability.

 

For more information about Innophos’ EC grade calcium phosphates and other products, please visit our website.

 

About Innophos

Innophos is a leading global producer of specialty phosphate and mineral solutions serving food, beverage, nutrition, and industrial markets. Leveraging our expertise in phosphate science and technology, we partner with our customers to innovate and deliver products that excel in quality and performance. Headquartered in Cranbury, New Jersey, Innophos has an integrated manufacturing footprint that spans the United States, Canada, Mexico, and China. For more information, please visit www.innophos.com.

Contacts

Carrie Livingston

Email: carrie@colinkurtis.com
Phone: 815-519-8302