Author: Michelle Dryden

Categories
Business Digital - AI & Apps Education Lifestyle Regulations & Security Science Technology

Conveyer Policy APIs bring federal rules into businesses’ data ecosystems

TopicLake™ technology unlocks regulatory insights to put companies in control of compliance processes.

 

 

HACKENSACK, N.J. — (BUSINESS WIRE) — Conveyer, a revolutionary AI platform transforming the way that businesses operationalize data, today announced the launch of its Curated Data Repository, a powerful Data as a Service (DaaS) platform that organizes, summarizes, and filters large and complex datasets to enable seamless knowledge discovery.

 

The first dataset accessible via the Curated Data Repository is Conveyer’s U.S. Policy Data solution, a unique, constantly growing resource comprised of more than 16,000 regulations drawn from over 400 federal agencies and sub-agencies.

“Our U.S. Policy Data enables businesses to drink from the full firehose of regulatory policy information in real time, while providing the clear structure and trustworthy data analytics needed to make regulatory information immediately actionable across the enterprise,” says Carolyn Parent, Conveyer CEO.

 

“That’s a game-changer for government agencies, contractors, and enterprises — and a clear sign of the transformative power of Conveyer’s Curated Data Repository.”

 

A suite of flexible APIs enable organizations to rapidly unlock the full power of Conveyer’s U.S. Policy Data, drawing on a constantly expanding dataset that already incorporates over 16,000 enacted and proposed federal rules dating back to 2020. Conveyer also announced the first free-to-use public version of a subset of its U.S. Policy Data, allowing enterprise customers and other interested parties to explore the solution’s capabilities online via a powerful Microsoft Power BI front end.

 

Using Conveyer’s proprietary TopicLake™ technology, the Curated Data Repository automatically digests federal regulations into over 328,000 unique Topics, each representing an individual concept or idea. The Topics and underlying text are then further processed to yield over 10.2 million unique GenAI artifacts — including summaries, keywords, categories, auto-generated Q&As, and sentiment analysis — which can be seamlessly activated across existing data ecosystems to enable powerful analytics or create intuitive new tools for non-specialist users.

 

Conveyer’s Curated Data Repository and U.S. Policy Data bring key benefits including:

  1. Democratized data access, making data insights accessible across the organization for strategic decision making, advanced analytics, compliance assessments, and more.
  2. Dependable data quality, with robust pre-processing to validate and vet content before it reaches users, customers, or downstream AI models.
  3. Transparent data provenance, enabling insights to be activated with confidence and seamlessly verified by compliance teams and legal specialists.
  4. Effortless implementation, with IT teams able to connect to policy data using existing headcount and infrastructure, enabling end-users to seamlessly self-serve data insights.

 

Using the Curated Data Repository, organizations of all kinds can now seamlessly integrate Conveyer’s U.S. Policy Data into their operations. Key use cases include accelerating product innovation by enabling teams to navigate complex new privacy or security regulations; increasing the speed of legal discovery across disparate datasets; and helping clinicians and healthcare administrators to improve patient care by amplifying the value of existing tools.

 

“For any business impacted by federal rulemaking, the U.S. Policy Data Source is a game-changer,” Parent says. “We’re turning unstructured federal rules and policies into structured data — and our new APIs enable that data to be harnessed across organizations to enable innovation, support compliance, and drive strategic planning at all levels.”

 

A subset of Conveyer’s U.S. Policy Data can be explored online, and the Conveyer team is available to discuss off-the-shelf and bespoke API implementations to give enterprises instant access to the full range of federal rulemaking.

 

About Conveyer

Conveyer is a revolutionary AI platform that ingests organization-wide data and quickly generates high-trust, high-accuracy topics, metatags, and new data for AI models. With 80% of the world’s content unstructured, Conveyer makes the power of AI more accessible across a wide band of high-value use cases.

 

Conveyer’s Data Transformation product is already trusted and deployed in production by Fortune 100 companies across a variety of sectors, including automotive, industrial, materials, technology, and utilities. These products are a powerful demonstration of the core technology: the ability to transform data using AI into high-trust business applications that dramatically reduce costs and support development of future AI applications by creating pre-packaged, cleaned training data for company-wide digital transformation.

Find out more at www.conveyer.com

Contacts

Ben Whitford

ben.whitford@conveyer.com

Categories
Business Healthcare Lifestyle Science

IFAS acquires 16th location with new office in Lancaster Co., Pa.

CONSHOHOCKEN, Pa. — (BUSINESS WIRE) — Pennsylvania and New Jersey-based Integrated Foot and Ankle Specialists (IFAS) ended 2023 with the successful acquisition, which closed on Dec. 29, 2023, of Quarryville Family Foot Care in Lancaster County, Pennsylvania.

 

This transaction marked the fifth acquisition of the calendar year, the first full calendar year of operations for the company.

 

 

During 2023, IFAS also completed the acquisitions of Foot & Ankle Center of Chester County, Berkshire Podiatry, Bryn Mawr Foot & Ankle Center and Lancaster Podiatry. These transactions grew the business by a total of 11 office locations in Pennsylvania, as well as allowing us to serve patients through relationships with Jefferson Health, Mainline Health, Tower Health, and additional health systems and nursing facilities in Pennsylvania and New Jersey. As of the close of 2023, IFAS operates 16 locations in eight counties in Pennsylvania and New Jersey, employing over 80 doctors and staff members and is expected to continue to expand with our active pipeline for 2024.

 

IFAS commenced operations in 2022 as a joint venture between Avonwood Capital Partners and Mereo Capital Partners, two suburban Philadelphia-based Private Equity firms with a background in healthcare investing and operations. The joint venture focuses on the continuum of foot and ankle care, as a patient’s ability to ambulate and stay active is a key indicator of overall health and wellness.

 

IFAS is in active discussions to expand our network of practices in the Mid-Atlantic and Northeast with potential doctor-partners in Pennsylvania, New Jersey, New York, Delaware, Maryland and Virginia.

 

For more information, find us at https://integratedfootandankle.com/join-our-network/.

Contacts

Teresa Ciaccio, tciaccio@integratedfootandankle.com

Categories
Business Culture Foodies/Tastylicious Healthcare Lifestyle Regulations & Security Science

Reckitt/Mead Johnson Nutrition voluntarily recalls select batches of Nutramigen Hypoallergenic Infant Formula Powder because of possible health risk

  • All product tested by MJN was confirmed negative for contaminants.
  • No illnesses or adverse consumer reactions have been reported to date.
  • No Nutramigen liquid formulas or any other Reckitt nutrition products are impacted.

 

 

PARSIPPANY, N.J. — (BUSINESS WIRE) — Reckitt/Mead Johnson Nutrition (MJN), a producer of nutrition products, announced today that it has voluntarily chosen to recall from the U.S. market select batches of Nutramigen Powder, a specialty infant formula for the dietary management of Cows Milk Allergy (CMA) in 12.6 and 19.8 oz cans, due to a possibility of contamination with Cronobacter sakazakii in product sampled outside the U.S. All product in question went through extensive testing by MJN and tested negative for the bacteria.


Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.

 

Nutramigen in 12.6 and 19.8 oz containers was manufactured in June 2023 and distributed primarily in June, July, and August 2023. Based on the limited availability of the remaining stock of this special infant formula, it is believed that much, if not all, of the products recalled in the United States have been consumed. There are no reports of illnesses or adverse events to date. The products were distributed through retail stores nationwide. The batches in question can be identified by the batch code on the bottom of the can.

 

The following recalled product batch codes and can size associated with each batch were distributed in the U.S.:

  • ZL3FHG (12.6 oz cans);
  • ZL3FMH (12.6 oz cans);
  • ZL3FPE (12.6 oz cans);
  • ZL3FQD (12.6 oz cans);
  • ZL3FRW (19.8 oz cans); and
  • ZL3FXJ (12.6 oz cans).

 

The products have a UPC Code of 300871239418 or 300871239456 and “Use By Date” of “1 Jan 2025”.

 

No other U.S. distributed Nutramigen batches or other Reckitt products are impacted

Reckitt/Mead Johnson Nutrition manufactured additional products during this finished product campaign and distributed them outside of the U.S. Reckitt/Mead Johnson Nutrition will be contacting the regulatory authorities in each of those countries to determine the proper disposition of those products.

 

If parents have any questions, they should consult with their pediatrician or contact us at 866-534-9986 24/7 or by email at consumer.relations@rb.com

 

We are committed to the highest level of quality and safety and it is for this reason that we have taken this measure. Other testing of the batches in question tested negative for Cronobacter and other bacteria.

 

The health and safety of infants is our highest priority. All of our products undergo rigorous and industry-leading quality tests and checks to ensure that they meet or exceed all standards set by regulatory bodies, including the World Health Organization and the U.S. Food and Drug Administration. It is for this reason that we have confidence in the safety and quality of every infant formula we make.

 

What Consumers Should Do if They Purchased This Product

Consumers who purchased Nutramigen should check the bottom of the can to identify whether the batch number is affected. Product with the batch codes listed above should be disposed of, or contact us for a total refund. Please contact us at 866-534-9986 or by email at consumer.relations@rb.com and we will help verify if this product was impacted. If you have any concerns, contact your health care provider. For more information, please visit us at www.enfamil.com.

Contacts

Media Contact: US.CA.MEDIAandPR@reckitt.com

Categories
Business Economics Energy Science Technology

Cenntro regains compliance with Nasdaq minimum bid price rule

FREEHOLD, N.J. — (BUSINESS WIRE) — Cenntro Electric Group Limited (NASDAQ: CENN) (“mCenntro” or “the Company”), a leading electric vehicle technology company with advanced, market-validated electric commercial vehicles, announced today that on Dec. 22, 2023, the Company received written notice from The Nasdaq Stock Market LLC (“Nasdaq”) that for the ten consecutive business days from Dec. 8, 2023, to Dec. 21, 2023, the closing bid price of the Company’s common stock has been at $1.00 per share or greater. Accordingly, Cenntro has regained compliance with Nasdaq Listing Rule 5550(a)(2).

About Cenntro Electric Group Ltd.

Cenntro Electric Group Ltd. (or “Cenntro”) (NASDAQ: CENN) is a leading designer and manufacturer of electric commercial vehicles. Cenntro’s purpose-built ECVs are designed to serve a variety of organizations in support of city services, last-mile delivery, and other commercial applications. Cenntro plans to lead the transformation in the automotive industry through scalable, decentralized production, and smart driving solutions empowered by the Cenntro iChassis. For more information, please visit Cenntro’s website at: www.cenntroauto.com.

 

Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts. Such statements may be, but need not be, identified by words such as “may,” “believe,” “anticipate,” “could,” “should,” “intend,” “plan,” “will,” “aim(s),” “can,” “would,” “expect(s),” “estimate(s),””project(s),” “forecast(s)”, “positioned,” “approximately,” “potential,” “goal,” “strategy,” “outlook” and similar expressions. Examples of forward-looking statements include, among other things, statements regarding assembly and distribution capabilities, decentralized production, and fully digitalized autonomous driving solutions. All such forward-looking statements are based on management’s current beliefs, expectations and assumptions, and are subject to risks, uncertainties and other factors that could cause actual results to differ materially from the results expressed or implied in this communication. For additional risks and uncertainties that could impact Cenntro’s forward-looking statements, please see disclosures contained in Cenntro’s public filings with the SEC, including the “Risk Factors” in Cenntro’s Annual Report on Form 10K/A filed with the Securities and Exchange Commission on July 6, 2023 and which may be viewed at www.sec.gov.

Contacts

Investor Relations Contact:
Chris Tyson

MZ North America

CENN@mzgroup.us
949-491-8235

Company Contact:
PR@cenntroauto.com
IR@cenntroauto.com

Categories
Business Economics Healthcare Lifestyle Science

CCM Biosciences announces launch of 5Prime Sciences business unit

New business unit is focused on DNA Biotechnology and Molecular Diagnostics, leveraging state-of-the-art platforms for enzyme engineering

 

Global annual revenue from company’s intellectual property portfolio is $30-50M

 

 

MOUNT LAUREL, N.J. — (BUSINESS WIRE) — Diversified biotechnology company CCM Biosciences (CCM Bio) announced the launch of its business unit CCM 5Prime Sciences (5Prime) focused on the development and application of proprietary technology in the domain of DNA biotechnology. 5Prime’s technology platform includes multiple patent-protected, globally commercialized compositions and methods for molecular cloning, next-generation DNA sequencing and molecular diagnostics.

 

5Prime has two focus areas: 1) in vitro diagnostic (IVD) tests: a wide array of companion diagnostics (CDx) tests for targeted cancer, rare disease, and prenatal/preimplantation diagnostics, developed using the droplet digital Polymerase Chain Reaction (ddPCR) and Next-Generation Sequencing (NGS) methodologies, which accompany the personalized medicine therapeutic (Rx) pipeline of CCM Bio; 2) synthetic biology: engineered DNA- and RNA-manipulating enzymes that improve upon the enzymes used in IVD tests, in PCR reagents, and also in enzymatic DNA/RNA synthesis.

 

Proven technology behind market-leading DNA sequencing products and diagnostic tests; including one of the 5 highest revenue-generating technologies invented in the history of Princeton University

 

Focus areas 1 and 2 are based on the company’s patented technology originating in the PhD thesis work of Co-Founder and CEO Dr. Raj Chakrabarti at Princeton University. According to the Princeton University Office of Technology Licensing, patents in this portfolio, which are now controlled by 5Prime, are among the top 5 revenue-generating patents in the history of the university, having been commercialized in collaboration with companies such as Celera Diagnostics, Quest Diagnostics, Abbott, New England Biolabs, and Toyobo Life Sciences. Diagnostic tests and products based on the company’s intellectual property include the XSense test from Quest Diagnostics, which is the leading DNA-based carrier screening test for autism (Fragile X syndrome); and the Q5 polymerase kit marketed by New England Biolabs, which is the leading high-fidelity polymerase kit for DNA sequencing.

 

In the context of molecular diagnostics, NGS is typically applied to diagnose in high-throughput the patterns of DNA mutations in genes. A related method called RNA-Seq, which applies NGS to RNA rather than DNA to measure real-time gene expression levels, has emerged as a foundation for modern personalized medicine. However, a notorious difficulty in both traditional NGS and RNA-Seq is sequence bias, which results in inaccurate estimates of the relative copy numbers of different genes and associated disease-causing mutations, and which has limited the transformative potential of these methods. ddPCR is a sensitive method for diagnosing mutations in specific disease-associated genes that is also limited by problems of sequence bias.

 

5Prime’s technology enables the efficient polymerization and amplification of nearly any DNA or RNA sequence to overcome sequence bias in nucleic acid amplification and associated diagnostic methods like NGS and ddPCR, the global markets for which were valued at $10B and $6B, respectively, in 2022 and expected to surpass $44B and $14B, respectively, by 2032. Its state-of-the-art synthetic biology platform for polymerase enzyme engineering generates proprietary polymerases with optimal properties for NGS or PCR-based diagnostic tests, by applying machine learning algorithms to the big data generated from ultrahigh-throughput, microfluidic experimental screening of enzyme activity. In addition, the company’s technology platform applies proprietary nonaqueous media and computational systems biology methods in conjunction with such enzymes to dramatically improve nucleic acid polymerization and amplification efficiency.

 

About CCM Biosciences

CCM Biosciences, Inc. is a biotechnology company dedicated to discovering and developing novel drugs – including small molecules, gene therapies, biologics, and nanomedicines – as well as associated companion diagnostics. CCM Bio’s patented molecular discovery platforms were developed at Chakrabarti Advanced Technology, a privately funded R&D institute founded in 2010 with scientists in the US, France and India and with publications in leading scientific journals including PNAS, Nucleic Acids Research, American Chemical Society journals and Nature Publishing Group journals. CCM Bio is partnered with the global chemical and pharmaceutical services company PMC Group, Inc. for fully integrated discovery, development and manufacturing of drugs and diagnostics.

Contacts

Dr. Anisha Ghosh
email: anisha@ccm-bio.com

Categories
Business Culture Economics Healthcare Lifestyle Local News Perks Science

PureTech founded entity Karuna Therapeutics to be acquired by Bristol Myers Squibb for $14 billion

Transaction Delivers KarXT, a First-in-Class M1 / M4 Muscarinic Receptor Agonist, with Differentiated Efficacy and Safety

KarXT Is a Potential First-in-Class Treatment for Schizophrenia and as an Adjunctive Therapy, and First-in-Disease Treatment for Alzheimer’s Disease Psychosis, with Promise in Additional Neuropsychiatric and Neurodegenerative Indications

KarXT Is Expected to Launch in the U.S. for the Treatment of Schizophrenia in Adults with a Prescription Drug User Fee Act Date of Sept. 26, 2024

Bristol Myers Squibb to host a conference call today at 8 a.m. ET

 

Bristol Myers Squibb strengthens neuroscience portfolio with acquisition of Karuna Therapeutics

 

PRINCETON, N.J. & BOSTON — Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) Friday announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired. The transaction was unanimously approved by both the Bristol Myers Squibb and Karuna Boards of Directors.

 

Karuna is a biopharmaceutical company driven to discover, develop and deliver transformative medicines for people living with psychiatric and neurological conditions. Karuna’s lead asset, KarXT (xanomeline-trospium), is an antipsychotic with a novel mechanism of action (MoA) and differentiated efficacy and safety. Karuna’s New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults was accepted for review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) date of Sept. 26, 2024. KarXT is also in registrational trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease. Bristol Myers Squibb believes KarXT represents a significant revenue contribution opportunity. Bristol Myers Squibb also sees potential from Karuna’s early-stage and pre-clinical pipeline.

 

“There are tremendous opportunities in neuroscience, and Karuna strengthens our position and accelerates the expansion and diversification of our portfolio in the space. We expect KarXT to enhance our growth through the late 2020s and into the next decade,” said Christopher Boerner, Ph.D., Chief Executive Officer of Bristol Myers Squibb. “This transaction fits squarely within our business development priorities of pursuing assets that are strategically aligned, scientifically sound, financially attractive, and have the potential to address areas of significant unmet medical need. We look forward to welcoming the talented Karuna team to Bristol Myers Squibb.”

 

“Schizophrenia and Alzheimer’s disease psychosis affect millions of people worldwide, with limited to no treatment options. KarXT’s novel mechanism has resulted in a transformational profile in schizophrenia, with compelling efficacy and a differentiated safety profile,” said Samit Hirawat, M.D., Executive Vice President, Chief Medical Officer, Drug Development of Bristol Myers Squibb. “KarXT also has the potential to deliver meaningful benefits to patients as an adjunctive treatment for patients with schizophrenia and as a first treatment for Alzheimer’s disease psychosis.”

 

Bill Meury, President and Chief Executive Officer of Karuna Therapeutics, said, “Karuna’s portfolio offers advancements in treatment not seen in many years. With Bristol Myers Squibb’s long-standing expertise in developing and commercializing medicines on a global scale and legacy in neuroscience, KarXT and the other assets in our pipeline will be well-positioned to reach those living with schizophrenia and Alzheimer’s disease psychosis. This announcement is a testament to the Karuna team’s talent, hard work, and innovation.”

 

Delivering Meaningful Benefits to Patients with KarXT

KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. KarXT has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments, including no meaningful weight gain, extrapyramidal symptoms, increased prolactin levels, akathisia and/or sedation.

 

Given this differentiated profile, KarXT has meaningful and expanding revenue potential in schizophrenia and with upside in additional indications and geographies:

  • Schizophrenia: KarXT is expected to launch in late 2024 in the U.S. as a treatment for schizophrenia in adults. There are approximately 1.6 million1 people treated for schizophrenia in the U.S., a significant portion of whom do not respond to currently available therapies and experience unacceptable side effects.
  • Adjunctive schizophrenia: A registrational clinical trial is currently underway evaluating KarXT as adjunctive treatment with current standard of care agents for the treatment of schizophrenia, with data expected in 2025.
  • Alzheimer’s disease psychosis: Registrational clinical trials are currently underway evaluating KarXT for the treatment of Alzheimer’s disease psychosis, with data expected in 2026. There are more than 6 million2 people living with Alzheimer’s disease in the U.S. There are currently no approved treatments for Alzheimer’s disease psychosis.
  • Additional indications: Bristol Myers Squibb believes KarXT also has potential in additional indications, including Bipolar I disorder, which impacts approximately 1.4 million1 people in the U.S., and Alzheimer’s disease agitation.

 

The transaction is expected to be dilutive to Bristol Myers Squibb’s non-GAAP diluted earnings per share by approximately $0.30 in 2024 from the financing cost of the transaction, as Bristol Myers Squibb expects to offset the operational expenses of the transaction through continued resource allocation, cost efficiencies and portfolio prioritization. The accounting treatment as a business combination or asset acquisition will be determined upon the expected close of the transaction. Bristol Myers Squibb expects to finance the acquisition with primarily new debt issuance. Bristol Myers Squibb’s cash flows and strong financial profile enable continued commitment to strong investment-grade credit ratings and investment for growth through business development opportunities and distributions to shareholders through ongoing dividends and share repurchases.

 

Transaction Terms and Financing

Under the terms of the merger agreement, Bristol Myers Squibb will acquire all outstanding shares of Karuna common stock for $330.00 per share in cash representing an approximately 53.4% premium to Karuna Therapeutic’s closing stock price on Dec. 21, 2023, for a total equity value of approximately $14.0 billion, or $12.7 billion net of estimated cash acquired.

 

The transaction is expected to close in the first half of 2024, subject to customary closing conditions, including approval of Karuna stockholders and receipt of required regulatory approvals.

 

Conference Call Information

Bristol Myers Squibb will host a conference call today, Friday, Dec. 22, 2023, at 8:00 a.m. ET during which company executives will review discuss the transaction and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at http://investor.bms.com.

 

Investors and the public can register for the live conference call here. Those unable to register can access the live conference call by dialing in the U.S. toll-free 1-866-777-2509 or international +1 412-317-5413. Materials related to the call will be available at http://investor.bms.com prior to the start of the conference call.

 

A replay of the webcast will be available at http://investor.bms.com approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on December 22, 2023, through 11:30 a.m. ET on Jan. 4, 2024, by dialing in the U.S. toll free 1-877-344-7529 or international +1 412-317-0088, confirmation code: 3194180.

 

Advisors

Gordon Dyal & Co. and Citi are serving as financial advisors to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel. Goldman Sachs & Co. LLC is serving as exclusive financial advisor to Karuna, and Simpson Thacher & Bartlett LLP is serving as legal counsel.

 

About Bristol Myers Squibb

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

 

About Karuna Therapeutics

Karuna Therapeutics is a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions. At Karuna, we understand there is a need for differentiated and more effective treatments that can help patients navigate the challenges presented by serious mental illness. Utilizing our extensive knowledge of neuroscience, we are harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples’ lives. For more information, please visit www.karunatx.com.

 

Additional Information and Where to Find It

In connection with the proposed acquisition of Karuna Therapeutics by Bristol Myers Squibb, Karuna Therapeutics intends to file a preliminary and definitive proxy statement. The definitive proxy statement and proxy card will be delivered to the stockholders of Karuna Therapeutics in advance of the special meeting relating to the proposed acquisition. This press release is not a substitute for the proxy statement or any other document that may be filed by Karuna Therapeutics with the SEC. KARUNA THERAPEUTICS’ STOCKHOLDERS AND INVESTORS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY EACH OF BRISTOL MYERS SQUIBB AND KARUNA THERAPEUTICS WITH THE SEC IN CONNECTION WITH THE PROPOSED ACQUISITION OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED ACQUISITION AND THE PARTIES TO THE PROPOSED ACQUISITION. Investors and security holders will be able to obtain a free copy of the proxy statement and such other documents containing important information about Bristol Myers Squibb and Karuna Therapeutics, once such documents are filed with the SEC, through the website maintained by the SEC at www.sec.gov. Bristol Myers Squibb and Karuna Therapeutics make available free of charge at Bristol Myers Squibb’s website at www.bms.com/investors and Karuna Therapeutics’ website at https://karunatx.com/, respectively, copies of materials they file with, or furnish to, the SEC.

 

Participants in the Solicitation

This press release does not constitute a solicitation of a proxy, an offer to purchase or a solicitation of an offer to sell any securities. Bristol Myers Squibb, Karuna Therapeutics and their respective directors, executive officers and certain employees may be deemed to be participants in the solicitation of proxies from the stockholders of Karuna Therapeutics in connection with the proposed acquisition. Information regarding Bristol Myers Squibb’s directors and executive officers is contained in Bristol Myer Squibb’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the SEC on February 14, 2023, and its definitive proxy statement for the 2023 annual meeting of stockholders, which was filed with the SEC on March 23, 2023. Information regarding Karuna Therapeutics’ directors and executive officers is contained in Karuna Therapeutics’ definitive proxy statement for the 2023 annual meeting of stockholders, which was filed with the SEC on April 27, 2023. To the extent holdings of Bristol Myers Squibb’s or Karuna Therapeutics’ securities by their respective directors or executive officers have changed since the amounts set forth in such 2023 proxy statements, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the identity of potential participants, and their direct or indirect interests, by security holdings or otherwise, will be included in the definitive proxy statement relating to the proposed acquisition when it is filed with the SEC. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov, Bristol Myers Squibb’s website at www.bms.com and Karuna Therapeutics’ website at https://karunatx.com/.

 

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding, among other things, the proposed acquisition of Karuna Therapeutics by Bristol Myers Squibb, the expected timetable for completing the transaction, future opportunities for the combined businesses, the expected benefits of Bristol Myers Squibb’s acquisition of Karuna Therapeutics and the development and commercialization of Karuna Therapeutics’ product candidates, including the therapeutic and commercial potential of KarXT and Karuna Therapeutics’ other technologies and products in development. These statements may be identified by the fact they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance, although not all forward-looking statements contain such terms. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. These statements are only predictions, and such forward-looking statements are based on current expectations and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them, that are difficult to predict, may be beyond our control and could cause actual outcomes and results to differ materially from those expressed in, or implied by, the forward-looking statements. Actual results may differ materially because of numerous risks and uncertainties including with respect to (i) the approval of Karuna Therapeutics’ stockholders of the proposed acquisition, which may be delayed or may not be obtained, (ii) the risk that the expected benefits or synergies of the acquisition will not be realized, (iii) the risk that legal proceedings may be instituted related to the merger agreement, (iv) any competing offers or acquisition proposals for Karuna Therapeutics, (v) the possibility that various conditions to the consummation of the acquisition may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the acquisition and (vii) unanticipated difficulties or expenditures relating to the proposed acquisition, including the response of business partners and competitors to the announcement of the proposed acquisition or difficulties in employee retention as a result of the announcement and pendency of the proposed acquisition. The actual financial impact of this transaction may differ from the expected financial impact described in this press release. In addition, the compounds described in this press release are subject to all the risks inherent in the drug development process, and there can be no assurance that the development of these compounds will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2022, and Karuna Therapeutics’ business, particularly those identified in the risk factors discussion in Karuna Therapeutics’ Annual Report on Form 10-K for the year ended December 31, 2022, as well as other documents that may be filed by Bristol Myers Squibb or Karuna Therapeutics from time to time with the SEC. Neither Bristol Myers Squibb nor Karuna Therapeutics undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. The forward-looking statements made in this press release relate only to events as of the date on which the statements are made and readers are cautioned not to place undue reliance on such statements.

 

Use of Non-GAAP Financial Information and Financial Guidance

In discussing financial guidance, Bristol Myers Squibb refers to financial measures that are not in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The non-GAAP financial measures are provided as supplemental information to the financial measures presented in this communication that are calculated and presented in accordance with GAAP and are presented because management has evaluated the company’s financial results both including and excluding the adjusted items or the effects of foreign currency translation, as applicable, and believes that the non-GAAP financial measures presented portray the results of the company’s baseline performance, supplement or enhance management, analysts and investors overall understanding of the company’s underlying financial performance and trends and facilitate comparisons among current, past and future periods.

 

Non-GAAP earnings and related EPS information are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because Bristol Myers Squibb believes they neither relate to the ordinary course of Bristol Myers Squibb’s business nor reflect Bristol Myers Squibb’s underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods.

 

Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to or as a substitute for the related financial measures that are prepared in accordance with GAAP and are not intended to be considered in isolation and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.

 

A reconciliation of the forward-looking non-GAAP measures presented in this communication is not provided due to the inherent difficulty in forecasting and quantifying items that are necessary for such reconciliation. Namely, we are not able to reliably predict the impact of specified items such as unwind of inventory purchase price adjustments, accelerated depreciation and impairment of property, plant and equipment and intangible assets and stock compensation resulting from acquisition-related equity awards, or currency exchange rates beyond the next twelve months. As a result, the reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is not available without unreasonable effort. In addition, Bristol Myers Squibb believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. The variability of the specified items may have a significant and unpredictable impact on our future GAAP results. In addition, the non-GAAP financial guidance in this communication excludes the impact of any potential additional future strategic acquisitions and divestitures and any specified items that have not yet been identified and quantified. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this communication.

 

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases.

Contacts

PureTech
Public Relations

publicrelations@puretechhealth.com
Investor Relations

IR@puretechhealth.com

EU Media
Ben Atwell, Rob Winder

+44 (0) 20 3727 1000

ben.atwell@FTIconsulting.com

U.S. Media
Nichole Sarkis

+1 774 278 8273

nichole@tenbridgecommunications.com

Read full story here

Categories
Business Culture Digital - AI & Apps Healthcare Lifestyle Perspectives Regulations & Security Science

HealthEC, LLC data event impacts companies nationwide, including Corewell Health

GRAND RAPIDS, Mich. — (BUSINESS WIRE) — Please replace the release with the following corrected version due to multiple revisions.

 

The updated release reads:

HEALTHEC, LLC DATA EVENT IMPACTS COMPANIES NATIONWIDE, INCLUDING COREWELL HEALTH

 

Population health management platform HealthEC, LLC, is notifying people nationwide of a data security event that happened earlier this year. For more information, please see HealthEC’s news release.

 

The company enables value-based health systems to identify high-risk patients, close gaps in care and recognize barriers to optimal care. HealthEC is a vendor for Corewell Health in Southeast Michigan.

 

The information of approximately 1 million patients of Corewell Health in Southeast Michigan could be impacted by the HealthEC data event. HealthEC is sending letters to every person who was impacted.

 

Not all individuals have the same data impacted, but the possible impacted data could include: Name; address; date of birth; Social Security number; medical record number; medical information like diagnosis, diagnosis code, mental/physical condition, prescription information, and provider’s name; health insurance information including beneficiary number, subscriber number, Medicaid and/or Medicare identification; billing and claims information including patient account number, patient identification number, treatment cost information. This event did not impact platforms such as Epic and MyChart and they are safe to use.

 

HealthEC is offering 12 months of credit monitoring and identity protection services through TransUnion. Instructions on how to activate these services is being sent to all impacted people.

 

Those seeking additional information can contact HealthEC toll-free at 1-833-466-9216 or visit the HealthEC website. People can also write to HealthEC at Attn: Compliance Officer, 343 Thornall St., Suite 630, Edison, NJ 08837.

Contacts

Ellen Bristol, Ellen.Bristol@corewellhealth.org

Categories
Business Healthcare Lifestyle Perspectives Regulations & Security Science

Patritumab Deruxtecan granted Priority Review in the U.S. for certain patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer

  • Submission based on HERTHENA-Lung01 results showing patritumab deruxtecan demonstrated clinically meaningful and durable responses in patients with advanced EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies
  • Application being evaluated under FDA Real-Time Oncology Review
  • If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients

 

 

BASKING RIDGE, N.J. & RAHWAY, N.J. — (BUSINESS WIRE) — Daiichi Sankyo (TSE: 4568) and Merck (known as MSD outside of the United States and Canada) (NYSE: MRK) announced today that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.

The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is June 26, 2024. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in December 2021.

 

The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The BLA is being reviewed under the Real-Time Oncology Review (RTOR) program, an initiative of the FDA which is designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application.

 

Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and Merck.

 

The BLA is based on the primary results from the HERTHENA-Lung01 pivotal phase 2 trial and data results presented at the IASLC 2023 World Conference on Lung Cancer (#WCLC23), which were simultaneously published in the Journal of Clinical Oncology.

 

In HERTHENA-Lung01, patritumab deruxtecan was studied in 225 patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR TKI and platinum-based chemotherapy, which demonstrated an objective response rate (ORR) of 29.8% (95% CI: 23.9-36.2), including one complete response and 66 partial responses. The median duration of response was 6.4 months (95% CI: 4.9-7.8). The safety profile of patritumab deruxtecan observed in HERTHENA-Lung01 was consistent with previous phase 1 clinical trials in NSCLC with a treatment discontinuation rate of 7.1% due to treatment-emergent adverse events (TEAEs). 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. One grade 5 ILD event was observed.

 

“The FDA’s prioritization of the BLA submission reflects the strength of the data from HERTHENA-Lung01 and emphasizes the need to provide new options to patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “If approved, patritumab deruxtecan could become the first HER3 directed medicine approved in the US and the second DXd antibody drug conjugate approved from Daiichi Sankyo’s oncology pipeline.”

 

“The acceptance of the BLA submission of patritumab deruxtecan marks an important step in potentially bringing this new medicine to previously treated patients with EGFR-mutated non-small cell lung cancer who often experience recurrence and have few remaining treatment options,” said Marjorie Green, MD, Senior Vice President and Head of Late-Stage Oncology, Global Clinical Development, Merck Research Laboratories. “Today is the first of many important milestones from our collaboration with Daiichi Sankyo, as we work together to bring new and potentially first-in-class antibody drug conjugates to people living with cancer.”

 

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 blinded independent central review (BICR). Secondary endpoints included duration of response, progression-free survival (PFS), disease control rate, and time to response – all assessed by both BICR and investigator assessment – as well as investigator-assessed ORR, overall survival, safety and tolerability.

 

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.1 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.2,3,4

 

About HER3

HER3 is a member of the EGFR family of receptor tyrosine kinases.5 It is estimated that about 83% of primary NSCLC tumors and 90% of advanced EGFR-mutated tumors express HER3 after prior EGFR TKI treatment.6,7 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 Daiichi Sankyo and Merck Collaboration

Daiichi Sankyo and Merck entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply.

 

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. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

 

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.

 

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

 

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

 

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

 

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

References

1 World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Accessed September 2023.

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

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

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

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

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

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

Contacts

Daiichi Sankyo
Global/US Media:
Jennifer Brennan

Daiichi Sankyo, Inc.

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

Japan Media:
Koji Ogiwara

Daiichi Sankyo Co., Ltd.

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

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

Merck
Media:
Robert Josephson

+1 203 914 2372

robert.josephson@merck.com

Investors:
Peter Dannenbaum

+1 732 594 1579

peter.dannenbaum@merck.com

Categories
Business Culture Digital - AI & Apps Healthcare Lifestyle News Now! Programs & Events Science Technology

Organon to present at the 42nd Annual J.P. Morgan Healthcare Conference

JERSEY CITY, N.J. — (BUSINESS WIRE) — Organon (NYSE: OGN), announced on Thursday that Kevin Ali, Chief Exec. Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 9, 2024, at 1:30 p.m. PT.

 

Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at: https://jpmorgan.metameetings.net/events/healthcare24/sessions/49500-organon/webcast?gpu_only=true&kiosk=true

 

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

 

Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

 

For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formally known as Twitter) and Facebook.

Contacts

Media:

Karissa Peer

(614) 314-8094

Kate Vossen

(732) 675-8448

Investor:

Jennifer Halchak

(201) 275-2711

Alex Arzeno

(646) 430-2028

Categories
Business Culture Lifestyle Perspectives Regulations & Security

AM Best assigns Credit Ratings to Federal Life Insurance Company

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance—AM Best has assigned a Financial Strength Rating of A- (Excellent) and a Long-Term Issuer Credit Rating of “a-” (Excellent) to Federal Life Insurance Company (Fed Life) (Riverwoods, IL). The outlook assigned to these Credit ratings (ratings) is stable.

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

 

The ratings also reflect AM Best’s assessment that, based on Fed Life’s business plan, the company will build and maintain a balance sheet assessment of very strong supported by risk-adjusted capitalization also at the very strong level, as measured by Best Capital Adequacy Ratio (BCAR). Capital contributions in 2023 and retained earnings through the forecast period are expected to support net premium growth. Direct premium growth is expected to be relatively rapid based on projections, but capital at Fed Life is anticipated to be managed through affiliated reinsurance and capital infusions as necessary. Financial flexibility is viewed as positive as the company has access to additional capital at the holding company level (Federal Life Group, Inc.), and from its ultimate parent organization, Insurance Capital Group, LLC (ICG). The holding company has access to additional capital from the ultimate owner, ICG. Investment risk is projected as low but may increase to moderate depending on the evolution of the liability profile of the company, which could impact future balance sheet metrics.

 

The adequate operating performance assessment and the neutral business profile assessment are based on Fed Life’s business plans presented to AM Best. The plan includes an expectation of rapid premium growth and improving operating profitability that supports an adequate operating performance assessment. In addition, it also includes the introduction of additional products, which in combination with a larger and more geographically diversified premium base, would support a neutral business profile assessment. Should Fed Life materially underperform its business plan these assessments would no longer be supported. An ERM structure has been established and is expected to evolve alongside the product risks and operational complexity of the business.

 

Fed Life, originally incorporated in 1899 and mutualized in 1962, was demutualized in 2018 and under its new ownership is focused now on a portfolio of accident and health, as well as life and annuity (L/A) products, which it plans to market nationwide. The company engaged with a largely new management team in 2022 and 2023 to support the plan, and introduced its first new product, a hospital indemnity product, in 2022. Additional new products are in development to supplement the company’s hospital indemnity product and legacy L/A book of business. Rapid premium growth in 2022 and 2023 evidence early successes of the plan; however, successful launches of new products and further development of distribution are key to realizing the growth and expansion milestones presented to AM Best. AM Best will monitor the performance of Fed Life against key milestones set out in the business plan and internal expectations to evaluate if ongoing performance remains supportive of the adequate operating performance and neutral business profile assessments.

 

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

John McGlynn

Senior Financial Analyst
+1 908 882 2106
john.mcglynn@ambest.com

Joseph Zazzera
Director
+1 908 882 2442
joseph.zazzera@ambest.com

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

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