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Amneal launches second Biosimilar with RELEUKO® (filgrastim-ayow) in the United States

Second of three approved U.S. oncology biosimilars Amneal expects to launch

BRIDGEWATER, N.J. — (BUSINESS WIRE) — Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the commercial launch of RELEUKO® (filgrastim-ayow), a biosimilar referencing Neupogen®. RELEUKO® is used to treat neutropenia which is commonly experienced by patients undergoing chemotherapy. This product was developed in collaboration with Kashiv Biosciences, LLC located in Chicago, Illinois.

 

“RELEUKO is our second U.S. biosimilar launch and represents the next step in building out our biosimilars business. This product is another important oncology therapeutic offering for providers and their patients as we look to make essential medicines more accessible for all,” said Harsher Singh, SVP of Amneal Biosciences division.

 

According to IQVIA®, U.S. annual sales for filgrastim for the 12 months ended August 2022 were $390 million, of which $272 million represented biosimilar sales.

 

About RELEUKO

RELEUKO® in the U.S. is indicated:

  • To decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever.
  • To reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
  • To reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
  • To reduce the incidence and duration of sequelae of severe neutropenia‚ (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

 

IMPORTANT SAFETY INFORMATION

Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.

 

Before you take RELEUKO®, tell your healthcare provider if you are pregnant or plan to breast feed, and if you have sickle cell disorder, kidney problems or receiving radiation therapy.

 

WARNINGS AND PRECAUTIONS

  • Fatal splenic rupture: Patients may experience enlarged spleen which can rupture and cause death.
  • Acute respiratory distress syndrome (ARDS): Patients may develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue RELEUKO® in patients with ARDS.
  • Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving RELEUKO®. Discontinue RELEUKO® if sickle cell crisis occurs.
  • Serious allergic reactions, including anaphylaxis: Permanently discontinue RELEUKO® in patients with serious allergic reactions.
  • Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on RELEUKO®. Consider dose-reduction or interruption of RELEUKO® in patients with kidney injury.
  • Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using RELEUKO® in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
  • Decreased platelet count (thrombocytopenia); increased white blood cell count (leukocytosis) and inflammation of your blood vessels (cutaneous vasculitis) have been reported. Monitor platelet counts and white blood cell count.

 

ADVERSE REACTIONS

Most common adverse reactions in patients:

  • With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs are pyrexia, pain, rash, cough, and dyspnea.
  • With AML are pain, epistaxis and rash.
  • With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by Bone Marrow Transplant is rash.
  • With severe chronic neutropenia are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia.

 

For full prescribing information, see package insert located here.

 

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more, please visit www.amneal.com.

 

Cautionary Statement on Forward-Looking Statements

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance, the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words are intended to identify estimates and forward-looking statements.

 

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

 

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry, in general, specifically from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods and any associated supply chain disruptions; existing and future legal proceedings, the outcome of which are uncertain and may divert management resources and require us to incur substantial defense or settlement payments and costs; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the impact of severe weather; the impact of the ongoing COVID-19 pandemic, and the emergence of variant strains; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration (“FDA”) product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; the impact of global economic conditions, including any economic effects stemming from adverse geopolitical events, an economic downturn, inflation and rising interest rates; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Contacts

Anthony DiMeo

Head of Investor Relations

anthony.dimeo@amneal.com

Categories
Business International & World Lifestyle

OPEX® celebrates new EMEA headquarters training and service hub in Germany with a grand opening event

MOORESTOWN, N.J. — (BUSINESS WIRE) — OPEX® Corporation, a global leader in Next Generation Automation for almost 50 years, is celebrating the grand opening of OPEX GmbH, its European headquarters in Duisburg, Germany. The facility will serve as a centralized European hub for clients and partners to discover, test, and interact with OPEX’s innovative warehouse automation and document and mail automation technologies designed to improve workflow and drive efficiencies in infrastructure.

To mark the grand opening, a ribbon-cutting ceremony will be held on 7 December 2022. Customers, partners, regional government officials, and media are invited to attend the event along with the company’s chief executive officer and extended leadership team.

 

“Our business has been expanding in many parts of the world, including growth in the European market,” said David Stevens, OPEX CEO. “The new facility provides an opportunity to better streamline services and demonstrate how our leading-edge automation technology helps clients solve their most significant business challenges today and in the future.”

 

The new facility offers hands-on and virtual training classes for the full line of OPEX document and mail automation solutions, including the Gemini™ and Falcon® document scanners and OMATION® mail openers, as well as the Sure Sort® warehouse automation sorting system. OPEX technicians will be on-site during the grand opening to give product demonstrations.

 

“Since so many of our solutions are built to order, it is important that clients, partners, and super-users be able to learn about and interact with the technology to understand how it can best benefit their individual operations,” said Scott Maurer, President, OPEX International. “Clients can bring in their own documents and products to get a more realistic demonstration of our automation solution capabilities.”

 

Prior to the facility opening in Germany, product demonstrations were performed primarily at OPEX’s headquarters in Moorestown, New Jersey or in its Plano, Texas facility. Parts were serviced and shipped from the United States or the United Kingdom. Now, clients in other regions can receive parts and secure service faster and more efficiently.

 

For nearly five decades, OPEX has served as a trusted partner, collaborating closely with clients to develop customized, scalable solutions that transform how they conduct business.

 

OPEX is vertically integrated—innovating, engineering, manufacturing, selling, and servicing its automated solutions. This translates to the highest degree of quality equipment, reliable operations, product longevity, and exceptional client experience.

 

About OPEX

OPEX Corporation is a global leader in Next Generation Automation, providing innovative, unique solutions for warehouse, document, and mail automation. With headquarters in Moorestown, NJ, USA—and facilities in Pennsauken, NJ; Plano, TX; France; Germany; Switzerland; the United Kingdom; and Australia—OPEX has more than 1,600 employees who are continuously reimagining and delivering customized, scalable technology solutions that solve the business challenges of today and in the future.

Contacts

Colleen Ciak

cciak@opex.com
+1 856.727.1100, ext. 5350

+1 856.912.4952 Cell

Categories
Business Healthcare Science

Tevogen Bio to study therapeutic potential of its investigational COVID-19 T cell therapy in long COVID

  • Tevogen’s investigational precision T cell product, TVGN 489, is designed to address the unmet need of COVID-19 patients who are unable to take or unlikely to benefit from currently available prevention or treatment strategies and potentially those with Long COVID, where there are no currently available treatment options
  • Given that no dose limiting toxicities or treatment-related adverse events were observed in the TVGN 489 POC trial, Tevogen intends to explore the potential of this therapy for the treatment of Long COVID
  • Tevogen’s research pipeline includes off-the-shelf, allogeneic genetically unmodified precision CD8+ T Lymphocyte therapeutics for the treatment of immunocompromised patients with COVID-19, patients with other serious viral infections, viral-induced cancers, several non-virally induced common cancers, and neurologic diseases, including multiple sclerosis
  • Tevogen’s inventions are designed to overcome both cost and geography related patient access barriers and aims to transform cancer treatment by developing cell therapies as first-line options

 

WARREN, N.J. — (BUSINESS WIRE) — #COVID19—Tevogen Bio, a late-stage clinical biotechnology company specializing in the development of cellular immunotherapies in oncology, neurology, and virology announced today its intention to study potential therapeutic use of its investigational COVID-19 T cell therapy, TVGN-489, in Long COVID. The finding that none of the patients in the TVGN 489 Proof-of-Concept (POC) trial, treated for their initial COVID infection, developed Long COVID to date is leading Tevogen to explore the potential of TVGN 489 to also treat Long COVID.

“I’m greatly encouraged by the POC trial experience of TVGN 489 and hopeful that our investigational COVID-19 therapy will eventually offer hope to a substantial segment of Long COVID patients.” said Dr. Neal Flomenberg, Tevogen’s Chief Scientific Officer.

 

“Anyone that knows someone who has been impacted by this debilitating disease understands the importance of advancing science to alleviate the suffering from Long COVID,” said Tevogen CEO Ryan Saadi, M.D., M.P.H. “I’m hopeful that our innovative T cell technology will eventually offer accessible immunotherapies to millions suffering from viral infections, cancers and other diseases with high unmet need.”

 

TVGN-489 is highly purified cytotoxic CD8+ T lymphocytes (CTLs) designed to detect and kill SARS-CoV-2 infected cells. These allogeneic genetically unmodified CTLs are enriched and expanded in the lab and recognize proteins from across the entire SARS-CoV-2 genome, not just the spike protein.

 

In July 2022, TVGN-489 completed proof-of-concept clinical trial enrollment with zero treatment-related adverse events. Patients treated were infected with a range of all COVID variants at the time, from Delta through Omicron BA.5. Additionally, each patient had co-morbidities rendering them high risk and 50 percent of those additionally met the definition of being immunocompromised.

 

About Tevogen’s Next Generation Precision T Cell Platform

Tevogen’s next generation precision T cell platform is designed to provide increased immunologic specificity to eliminate malignant and virally infected cells, while allowing healthy cells to remain intact. Multiple targets are selected in advance with the goal of overcoming the mutational capacity of cancer cells and viruses which can otherwise allow for escape from immunologic targeting.

 

Tevogen is investigating its technology’s potential to overcome the primary barriers to the broad application of personalized T cell therapies: potency, purity, production-at-scale, and patient-pairing, without the limitations of current approaches. Tevogen’s goal is to open the vast and unprecedented potential of developing personalized immunotherapies for large patient populations impacted by common cancers and viral infections.

 

Tevogen announced the completion of patient enrollment in the Proof-of-Concept clinical trial of its lead product, TVGN-489, for ambulatory, acute-risk COVID-19 patients, with no dose-limiting toxicities or significant treatment-related adverse events observed for any patient at any dose level.

 

TVGN-489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with activity against multiple, precise targets across the entire SARS-CoV-2 genome.

 

About Tevogen Bio

Tevogen Bio is driven by a team of distinguished scientists and highly experienced biopharmaceutical leaders who have successfully developed and commercialized multiple franchises. Tevogen’s leadership believes that accessible personalized immunotherapies are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation in the post-pandemic world.

 

Forward Looking Statements

This press release contains certain forward-looking statements relating to Tevogen Bio™ Inc (the “Company”) and its business. These statements are based on management’s current expectations and beliefs as of the date of this release and are subject to several factors which involve known and unknown risks, delays, uncertainties, and other factors not under the Company’s control that may cause actual results, performance or achievements to be materially different from the results, performance or other expectations implied by these forward-looking statements. Forward-looking statements can sometimes be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “believe,” “potential,” and “possible,” or their negatives or comparable terminology, as well as other words and expressions referencing future events, conditions, or circumstances. In any forward-looking statement in which the Company expresses an expectation or belief as to future results, there can be no assurance that the statement or expectation or belief will be achieved. Various factors may cause differences between the Company’s expectations and actual results, including, among others: the Company’s limited operating history; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, and approval and commercial development; risks associated with intellectual property protection; and risks related to matters that could affect the Company’s future financial results, including the commercial potential, sales, and pricing of the Company’s products. Except as required by law, the Company undertakes no obligation to update the forward-looking statements or any of the information in this release, or provide additional information, and expressly disclaims any and all liability and makes no representations or warranties in connection herewith or with respect to any omissions therefrom.

Contacts

Tevogen Communications

T: 1 877 TEVOGEN, Ext 714

Communications@Tevogen.com

Categories
Business Culture Environment Lifestyle Science Technology

GrowGeneration announces 60th location at Mount Holly, NJ store opening

DENVER — (BUSINESS WIRE) — GrowGeneration Corp. (NASDAQ: GRWG) (“GrowGen” or “the Company”), the largest chain of specialty hydroponic and organic garden centers in the United States, today announced the opening of the Company’s newest store in Mount Holly, New Jersey on November 21, 2022.


The Mount Holly location represents the Company’s 60th store and officially expands operations into 16 states. The new store is 7,700 square feet and will include vertical farming demonstrations and educational support for growers to build and maintain state-of-the-art grow operations to maximize their yields.

 

Darren Lampert, Co-Founder and Chief Executive Officer of GrowGen said, “We are excited to open our first store in New Jersey and increase our reach and operations into a fast-growing and strategically important market. We expect New Jersey to be highly active in the coming years, with a strong medical patient base, over 800 conditional licenses that have been issued, microenterprise and social equity licenses, as well as a pending law to allow for home cultivation.”

 

Mr. Lampert continued, “As we expand our footprint in the Northeastern United States, we are excited to continue our efforts in cooperation with Harvest 360 to support our national program with education and training for Social Equity License holders. The program focuses on delivering top-notch support and solutions to operators and their communities. To date, we have 30 holders of micro licenses who are active in the program within the New York and New Jersey markets.”

 

About GrowGeneration Corp:

GrowGen owns and operates specialty retail hydroponic and organic gardening centers. Currently, GrowGen has 60 stores across 16 states, which include 22 locations in California, 6 locations in Colorado, 6 locations in Michigan, 5 locations in Maine, 5 locations in Oklahoma, 4 locations in Oregon, 3 locations in Washington, 1 location in Arizona, 1 location in Florida, 1 location in Massachusetts, 1 location in Mississippi, 1 location in Missouri, 1 location in New Jersey, 1 location in New Mexico, 1 location in Rhode Island, and 1 location in Virginia. GrowGen also operates an online superstore for cultivators at growgeneration.com. GrowGen carries and sells thousands of products, including organic nutrients and soils, advanced lighting technology and state of the art hydroponic equipment to be used indoors and outdoors by commercial and home growers.

Contacts

Investor Contact
ICR, Inc.

GrowGenIR@icrinc.com

Categories
Business Healthcare Science

Blue Earth Diagnostics highlights presentations on Axumin® (Fluciclovine F 18) at upcoming RSNA® 2022 Annual Meeting

MONROE TOWNSHIP, N.J. & OXFORD, England — (BUSINESS WIRE) — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced presentations on Axumin® (fluciclovine F 18) at the upcoming Radiological Society of North America (RSNA) 108th Scientific Assembly and Annual Meeting, to be held in Chicago, Ill., from November 27 to December 1, 2022. Details of selected oral and poster presentations are listed below.

Two presentations from Emory University will discuss additional analyses from EMPIRE-1, the first prospective, randomized controlled trial to demonstrate that 18F-fluciclovine PET/CT-guided radiation therapy improved event-free survival rates in men with biochemical recurrence of prostate cancer. Another presentation compares the diagnostic performance of bone scintigraphy with 18F-fluciclovine in detecting bone metastases in men with prostate cancer at various PSA levels. Details of selected oral and poster presentations by Blue Earth Diagnostics’ collaborators are listed below.

 

NOTE: Axumin® (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen (PSA) levels following prior treatment.

 

HIGHLIGHTED SCIENTIFIC PRESENTATIONS

Oral presentation

Thursday, December 1, 2022

Title:

Failure-free Survival of Prostate Cancer Patients After Conventional Imaging Versus 18F-fluciclovine PET-guided Salvage Radiotherapy Stratified by Serum PSA Level: A Secondary Sub-group Analysis of a Randomized Control Trial

Presenter:

Ismaheel Lawal, MD, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University, Atlanta, Ga.

Session Type:

Oral Scientific Session

Session Title:

Science Session with Keynote: Nuclear Medicine/Molecular Imaging (Prostate Cancer Imaging)

Presentation Time:

1:30 – 2:30 PM CT

Location:

S402, McCormick Place

Presentation No.:

R-6-SNMMI 08-1

Poster presentations

Tuesday, November 29, 2022

Title:

Bone Scan versus F-18 Fluciclovine PET/CT at Different PSA Levels: A Single Center Comparison Study

Presenter:

Hatice Savas, MD, Associate Professor, Feinburg School of Medicine, Northwestern University, Chicago, Ill.

Session Type:

Scientific Poster Session

Session Title:

Nuclear Medicine/Molecular Imaging Tuesday Poster Discussion

Presentation Time:

9:00 – 9:30 AM CT

Location:

Learning Center NMMI-DPS, McCormick Place

Session No.:

T2-SPNMMI-1

Title:

Impact of 18F-fluciclovine PET/CT on Failure-free Survival in Biochemical Recurrence of Prostate Cancer Following Salvage Radiation Therapy

Presenter:

Charles Marcus, MBBS, Assistant Professor, Department of Imaging and Radiology Sciences, Emory University School of Medicine, Atlanta, Ga.

Session Type:

Scientific Poster Session

Session Title:

Nuclear Medicine/Molecular Imaging Tuesday Poster Discussion – A

Presentation Time:

12:15 – 12:45 PM CT

Location:

Learning Center NMMI-DPS, McCormick Place

Session No.:

T5A-SPNMMI-2

 

Axumin® (fluciclovine F 18) presentations

Blue Earth Diagnostics invites participants at RSNA 2022 to attend the presentations above. For full session details and scientific presentation listings, please see the RSNA 2022 online program here.

 

Indication and Important Safety Information About Axumin

INDICATION

Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

 

IMPORTANT SAFETY INFORMATION

  • Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
  • Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
  • Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
  • Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

 

To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Full Axumin prescribing information is available at https://www.axumin.com/prescribing-information.pdf.

About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com.

 

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging also enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. Visit: www.braccoimaging.com.

Contacts

For Blue Earth Diagnostics (U.S.)
Priscilla Harlan

Vice President, Corporate Communications

(M) (781) 799-7917

priscilla.harlan@blueearthdx.com

For Blue Earth Diagnostics (UK)
Clare Gidley

Associate Director Marketing and Communications

Tel: +44 (0)1865 784186

clare.gidley@blueearthdx.com

Media
Sam Brown Inc.

Mike Beyer

(M) (312) 961-2502

mikebeyer@sambrown.com

Categories
Business

Cenntro to exhibit full logistar EV line and All Electric iChassis at CES 2023

Press Event to Unveil Production iChassis on January 4, 2023

Booth Meetings with Management Available for Institutional Investors, Sell-Side and Industry Analysts

 

FREEHOLD, N.J. — (BUSINESS WIRE) — Cenntro Electric Group Limited (NASDAQ: CENN), a leading EV technology company with advanced, market-validated electric commercial vehicles, today announced that it will showcase its vehicles at the upcoming 2023 Consumer Electronics Show (CES®), one of world’s largest technology trade shows taking place January 5-8, 2023 in Las Vegas. In conjunction with CES, the Company will also hold a press event on January 4th to unveil its production version of the iChassis and hold investor meetings at its booth to provide an overview of Cenntro and discuss the future of Mobility.

“CES is the world’s leading event for showcasing the future of sustainable transportation and technology, and we are looking forward to presenting our fleet and iChassis to attendees,” said Peter Wang, Chairman and CEO of Cenntro. “Cenntro is dedicated to delivering Electric Vehicle solutions that municipalities and corporate fleets, both large and small, can utilize to reduce emissions without sacrificing performance. Our purpose-built ECVs are designed to support urban logistics and services, last-mile delivery and other commercial applications purpose-built for the demands of the city.

 

“Technology has become an integral differentiator in EV vehicles and transportation, and CES® is the most influential tech tradeshow worldwide to unveil Cenntro’s iChassis. The iChassis opens the promise of automated and autonomous driving to new applications and businesses today, moving beyond the roads and bringing autonomy to everyday commercial functions from warehouses to surveillance to mobile vending and delivery. We believe these functions are the sweet spot for adoption of automated and autonomous vehicles and will drive new innovation for the implementation of autonomy,” concluded Wang.

 

Cenntro Exhibit at Booth 5840

Cenntro’s exhibit at Booth 5840 in the West Hall will be an almost 10,000 square feet display of its complete All Electric Commercial product line. The exhibit will include the full Logistar line which features the versatile, compact cargo van, the LS100, the multi-purpose LS200 available in van or box truck configurations, the segment defining LS260 van and the Class 4 LS400 purpose-built for last mile delivery and urban services. Cenntro will also showcase its Off-Road Vehicle offerings, the TeeMak, and the Antric One, an auto grade four wheeled e-cargo bike purpose-built for delivery services and general cargo transport.

 

Press Event for All Electric iChassis

Cenntro’s production version, state of the art All Electric iChassis, will make its world premiere at a press conference on Tuesday, January 4, 2023 at 12:00 pm at the Mandalay Bay Hotel, the venue for CES Press Conferences. The open-platform, fully programmable iChassis has been designed for automated and autonomous driving. The iChassis opens innovation to third-parties to develop their own software and design hardware to control and maneuver the vehicle and to develop new applications that are unique to their needs.

 

Investor Meetings & Mobility Dinner

Cenntro’s executive team will hold meetings with institutional investors, sell-side and industry analysts to learn more about the Company and its products at booth 5840 in the West Hall of the Las Vegas Convention Center January 5-8, 2023.

 

For more information or to request a booth meeting, please contact: ir@cenntroauto.com

 

About Cenntro Electric

Cenntro Electric Group Ltd. (or “Cenntro”) (NASDAQ: CENN) is a leading designer and manufacturer of electric light and medium-duty 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 has committed to lead the transformation of commercial fleets to zero-emissions vehicles and develop a full line of zero-emission commercial vehicles 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 20-F filed with the Securities and Exchange Commission on April 25, 2022 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 Lifestyle Science

inTEST Corporation to participate in the 11th Annual NYC Summit

MT. LAUREL, N.J. — (BUSINESS WIRE) — inTEST Corporation (NYSE American: INTT), a global supplier of innovative test and process solutions for use in manufacturing and testing in key target markets which include automotive, defense/aerospace, industrial, life sciences, security, and semiconductor (“semi”), today announced that Nick Grant, President & CEO, and Duncan Gilmour, Chief Financial Officer, will participate in the 11th Annual NYC Summit, being held Tuesday, December 13th at Mastro’s New York.

 

The inTEST presentation is scheduled to begin at 9:30 a.m. Eastern Time, in a “round-robin” format consisting of small group meetings with company management teams. The presentation material utilized during the NYC Summit will be accessible on the events page of the Company’s website https://ir.intest.com.

 

Attendance at the NYC Summit is by invitation only and is available solely to accredited investors and publishing research analysts. During the event, investors and analysts will have the opportunity to meet with the majority of the 12 management teams during the small group meeting sessions, as well as opportunities to meet with management during the breakfast and lunch networking sessions.

 

The 12 management teams collectively hosting the 11th Annual NYC Summit 2022 include: ACM Research (ACMR), Advanced Energy (AEIS), Aehr Test (AEHR), Alpha & Omega Semiconductor (AOSL), Axcelis (ACLS), FormFactor (FORM), Ichor Systems (ICHR), inTEST (INTT), Intevac (IVAC), Kulicke & Soffa (KLIC), Onto Innovation (ONTO), and SkyWater Technology (SKYT). Both Cowen and Stifel are sponsors of the conference.

 

About inTEST Corporation

inTEST Corporation is a global supplier of innovative test and process solutions for use in manufacturing and testing in key target markets which include automotive, defense/aerospace, industrial, life sciences, and security, as well as both the front-end and back-end of the semiconductor manufacturing industry. Backed by decades of engineering expertise and a culture of operational excellence, inTEST solves difficult thermal, mechanical, and electronic challenges for customers worldwide while generating strong cash flow and profits. inTEST’s strategy leverages these strengths to grow organically and with acquisitions through the addition of innovative technologies, deeper and broader geographic reach, and market expansion. For more information, visit www.intest.com.

Contacts

inTEST Corporation

Duncan Gilmour

Chief Financial Officer, Treasurer and Secretary

(856) 505-8999

Investors:

Deborah K. Pawlowski

Kei Advisors LLC

dpawlowski@keiadvisors.com
(716) 843-3908

Categories
Business Science

Blue Earth Diagnostics highlights upcoming presentation of results from Phase 3 LIGHTHOUSE study of investigational PET imaging agent 18F-rhPSMA-7.3 in newly diagnosed prostate cancer

− First presentation of results to be made at 23rd Annual Scientific Meeting in Urologic Oncology (SUO) −

 

MONROE TOWNSHIP, N.J. & OXFORD, England — (BUSINESS WIRE) — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced presentations on investigational rhPSMA compounds and Axumin® (fluciclovine F 18) at the upcoming 23rd Annual Scientific Meeting in Urologic Oncology (SUO), to be held in San Diego, Calif., from November 30 to December 2, 2022. They include the first presentation of key results from Blue Earth Diagnostics’ completed Phase 3 LIGHTHOUSE trial (NCT04186819) investigating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET in newly diagnosed prostate cancer. 18F-rhPSMA-7.3 is an investigational Prostate-Specific Membrane Antigen-targeted radiohybrid (rh) PET imaging agent. An rhPSMA presentation from Blue Earth Diagnostics’ sister company, Blue Earth Therapeutics, will report on its ongoing Phase 1/2 trial investigating the use of 177Lu-rhPSMA-10.1 for treatment in metastatic castrate-resistant prostate cancer. In addition, a further presentation will report findings from experiments designed to better understand PSMA regulation in castrate-resistant and neuroendocrine prostate cancer and the potential role of 18F-fluciclovine PET imaging when these tumors have low PSMA expression.

Details of selected presentations by Blue Earth Diagnostics and its collaborators are listed below.

 

NOTE: Axumin® (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen (PSA) levels following prior treatment. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

 

HIGHLIGHTED SCIENTIFIC PRESENTATIONS

SUO has designed this year’s meeting to feature all presentations in digital poster format, presented in scheduled blocks and available in the online poster gallery.

Thursday, December 1, 2022

Investigational rhPSMA

18F-rhPSMA-7.3

Title:

Diagnostic Performance and Safety of 18F-rhPSMA-7.3 PET in Patients with Newly Diagnosed Prostate Cancer: Results from a Phase 3, Prospective, Multicenter Study (LIGHTHOUSE)

Presenter:

Brian Chapin, MD, Assistant Professor, Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, on behalf of the LIGHTHOUSE Study Group

Time:

2:00 −3:00 PM PT

Number:

134

177Lu-rhPSMA-10.1

Title:

The Safety, Tolerability, Radiation Dosimetry and Efficacy of 177Lu-rhPSMA-10.1 for Metastatic Castrate-resistant Prostate Cancer: A Phase 1/2 Trial in Progress

Presenter:

Koby Amankwah, Weill Cornell Cancer Center, New York, NY

Time:

9:00 – 10:00 AM PT

Number:

73

Axumin® (fluciclovine F 18)

Title:

Detection of PSMA-Low Castration Resistant and Neuroendocrine Prostate Cancer with 18F-Fluciclovine PET Imaging

Presenter:

Himisha Beltran, MD, Associate Professor, Medical Oncology, Dana-Farber Cancer Institute, Boston, Mass.

Time:

9:00 − 10:00 AM PT

Number:

72

Blue Earth Diagnostics invites participants at the SUO 23rd Annual Meeting to attend the presentations above and to learn more about the company at its Medical Affairs educational booth. For session details and scientific presentation listings, please see the SUO online program here.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: (“SPOTLIGHT,” NCT04186845), in men with recurrent disease and (“LIGHTHOUSE,” NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

Indication and Important Safety Information About Axumin

INDICATION

Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

  • Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
  • Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
  • Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
  • Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at https://www.axumin.com/prescribing-information.pdf.

About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com.

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging also enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. Visit: www.braccoimaging.com.

Contacts

For Blue Earth Diagnostics (U.S.)
Priscilla Harlan

Vice President, Corporate Communications

(M) (781) 799-7917

priscilla.harlan@blueearthdx.com

For Blue Earth Diagnostics (UK)
Clare Gidley

Associate Director Marketing and Communications

Tel: +44 (0)1865 784186

clare.gidley@blueearthdx.com

Media
Sam Brown Inc.

Mike Beyer

(M) (312) 961-2502

mikebeyer@sambrown.com

Categories
Business

AM Best affirms credit ratings of Definity Financial Corporation and its subsidiary

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has affirmed the Long-Term Issuer Credit Rating (Long-Term ICR) of “bbb-” (Good) of Definity Financial Corporation (Definity Financial) (Ontario, Canada). Concurrently, AM Best has affirmed the Financial Strength Rating of A- (Excellent) and the Long-Term ICR of “a-” (Excellent) of Definity Insurance Company (Definity Insurance). Both companies are domiciled in Ontario, Canada. The outlook of these Credit Ratings (ratings) is stable.

 

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

The rating affirmations also reflect improved operating performance, partially due to refinement of underwriting practices and expansion into commercial lines, as well as a tempering of the group’s expense ratio, which historically was elevated due to scaling of its digital platform and expenses associated with its recent demutualization and IPO. Risk-adjusted capitalization is expected to be maintained at a level that is supportive of strong business growth as the group executes its business strategy. As a newly formed public entity, the group’s balance sheet is presently unlevered. However, going forward, AM Best expects that financial leverage and interest coverage will be maintained at levels commensurate with its current ratings.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2022 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Michael Buckley
Financial Analyst
+1 908 439 2200, ext. 5658
michael.buckley@ambest.com

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

Rosemarie Mirabella
Director
+1 908 439 2200, ext. 5892
rosemarie.mirabella@ambest.com

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

Categories
Business

AM Best revises outlooks to stable for Western Pacific Mutual Insurance Company, A Risk Retention Group

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best has revised the outlooks to stable from negative and affirmed the Financial Strength Rating of A- (Excellent) and the Long-Term Issuer Credit Rating of “a-” (Excellent) of Western Pacific Mutual Insurance Company, A Risk Retention Group (WPMIC) (Littleton, CO).

The Credit Ratings (ratings) reflect WPMIC’s balance sheet strength, which AM Best assesses as strongest, as well as its adequate operating performance, limited business profile and appropriate enterprise risk management.

 

The revised outlooks to stable from negative are based on AM Best’s expectation that WPMIC will see a stabilization in its key underwriting metrics as a result of the higher levels of net premiums earned that are anticipated in the coming years. The expected growth in earned premiums, which is based on the earnings schedule of the company’s 10-year home warranties, should help stabilize some of the recent volatility that has been displayed in the company’s loss and loss adjustment expense (LAE) ratio. In 2019 and 2020, the company saw increases in underwriting losses and reported pre-tax operating losses for the year as well, prompting AM Best to revise the company’s outlooks to negative from stable. The volatility in the company’s loss and LAE ratio is not only attributed to the lower amounts of earned premiums in those years, but also is associated with a higher number of losses in those years originating from Western’s national builders deductible program. Timing issues related to reimbursements for the deductibles from the builders in the deductible program have helped contribute to the deterioration in loss experience in recent calendar years. However, despite the volatility in 2019 and 2020, results have improved in 2021 and have been favorable through the first nine months of 2022. Prospectively, AM Best expects the company to maintain an adequate level of operating performance, as historically has been the case, and to maintain the supportive risk-adjusted capitalization needed for its current book of business.

 

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 © 2022 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Robert Gabriel
Financial Analyst
+1 908 439 2200, ext. 5725
robert.gabriel@ambest.com

Fred Eslami
Associate Director
+1 908 439 2200, ext. 5394
fred.eslami@ambest.com

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

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