Author: Michelle Dryden

Categories
Business Culture Energy Environment Lifestyle

New Jersey Natural Gas names Marissa Travaline vice president of customer service, marketing and energy efficiency

WALL, N.J. — (BUSINESS WIRE) — New Jersey Natural Gas, (NJNG), a regulated subsidiary of New Jersey Resources (NYSE: NJR), announced the appointment of Marissa Travaline as Vice President, Customer Service, Marketing and Energy Efficiency effective Monday.

 

In this role, Ms. Travaline will be responsible for overseeing a diverse team of employees and developing, implementing and executing NJNG’s customer experience strategy, customer service and call center operations, residential and commercial growth objectives and energy-efficiency programs.

 

“Marissa brings nearly two decades of strong strategic and operational leadership to New Jersey Natural Gas, skills that will serve our customers and our company well as we lead the way to a clean energy future,” said Steve Westhoven, President and CEO of New Jersey Natural Gas. “As the energy industry continues to evolve, managing the customer experience is more important than ever. I am confident Marissa will be an effective member of our executive team and will drive our customer service, marketing and energy-efficiency priorities.”

 

NJNG is the largest stand-alone natural gas utility in New Jersey with nearly 575,000 customers throughout six counties. The utility is recognized for its innovative energy-efficiency programs, including on-bill repayment plans, financing options and whole-house solutions, which have helped customers use less energy, save money and reduce emissions for nearly a decade and a half. NJNG was also named one of the Easiest Utilities To Do Business With and a Most Trusted Brand by Escalent according to its 2023 Cogent Syndicated Utility Trusted Brand and Customer Engagement™: Residential report. This is the ninth time out of the past 10 years the company was recognized for brand trust among customers.

 

Prior to joining NJR, Ms. Travaline spent nearly 20 years working in the energy industry. Over the course of her extensive career, she developed in-depth experience in customer operations, customer experience, corporate external relations, investor relations and corporate communications.

 

About New Jersey Resources

New Jersey Resources (NYSE: NJR) is a Fortune 1000 company that, through its subsidiaries, provides safe and reliable natural gas and clean energy services, including transportation, distribution, asset management and home services. NJR is composed of five primary businesses:

  • New Jersey Natural Gas, NJR’s principal subsidiary, operates and maintains over 7,700 miles of natural gas transportation and distribution infrastructure to serve nearly 575,000 customers in New Jersey’s Monmouth, Ocean and parts of Morris, Middlesex, Sussex and Burlington counties.
  • Clean Energy Ventures invests in, owns and operates solar projects with a total capacity of more than 462 megawatts, providing residential and commercial customers with low-carbon solutions.
  • Energy Services manages a diversified portfolio of natural gas transportation and storage assets and provides physical natural gas services and customized energy solutions to its customers across North America.
  • Storage and Transportation serves customers from local distributors and producers to electric generators and wholesale marketers through its ownership of Leaf River Energy Center and the Adelphia Gateway Pipeline, as well as our 50% equity ownership in the Steckman Ridge natural gas storage facility.
  • Home Services provides service contracts as well as heating, central air conditioning, water heaters, standby generators, solar and other indoor and outdoor comfort products to residential homes throughout New Jersey.

 

NJR and its nearly 1,300 employees are committed to helping customers save energy and money by promoting conservation and encouraging efficiency through Conserve to Preserve® and initiatives such as The SAVEGREEN Project® and The Sunlight Advantage®.

 

For more information about NJR:

www.njresources.com
Follow us on X (formerly Twitter) @NJNaturalGas.

“Like” us on facebook.com/NewJerseyNaturalGas.

Contacts

Media:

Mike Kinney

732-938-1031

mkinney@njresources.com

Investor:
Adam Prior

732-938-1145

aprior@njresources.com

Categories
Business Culture Digital - AI & Apps Economics Lifestyle Perks Regulations & Security Technology

Gannett and Jackpocket announce exclusive agreement

Jackpocket to serve as the official digital lottery courier of the USA TODAY Network

 

MCLEAN, Va. — (BUSINESS WIRE) — Gannett Co., Inc. (NYSE: GCI) and the USA TODAY Network on Monday announced a multi-year agreement to become the official media partner of Jackpocket, America’s #1 lottery app*. As the exclusive digital lottery courier of the USA TODAY Network, Jackpocket will reach a broad audience across the country and provide a fun and convenient way for the USA TODAY Network audience to order lottery tickets – right from their phones.

“Partnering with Jackpocket as Gannett’s official digital lottery courier will leverage the synergies between our mutual audiences including our 45 million engaged sports fans,” said Kate Gutman, Gannett Senior Vice President of Content Ventures. “Given our reach and authority across the U.S., we hope to introduce Jackpocket as a simple and fun way to order official state lottery tickets from the comfort of home or on a device.”

 

Jackpocket will be integrated into lottery content across the USA TODAY Network including USA TODAY and local publications such as AZCentral.com, Northjersey.com and Statesman.com. Jackpocket will also be the exclusive launch sponsor for the USA TODAY Network’s lottery hub at usatoday.com/lottery.

 

“Jackpocket is thrilled to become the official Digital Lottery Courier of the USA TODAY Network,” said Peter Sullivan, Jackpocket founder and CEO. “This partnership signifies a pivotal moment in our mission to bring a convenient lottery experience to everyone. We’re excited to introduce Jackpocket to Gannett’s dedicated national audience, making the lottery more accessible and enjoyable for all.”

 

*According to data from AppFollow

 

ABOUT GANNETT

Gannett Co., Inc. (NYSE: GCI) is a subscription-led and digitally-focused media and marketing solutions company committed to empowering communities to thrive. With an unmatched reach at the national and local level, Gannett touches the lives of millions with our Pulitzer Prize-winning content, consumer experiences and benefits, and advertiser products and services. Our current portfolio of media assets includes USA TODAY, local media organizations in 43 states in the U.S., and Newsquest, a wholly owned subsidiary operating in the United Kingdom with more than 150 local news media brands. Gannett also owns digital marketing services companies branded LocaliQ, and runs one of the largest media-owned events business in the U.S., USA TODAY NETWORK Ventures. To connect with us, visit www.gannett.com.

 

ABOUT JACKPOCKET

Jackpocket is on a mission to create a more convenient, fun, and responsible way to take part in the lottery. The first licensed third-party lottery courier app in the United States, Jackpocket provides an easy, secure way to order official state lottery tickets. Jackpocket is currently available in Arizona, Arkansas, Colorado, Idaho, Massachusetts, Minnesota, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Texas, Washington D.C., and West Virginia, and is expanding to many new markets. Download the app on iOS and Android or participate via desktop. Follow along on Facebook, Twitter, and Instagram.

 

Cautionary Note 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, Section 21E of the Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, that relate to our current expectations and views of future events. All statements other than statements of historical facts contained in this press release, including statements relating to whether the transaction will drive Jackpocket’s or Gannett’s revenue and cash flow growth, result in or be able to leverage any synergies or be accretive to Jackpocket’s or Gannett’s revenue, are all forward looking statements. These statements represent our opinions, expectations, beliefs, intentions, estimates or strategies regarding the future, which may not be realized. In some cases, you can identify forward-looking statements by terms such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” “could,” “will,” “would,” “ongoing,” “future” or the negative of these terms or other similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements are based largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements involve known and unknown risks, uncertainties, contingencies, changes in circumstances that are difficult to predict and other important factors that may cause our actual results, performance, or achievements to be materially and/or significantly different from any future results, performance or achievements expressed or implied by the forward-looking statement. For a discussion of some of the risks and important factors that could cause actual results to differ materially from our expectations, see the risks and other factors detailed in Gannett’s 2021 Annual Report on Form 10-K and Gannett’s quarterly reports on Form 10-Q and each of Gannett’s other filings with the SEC, in each case as such factors may be updated from time to time. Any forward-looking statements contained in this press release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. Gannett disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by applicable law.

Contacts

Lark-Marie Anton

Gannett

Chief Communications Officer

(646) 906-4087

lark@gannett.com

Lauren Hovey

Jackpocket

Senior Vice President

(330) 819-2145

Lauren.hovey@clyde.us

Categories
Business Healthcare Lifestyle Science

Bausch + Lomb completes acquisition of XIIDRA®

Poised for Significant Growth in Prescription Dry Eye Segment

 

VAUGHAN, Ontario — (BUSINESS WIRE) — Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, recently announced it has completed its acquisition of XIIDRA (lifitegrast ophthalmic solution) 5%, a non-steroid eye drop specifically approved to treat the signs and symptoms of dry eye disease (DED) focusing on inflammation associated with dry eye, and certain other ophthalmology assets.

 

In addition to XIIDRA, Bausch + Lomb’s dry eye offering includes eye and contact lens drops from the company’s consumer brand franchises and its pharmaceutical business, including MIEBO™ (perfluorohexyloctane ophthalmic solution), which launched in the United States earlier this month as the first and only FDA-approved prescription eye drop for DED that directly targets tear evaporation.

 

“We expect to quickly take a leading position in the growing prescription dry eye category with the XIIDRA acquisition and MIEBO launch and, importantly, help the millions of patients not currently receiving adequate treatment for dry eye disease,” said Brent Saunders, chairman and CEO, Bausch + Lomb.

 

DED affects approximately 739 million people worldwide, including approximately 38 million people in the United States.1 The prescription U.S. DED field is expected to grow at a double-digit compounded annual growth rate over the next five years.2

 

As part of the transaction, Bausch + Lomb also acquired libvatrep (also known as SAF312), an investigational compound being studied for the treatment of chronic ocular surface pain, and AcuStream™ technology, an investigational device that may have the potential to facilitate precise dosing and accurate delivery of certain topical ophthalmic medications to the eye.3,4 Libvatrep is currently in Phase 2b development with study results anticipated to be completed in the second half of 2023.

 

Transaction Details

Under the terms of the agreement, Bausch + Lomb, through an affiliate, acquired XIIDRA and the other ophthalmology assets from Novartis for up to $2.5 billion, including an upfront payment of $1.75 billion in cash with potential milestone obligations of up to $750 million based on sales thresholds and pipeline commercialization. Bausch + Lomb also brought on the sales force supporting XIIDRA. The company funded the acquisition with the previously announced offering of $1.4 billion aggregate principal amount of 8.375% senior secured notes due 2028 (“Notes”) and $500 million of new term B loans under an incremental term loan facility (“Term Loan Facility”). The issuance of the Notes and the closing of the Term Loan Facility occurred substantially concurrently with the closing of the acquisition.

 

WHAT IS XIIDRA?

XIIDRA (lifitegrast ophthalmic solution) 5% is a prescription eye drop used to treat the signs and symptoms of dry eye disease.

 

IMPORTANT SAFETY INFORMATION

Do not use XIIDRA if you are allergic to any of its ingredients. Seek medical care immediately if you get any symptoms of an allergic reaction.

 

The most common side effects of XIIDRA include eye irritation, discomfort or blurred vision when the drops are applied to the eyes, and an unusual taste sensation.

 

To help avoid eye injury or contamination of the solution, do not touch the container tip to your eye or any surface. If you wear contact lenses, remove them before using XIIDRA and wait for at least 15 minutes before placing them back in your eyes.

 

It is not known if XIIDRA is safe and effective in children under 17 years of age.

 

Click here for full Prescribing Information for XIIDRA.

 

WHAT IS MIEBO?

MIEBO™ (perfluorohexyloctane ophthalmic solution) is used to treat the signs and symptoms of dry eye disease.

 

IMPORTANT SAFETY INFORMATION

  • Patients should remove contact lenses before using MIEBO and wait for at least 30 minutes before reinserting.
  • It is important for patients to use MIEBO exactly as prescribed.
  • It is not known if MIEBO is safe and effective in children under the age of 18.
  • The most common eye side effect seen in studies was blurred vision (1% to 3% of patients reported blurred vision and eye redness).

Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Click here for full Prescribing Information for MIEBO.

About Bausch + Lomb

Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visit www.bausch.com and connect with us on Twitter, LinkedIn, Facebook and Instagram.

 

Bausch + Lomb Forward-looking Statements

This news release may contain forward-looking statements, including, but not limited to, the anticipated impact of the transaction, including our anticipated stake in the dry eye field. Forward-looking statements may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “will,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb’s filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators (including its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023, and its Annual Report on Form 10-K for the fiscal year ended Dec. 31, 2022), which factors are incorporated herein by reference. In addition, such risks and uncertainties include, but are not limited to, the following: the effect of the announcement or closing of the Transaction on the market price of Bausch + Lomb’s common stock and Bausch + Lomb’s ability to maintain relationships with customers, suppliers, other business partners or governmental entities; the impact of the Transaction on Bausch + Lomb’s business, financial position and results of operations, including with respect to expectations regarding margin expansion, accretion and deleveraging; the possibility that the expected benefits of the Transaction will not be realized or will not be realized within the expected time period; and risks relating to potential diversion of management attention away from Bausch + Lomb’s ongoing business operations. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

 

References

  1. Downs P. 2020 Dry Eye Products Market Report: A Global Analysis for 2019 to 2025. Market Scope; 2020.
  2. U.S. dry-eye size including aqueous supplements, secretagogues, corticosteroids, LFA-1 antagonists, calcineurin inhibitors across anti-inflammatory and non-anti-inflammatory drug classes. Source: DRG (12/2022); Expert interviews; Analyst reports.
  3. Quiroz-Mercado H, Ivri E, Gonzalez-Salinas R, et al. Clinical evaluation of a novel electromechanical topical ocular drug delivery system: two phase 1 proof of concept studies. Clin Ophthalmol. 2020;14:139-147.
  4. Data on file. AcuStream repetitive acute and real-time delivery study. Novartis, 2022.

© 2023 Bausch + Lomb.

Contacts

Media:
T.J. Crawford

tj.crawford@bausch.com
(908) 705-2851

Lainie Keller

lainie.keller@bausch.com
(908) 927-1198

Investor:
George Gadkowski

george.gadkowski@bausch.com
(877) 354-3705 (toll free)

(908) 927-0735

Categories
Business Lifestyle Regulations & Security

AM Best affirms Credit Ratings of Greenlight Capital Re, Ltd. and its subsidiaries

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has affirmed the Financial Strength Rating of A- (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICR) of “a-” (Excellent) of Greenlight Reinsurance, Ltd. (Cayman Islands) and Greenlight Reinsurance Ireland, Designated Activity Company (Ireland). Additionally, AM Best has affirmed the Long-Term ICR of “bbb-” (Good) of Greenlight Capital Re, Ltd. (Cayman Islands) (GLRE) [NASDAQ: GLRE], the ultimate holding company. The outlook of these Credit Ratings (ratings) is stable.

 

The ratings reflect GLRE’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 (ERM).

 

GLRE’s balance sheet strength assessment of very strong is supported by the strongest level of risk-adjusted capitalization, as measured by Best’s Capital Adequacy Ratio (BCAR). Consolidated surplus increased 5.8% in 2022, and has continued to grow throughout 2023, trending positively after a period of decline. AM Best expects the group to maintain risk-adjusted capital levels in line with its current ratings.

 

AM Best views GLRE’s operating performance as marginal, given its historically volatile investment returns and marginal underwriting performance. However, the group’s 2022 combined ratio is below the current five-year average, and inclusive of corporate expenses is 104.6% compared to a 105.2% five-year average. The group’s return metrics also continue to trend positively, with five consecutive years of improving returns on equity and revenue. Investment returns since 2019 also have been accretive to results. Though the group’s operating performance metrics are trending positively, it has not yet had a full year of underwriting profitability.

 

AM Best views GLRE’s business profile as neutral. The company was incorporated in the Cayman Islands in 2004 and is one of the longest-tenured total return reinsurers. Through its operating subsidiaries, GLRE provides property/casualty reinsurance on a global scale. GLRE has taken steps to diversify its platforms, including through significant investments in its innovation-related operations, including the 2022 launch of the Greenlight Re Innovations Syndicate 3456 at Lloyd’s. Additionally, GLRE’s ERM is deemed appropriate for the company’s business complexity and overall risk profile.

 

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

Christopher Pennings
Financial Analyst
+1 908 882 2237
christopher.pennings@ambest.com

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

Steven M. Chirico, CFA
Director
+1 908 882 1694
steven.chirico@ambest.com

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

Categories
Healthcare Lifestyle Science Technology

Blue Earth Diagnostics highlights presentations on POSLUMA® (Flotufolastat F 18) in prostate cancer at upcoming ASTRO 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 POSLUMA® (flotufolastat F 18) injection (formerly known as 18F-rhPSMA-7.3) at the upcoming American Society for Therapeutic Radiology and Oncology (ASTRO) 2023 Annual Meeting, to be held in San Diego, Calif., from Oct. 1-4, 2023.

 

POSLUMA is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

 

“PET imaging with POSLUMA reveals clinical information crucial to decision-making for men with prostate cancer, and we are excited to share further information with the radiation oncology community at ASTRO 2023,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “Phase 3 results from the SPOTLIGHT trial demonstrated the ability of POSLUMA to detect recurrent disease even at low prostate specific antigen (PSA) levels, and Dr. Ashesh Jani’s oral presentation will detail further information about its diagnostic performance at PSA levels <1 ng/mL. Dr. Phillip Kuo will present additional results from the Phase 3 LIGHTHOUSE trial that evaluated POSLUMA performance in newly diagnosed patients having high/very high risk prostate cancer and negative results with conventional imaging. Blue Earth Diagnostics will also host an Industry-Expert Theater event, ‘POSLUMA: Precision PET Imaging that is Truly Revealing’.”

 

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

 

HIGHLIGHTED SCIENTIFIC PRESENTATIONS

Monday, Oct. 2, 2023

Oral presentation

Title:

Detection Rate of 18F-rhPSMA-7.3 PET in Patients with Suspected Prostate Cancer Recurrence at PSA Levels <1 ng/mL: Data from the Phase 3 SPOTLIGHT Study

Presenter:

Ashesh B. Jani, MD, FASTRO, Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Ga., for the SPOTLIGHT Study Group

Session Type:

Oral

Session Title:

SS11 – GU 3 Novel Prognostication Techniques for Prostate Cancer

Presentation Time:

3:30 – 3:37 PM PT

Location:

Room 6 D/E

Presentation No.:

160

Tuesday, October 3, 2023

Poster presentation   

Title:

Diagnostic Performance of 18F-rhPSMA-7.3 PET in Men with Newly Diagnosed High-risk Prostate Cancer and Negative Conventional Imaging

Presenter:

Phillip H. Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering, University of Arizona, Tucson, Ariz., on behalf of  Gary A. Ulaner, MD, Ph.D., Hoag Family Cancer Institute, Irvine, Calif. and University of Southern California, Los Angeles, Calif., for the LIGHTHOUSE Study Group

Session Title:

PQ 06 – Poster Q&A 06 – Session 06 – Genitourinary Cancer, Patient Safety and Nursing

Presentation Time:

2:30 – 3:45 PM PT

Location:

Hall B1

Presentation No.:

2972

 

Blue Earth Diagnostics invites participants at the 2023 ASTRO Annual Meeting to attend the presentations above and visit the company at Exhibit Booth 2223. Blue Earth Diagnostics is hosting an Industry-Expert Theater event, “POSLUMA: Precision PET Imaging that is Truly Revealing,” with invited speaker Dr. Nicholas Zouain, Radiation Oncologist, Medical Director of West Florida Radiation Therapy, US Oncology Network, Clearwater, Fla. The event will be held on Sunday, October 1, 2023, from 12:00 PM to 1:00 PM PT, in Theater 1 of the San Diego Convention Center. For full session details and scientific presentation listings, please see the ASTRO online program here.

 

Indication and Important Safety Information About POSLUMA

INDICATION

POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

  • with suspected metastasis who are candidates for initial definitive therapy
  • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

 

IMPORTANT SAFETY INFORMATION

  • Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
  • Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
  • POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
  • The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
  • Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.

 

To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Full POSLUMA prescribing information is available at www.posluma.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

+44 (0)1865 784186

clare.gidley@blueearthdx.com

Media
Sam Brown Inc.

Mike Beyer

(M) (312) 961-2502

mikebeyer@sambrown.com

Categories
Business Culture Economics Energy Environment Lifestyle

Tankfarm raises $23M to fuel innovation in propane

NASHVILLE, Tenn. — (BUSINESS WIRE) — Tankfarm, the tech-enabled propane distribution platform, announced today that it has closed on a $23M Series-B round led by a handful of prominent family offices and existing investors. The capital will go towards customer acquisition, continued development of Tankfarm’s patent-pending technology platform, and extending its national propane delivery footprint which currently spans 37 states and over 400 locations.

“In the midst of a very challenging economic and fundraising environment, our investors stepped up and have put Tankfarm on a path to becoming one of the largest propane distribution companies in the US market,” Heaney said. “It is a testament to our fantastic team, and also to the belief our investors have in our vision. We are deeply grateful to all of them.”

 

Tankfarm invests in software and sensors to improve the customer experience for propane consumers, and to make deliveries more efficient and profitable. The company aims to improve the propane industry’s approach to technology, so it can begin to meet the expectations of today’s propane consumer. The $35B U.S. propane industry is highly fragmented and has been slow to embrace new technology.

 

“This really is just the beginning,” Heaney added. “Every day our technology moat gets a bit deeper, creating an increasingly durable source of competitive advantage in an industry that has traditionally underinvested in technology.”

 

For more information, visit: https://tankfarm.io

 

About Tankfarm

Tankfarm is a propane distribution company that invests in proprietary software and sensors to create a superior customer experience and greater logistical efficiency to the propane industry. Tankfarm offers transparent pricing, no fees, free tank monitoring and a guarantee that our customers will never run out of propane. The Tankfarm supplier network spans 37 states and over 400 locations.

 

Tankfarm is a member of the World Liquid Propane Gas Association (WLPGA), the National Propane Gas Association (NPGA), the Propane Gas Association of New England (PGANE), the Maine Energy Marketers Association, the New York Propane Gas Association (NYPGA), the New Jersey Propane Gas Association (NJPGA), the Pennsylvania Propane Gas Association (PAPGA), the Mid-Atlantic Propane Gas Association (MAPGA) the Virginia Propane Gas Association (VPGA), the Rocky Mountain Propane Association (RMPA), the Western Propane Gas Association (WPGA), the Pacific Propane Gas Association (PPGA), and the Texas Propane Gas Association (TPGA).

Contacts

Andrew Heaney

support@tankfarm.io
855-976-4141

Categories
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The Menopause Society Annual Meeting 2023: Bayer to present latest real-world evidence of menopausal symptoms and their treatment

 

  • Real-world evidence (RWE) research results on treatment utilization and pathways in women with menopausal symptoms via poster presentations on the CHAPTER natural menopause study, CHAPTER i-menopause study and REALISE study
  • These poster presentations reinforce Bayer’s leadership and commitment to understanding and advancing women’s healthcare specifically for those who are experiencing menopause symptoms

 

 

BERLIN & WHIPPANY, N.J. — (BUSINESS WIRE) — Bayer will present the latest RWE research results which focuses on treatment utilization and pathways in women with menopausal symptoms at the upcoming Menopause Society Annual Meeting (formerly The North American Menopause Society). The Menopause Society Annual Meeting takes place from September 27 – 30, in Philadelphia, Pennsylvania, USA.

 

Key Highlights of Bayer’s presentations at The Menopause Society annual meeting 2023 are:

REALISE iVMS: What do women with breast cancer take for menopause symptoms? A real-world analysis of treatment utilization from the US and Europe

  • Approximately 20% of women with vasomotor symptoms (VMS) induced by breast cancer treatment received hormonal therapy (HT).
  • Regardless of severity of symptoms, women were prescribed HT at similar rates for their VMS.
  • Evidence of HT prescribing, despite contraindications, suggests clinicians are seeking treatment options (indicating significant symptom burden) and an unmet need for non-HT options.

 

CHAPTER natural menopause: Characterizing treatment pathways for natural menopausal symptoms in US women

  • Two-thirds of natural menopausal women did not receive treatment for menopausal symptoms, which might suggest undertreatment in this population.
  • Paroxetine was prescribed to fewer women than other non-hormonal therapies , despite being the only non-HT approved for VMS in the US.
  • Benzodiazepines were highly prescribed suggesting an unmet need for treatments for the management of menopause-associated sleep and mood disturbances.

 

CHAPTER i-menopause: Characterizing treatment pathways for endocrine therapy (ET)-related menopausal symptoms in US

  • Only one-third of women initiating ET for breast cancer or high breast cancer risk received treatment for menopausal symptoms, which might suggest symptoms often go unrecognized and untreated.
  • Benzodiazepines were the most common treatment prescribed, reflecting a requirement for management of menopause-associated sleep and mood disturbances.
  • Despite being contraindicated, HT was prescribed to approximately 15% of women, suggesting an unmet need for effective, long-term non-HT management options for ET-related menopausal symptoms.

 

The research presented showcases the commitment of Bayer as a leader in women’s healthcare to broaden therapeutic choices and to increase awareness and education around menopausal symptoms. Additionally, as part of this commitment, the company is investigating new approaches, including elinzanetant, a late-stage investigational drug with a data readout expected in late 2023.

 

The official poster session will be held on Thursday, September 28, from 6:15 PM to 7:15 PM EST.

 

About Vasomotor Symptoms

Vasomotor symptoms (VMS; also referred to as hot flashes) are a result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons due to withdrawal of estradiol, which can result from progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

 

VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.

 

Vasomotor symptoms may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. There are currently no treatment options available for these women.

 

About Menopause

By 2030, the world population of women in the menopause phase is projected to increase to 1.2 billion, with 47 million new entrants each year. Menopause is a natural phase in women’s lives, related to progressive decline of ovarian function, which usually occurs in women in their late 40s or early 50s. It can also be the result of surgical or medical treatment, for example for breast cancer. The decline in hormone production by the ovaries can lead to various symptoms, which can dramatically affect a woman’s health, quality of life, consumption of healthcare and work productivity. The most frequently reported and bothersome symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. For this reason, maintaining functional ability and quality of life is extremely relevant from both a healthcare and socio-economic perspective.

 

About Elinzanetant

Elinzanetant is an investigational, first, non-hormonal, orally administered, selective neurokinin-1,3 receptor antagonist currently in clinical development for the treatment of vasomotor symptoms (hot flashes) associated with menopause. Elinzanetant seeks to address vasomotor symptoms by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons), that due to the absence of estrogen, become hyperactive in menopausal women and consequently disrupt body heat control mechanisms resulting in hot flashes.

 

The clinical Phase III development program with elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. The OASIS 1,2 and 3 investigate the efficacy and safety of elinzanetant in women with vasomotor symptoms associated with menopause. The OASIS 4 study is an expansion of the clinical phase III program and investigates the efficacy and safety of elinzanetant in women with vasomotor symptoms by endocrine therapy for treatment or prevention of breast cancer.

 

The design and dosing of the Phase III clinical development program is based on the positive data from two Phase II studies (RELENT-1 and SWITCH-1). RELENT-1 was a Phase Ib/IIa study investigating the safety, pharmacokinetics and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase IIb study, which investigated the efficacy and safety of four different doses of elinzanetant compared to placebo in patients with vasomotor symptoms. Full results of the study have been published in March 2023 in Menopause – The Journal of the Menopause Society (formerly the North American Menopause Society) and are available at: https://doi.org/10.1210/jendso/bvaa046.2071.

 

About Women’s Healthcare at Bayer

Bayer is a global leader in women’s healthcare with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

 

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

 

Find more information at https://pharma.bayer.com/
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kw (2023-0136e)

 

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contacts

Contact for Global media inquiries:
Katja Wiggers, phone +49 30 221541614
Email: katja.wiggers@bayer.com

Contact for US media inquiries:
Courtney Ambrosi, phone 1 (908) 798-1107
Email: courtney.ambrosi@bayer.com

Categories
Business Technology

Calix continues 24-year leadership in US rural broadband by expanding strategy to include American manufacturing, ensuring full participation in the Broadband Equity, Access, and Deployment (BEAD) program

Calix and its strategic manufacturing solutions provider, Jabil, join with government leaders, including US Assistant Secretary of Commerce Alan Davidson and Michigan Lieutenant Governor Garlin Gilchrist, to unveil the details of its strategy to meet Build America, Buy America (BABA) requirements by manufacturing critical broadband hardware systems from the unique US-built Calix software and cloud platform at Jabil’s facility in Auburn Hills, Michigan

 

AUBURN HILLS, Mich. & SAN JOSE, Calif. — (BUSINESS WIRE) — Calix, Inc. (NYSE: CALX) today affirmed its commitment to “Build America, Buy America” (BABA) for the Broadband Equity, Access, and Deployment (BEAD) program during a special event held at a manufacturing facility in Auburn Hills, Michigan, operated by Jabil Inc (NYSE: JBL). This commitment includes expanding a manufacturing services agreement with Jabil at its Michigan facility. Calix was joined by government leaders United States Assistant Secretary of Commerce Alan Davidson and Michigan Lieutenant Governor Garlin Gilchrist.

Calix was founded in the United States (US) 24 years ago with an exclusive focus on enabling rural broadband service providers (BSPs). Over the past 12 years, Calix has invested $1.2 billion to build the only end-to-end software and cloud broadband platform, further establishing the company as the leading technology partner to rural BSPs across the US. Calix has more than 1,300 active US customers and nearly 100 percent serve rural markets, where they are leading the way to close the digital divide. The decision to move manufacturing to the US will ensure that Calix customers can leverage the BEAD program to meet this objective—and it will create new, high-value manufacturing jobs nationwide by building on decades of US-led innovation across Calix Cloud®, software, and systems.

 

“We founded Calix 24 years ago in the US by focusing on and partnering with US rural broadband providers as they innovated to close the digital divide,” said Calix Chairman Carl Russo. “Cooperatives, tribal and community-owned, family and community run, and private equity-backed local broadband providers are the lifeblood of rural America, and we appreciate the opportunity to partner with federal and state leaders on broadband programs that help them expand the great work that they do every day. In doing so, they have created tremendous value for underserved communities across the US as our America-led software and cloud innovation in broadband has enabled even the smallest BSP to thrive and provide the essential broadband services that enable economic growth, education, health, and safety. Calix, our customers, and our partners are tremendously thankful to the National Telecommunications and Information Administration (NTIA) and the Commerce Department for their leadership in ensuring that we can deliver world-class broadband and life-enhancing managed services to every citizen and local business. More importantly, they are doing it through a program that will help us meet this objective through Calix America-led software and cloud innovation while contributing to America’s manufacturing renaissance.”

 

With an initial investment from Calix of $4 million to $6 million and an ongoing spend for operations of $10 million to $15 million per year, Calix manufacturing solutions providers will hire workers in manufacturing, operations, engineering, quality assurance, and administrative roles as they ramp US production of Calix optical solutions—a first step in the company’s BABA initiative. The ongoing collaboration with these manufacturers will create more than 100 American jobs, with additional jobs planned as Calix customers participate in the BEAD program over the next five to 10 years.

 

“President Biden’s Investing in America agenda and commitment to ‘Made in America’ is driving a resurgence in manufacturing across the country,” said US Secretary of Commerce Gina Raimondo. “Today’s announcement is more evidence that we can close the digital divide and connect everyone in America to high-speed internet networks built by American workers with American-made equipment.”

 

“The ‘Internet for All’ initiative is not just a connectivity program; it’s a jobs program—for the people who build the networks and for the people who make the equipment those networks need,” said USAssistant Secretary of Commerce for Communications and Information and NTIA Administrator Alan Davidson.“If network equipment can be made in America, it should be made in America. Companies like Calix are stepping up and answering that call.”

 

Today, Calix employs over 1,000 professionals in the US who design, develop, market, sell, and service its end-to-end broadband platform and managed services. Calix will add to its US operations by expanding its hardware manufacturing relationships. Specifically, Calix has longstanding partnerships with three manufacturing solutions providers: a five-year partnership with Jabil, an eight-year partnership with Gemtek, and a 10-year partnership with Hisense Broadband. The manufacturing services agreements between Calix and these providers reflect the following:

  • Jabil will produce optical network terminals (ONTs) and optical line terminals (OLTs) in Michigan
  • Gemtek will produce ONTs at its California facility
  • Hisense Broadband will produce optical modules at its New Jersey facility

 

“Jabil is excited to join Calix in supporting the BEAD program while bridging the digital divide to bring critical broadband access to those who need it most,” said Jabil Executive Vice President of Operations Gerald “JJ” Creadon. “As a global manufacturing solutions provider, we have a presence in 30 countries and more than 100 facilities, yet Jabil was founded less than 30 miles from this state-of-the-art factory in Auburn Hills. We are extremely proud to ramp production of Calix’s industry-leading platforms here in Michigan, incorporating the latest automation and process technologies to accelerate the delivery of Calix’s industry-leading broadband-access equipment.”

 

Creadon joined leaders of the NTIA at the event, along with many Calix customers, including Robert Hance, President and CEO of Midwest Energy and Communications (MEC) in Cassopolis, Michigan.

 

“Midwest Energy and Communications has been committed to serving rural communities in Michigan, Indiana, and Ohio for nearly a century,” said Hance. “From our founding as an electric cooperative in the 1930s, our mission has never changed: bringing essential services where no one else would meet the needs of the communities. That’s why we added fiber broadband services to our offerings eight years ago. This has resulted in tremendous investment into our region while enabling children, parents, and communities to thrive. Calix has always been an essential partner to MEC, enabling rural service providers like us to innovate through their software and cloud platform and systems at the fastest pace in the industry. We are thrilled that Calix is partnering with the NTIA to take the critical step to bring hardware manufacturing to the US while continuing their leadership as an American innovator. Thanks to this commitment, we are confident that we can lead the way in delivering new services that are essential to our communities.”

 

Calix will continue to partner with the NTIA, leading broadband associations, and state broadband offices to ensure that Calix products and solutions can be leveraged by customers across federal and state broadband programs such as BEAD. Once the NTIA issues final guidance on BABA, Calix will share additional details of its programs with industry associations and customers.

 

Learn more about the resources Calix makes available to customers related to broadband funding.

 

About Calix

Calix, Inc. (NYSE: CALX)—Broadband service providers of all sizes leverage the Calix platform and teams to simplify their business and excite their subscribers to grow the value of their business and for their communities for generations. The democratizing power of the platform and portfolio of managed services enables them to operate efficiently, acquire subscribers, and deliver exceptional experiences. Calix is dedicated to driving continuous improvement in partnership with our growing ecosystem to support the transformation of our customers and their communities.

 

This press release contains forward-looking statements that are based upon management’s current expectations and are inherently uncertain. Forward-looking statements are based upon information available to us as of the date of this release, and we assume no obligation to revise or update any such forward-looking statement to reflect any event or circumstance after the date of this release, except as required by law. Actual results and the timing of events could differ materially from current expectations based on risks and uncertainties affecting Calix’s business. The reader is cautioned not to rely on the forward-looking statements contained in this press release. Additional information on potential factors that could affect Calix’s results and other risks and uncertainties are detailed in its quarterly reports on Form 10-Q and Annual Report on Form 10-K filed with the SEC and available at www.sec.gov.

 

Calix and the Calix logo are trademarks or registered trademarks of Calix and/or its affiliates in the US and other countries. A listing of Calix’s trademarks can be found at https://www.calix.com/pages/trademarks.html. Third-party trademarks mentioned are the property of their respective owners.

Contacts

Press Inquiries:
Alison Crisci

919-353-4323

alison.crisci@calix.com

Investor Inquiries:
Jim Fanucchi

investorrelations@calix.com

Categories
Business Healthcare Science

Ifinatamab Deruxtecan continues to demonstrate durable responses in patients with advanced small cell lung cancer in early trial

  • Encouraging objective response rate of 52.4% was seen with ifinatamab deruxtecan in heavily pretreated patients
  • IDeate-01 phase 2 trial currently enrolling patients with extensive-stage small cell lung cancer

 

 

TOKYO & BASKING RIDGE, N.J. — (BUSINESS WIRE) — Updated results from a subgroup analysis of a phase 1/2 trial showed that ifinatamab deruxtecan (I-DXd) continues to demonstrate durable responses in patients with heavily pretreated advanced small cell lung cancer (SCLC). These data were presented today during an oral presentation (OA05.05) at the 2023 World Conference on Lung Cancer (#WCLC23) hosted by the International Association for the Study of Lung Cancer.

 

Ifinatamab deruxtecan is a specifically engineered potential first-in-class B7-H3 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo’s (TSE: 4568) proprietary DXd ADC technology.

 

Lung cancer is the second most common cancer worldwide and SCLC represents about 15% of all cases.1,2 Approximately 65% of all SCLC tumors have a moderate-to-high expression of B7-H3, which is associated with disease progression and lower survival.2,3,4

 

A confirmed objective response rate (ORR) of 52.4% (95% CI: 29.8-74.3) was observed in 21 patients with advanced SCLC receiving ifinatamab deruxtecan (6.4 to 16.0 mg/kg) in the dose escalation part of the phase 1/2 trial. One complete response (CR) and 10 partial responses (PRs) were seen. A median duration of response (DOR) of 5.9 months (95% CI: 2.8-7.5) was observed. Median progression-free survival (PFS) was 5.6 months (95% CI: 3.9-8.1) and median overall survival (OS) was 12.2 months (95% CI: 6.4-NA) as of data cutoff of January 31, 2023.

 

Tumor reduction seen with ifinatamab deruxtecan was observed across a broad range of B7-H3 protein expression levels and no apparent trend of correlation between clinical efficacy parameters and B7-H3 protein expression was observed.

 

“With limited effective treatment options beyond traditional chemotherapy and immunotherapy, small cell lung cancer can be difficult to treat,” said Melissa Johnson, MD, Director, Lung Cancer Research, Sarah Cannon Research Institute. “The high response rate, along with the fact that all patients except one experienced a reduction in tumor size with ifinatamab deruxtecan, is promising.”

 

The safety profile of ifinatamab deruxtecan in patients with SCLC was consistent with previous reports in the overall population of this phase 1/2 trial. Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 36.4% of patients. The most common (>20%) TEAEs occurring in patients were nausea (59.1%), fatigue (50.0%), anemia (27.3%), vomiting (27.3%) and decreased appetite (22.7%). There was one grade 2 event confirmed to be treatment-related interstitial lung disease (ILD) or pneumonitis as determined by an independent adjudication committee. There was one grade 5 event of COVID-19 pneumonia that was determined not to be treatment related.

 

“In addition to the response rate seen with ifinatamab deruxtecan, we are further encouraged by the median overall survival seen in these patients at approximately one year,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “Additional evaluation of this B7-H3 directed antibody drug conjugate is underway in our ongoing phase 2 trial in patients with previously treated extensive-stage small cell lung cancer and we look forward to learning these results.”

 

In the subset of patients with SCLC, two patients (9.1%) had brain metastases at baseline. Patients were heavily pretreated receiving a median of two prior lines of systemic therapy in the locally advanced/metastatic setting (range, 1-7), including platinum-based chemotherapy (100%), immunotherapy (81.8%), taxane chemotherapy (22.7%) and irinotecan or topotecan chemotherapy (22.7%). The median duration of follow up was 11.7 months (95% CI: 4.63-12.88) and two patients remain on treatment with ifinatamab deruxtecan.

 

Summary of SCLC Subset Analysis of Phase 1/2 Trial

Efficacy Measure

 Patients with SCLC receiving doses of ifinatamab deruxtecan

(between 6.4 and 16.0 mg/kg)

n=21

Confirmed ORR, % (95% CI)

 52.4% (29.8-74.3)

CR, n (%)

 1 (4.8%)

PR, n (%)

 10 (47.6%)

DOR, median (95% CI), months

 5.9 months (2.8-7.5)

PFS, median (95% CI), months

 5.6 months (3.9-8.1)

OS, median (95% CI), months

 12.2 months (6.4-NA)

CR, complete response; DOR, duration of response; NA, not applicable; ORR, objective response rate; OS, overall survival; PR, partial response; PFS, progression-free survival.

 

About the Phase 1/2 Trial

The phase 1/2 trial is the first-in-human, open-label study evaluating the safety, tolerability and preliminary activity of ifinatamab deruxtecan in adult patients with advanced/unresectable or metastatic solid tumors that are refractory or intolerable to standard treatment or for whom no standard treatment exists.

 

The phase 1 part of the trial (dose escalation) is assessing the safety and tolerability of increasing doses of ifinatamab deruxtecan to determine the maximum tolerated dose or recommended dose for expansion (RDE). This portion of the trial enrolled approximately 100 patients with advanced/unresectable or metastatic SCLC, squamous non-small cell lung cancer (NSCLC), metastatic castration-resistant prostate cancer (CRPC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma, bladder cancer, sarcoma, endometrial cancer, melanoma or breast cancer.

 

The phase 2 part of the trial (dose expansion) is evaluating the safety, tolerability and preliminary activity of ifinatamab deruxtecan in patients with squamous NSCLC, metastatic CRPC or ESCC.

 

The dose escalation part of the trial is evaluating dose-limiting toxicity and safety. The dose expansion part of the trial is evaluating ORR, DOR, disease control rate, PFS, OS and safety. Pharmacokinetic endpoints, exploratory biomarker and immunogenicity endpoints also will be assessed.

 

Patient enrollment in the ESCC and squamous NSCLC cohorts of the dose expansion part of the trial remains underway in Asia and North America. For more information, please visit ClinicalTrials.gov.

 

About Small Cell Lung Cancer

Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide.1 The two main types of lung cancer include NSCLC, which represents more than 80 to 85% of all cases, and SCLC, which comprises about 15% of cases.2 The five-year survival rate is only 3% for patients diagnosed with advanced SCLC.5

 

About B7-H3

B7-H3 is a transmembrane protein that belongs to the B7 family, which also includes PD-L1.6 B7-H3 is overexpressed in a wide range of cancer types, including lung, prostate and esophageal, and its overexpression has been shown to correlate with poor prognosis in some cancers, making B7-H3 a promising therapeutic target.2,4,7,8,9,10 There are no B7-H3 directed medicines approved for the treatment of any cancer.

 

About Ifinatamab Deruxtecan

Ifinatamab deruxtecan (I-DXd) is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

 

Ifinatamab deruxtecan is being evaluated in a global development program, which includes IDeate-01, a phase 2 monotherapy trial in patients with previously treated extensive-stage SCLC, and a phase 1/2 first-in-human trial in collaboration with Sarah Cannon Research Institute.

 

About the DXd ADC Portfolio of Daiichi Sankyo

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

 

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

 

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

 

About Daiichi Sankyo

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

___________________________

References:

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

2 Schabath MB, et al. Cancer Epidemiol Biomarkers Prev. 2019 Oct;28(10):1563-1579.

3 Sung H, et al. CA Cancer J Clin. 2021;71(3): 209-249.

4 Dong P, et al. Front Oncol. 2018;8:264

5 SEER. Small Cell Carcinoma of the Lung and Bronchus SEER 5-Year Relative Survival Rates. 2012-2018. Accessed September 2022.

6 Qiu M-j, et al. Front. Oncol. 2021;11:600238.

7 Yamato M, et al. Mol Cancer Ther. 2022;21:635-46.

8 Picarda E, et al. Clin Cancer Res. 2016;22(14):3425-3431.

9 Bendell JC, et al. J Clin Oncol. 2020;39(15 suppl 1). Abstract TPS3646.

10 Kontos F, et al. Clin Cancer Res. 2021;27(5):1227-1235.

Contacts

Global/US:
Jennifer Brennan

Daiichi Sankyo, Inc.

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

Japan:
Koji Ogiwara

Daiichi Sankyo Co., Ltd.

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

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

Categories
Business Culture Foodies/Tastylicious Lifestyle News Now! Programs & Events

Sprouts Farmers Market celebrates milestone with 400th store opening in Haddon Township, NJ

Sprouts continues to stretch from coast to coast

 

PHOENIX — (BUSINESS WIRE) — Sprouts Farmers Market, one of the largest and fastest growing specialty retailers of fresh, natural and organic food in the United States, opens its 400th store.

 

Its newest store opened on Sept. 8 located at 640 W. Cuthbert Blvd. in Haddon Township, N.J. As a part of Sprouts’ five-year plan, it remains committed to a robust growth strategy, aiming to expand 10 percent year over year.

 

“Following the unveiling of our 399th store just last week in Rialto, Calif., and now, on the opposite coast, our 400th store celebrates its opening in Haddon Township, N.J.,” said Jack Sinclair, chief executive officer of Sprouts.

 

“The expansion not only marks a significant milestone, but also represents our success in offering high quality better-for-you products to our customers coast to coast. To our remarkable teams, loyal customers, and supportive partners, thank you for being integral to this incredible accomplishment.”

 

Haddon Township, N.J. marks the 23rd store opening for Sprouts this year. Each new store adheres to an innovative design concept, featuring a 23,000-square-foot footprint, and a bright and airy farmers market experience with an open layout, community feel, and produce at the heart of the market.

 

“Our journey has been nothing short of extraordinary, with our trajectory fueled by our dedication to delivering a wide assortment of organic groceries, local farm-fresh produce, and quality healthy products that cater to any dietary needs,” said Nick Konat, chief operating officer of Sprouts.

 

“As we celebrate our 400th store milestone, we now set our sights on the promising path ahead, looking forward to continuing growth and positive impact in the communities we serve.”

 

Sprouts is currently located in 23 states across the U.S., including Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Kansas, Louisiana, Maryland, Missouri, Nevada, New Jersey, New Mexico, North Carolina, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington.

 

For a list of current stores, visit www.sprouts.com/stores.

 

About Sprouts Farmers Market, Inc.

Sprouts is the place where goodness grows. True to its farm-stand heritage, Sprouts offers a unique grocery experience featuring an open layout with fresh produce at the heart of the store. Sprouts inspires wellness naturally with a carefully curated assortment of better-for-you products paired with purpose-driven people. The healthy grocer continues to bring the latest in wholesome, innovative products made with lifestyle-friendly ingredients such as organic, plant-based and gluten-free. Headquartered in Phoenix, and one of the largest and fastest growing specialty retailers of fresh, natural and organic food in the United States, Sprouts employs approximately 31,000 team members and operates approximately 400 stores in 23 states nationwide. To learn more about Sprouts, and the good it brings communities, visit about.sprouts.com.

Contacts

480.263.0441, media@sprouts.com