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Cornerstone Building Brands celebrates Manufacturing Day 2023

Exterior building solutions company celebrates team member impact and future manufacturing workforce

 

CARY, N.C. — (BUSINESS WIRE) — Cornerstone Building Brands, Inc. “(Cornerstone Building Brands),” the largest manufacturer of exterior building products in North America by sales, announced plans to celebrate National Manufacturing Day (MFG Day) across its North American facilities.

 

Beginning on Friday, and continuing throughout October, the company will host events to honor its nearly 20,000 team members and open its doors to future manufacturing talent through a series of open houses.

 

“At Cornerstone Building Brands our people are the difference, dedicated to understanding and delivering on our customers’ needs by embodying a culture grounded in customer-centricity, interconnectedness and continuous improvement,” said Rose Lee, president and CEO of Cornerstone Building Brands.

 

“Manufacturing Month is the perfect opportunity for future talent to learn more about the wide range of career opportunities available within the industry, as well as the specific goals our winning team of top-tier talent is working together to achieve.”

 

MFG Day, an initiative of the Manufacturing Institute and supported by the National Association of Manufacturers, has been celebrated on the first Friday of October since 2012. This year’s celebrations come at a particularly crucial time for the future of the modern manufacturing industry as thousands of jobs remain unfilled month-to-month. According to the latest research from the Manufacturing Institute, this skills gap has led to more than 2.1 million U.S. manufacturing jobs that need to be filled by 2030.1

 

Cornerstone Building Brands is addressing this deficit by opening its doors to the next generation of manufacturing professionals. At its exterior siding facility in Jasper, Tennessee, and its windows facility in North Brunswick, New Jersey, high school students, teachers and community leaders are invited to tour the facilities and experience the product development process hands-on. Cornerstone Building Brands facility and company leadership will also be in attendance to facilitate event activities and offer insight into available career and professional development opportunities.

 

“I’m proud to be part of a team that works together safely, inclusively and with integrity to ensure our products reach the highest quality levels every time,” said John Wallace, executive vice president, operational excellence at Cornerstone Building Brands.

 

“We look forward to continuing this standard of excellence and welcoming the next generation to explore the many opportunities in an ever-evolving manufacturing industry.”

 

In addition to community events, the company is also shining a light on its network of team members across North America who are dedicated to making a positive impact on their customers and communities. At its more than 170 locations, Cornerstone Building Brands is recognizing team members throughout October by hosting team building and employee appreciation events, celebrating the work team members do every day as critical members of the manufacturing industry.

 

This year’s Manufacturing Month celebrations are just one way the company positively impacts the communities where team members live, work and play. Through Cornerstone Building Brands Cares initiatives, the company works with local partners and charitable organizations to donate building products, facilitate house builds and strengthen volunteer engagement. To date, Cornerstone Building Brands has donated more than $3.1 million in products and resources, helping to build or remodel more than 670 homes in 90 communities through its Home for Good project.

 

To learn more about Manufacturing Day at Cornerstone Building Brands, visit cornerstonebuildingbrands.com/mfgday.

 

About Cornerstone Building Brands

Cornerstone Building Brands is the largest manufacturer of exterior building products by sales for residential and low-rise non-residential buildings in North America. Headquartered in Cary, N.C., we serve residential and commercial customers across the new construction and repair and remodel markets. Our market-leading portfolio of products spans vinyl windows, vinyl siding, stone veneer, metal roofing, metal wall systems and metal accessories. Cornerstone Building Brands’ broad, multichannel distribution platform and expansive national footprint includes nearly 20,000 employees at manufacturing, distribution and office locations throughout North America. Corporate stewardship and environmental, social and governance (ESG) responsibility are embedded in our culture. We are committed to contributing positively to the communities where we live, work and play. For more information, visit us at www.cornerstonebuildingbrands.com.

1 http://www.mfgday.com/wp-content/uploads/2020/04/MFG-Day-2023-Government-Official-Toolkit.pdf

 

Contacts

Investor Relations:
Jason Uthe

SVP, Finance & Investor Relations

response@cornerstone-bb.com

 

Media Relations:
Susan Selle

Chief Marketing Officer

response@cornerstone-bb.com

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Dodge Momentum Index rises 3% in September following August decline

Institutional planning drives DMI higher, while commercial planning declines

 

HAMILTON, N.J. — (BUSINESS WIRE) — The Dodge Momentum Index (DMI), issued by Dodge Construction Network, improved 3% in September to 182.5 (2000=100) from the revised August reading of 178.0. Over the month, the commercial component of the DMI fell 1%, while the institutional component increased 9%.

 

“Solid demand for data centers, life science labs and hospitals supported the uptick in nonresidential planning activity last month,” said Sarah Martin, associate director of forecasting for Dodge Construction Network. “While month-to-month trends can be volatile, year-to-date trends show an overall decrease in commercial planning, offset by more institutional projects entering the queue. If financial conditions improve in early 2024, steady planning activity should follow.”

 

Weaker office planning drove the commercial segment of the DMI down, while the acceleration in the institutional segment was supported by stronger education, notably life science buildings, and healthcare planning activity. Year over year, the DMI was 5% lower than in September 2022. The commercial segment was 12% below year-ago levels, while the institutional segment was up 12% over the same time period.

 

A total of 20 projects valued at $100 million or more entered planning in September. The largest commercial projects to enter planning included the $400 million Platform 16 office development in San Jose, California and the $230 million Waterford Millstone Data Center in Waterford, Connecticut. The largest institutional projects to enter planning included the $927 million UC San Diego Research Park in San Diego, California and phases three and four of the Kilroy Oyster Point Life Sciences Complex in San Francisco, California, valued at a total of $634 million.

 

The DMI is a monthly measure of the initial report for nonresidential building projects in planning, shown to lead construction spending for nonresidential buildings by a full year.

 

Watch Associate Director of Forecasting Sarah Martin discuss September’s DMI here.

 

About Dodge Construction Network

Dodge Construction Network leverages an unmatched offering of data, analytics, and industry-spanning relationships to generate the most powerful source of information, knowledge, insights, and connections in the commercial construction industry. The company powers four longstanding and trusted industry solutions—Dodge Data & Analytics, The Blue Book Network, Sweets, and IMS—to connect the dots across the entire commercial construction ecosystem. Together, these solutions provide clear and actionable opportunities for both small teams and enterprise firms. Purpose-built to streamline the complicated, Dodge Construction Network ensures that construction professionals have the information they need to build successful businesses and thriving communities. With over a century of industry experience, Dodge Construction Network is the catalyst for modern commercial construction.

Contacts

Amy Roepke | Dodge Construction Network | Amy.Roepke@construction.com

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Sony researchers: skin tone measures adopted by Google, Meta, and others for their image algorithms don’t properly capture the red and yellow hues in human skin

—  Google, Meta, and others test their algorithms for bias using standardized skin tone scales. Sony says those tools ignore the yellow and red hues at work in human skin color.

 

Paresh Dave / Wired:

 

 

After evidence surfaced in 2018 that leading face-analysis algorithms were less accurate for people with darker skin, companies including Google and Meta adopted measures of skin tone to test the effectiveness of their AI software.

 

New research from Sony suggests that those tests are blind to a crucial aspect of the diversity of human skin color.

 

By expressing skin tone using only a sliding scale from lightest to darkest or white to black, today’s common measures ignore the contribution of yellow and red hues to the range of human skin, according to Sony researchers. They found that generative AI systems, image-cropping algorithms, and photo analysis tools all struggle with yellower skin in particular. The same weakness could apply to a variety of technologies whose accuracy is proven to be affected by skin color, such as AI software for face recognition, body tracking, and deepfake detection, or gadgets like heart rate monitors and motion detectors.

 

“If products are just being evaluated in this very one-dimensional way, there’s plenty of biases that will go undetected and unmitigated,” says Alice Xiang, lead research scientist and global head of AI Ethics at Sony. “Our hope is that the work that we’re doing here can help replace some of the existing skin tone scales that really just focus on light versus dark.”

 

But not everyone is so sure that existing options are insufficient for grading AI systems. Ellis Monk, a Harvard University sociologist, says a palette of 10 skin tones offering light to dark options that he introduced alongside Google last year isn’t unidimensional.

 

“I must admit being a bit puzzled by the claim that prior research in this area ignored undertones and hue,” says Monk, whose Monk Skin Tone scale Google makes available for others to use.

 

“Research was dedicated to deciding which undertones to prioritize along the scale and at which points.”

 

He chose the 10 skin tones on his scale based on his own studies of colorism and after consulting with other experts and people from underrepresented communities.

 

X. Eyeé, CEO of AI ethics consultancy Malo Santo and who previously founded Google’s skin tone research team, says the Monk scale was never intended as a final solution and calls Sony’s work important progress. But Eyeé also cautions that camera positioning affects the CIELAB color values in an image, one of several issues that make the standard a potentially unreliable reference point.

 

“Before we turn on skin hue measurement in real-world AI algorithms—like camera filters and video conferencing—more work to ensure consistent measurement is needed,” Eyeé says.

 

Read more at links:

Sony researchers: skin tone measures adopted by Google, Meta, and others for their image algorithms don’t properly capture the red and yellow hues in human skin

https://www.wired.com/story/ai-algorithms-are-biased-against-skin-with-yellow-hues/

 

 

— Techmeme

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Sanofi and Teva announce exclusive collaboration to deliver inflammatory bowel disease treatment

  • TEV ‘574, a novel anti-TL1A therapy, is being developed to treat ulcerative colitis and Crohn’s disease
  • Collaboration supports Sanofi’s immunology strategy of exploring novel mechanisms of action for chronic inflammatory diseases
  • Collaboration leverages the innovative R&D and commercial expertise of both companies

 

PARIS & PARSIPPANY, N.J. — (BUSINESS WIRE) — Sanofi (EURONEXT: SAN and NASDAQ: SNY) and Teva Pharmaceuticals, a U.S. subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announce today a collaboration to co-develop and co-commercialize asset TEV ‘574, currently in Phase 2b clinical trials for the treatment of Ulcerative Colitis and Crohn’s Disease, two types of inflammatory bowel disease.

 

Paul Hudson

Chief Executive Officer, Sanofi

“Anti-TL1As are a promising class of therapies, and we believe that TEV ‘574 could emerge as a best-in-class option for people living with serious gastrointestinal diseases. This collaboration strengthens our commitment to advancing innovative treatment options for inflammatory conditions with a high unmet need and bolsters our goal to be an industry leader in immunology.”

 

Richard Francis

President and Chief Executive Officer, Teva

“This is a new era for Teva, and our robust, innovative pipeline is key to our Pivot to Growth strategy. This collaboration further validates the great science that Teva has to offer with our internally developed anti-TL1A. We are honored to partner with Sanofi to bring their proven capabilities, leadership, and success in the immunology and gastroenterology space together with our capabilities to optimize development and global launches.”

 

Under the terms of the new collaboration agreement, Teva will receive an upfront payment of €469 million ($500 million) and up to €940 million ($1 billion) in development and launch milestones. Each company will equally share the development costs globally and net profits and losses in major markets, with other markets subject to a royalty arrangement and Sanofi will lead the development of the Phase 3 program. Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world. The transaction will become effective after customary closing conditions are met. Initial program results are expected to be available in 2024.

 

Inflammatory bowel disease (IBD) is the term for two conditions — Crohn’s disease and ulcerative colitis – characterized by chronic inflammation of the gastrointestinal (GI) tract. Prolonged inflammation results in damage to the GI tract. The common symptoms for both conditions are persistent diarrhea, rectal bleeding, abdominal pain, fatigue, and weight loss. An estimated ~10 million people worldwide live with IBD.

 

Teva Investor Call

Teva will hold an investor call and live webcast today (Wednesday, October 4, 2023) at 8:00 a.m. ET to discuss this collaboration. To participate, please register in advance here to obtain a local or toll-free phone number and your personal pin. A live webcast of the call will be available on Teva’s website at: https://ir.tevapharm.com/Events-and-Presentations.

 

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

 

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative and biopharmaceutical products. Learn more at www.tevapharm.com.

 

Sanofi Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 

Teva Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include: risks relating to our exclusive collaboration with Sanofi, including uncertainties around the effective date of the collaboration and our ability to satisfy the closing conditions related thereto; risks related to the timing of and our ability to achieve expected results for TEV-48574 (anti-TL1A), including our ability to commercialize TEV-48574 (anti-TL1A); the extent to which we will realize the anticipated financial and other benefits of the Sanofi collaboration; our ability to satisfy the conditions to receiving milestone cash payments under the Sanofi collaboration agreement; the risk that we will incur significant costs in connection with the development of TEV-48574 (anti-TL1A), which may exceed any revenue generated by TEV-48574 (anti-TL1A); risks that regulatory approvals and other requirements may delay the development and commercialization of TEV-48574 (anti-TL1A); our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our innovative medicines, including AUSTEDO®, AJOVY® and COPAXONE®, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our ability to successfully launch and execute our new Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines; our substantial indebtedness which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2023 and in our Annual Report on Form 10-K for the year ended December 31, 2022, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

 

Contacts

Sanofi Media Relations
Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com

Sanofi Investor Relations
Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com
Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com
Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
Tarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com

Teva Investor Relations
Ran Meir | (267) 468-4475

Yael Ashman | +972 (3) 914 8262

Sanjeev Sharma | (973) 524-1908

Teva Corporate Affairs
Kelley Dougherty | (973) 658-0237

Eden Klein | +972 (3) 906 2645

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Business Healthcare Lifestyle Science

Additional results of POSLUMA® (Flotufolastat F 18) performance in newly diagnosed, high-risk prostate cancer patients presented at ASTRO

− Sub-group analysis from Blue Earth Diagnostics’ Phase 3 LIGHTHOUSE trial highlights POSLUMA utility to guide treatment selection and potentially avoid futile surgery –

 

 

MONROE TOWNSHIP, N.J. & OXFORD, England — (BUSINESS WIRE) — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, on Wednesday announced results from a sub-group analysis from the Phase 3 LIGHTHOUSE trial (NC04186819) which evaluated the safety and diagnostic performance of POSLUMA® (flotufolastat F 18) PET in men with newly diagnosed prostate cancer. Specifically, this sub-group examined the performance of flotufolastat F 18 PET in newly diagnosed, high-risk prostate cancer patients who had negative results with conventional imaging. Recently approved by the U.S. FDA, 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.

 

Results highlights:

  • The sensitivity and specificity of flotufolastat F 18 for the detection of pelvic lymph nodes in 174 patients who underwent surgery ranged from 24-33% and 92-96%, respectively, across 3 blinded, independent readers.
  • The detection rate for M1 lesions (lesions that have spread beyond the pelvic area) for flotufolastat F 18 in 197 patients was 14% – 25% across the 3 readers.
  • Of identified lesions, 16-25 were successfully verified as True Positive, providing a M1 Verified Detection Rate (VDR) of 8.1 – 13%, across the 3 readers.

 

“Effective initial staging of prostate cancer, particularly with regards to the detection of metastatic disease, is critical to optimal clinical management of patients,” said Phillip H. Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering. “The demonstrated performance of PSMA-PET imaging fits an important unmet need, given that conventional imaging techniques are limited in the information they provide. This analysis from the LIGHTHOUSE study showed that flotufolastat F 18 provides clinically useful information about the presence of both metastatic pelvic lymph nodes and M1 disease prior to surgery in patients with high-risk prostate cancer who had negative results on conventional imaging. Such information can help guide treatment selection and potentially avoid futile surgery for patients with high-risk disease.”

 

“We are pleased to present these results from the LIGHTHOUSE study to the radiation oncology community at ASTRO,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “POSLUMA provides physicians with high-quality diagnostic information based on its diagnostic performance even at low PSA levels, high-affinity PSMA binding and low urinary bladder activity. In a post-hoc Phase 3 analysis, as well as in preclinical and Phase 1 studies, POSLUMA demonstrated low urinary bladder activity, providing for enhanced image evaluation in the prostate and regions near the ureters for patients with prostate cancer. The product is labeled with the radioisotope fluorine-18 (18F) to leverage the high image quality of 18F-labeled PSMA PET imaging, to facilitate effective detection of disease and enable broad, readily available geographic access for patients through the manufacturing and distribution network of our commercial U.S. manufacturer and distributor, PETNET Solutions Inc, A Siemens Healthineers Company. Nationally recognized clinical oncology guidelines for prostate cancer now include POSLUMA, alongside and for all the same categories as the other currently FDA-approved PSMA PET radiopharmaceuticals.”

 

The findings were discussed in a poster Q&A session at the 2023 ASTRO Annual Meeting on October 3, 2023,“Diagnostic Performance of 18F-rhPSMA-7.3 PET in Men with Newly Diagnosed High-risk Prostate Cancer and Negative Conventional Imaging,” by 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. Full session details and the abstract are available in the ASTRO online program here.

 

About the study

The sub-group analysis of LIGHTHOUSE data evaluated a subgroup of patients with high/very high-risk prostate cancer who had no evidence of nodal or metastatic disease on conventional imaging. Treatment-naïve patients scheduled for radical prostatectomy (RP) plus pelvic lymph node (PLN) dissection underwent flotufolastat F 18 PET. Local readers interpreted the scans prior to RP and ahead of a blinded read by 3 central readers. If the local read indicated M1 disease, verification (biopsy, surgery, or confirmatory follow-up imaging) of PET-positive M1 lesions was attempted before treatment. The analysis evaluated flotufolastat F 18 sensitivity and specificity for detection of PLN metastases in all high/very high-risk patients with negative conventional imaging at baseline who underwent flotufolastat F 18 PET and subsequent surgery. Histopathology was used as the standard of truth (SoT). Additionally, the M1 verified detection rate (VDR; % of patients with true positive (TP) M1 lesions using histopathology or follow-up imaging as SoT out of all patients scanned) was assessed in an extended population of all patients who had flotufolastat F 18 PET, regardless of surgery.

 

The sensitivity and specificity for PLN detection among 174 men with very/high-risk PCa and negative conventional imaging ranged from 24-33% and 92-96%, respectively, across the 3 readers. M1 lesions were identified in 28-51 of the 197 patients in the extended population, giving an overall M1 detection rate of 14-26%, across the 3 readers. Of the identified lesions, 16-25 were successfully verified (predominantly using follow-up imaging as SoT) as TP, providing a M1 VDR of 8.1-13%, across the 3 readers.

 

No serious adverse events were observed in the LIGHTHOUSE study. Overall, 28 of the 356 (7.9%) patients who received flotufolastat F 18 had at least one treatment-emergent adverse event that was considered possibly related to flotufolastat F 18. The most frequently reported adverse event for patients in the LIGHTHOUSE study was injection site pain among 0.8% (3/356) of patients.

 

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

Radiohybrid Prostate-Specific Membrane Antigen (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 imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use – providing the potential for creating a true theranostic technology. 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 sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics received U.S. Food and Drug Administration approval for its radiohybrid PET diagnostic imaging product for use in prostate cancer in 2023. rhPSMA compounds for potential therapeutic use are investigational and have not received regulatory approval.

 

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 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. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. 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) 7917 536939

clare.gidley@blueearthdx.com

Media
Sam Brown Inc.

Mike Beyer

(M) (312) 961-2502

mikebeyer@sambrown.com

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Electeds to join Iris House in celebrating new location

Longtime HIV/AIDS service organization for women hosts White House Lawn Party with relocation to expanding Plainfield, NJ site

 

PLAINFIELD, N.J. — (BUSINESS WIRE) — Iris House, an organization focused on the needs of women living with HIV/AIDS in New York City and the greater New York/New Jersey area, is hosting – along with its affiliate organization AIDS Healthcare Foundation (AHF) – a ‘White House Garden Party’ on Wednesday, Oct. 4 to celebrate its new home in Plainfield, New Jersey.

 

Iris House will mark its 30th anniversary later this month with another celebration on Oct. 19.

 

WHAT:

‘White House Lawn Party’ celebrating Iris House’s new Plainfield, NJ location

WHEN:

Wednesday, October 4, 2023

TIME:

4:30 pm – 6:30 pm ET

WHERE:

209 West 8th Street, Plainfield, NJ 07060

WHO:

  • Ingrid Floyd, Executive Director, Iris House
  • Hon. Adrian O. Mapp, Mayor of Plainfield
  • Hon. Charles McRae, Plainfield City Council President
  • Hon. Rebecca Williams, Union County Commissioner
  • Donna Tempesta, AHF Northern Bureau Chief and VP of Finance
  • Marlene LaLota, AHF Senior Regional Director, Northern Region, and
  • Hon. Linda. S. Carter, NJ Assemblywoman (District 22) with presentation of an Iris House Resolution

 

“Our ‘White House’ moniker for both this party and our new building refers to the impressive regal white structure in Plainfield that now is home to Iris House staff and many of our services. In our work in New Jersey, we have a particular focus on youth and young adults, which we will be able to expand on at this new site in addition to continue our services to and for women living with HIV,” said Ingrid Floyd, Iris House Executive Director.

 

“We are grateful to share this special day— and this space—with many dedicated elected officials and supporters as well as with AHF, our partner in fighting AIDS and providing HIV care and services.”

 

The Plainfield site eventually will house a new, state-of-the-art AHF Healthcare Center providing cutting-edge medical care and services to patients regardless of ability to pay and will also feature an AHF Pharmacy Access Center.

 

ABOUT:

Iris House Established in 1993, Iris House focuses on the needs of women living with HIV or AIDS in New York City and the greater New York/New Jersey area. It affiliated with AHF in July 2019.

 

AIDS Healthcare Foundation (AHF), the world’s largest HIV/AIDS healthcare organization, provides cutting-edge medicine and advocacy to more than 1.9 million individuals across 45 countries, including the U.S. and in Africa, Latin America/Caribbean, the Asia/Pacific Region, and Eastern Europe. To learn more about AHF, visit us online at AIDShealth.org, find us on Facebook, follow us on Instagram, Twitter, and TikTok, and subscribe to our AHFter Hours podcast.

Contacts

Rasheed Gonga, AHF Advocacy, Legislative Affairs & Community Engagement

(201) 241-0927

Rasheed.gonga@ahf.org

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
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
Culture Economics Healthcare Lifestyle Local News Science

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/
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on Twitter: @BayerPharma

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 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.

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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