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New Tezepelumab Data Continue To Strengthen Profile For A Broad Population Of Severe Asthma Patients

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THOUSAND OAKS, Calif., May 13, 2021 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced detailed results for tezepelumab, a potential first-in-class treatment, from the pivotal NAVIGATOR Phase 3 trial demonstrating superiority across every primary and key secondary endpoint in a broad population of severe asthma patients, compared to placebo when added to standard of care (SoC). These results were published in the New England Journal of Medicine and will be presented this week at the American Thoracic Society (ATS) 2021 International Conference.1,2

In one of the pre-specified exploratory analyses of NAVIGATOR, reductions in annualized asthma exacerbation rates (AAERs) were observed over 52 weeks in tezepelumab-treated patients compared to placebo when added to SoC across four patient subgroups, based on blood eosinophil count and fractional exhaled nitric oxide (FeNO) levels. Blood eosinophil counts and FeNO levels are two key inflammatory biomarkers used by clinicians to inform treatment options and were defined as blood eosinophil count (≥300 or <300 cells per microlitre) and FeNO (≥25 or <25 parts per billion).

In patients with elevated baseline blood eosinophil counts (≥300 cells per microlitre) and FeNO levels (≥25 parts per billion), tezepelumab achieved a clinically meaningful 77% reduction in the AAER, compared to placebo.1,2

In a separate exploratory analysis of exacerbations requiring hospitalizations, tezepelumab showed an 85% reduction over 52 weeks compared to placebo when added to SoC.

Tezepelumab also demonstrated statistically significant improvements in key secondary endpoints compared to placebo in lung function, asthma control and health-related quality of life. Improvements were observed in tezepelumab-treated patients as early as week two of treatment or the first time point assessment and were sustained throughout the treatment period.1

These results build on the NAVIGATOR data presented in February 2021 which showed a statistically significant and clinically meaningful3 reduction in the primary endpoint of AAER over 52 weeks in the overall patient population. Clinically meaningful reductions in AAER compared to placebo were observed in the tezepelumab-treated patients irrespective of blood eosinophil counts, allergy status or FeNO level.1

“Managing severe asthma is challenging with multiple inflammatory pathways often contributing to the complexity of a patient’s disease. These latest results underscore the potential of tezepelumab to transform treatment for a broad population of severe asthma patients regardless of their type of inflammation,” said Professor Andrew Menzies-Gow, Director of the Lung Division, Royal Brompton Hospital, London, UK, and principal investigator of the NAVIGATOR Phase 3 trial.

“Severe, uncontrolled asthma is debilitating, with patients experiencing frequent exacerbations that lead to hospitalization. For this reason, we were incredibly pleased to see that patients who received tezepelumab during the trial had a reduction in both ER visits and hospitalizations,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Advancing the science to address unmet patient needs such as these has been the driving force behind Amgen’s inflammation research for more than two decades. Along with our partner AstraZeneca, we are incredibly proud of these results and tezepelumab’s potential for a broad population of patients with asthma.”

Additional Data to be Presented

Further results from the tezepelumab PATHFINDER clinical trial program will be presented at the ATS conference this week, including the primary analyses from the SOURCE Phase 3 and CASCADE Phase 2 trials.

As previously disclosed, the SOURCE Phase 3 trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. Data to be presented show the number of patients that achieved a ≥90% reduction in OCS dose was numerically higher for tezepelumab-treated patients at 54.1% compared to 46.1% in the placebo group.4

In SOURCE, tezepelumab-treated patients showed improvements in exacerbations, forced expiratory volume in one second and patient-reported outcomes compared to placebo,4 consistent with improvements shown in pooled post-hoc analyses in OCS dependent patients from the PATHWAY Phase 2 and NAVIGATOR Phase 3 trials. New trials are being planned to evaluate the ability of tezepelumab to reduce OCS use while maintaining asthma control in patients with chronic maintenance OCS therapy. Any new trial would aim to address unique aspects of the SOURCE trial design that may have contributed to the result of the primary endpoint.

Also being presented at the ATS Conference, results from the CASCADE Phase 2 mechanistic trial showed that in a broad population of patients with moderate to severe asthma, tezepelumab reduced eosinophils in airway tissue compared to placebo across subgroups of baseline blood eosinophil count, FeNO level and allergic status.5 Importantly, tezepelumab was also associated with a reduction in airway hyper-responsiveness compared to placebo,5 which is a major hallmark of asthma irrespective of eosinophilic airway inflammation.

There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in NAVIGATOR,1 SOURCE4 and CASCADE.5 The most frequently reported adverse events for tezepelumab in the NAVIGATOR trial were nasopharyngitis, upper respiratory tract infection, headache and asthma,1 in the SOURCE trial were nasopharyngitis, upper respiratory tract infection, asthma, and bronchitis bacterial, and in the CASCADE trial were nasopharyngitis, post-procedural (bronchoscopy) complications and headache.

About Severe Asthma
Globally, there are approximately 2.5 million severe asthma patients who are uncontrolled or biologic eligible, with approximately 1 million in the U.S. Many severe asthma patients have an inadequate response to currently available biologics and oral corticosteroids and thus fail to achieve asthma control.6-8 Uncontrolled asthma occurs when symptoms persist despite treatment. Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life.6-8 Patients with severe uncontrolled asthma have twice the risk of asthma-related hospitalizations.9,10 There is also a significant socio-economic burden, with these severe uncontrolled asthma patients accounting for 50% of asthma-related costs.11

Multiple inflammatory pathways are involved in the pathogenesis of asthma.12-14 Eosinophilic asthma, and more broadly, T2 inflammation-driven asthma, accounts for about two-thirds of patients with severe asthma.14 These patients are typically characterized as having elevated levels of inflammatory biomarkers, including blood eosinophils, serum IgE and fractional exhaled nitric oxide (FeNO).15,16 However, many patients do not fit the criteria for eosinophilic or allergic asthma, may have unclear or multiple drivers of inflammation, and may not qualify for or respond well to a current biologic medicine.16

NAVIGATOR and the PATHFINDER Clinical Trial Program
Building on the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATOR1,17 and SOURCE.4,18 The program includes an additional planned long-term safety trial, DESTINATION and a mechanistic trial, CASCADE.5

NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in 1,061 adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without OCS. NAVIGATOR met the primary endpoint with tezepelumab added to SoC demonstrating a statistically significant and clinically meaningful reduction in the AAER over 52 weeks in the overall patient population, compared to placebo added to SoC. The trial also met the primary endpoint in the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER in that patient population. Similar reductions in AAER were observed in the subgroup of patients with baseline eosinophil counts less than 150 cells pstoper microliter.25

NAVIGATOR endpoint: AAER in patients grouped by baseline blood eosinophil count and FeNO1

Biomarker subgroup

Results over 52 weeks

Tezepelumab added to SoC versus placebo added to SoC

Blood eosinophil count ≥300 cells/mcl FeNO ≥25 parts per billion

77% reduction (95% CI: 67, 84)

Blood eosinophil count ≥300 cells/mcl FeNO <25 parts per billion

39% reduction (95% CI: -7, 65)

Blood eosinophil count <300 cells/mcl FeNO ≥25 parts per billion

53% reduction (95% CI: 33, 67)

Blood eosinophil count <300 cells/mcl FeNO <25 parts per billion

29% reduction (95% CI: 0, 50)

CI: Confidence interval

NAVIGATOR is the first Phase 3 trial to show benefit in severe asthma irrespective of eosinophils by targeting the thymic stromal lymphopoietin (TSLP). The U.S. Food and Drug Administration Breakthrough Therapy Designation was granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype.

SOURCE is a Phase 3 multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial for 48 weeks in adult patients with severe asthma who require continuous treatment with ICS plus long-acting beta2-agonists (LABA), and chronic treatment with maintenance OCS therapy. In the trial, patients were randomized to receive tezepelumab 210 mg every four weeks or placebo as add-on therapy, with patients maintained on their currently prescribed ICS plus LABA, with or without other asthma controller therapy.

CASCADE is a Phase 2 mechanistic, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in adults aged 18–75 years with moderate to severe, uncontrolled asthma. The primary endpoint was the change from baseline (pre-dose) to end of treatment in airway submucosal inflammatory cells (eosinophils, neutrophils, T cells and mast cells) from bronchoscopic biopsies.5

Patients who participated in the NAVIGATOR and SOURCE trials were eligible to continue in DESTINATION, a Phase 3 extension trial assessing long-term safety and efficacy.19

About Tezepelumab
Tezepelumab is being developed by AstraZeneca in collaboration with Amgen (see AstraZeneca and Amgen collaboration below) as an investigational, potential first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults. Specifically, tezepelumab targets and blocks thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.20,21

TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.20,21 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.20,22 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.20,22 By working at the top of the cascade, tezepelumab helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.20,22

Amgen and AstraZeneca collaboration
In 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement in North America, Amgen and AstraZeneca will jointly commercialize tezepelumab; Amgen will record sales in the U.S. and AstraZeneca will record sales in Canada.  Outside the U.S., Amgen will record sales as collaboration revenue.

Amgen Inflammation
Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs. For those with debilitating moderate to severe rheumatoid arthritis, psoriatic arthritis, moderate to severe plaque psoriasis, ankylosing spondylitis, asthma, and other chronic conditions, the suffering and needs are severe. Complex diseases of inflammation have defied simple solutions, and the breadth of inflammatory disease and the burden patients bear is not well understood.

For more than two decades, Amgen has been committed to advancing the science and the understanding around inflammation to address the unmet patient needs that exist and expanding our portfolio. We lead with science through discovery research that is disease-agnostic and biology-first, modality-second. In doing so, we have introduced and evolved novel therapies that have changed the lives of patients.

Our commitment to patients is reflected not only in where we have succeeded, but in where we have failed and opened new doors. Throughout, we have remained dedicated to the principle of leading with science, pursuing where pathways and promising discoveries in inflammation take us, and not relenting until innovative solutions for patients are found. It’s a commitment that extends beyond introducing novel therapies. We are focused on improving the entire patient journey.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19, or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on Amgen’s business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

Amgen’s results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen’s products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen’s business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen’s business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for Amgen’s manufacturing activities, the distribution of Amgen’s products, the commercialization of Amgen’s product candidates, and Amgen’s clinical trial operations, and any such events may have a material adverse effect on Amgen’s product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen’s products are supplied by sole third-party suppliers. Certain of Amgen’s distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen’s efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen’s systems and Amgen’s data. Amgen’s stock price may be volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Amgen’s business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

The scientific information discussed in this news release related to Amgen’s product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

Further, any scientific information discussed in this news release relating to new indications for Amgen’s products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

CONTACT: Amgen, Thousand Oaks
Michael Strapazon, 805-313-5553 (media)
Megan Fox, 805-447-1423 (media)
Arvind Sood, 805-447-1060 (investors)

References



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Menzies-Gow A, Corren J, Bourdin A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021 Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2034975

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Corren J, Bourdin A, Chupp G, et al. Efficacy of tezepelumab in patients with severe, uncontrolled asthma grouped by baseline blood eosinophil count and fractional exhaled nitric oxide level: results from the NAVIGATOR phase 3 study. Am J Respir Crit Care Med. 2021;203:A1198.

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Bonini M, Di Paolo M, Bagnasco D, et al. Minimal clinically important difference for asthma endpoints: an expert consensus report. Eur Respir Rev. 2020;29:190137.

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Wechsler ME, Mezies-Gow A, Brightling CE, et al. Oral corticosteroid-sparing effect of tezepelumab in adults with severe asthma. Am J Respir Crit Care Med. 2021;203:A1197.

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Diver S, Khalfaoui L, Emson C, et al. Effect of Tezepelumab on Airway Inflammation in Patients with Moderate-to-Severe Uncontrolled Asthma: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study (CASCADE). Am J Respir Crit Care Med. 2021;203:A1456.

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Kupczyk M, Wenzel S. U.S. and European severe asthma cohorts: what can they teach us about severe asthma? J Intern Med 2012;272:121–32.

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Wenzel S. Severe Asthma in Adults. Am J Respir Crit Care Med. 2005; 172; 149–60.

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Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014; 43: 343–73.

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Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 12; 24: 14009.

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World Allergy Organization (WAO). The management of severe asthma: economic analysis of the cost of treatments for severe asthma. Available at: https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php  [Last accessed: April 2021].

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Busse WW. Biological Treatments for Severe Asthma: A Major Advance in Asthma Care. Allergol Int 2019; 68: 158–66.

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Godar M, Blanchetot C, de Haard H, et al. Personalized medicine with biologics for severe type 2 asthma: current status and future prospects. MAbs. 2018; 10 (1): 34–45.

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Rabe KF, Busse W, Pavord I, Castro M. Raising the clinical bar beyond current biologics in uncontrolled persistent asthma: translating emerging data in future clinical decisions. EMJ Allergy Immunol. 2018; 3: 60-9.

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Peters MC, Mekonnen ZK, Yuan S, et al. Measures of gene expression in sputum cells can identify TH2-high and TH2-low subtypes of asthma. J Allergy Clin Immunol. 2014; 133: 388–94.

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Clinicaltrials.gov. Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SOURCE) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03406078. [Last accessed: April 2021].

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Fahy JV. Type 2 inflammation in asthma–present in most, absent in many. Nat Rev Immunol. 2015; 15: 57-65.

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Menzies-Gow A, Colice G, Griffiths JM et al. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020;21:266.

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Weschler ME, Colice G, Griffiths JM, et al. SOURCE: A Phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of Tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma. Respir Res. 2020;21:264.

19.

Clinicaltrials.gov. Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma (DESTINATION) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03706079. [Last accessed: April 2021].

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Corren J, Parnes JR, Wang L, et al. Tezepelumab in Adults with Uncontrolled Asthma [published correction appears in N Engl J Med. 2019;380:2082]. N Engl J Med. 2017;377:936-946.

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Varricchi G, Pecoraro A, Marone G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018;9:1595.

22.

Li Y, Wang W, LV Z et al. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. The Journal of Immunology. 2018;200:2253–2262

SOURCE Amgen

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Topspin Consumer Partners Closes Oversubscribed Fund II at Hard Cap of $205 million

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MAMARONECK, N.Y., June 16, 2021 /PRNewswire/ — Topspin Consumer Partners (“Topspin”), an operationally-driven private equity firm focused on the consumer sector, is pleased to announce the final closing of Topspin Consumer Partners II (“TCP II”) at its hard cap of $205 million. The fund was oversubscribed with strong support from existing investors combined with significant new commitments from a diverse base of new institutional limited partners including funds of funds, global asset managers and family offices.

Consistent with its predecessor fund, TCP II will seek to partner with founder-owners and top management teams to make investments of $15 million to $35 million in lower middle market growth-oriented consumer products and services companies. Topspin is focused on branded consumer “essentials” that are capturing market share within established niches and can leverage digital marketing and e-commerce platforms to drive growth. Topspin invests with founders and teams who are looking to continue the transformation of their businesses into leading middle market companies and works collaboratively with them to implement operational best practices, upgrade product development processes and capabilities, and enhance sales, distribution and marketing strategies. To date, Topspin has already closed three platform investments and three add-on investments in the new fund.

The Topspin investment team has been investing together for more than a decade and brings deep operational experience to their underwriting and value creation processes. The team is supported by a seasoned industry board of advisors and a broad network of experienced executives in various consumer segments.

“Topspin appreciates the support from the investment community that enabled this successful fundraise,” said Leigh Randall, Managing Partner of Topspin. “The strong performance of our portfolio companies during the uncertain conditions of the coronavirus pandemic was critical in maintaining and furthering investor confidence in our ability to create value in the consumer sector. Our experience and prior successes in the digital marketplace have positioned us favorably to take advantage of an accelerating trend in our industry.”

MVision Private Equity Advisers acted as the global strategic adviser to Topspin and Goodwin Procter served as legal counsel in the formation of the fund.

About Topspin Consumer Partners
Topspin Consumer Partners is a Mamaroneck, NY-based private equity firm that makes investments in established, profitable and fast-growing middle-market consumer businesses. The firm invests across a number of sub-verticals within consumer, including health & wellness, personal care/beauty, food/beverage, household goods, pet, and children’s products. The Topspin team has considerable operational expertise and collaborates with founder-owners and management teams to build businesses of varying stages and sizes. Further information on Topspin can be found at www.topspincp.com.

Contacts

Leigh Randall
Managing Partner
Topspin Consumer Partners
[email protected]
914-834-7370

Hussein Khalifa
Founding Partner
MVision Private Equity Advisers 
[email protected]
212-616-6850

SOURCE Topspin Consumer Partners

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The $365 Million Worldwide Solar Panel Recycling Industry is Expected to Grow at a CAGR of 19.3% from 2020 to 2027

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DUBLIN, June 16, 2021 /PRNewswire/ — The “Global Solar Panel Recycling Market 2020-2027 by Process (Mechanical, Thermal, Laser, Chemical), Panel Type (Monocrystalline, Polycrystalline, Thin Film), Shelf Life (Early Loss, Normal Loss), and Region: Trend Outlook and Growth Opportunity” report has been added to ResearchAndMarkets.com’s offering.

Global solar panel recycling market will reach $365.6 million by 2027, growing by 19.3% annually over 2020-2027 driven by the growing demand for clean energy on account of environmental protection, increasing growing adoption of solar power as a renewable source of energy, and rising support of the government toward sustainable development.

This report is based on a comprehensive research of the entire global solar panel recycling market and all its sub-segments through extensively detailed classifications. Profound analysis and assessment are generated from premium primary and secondary information sources with inputs derived from industry professionals across the value chain. The report is based on studies on 2017-2019 and provides estimate/forecast from 2020 till 2027 with 2019 as the base year.

In-depth qualitative analyses include identification and investigation of the following aspects:

  • Market Structure
  • Growth Drivers
  • Restraints and Challenges
  • Emerging Product Trends & Market Opportunities
  • Porter’s Fiver Forces

The trend and outlook of global market is forecast in optimistic, balanced, and conservative view by taking into account of COVID-19. The balanced (most likely) projection is used to quantify global solar panel recycling market in every aspect of the classification from perspectives of Process, Panel Type, Shelf Life, and Region.

Based on Process, the global market is segmented into the following sub-markets with annual revenue for 2017-2027 included in each section.

  • Mechanical Recycling
  • Thermal Recycling
  • Laser Recycling
  • Chemical Recycling
  • Other Processes

Based on Panel Type, the global market is segmented into the following sub-markets with annual revenue for 2017-2027 included in each section.

  • Monocrystalline Solar Panels
  • Polycrystalline Solar Panels
  • Thin Film Solar Panels

Based on Shelf Life, the global market is segmented into the following sub-markets with annual revenue for 2017-2027 included in each section.

  • Early Loss
  • Normal Loss

Geographically, the following regions together with the listed national/local markets are fully investigated:

  • APAC (Japan, China, South Korea, Australia, India, and Rest of APAC; Rest of APAC is further segmented into Malaysia, Singapore, Indonesia, Thailand, New Zealand, Vietnam, Taiwan, and Philippines)
  • Europe (Germany, UK, France, Spain, Italy, Russia, Rest of Europe; Rest of Europe is further segmented into Netherlands, Switzerland, Poland, Sweden, Belgium, Austria, Ireland, Norway, Denmark, and Finland)
  • North America (U.S., Canada, and Mexico)
  • South America (Brazil, Chile, Argentina, Rest of South America)
  • MEA (UAE, Egypt, South Africa)

For each aforementioned region and country, detailed analysis and data for annual revenue are available for 2017-2027. The breakdown of all regional markets by country and split of key national markets by Process, Panel Type, and Shelf Life over the forecast years are also included.

The report also covers current competitive scenario and the predicted trend; and profiles key vendors including market leaders and important emerging players.

Key Topics Covered:

1 Introduction

2 Market Overview and Dynamics

3 Segmentation of Global Market by Process
3.1 Market Overview by Process
3.2 Mechanical Recycling
3.3 Thermal Recycling
3.4 Laser Recycling
3.5 Chemical Recycling
3.6 Other Processes

4 Segmentation of Global Market by Panel Type
4.1 Market Overview by Panel Type
4.2 Monocrystalline Solar Panels
4.3 Polycrystalline Solar Panels
4.4 Thin Film Solar Panels

5 Segmentation of Global Market by Shelf Life
5.1 Market Overview by Shelf Life
5.2 Early Loss
5.3 Normal Loss

6 Segmentation of Global Market by Region
6.1 Geographic Market Overview 2020-2027
6.2 North America Market 2020-2027 by Country
6.2.1 Overview of North America Market
6.2.2 U.S.
6.2.3 Canada
6.2.4 Mexico
6.3 European Market 2020-2027 by Country
6.3.1 Overview of European Market
6.3.2 UK
6.3.3 France
6.3.4 Germany
6.3.5 Spain
6.3.6 Italy
6.3.7 Russia
6.3.8 Rest of European Market
6.4 Asia-Pacific Market 2020-2027 by Country
6.4.1 Overview of Asia-Pacific Market
6.4.2 China
6.4.3 Japan
6.4.4 India
6.4.5 Australia
6.4.6 South Korea
6.4.7 Rest of APAC Region
6.5 South America Market 2020-2027 by Country
6.5.1 Argentina
6.5.2 Brazil
6.5.3 Chile
6.5.4 Rest of South America Market
6.6 MEA Market 2020-2027 by Country
6.6.1 UAE
6.6.2 Egypt
6.6.3 South Africa
6.6.4 Other National Markets

7 Competitive Landscape
7.1 Overview of Key Vendors
7.2 New Product Launch, Partnership, Investment, and M&A
7.3 Company Profiles

  • Canadian Solar Inc.
  • EIKI SHOJI Co. Ltd.
  • First Solar Inc.
  • Interco Trading Inc.
  • PV Cycle a.i.s.b.l.
  • Reclaim PV Recycling Pty Ltd.
  • Reiling GmbH & Co. KG
  • REMA PV System AS
  • Rinovasol GMBH
  • Sharp Corporation
  • Silcontel Ltd.
  • SunPower Corporation
  • Trina Solar Co., Ltd.
  • Yingli Energy Co. Ltd.

For more information about this report visit https://www.researchandmarkets.com/r/6pbxxk

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
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U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

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Parallel’s goodblend™ Texas Launches the First CBN Cannabis Product Line for Patients Through Texas Compassionate Use Program

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“We are excited to debut yet another first-to-market cannabis product in Texas and to extend our Surterra Wellness line into the Massachusetts market with the launch of Dream +CBN. Our proprietary formulas are crafted to help qualifying patients improve their quality of sleep, which is a big contributor to overall health and well-being,” said William “Beau” Wrigley, Jr., Chief Executive Officer and Chairman of Parallel. “Dream +CBN exemplifies Parallel’s emphasis on bringing patients a wide variety of innovative product formats and proprietary cannabinoid blends through our dedicated R&D team.” 

In Texas, the Dream +CBN product line comes in a 15mg dose of CBN and THC per milliliter (ml), contains a proprietary Dream terpene profile, and is infused with the cannabinoid ratio of 2 CBN : 1 THC.

“goodblend Texas is proud to be the first medical cannabis dispensary in Texas to offer a product with the rare cannabinoid CBN to qualifying patients across the Lone Star State through the Compassionate Use Program. Good quality sleep is essential to overall health and well-being, and we are excited to provide qualifying patients a high-quality alternative to sleep aids to help them feel rested and restored,” said Marcus Ruark, President of goodblend Texas.

Medical cannabis patients across Texas already registered in the program, and those interested in learning more about cannabis, can access board-certified prescribers, medical cannabis information, services, and products in the following ways:

  • The goodblend Virtual Clinic is a service in which prospective patients can schedule consultations with a board-certified prescriber through a seamless experience. To get started, visit tx.goodblend.com/clinic.
  • goodblend.com offers a wide variety of products, easy online ordering, and free contactless home delivery, often in as little as three days.
  • goodblend’s partner clinics in Plano, Houston, Fort Worth, and San Antonio provide registered patients a convenient way to pick up goodblend cannabis products at locations in major metropolitan areas.

The launch of the first CBN product in Texas follows the recent news that Parallel invested $25M in a new state-of-the-art cannabis cultivation, production, and retail facility in San Marcos, Texas. This financial commitment expands Parallel’s ability to meet the growing demand for medical cannabis products in Texas. The planned 63,000 square-foot facility is expected to create hundreds of new jobs in the San Marcos region over the coming years. The company also recently introduced its goodblend™ retail brand, which reflects Parallel’s intent to lead the way to the future of cannabis by providing patients a trusted, consistent and seamless way to connect and learn, and to access innovative, high-quality cannabis products in a variety of formulations. The brand is about welcoming every type of customer and being an approachable source for customers’ well-being. 

About CBN

Cannabinol (CBN) was the first cannabinoid to be identified and isolated from the cannabis plant in 1899 long before the discovery of THC or CBD.  One of more than 100 cannabinoids found in the cannabis plant, CBN has grown in popularity lately as more customers claim its benefits for sleep. CBN is often used for its potential relaxing qualities and sedative effects when combined with THC. Like all cannabinoids, its effect is generated from the interactions between our endocannabinoid system and its receptors. CBN binds to both endocannabinoid and GABA receptors in the body, neurotransmitters that are crucial to the body’s natural sleep cycle. When THC is combined with CBN and other cannabinoids, effects and benefits are amplified.

About Surterra Wellness Dream + CBN

Surterra Wellness is a line of products designed to help people start living their best lives. It began as a Florida-only cannabis brand and is now offered in a number of product formats in Texas and as the Dream +CBN product in Massachusetts. 

In Texas, pricing and additional details on Surterra Wellness Dream +CBN (2 CBN : 1 THC), (available to order starting June 22) can be found at tx.goodblend.com.

In Massachusetts, the Surterra Wellness Dream +CBN 15 ml tincture oil blends a ratio of 1 CBN : 2 THC, and is sold exclusively through NETA retail stores to both medical and adult customers. Pricing and additional details can be found at netacare.org.

About Parallel

Parallel is one of the largest privately-held, vertically integrated, multi-state cannabis companies in the United States with a mission to pioneer well-being and improve the quality of life through cannabinoids. Parallel recently announced that it intends to become a public company through a definitive business combination agreement with Ceres Acquisition Corp. (“Ceres”), a special purpose acquisition corporation (SPAC). Parallel has ongoing operations in four medical and adult-use markets under the retail brands of Surterra Wellness in Florida; goodblend in Texas; New England Treatment Access (NETA) in Massachusetts, and The Apothecary Shoppe in Nevada. Parallel also has a license under its goodblend Pennsylvania brand for vertically integrated operations and up to six retail locations, in addition to a medical cannabis research partnership with the University of Pittsburgh School of Medicine. Subject to regulatory approval, Parallel will add Illinois as a sixth market when its recently announced acquisition of six Windy City Cannabis licenses is complete. Parallel has a diverse portfolio of high quality, proprietary and licensed consumer brands and products including Surterra Wellness, Coral Reefer, Float and Heights. Parallel operates approximately 50 locations nationwide, including 42 retail stores, and cultivation and manufacturing sites. Through its wholly-owned Parallel Biosciences subsidiary, it conducts advanced cannabis science and R&D for new product development in its facilities in Massachusetts, Florida, Texas and a facility in Budapest, Hungary through an exclusive license and partnership. Parallel follows rigorous operations and business practices to ensure the quality, safety, consistency, and efficacy of its products and is building its business by following strong values and putting the well-being of its customers and employees first. Find more information at www.liveparallel.com, or on Instagram and LinkedIn

For more information on goodblend Texas and its products, access  tx.goodblend.com and www.facebook.com/goodblendtx

Texas CUP License #0006

Media Contact
Taylor Foxman
[email protected]

Investor Contact
[email protected] 

Forward Looking Statements 

Certain information in this communication contains “forward-looking statements” and “forward-looking information” within the meaning of applicable Canadian securities legislation and U.S. securities law (referred to herein as forward-looking statements). Except for statements of historical fact, certain information contained herein constitutes forward-looking statements, which include, but are not limited to, statements related to activities, events or developments that Parallel expects or anticipates will or may occur in the future, statements related to Parallel’s business strategy objectives and goals, and Parallel’s management’s assessment of future plans and operations which are based on current internal expectations, estimates, projections, assumptions and beliefs, which may prove to be incorrect. Forward-looking statements can often be identified by the use of words such as “may”, “will”, “could”, “would”, “anticipate”, ‘believe”, expect “, “intend”, “potential “, “estimate”, “budget”, “scheduled”, “plans”, “planned”, “forecasts”, “goals” and similar expressions or the negatives thereof. Such statements are made pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995 and are based on Parallel’s management’s belief or interpretation of information currently available. Forward-looking statements are neither historical facts nor assurances of future performance. Forward-looking statements in this communication includes statements regarding the product launch, Parallel’s business plans in Texas, the effects of Parallel’s products on its customers and Parallel’s business strategy. Forward-looking statements are based on a number of factors and assumptions made by management and considered reasonable at the time such information is provided, and forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. 

SOURCE Parallel

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Adverty launches In-Play™ and In-Menu™ ads in Magic Finger 3D and World Hockey Manager 2021

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STOCKHOLM, June 16, 2021 /PRNewswire/ — Leading in-game advertising specialist, Adverty AB (publ), today announces two new games launching in its network, which will include Adverty’s seamless In-Play™ and In-Menu™ formats for both branding and performance advertising to global audiences.

First out is Magic Finger 3D from Lucky Kat Studios. With an amazing seamless integration of Adverty’s In-Play™ ads which include billboards as well as ads players can interact with, Magic Finger 3D also introduces Adverty’s Seamless In-Menu™ format.

“This combination of In-Play™ branding and In-Menu™ performance advertising is something the industry has been eagerly awaiting. The combination of performance advertising with strong branding leads to a powerful multiplier effect,” says Adverty CEO, Tobias Knutsson.

Herdjie Zhou, CEO of Lucky Kat Studios, adds: “We are delighted to launch In-Play™ and In-Menu™ in Magic Finger 3D – our most successful game to date, which recently surpassed 20 million downloads. With the additional and incremental revenue we have seen a solid increase in Average Revenue Per Daily Active User (ARPDAU) without any downside to player engagement.”

Magic Finger 3D gameplay video footage: https://youtu.be/WwTGW9OiA9A

Based in The Hague, The Netherlands Lucky Kat Studios produces and publishes casual games with a pop culture twist. In addition to its recent chart-topper Magic Finger 3D, Lucky Kat is also the creator of cult hits such as Road Crash, Nom Plant and Ice Cream Roll.

In addition, Gold Town Games (GTG)’s World Hockey Manager 2021 has now gone live with its first In-Play™ ads and has since decided to add more integrations. As of today, the leading ice hockey manager simulation game has added both a new In-Play™ integration as well as clickable In-Menu™ units that appear organically during breaks in the game.

Thomas Jonasson from Gold Town Games explains: “World Hockey Manager 2021 has a very well-defined audience with over 80% of players being male and aged 20-45; concentrated in countries where Ice Hockey is a popular sport. We believe that the addition of In-Menu™ adds to further support and enhance the value of the In-Play™ ads we are already leveraging will make our game very attractive to advertisers looking to reach our target audience.”

Thorbjörn Warin, Chief Supply Officer at Adverty, says: “We are thrilled to bring Adverty’s unique, seamless and unobtrusive ad offering to wider audiences. We are seeing a strong and increasing demand for advertising opportunities within the gaming vertical. In-game advertising is expected to see tremendous growth in the coming years, as more advertisers add gaming to their media mix and game publishers start using these new monetisation solutions.”

“We are thrilled to welcome Magic Finger 3D and World Hockey Manager 2021 to the world of seamless in-game advertising and we look forward to long and mutually beneficial relationships with Gold Town Games and Lucky Kat Studios. I am super excited to see the effects of this killer combination being delivered to such a large audience,” adds Tobias Knutsson.

This news follows Adverty’s recent partnerships with InMobi and Verizon Media, which enable a wide range of partners and advertisers to access Adverty’s in-game ad inventory, in order to reach wide audiences within gaming, maximise brand exposure and publisher monetisation.

Links to download iOS and Android versions for both games are available at:

Apple App Store:

https://apps.apple.com/app/magic-finger-3d/id1536745952
https://apps.apple.com/app/world-hockey-manager-2021/id1167490395

Google Play:

https://play.google.com/store/apps/details?id=com.ASmallGame.themagicfinger
https://play.google.com/store/apps/details?id=com.goldtowngames.worldhockeymanager

For further information, please contact:

Anders Rössel, CFO
Phone: +46 70 867 00 20
E-mail: [email protected]

This information is information that Adverty AB (publ) is obliged to disclose under the EU Market Abuse Regulation. The information was provided, through the contact of the above contact person, for publication on the 16th of June 2021.

Corpura Fondkommission AB, phone +46 (0)722 52 34 51, act as certified advisor/mentor for the company at NGM Nordic SME.

About Adverty 

Adverty, the leading in-game advertising platform, delivers seamless In-Play™ and In-Menu™ ads to connect brands and people through its revolutionary and patented technology built for games. The platform offers true in-game ad inventory at scale and allows content creators to monetise the complete experience with unobtrusive, easy-to-integrate, immersive ads. Founded in 2016, Adverty has offices in Stockholm, London, New York, Madrid, Helsinki, St Petersburg and Lviv and works with advertisers, agencies and developers to unlock audiences and gaming revenue streams. More information at www.adverty.com.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/adverty-ab/r/adverty-launches-in-play–and-in-menu–ads-in-magic-finger-3d-and-world-hockey-manager-2021,c3367485

The following files are available for download:

SOURCE Adverty AB

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