LONDON–(BUSINESS WIRE)–#insurance—AM Best has affirmed the Financial Strength Ratings of A (Excellent) and the Long-Term Issuer Credit Ratings of “a+” (Excellent) of MS Amlin AG (Switzerland), and Lloyd’s Syndicate 2001 (Syndicate 2001) (United Kingdom), which is managed by MS Amlin Underwriting Limited. The outlooks of these Credit Ratings (ratings) are stable.
The ratings of MS Amlin AG reflect its balance sheet strength, which AM Best assesses as very strong, as well as its adequate operating performance, neutral business profile and appropriate enterprise risk management (ERM). In addition, MS Amlin AG’s ratings benefit from enhancement due to the support of its ultimate parent, MS&AD Insurance Group Holdings, Inc. (MS&AD).
The ratings of Syndicate 2001 reflect the balance sheet strength of the Lloyd’s market, which AM Best assesses as very strong, as well as the market’s strong operating performance, favourable business profile and appropriate ERM. The Lloyd’s market rating is the floor for all syndicate ratings, reflecting the Lloyd’s chain of security, and, in particular, the role of the Central Fund, which partially mutualises capital at the market level.
MS Amlin AG is a mid-tier reinsurer with gross written premium of CHF 1.4 billion (USD 1.6 billion) in 2020. The company’s market position and brand benefit from its association with Syndicate 2001 and MS&AD. Syndicate 2001 is one of the largest Lloyd’s syndicates, with a capacity of GBP 1.6 billion for the 2021 year of account. MS Amlin AG and Syndicate 2001 are the key operating subsidiaries of Mitsui Sumitomo Insurance Company, Limited (MSI) in Europe. Syndicate 2001 writes a diversified book of property/casualty, marine and reinsurance business. MS Amlin AG writes reinsurance business only.
MS Amlin AG’s balance sheet strength is underpinned by its risk-adjusted capitalisation being at the strongest level, based on Best’s Capital Adequacy Ratio (BCAR) as at year-end 2020. The capital position is subject to potential volatility, due to the company’s exposure to high-severity losses. Nevertheless, AM Best expects that the company will maintain the strongest level of risk-adjusted capitalisation, supported by MS&AD if required. MS Amlin AG’s ratings consider the company’s strategic importance to MS&AD as the group’s principal international reinsurer.
MS Amlin AG and Syndicate 2001 reported underwriting losses in 2020 with combined ratios, as calculated by AM Best, of 106.7% and 118.8%, respectively. Loss ratios were impacted adversely by COVID-19 losses and to a lesser extent natural catastrophe events. Strategic portfolio remediation continued in 2020 and MS Amlin AG reported improved technical performance from 2019, excluding the COVID-19 losses. Syndicate 2001 exited a number of lines of business in 2020, which contributed to a reduction in net earned premium. MS Amlin AG and Syndicate 2001 reported positive investment returns in 2020.
On 1 January 2020, the ownership of MS Amlin AG along with Syndicate 2001’s managing agent and corporate member transferred from MS Amlin plc to MSI, a wholly owned subsidiary company of MS&AD. Throughout 2020 and continuing in 2021, a number of services and functions that were provided previously by a central company were transferred into the insurance entities. These structural changes increase transparency, simplify the operating model and facilitate greater oversight.
This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper media use of Best’s Credit Ratings and AM Best press releases, please view Guide for Media – Proper Use of Best’s Credit Ratings and AM Best Rating Action Press Releases.
AM Best is a global credit rating agency, news publisher and data analytics provider specialising in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.
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NICE uphold appeal by Kyowa Kirin, for POTELIGEO in the treatment of those living with certain ultra-rare blood cancers
LONDON–(BUSINESS WIRE)–The National Institute for Health and Care Excellence (NICE) has upheld an appeal lodged by Kyowa Kirin, Lymphoma Action and Leukaemia Care, and the UK Cutaneous Lymphoma Group (UKCLG) as part of the Single Technology Appraisal for POTELIGEO® (mogamulizumab) for the treatment of adults with the ultra-rare blood cancers mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.1
The oral appeal hearing took place on 10 May 2021 in front of an independent Appeal Panel appointed by NICE. The Panel heard arguments from representatives of the appellants against the decision not to recommend POTELIGEO, as published in a Final Appraisal Document (FAD) on 4 March 2021.2
The parties involved in the appeal welcome this decision as it represents a significant and positive step forward for the cutaneous T-cell lymphoma (CTCL) community, where there is a high clinical unmet need. Kyowa Kirin remains committed to finding a solution for people living with SS or MF to have access to POTELIGEO and will continue discussions with NICE and NHS England to find a resolution.
Richard Johnson, Northern Cluster General Manager, responsible for the UK at Kyowa Kirin, commented: “The outcome of this appeal is an important step in enabling access to an innovative treatment for people with MF or SS who have few systemic treatment options. We remain committed to working with the patient and clinical community, as appropriate, and we are optimistic that future reconsideration of evidence by the Committee, could resolve the challenges with this appraisal. We strongly believe in the clinical and cost effectiveness of POTELIGEO and will continue a dialogue with NICE and NHS England.”
MF and SS are two forms of CTCL3 which is a serious and potentially life-threatening form of cancer.4 Additionally, there is a significant impact on quality of life for those caring for an individual living with CTCL.5 CTCL is treatable but not curable and there is a clear unmet need for new treatment options.
Ropinder Gill, Chief Executive at Lymphoma Action commented: “We’re very grateful and pleased that the NICE Appeal Panel upheld the appeal around mogamulizumab on a number of grounds. This means that by relooking at aspects such as mogamulizumab’s cost effectiveness, there is an opportunity to make this treatment available to those people affected by skin lymphoma who have limited treatment options left. We are hopeful that NICE’s reassessment might bring parity with the SMC’s decision to make mogamulizumab available in Scotland.”
About POTELIGEO® (mogamulizumab)
Mogamulizumabis a first-in-class humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), a protein consistently expressed on cancerous cells seen in both MF and SS;6,7,8 once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells.9
Mogamulizumab has been shown to offer benefits to many patients with MF and SS.10 The MAVORIC trial compared the efficacy of mogamulizumab with vorinostat in previously treated people with relapsed or refractory mycosis fungoides or Sézary syndrome, two types of Cutaneous T-cell lymphoma (CTCL).10 Patients taking mogamulizumab experienced control over their disease for more than twice as long as those taking the comparator treatment, vorinostat*1 (7.7 months vs 3.1 months of median progression free survival), the primary endpoint of the trial.10 Levels of adverse events were similar between the two treatment groups.10 The MAVORIC trial is the largest in CTCL; it enrolled a total of 372 patients across 61 sites in 11 countries (of which 16 sites were in Europe, including three in England).10
About Mycosis Fungoides (MF) and Sézary Syndrome (SS)
MF and SS are characterised by localisation of cancerous white blood cells called T lymphocytes (T cells), to the skin.11,12 These cancerous T cells consistently express a protein called CC-chemokine receptor 4 (CCR4), which enables them to move from the blood to the skin.6,7,8 When these cancerous T cells move to the skin, they can create a localised inflammatory immune skin response, commonly resulting in visible skin symptoms of red patches or plaques 6,13,14,15,16 which can resemble psoriasis or eczema.11
MF and SS can affect the skin, blood, lymph nodes (part of the body’s immune system which is spread throughout the body) and internal organs.17 All four areas of the body are used to assess disease stage,18,19 and clinically significant involvement of the blood, particularly in more advanced disease, is linked with increased morbidity and an overall reduction in patient survival.18,20,21
CTCL can take, on average, between 2 and 7 years for individuals to receive a confirmed diagnosis.22 It is critical for doctors to consider CTCL as an early differential diagnosis as the patient’s prognosis can be affected if the disease progresses to later stages.23 Whilst most individuals that present with early stage disease do not progress to a more severe stage,24 patients with advanced disease have significantly poorer outcomes with only around half of patients (52%) surviving for just 5 years.18
CTCL is a ultra-rare disease that affects 0.7 per 100,000 patients across the UK.25 The annual incidence of MF in Europe is estimated to be between 1 in 110,000 to 1 in 350,000.26 The annual incidence of SS is 1 in 10,000,000.27 Together they represent approximately 65% of all cases of CTCL.17
About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan based Global Specialty Pharmaceutical Company with a more than 70-year heritage, the company applies cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity. You can learn more about the business of Kyowa Kirin at:
Date of Preparation: June 2021
1* Vorinostat is a USA FDA-licensed existing treatment for MF and SS and is currently unlicensed in the EU
1 National Institute for Health and Care Excellence. Single Technology Appraisal – Appeal Hearing. Advice on mogamulizumab for previously treated mycosis fungoides and Sezary syndrome [ID1405]. Available from https://www.nice.org.uk/guidance/gid-ta10305/documents/appeal-decision Last Accessed: June 2021.
2 NICE FAD on mogamulizumab for treating for previously treated mycosis fungoides and Sézary syndrome [ID1405]. Available from: https://www.nice.org.uk/guidance/gid-ta10305/documents/final-appraisal-determination-document. Last Accessed: June 2021.
3 European Medicines Agency (EMA). POTELIGEO 4mg/mL, concentrate for solution for infusion – product information. Available from https://www.medicines.org.uk/emc/product/11174. Last Accessed: June 2021.
4 National Organization for Rare Disorders: Cutaneous T-Cell Lymphomas. Available from: https://rarediseases.org/rare-diseases/cutaneous-t-cell-lymphomas/. Last Accessed: June 2021.
5 Williams et al (2020) – Health state utilities associated with caring for an individual with CTCL. Journal of Medical Economics. 2020; 23(10):1142-1150.
6 Ferenczi K, Fuhlbrigge RC, Pinkus J, et al. Increased CCR4 expression in cutaneous T cell lymphoma. J Invest Dermatol. 2002;119:1405-10.
7 Yoshie O, et al. Frequent Expression of CCR4 in Adult T-Cell Leukemia and Human T-cell Leukemia Virus Type 1-transformed T cells. Blood. 2002;99(5):1505-11.
8 Ishida T, et al. Clinical Significance of CCR4 Expression in Adult T-cell Leukemia/Lymphoma: Its Close Association With Skin Involvement and Unfavorable Outcome. Clin Cancer Res. 2003;9:3625-34.
9 Duvic M, et al. Mogamulizumab for the treatment of cutaneous T-cell lymphoma: recent advances and clinical potential. Ther Adv Hematol. 2016;7(3):171-174.
10 Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(9):1192-1204.
11 Cutaneous Lymphoma Foundation, Lymphoma Action and Lymphoma Coalition Europe. Cutaneous lymphoma – a patient’s guide. 2019. Available from: https://lymphoma-action.org.uk/sites/default/files/media/documents/2019-06/Cutaneous%20lymphoma%20-%20patient%26%23039%3Bs%20guide%20-%20English%20language%20source%20document%20-%20final%20version%20for%20publication%20-%20April%202019.pd Last accessed: June 2021.
12 Mariani M, Lang R, Binda E, et al. Dominance of CCL22 over CCL17 in induction of chemokine receptor CCR4 desensitization and internalization on human Th2 cells. Eur J Immunol. 2004;34(1):231-240.
13 Wilcox RA. Cutaneous T-cell lymphoma: 2016 update on diagnosis, risk-stratification, and management. Am J Hematol. 2016;91(1):151-65.
14 Ni X, Jorgensen JL, Goswami M, et al. Reduction of regulatory T cells by Mogamulizumab, a defucosylated anti-CC chemokine receptor 4 antibody, in patients with aggressive/refractory mycosis fungoides and Sézary syndrome. Clin Cancer Res. 2014; 21(2):274-85.
15 Kakinuma T, Sugaya M, Nakamura K, et al. Hymus and activation-regulated chemokine (TARC/CCL17) in mycosis fungoides: serum TARC levels reflect the disease activity of mycosis fungoides. J Am Acad Dermatol. 2003;48(1):23-30.
16 Girardi M, Heald PW, Wilson LD. The Pathogenesis of Mycosis Fungoides. NEJM. 2004;350(19):1978-88.
17 Olsen E, Vonderheid E, Pimpinelli N, et al. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007;110(6):1713-22.
18 Scarisbrick JJ, Prince M, Vermeer MH, et al. Cutaneous Lymphoma International Consortium Study of Outcome in Advanced Stages of Mycosis Fungoides and Sézary Syndrome: Effect of Specific Prognostic Markers on Survival and Development of a Prognostic Model. J Clin Oncol. 2015;33(32):3766-3773.
19 Willemze R, Hodak E, Zinzani PL et al. Primary cutaneous lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018;29(4):1-29.
20 Kim EJ, Hess S, Richardson SK, et al. Immunopathogenesis and therapy of cutaneous T cell lymphoma. J Clin Invest. 2005;115(4):798-812.
21 Scarisbrick JJ, Whittaker, S, Evans, AV, et al. Prognostic significance of tumor burden in the blood of patients with erythrodermic primary cutaneous T-cell lymphoma. Blood. 2001;97(3):624-30.
22 CL Foundation: A Patient’s Guide. Available from: https://www.clfoundation.org/sites/default/files/2018-04/a_patients_guide.pdf. Last Accessed: June 2021.
23 Agar N, et al. Survival Outcomes and Prognostic Factors in Mycosis Fungoides/Sezary Syndrome: Validation of the Revised International Society for Cutaneous Lymphomas/European Organisation for Research and Treatment of Cancer Staging Proposal. J Clin Ocol. 2010;28(31):4730-4739.
24 Krejsgaard T, Lindahl LM, Mongan NP, et al. Malignant inflammation in cutaneous T-cell lymphoma—a hostile takeover. Semin Immunopathol. 2017;39(3):269–282.
25 Gilson, D, et al. British Association of Dermatologists and UK Cutaneous Lymphoma Group Guidelines for the management of primary cutaneous lymphoma. British Journal of Dermatology. 2019. 180. pp.496-526
26 Orphanet: Mycosis Fungoides. Available from: https://www.orpha.net/consor/cgi-bin/OC_Exp.php?Lng=GB&Expert=2584. Last Accessed: June 2021.
27 Orphanet: Sézary syndrome. Available from: https://www.orpha.net/consor/cgi-bin/OC_Exp.php?Expert=3162. Last Accessed: June 2021.
Date of Preparation: June 2021
Contacts for Kyowa Kirin Co., Ltd.:
+ 44 (0)7771107406
CAMBRIDGE & WETHERBY, England–(BUSINESS WIRE)–Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce that it has received notice of registration of its AffiDX® SARS-CoV-2 antigen lateral flow test in the EU allowing the Company to place the product on the market in all 27 countries of the EU for professional use.
Lateral flow antigen tests are intended to provide a cost effective and rapid means of identifying individuals with a high viral load that means they are more likely to infect others. The clinical data for Avacta’s AffiDX® SARS-CoV-2 antigen lateral flow test reported 20 April 2021, demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct<27.
Avacta has multiple ongoing commercial discussions with distributors and end-user customers in countries that accept the CE mark for in vitro diagnostic products. The product registration by a Competent Authority in the EU allows the Company to sell the product in the EU for professional use. The Company is progressing multiple commercial opportunities with distributors and end users in Europe and this product registration is the key final step towards commercialisation.
Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: “We are delighted to receive confirmation of the registration of the AffiDX® SARS-CoV-2 antigen test in the EU. The EU is an important market for us, and the product registration is a key commercialisation milestone.
“The results of the recent clinical evaluation of the test at a clinical site in Europe demonstrate the test has excellent sensitivity across a range of viral loads, which would be considered infectious. This excellent performance and ease of nasal sampling, coupled with the fact that the AffiDX test is has been developed in the UK, is based on UK technology and is manufactured in the UK, are huge selling points for customers in Europe.
“Lateral flow tests have a crucial role to play in helping our societies and economies return to normal, and I am confident that the AffiDX® test will now play a significant part in this process.”
Zyme Communications (Trade and Regional Media)
Tel: +44 (0) 7787 502 947
LONDON & NEW YORK–(BUSINESS WIRE)–Fresha, a top beauty and wellness software platform, announced today a $100 million Series C investment led by General Atlantic, a leading global growth equity firm, with strategic participation from Huda Kattan of HB Investments and the founder of Huda Beauty, as well as Michael Zeisser of FMZ Ventures, former Chairman Investments at Alibaba Group, and Jonathan Green of Lugard Road Capital. Fresha’s existing global investors Partech, Target Global and FJ Labs also participated in the round, bringing the company’s total fundraising to $132 million to date. Fresha will leverage the new funds to further broaden its global community of partner salons and spas, scale product development, deepen its marketplace bookings and pursue strategic M&A.
Fresha allows consumers to discover, book and pay for beauty and wellness appointments with local businesses via its marketplace, while salons, spas and barbershops can leverage Fresha to manage their operations with its intuitive, subscription-free business software. The Fresha platform removes the critical pain points that service-based businesses often encounter by seamlessly facilitating the acceptance of online appointment bookings, processing of card payments and management of customer records, along with automations for marketing, staffing, product inventory and accounting, all in one place. In addition to its free offering, Fresha Plus provides partners with additional advanced features; rather than a traditional subscription model, the company collects fees on the usage of features for card payment processing and online bookings.
Fresha has amassed an extensive base of approximately 50,000 partner venues primarily spanning the United States, United Kingdom, Canada, Australia, New Zealand and Europe. In April 2021 alone, the company added over 4,000 new venues. The Fresha platform is used in 120 countries globally, and each month, customers book tens of millions of appointments on the platform, processing nearly $12 billion in value to date. Fresha’s focus on building easy-to-use, free software and offering business tools without any subscription fees, underpinned by a strong word-of-mouth effect, has helped the company build a loyal following and customer base. Fresha’s partner businesses rely on the platform for its ease of use, time-saving benefits and embedded features to grow sales, while end consumers enjoy a premium booking and payment experience.
“From the day we founded Fresha, our core focus has been on offering a solution that delights our customers. That drive has continued to direct our feature development and long-term vision. The rapid growth we’re seeing comes down to having happy customers that love using Fresha,” said Fresha Founder and CEO William Zeqiri. “The COVID-19 pandemic has accelerated the transition across the globe to online bookings and integrated card payments, now seen as essential to run any modern salon or spa. In May 2021, Fresha saw a thirty-fold increase in the volume of card payments processed on the platform compared to a year earlier.”
“Legacy software offerings for beauty and wellness businesses are often expensive to purchase and difficult to use. Salons face obstacles with inefficient scheduling, resulting in low occupancy and lost sales,” said Nick Miller, Fresha Co-Founder and Chief of Product. “More than ever, beauty and wellness businesses are opting to grow sales by leveraging tools to facilitate online payments, self-service bookings and automated marketing initiatives. Fresha’s technology optimizes appointment bookings with real-time online availability and boosts local discovery, helping partner salons grow sales,” he said.
“Fresha has emerged as a leader powering the beauty and wellness industry,” said Aaron Goldman, Global Co-Head of Financial Services and Managing Director at General Atlantic. “William, Nick and the Fresha team have built a product that is resonating with the market and creating long-term value through the intersection of its payments, software and marketplace offerings. We are thrilled to be partnering with the company and believe Fresha has significant opportunity to further scale its innovative platform.”
Huda Kattan shared her excitement at investing in the company: “I’ve witnessed first-hand the positive impact Fresha has for beauty entrepreneurs. The company is a force for good in the growing community of beauty professionals around the globe, who are increasingly adopting a self-employed approach. By making top business software accessible without any subscription fees, Fresha lets professionals focus on what they do best – offering great experiences for their customers.”
“We believe Fresha outpaces the competition by combining a superior product-market fit with outstanding execution capabilities,” said Philippe Collombel, General Partner at Partech. “William and Nick superbly steered Fresha during the COVID-19 pandemic. They have continued to innovate, accelerate signups of new salons, and boost revenues, whilst supporting new venues and small businesses in navigating the crisis. We can’t wait to see Fresha’s continued growth after this new funding round and are thrilled to partner once again with General Atlantic,” he said.
Previously, Fresha raised Series B investment from Paris-based Partech, along with Series A and Seed investments from Dubai-based MEVP. Launched in 2015 and with headquarters in London, the company is backed by investors from New York City, Silicon Valley and Europe.
Fresha is a leading global beauty and wellness platform. Each month, tens of millions of appointments are discovered, booked and paid with partner salons, spas and barbershops on Fresha. 50,000 partner venues in over 120 countries use the platform to manage their operations with Fresha’s intuitive, full-spectrum, subscription-free business software. Fresha transforms beauty and wellness business operations by enabling the acceptance of online appointment bookings, processing of card payments and managing customer records, along with automations for marketing, staffing, product inventory and accounting, all in one place. Launched in 2015 originally under the name Shedul, the company rebranded to Fresha in 2020. For more information, visit www.fresha.com, download Fresha on the App Store and Google Play or follow Fresha on Facebook and Instagram.
About General Atlantic
General Atlantic is a leading global growth equity firm providing capital and strategic support for growth companies. Established in 1980, General Atlantic combines a collaborative global approach, sector specific expertise, a long-term investment horizon, and a deep understanding of growth drivers to partner with great entrepreneurs and management teams to build market-leading businesses worldwide. General Atlantic has more than 175 investment professionals based in New York, Amsterdam, Beijing, Greenwich, Hong Kong, Jakarta, London, Mexico City, Mumbai, Munich, Palo Alto, São Paulo, Shanghai, and Singapore. For more information on General Atlantic, please visit the website: www.generalatlantic.com.
About Huda Kattan
Huda Kattan is chairwoman HB Investments (HBI), the private investment office of the founders of Huda Beauty: Huda (Chairwoman), Mona (President), Alya Kattan, Christopher Goncalo and is led by CEO Karan Wats. HBI invests in visionary entrepreneurs that share a common desire to build world-class consumer brands while creating meaningful impact; paring entrepreneurs with a brand building, marketing, PR and distribution ecosystem to help them unleash their magic. Going beyond traditional investment partnerships, HBI also runs a comprehensive incubator program called HB Angels, which provides seed funding and a brand-building ecosystem to a carefully selected group of in-house entrepreneurs. With a robust team of top marketing, PR, operations and supply chain talent, HBI is co-creating businesses that can change the world for the better.
Victoria Garcia Barker
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