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Results from Phase III SAkuraSky Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in The New England Journal of Medicine Online

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  • Satralizumab added to baseline immunosuppressant therapy significantly reduced risk of relapse in patients with neuromyelitis optica spectrum disorder (NMOSD).
  • Satralizumab added to baseline therapy showed a well-tolerated safety profile.
  • SAkuraSky study is a global phase III clinical study for NMOSD patients including aquaporin-4 antibodies (AQP4-IgG) seropositive and seronegative patients 

TOKYO–(BUSINESS WIRE)–#NMOSDChugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced that the results of the SAkuraSky Study (NCT02028884), a global phase III clinical study of satralizumab (development code: SA237) were published on November 27 in the online version of The New England Journal of Medicine (NEJM). Satralizumab is an anti-IL6 receptor humanized recycling antibody under development for the treatment of neuromyelitis optica spectrum disorder (NMOSD). The phase III study examined the efficacy and safety of satralizumab added to baseline therapy in patients with NMOSD.

Article: https://www.nejm.org/doi/full/10.1056/NEJMoa1901747

“Relapses of NMOSD may lead to accumulation of disabilities and can be life-threatening. These data further reinforce the importance of IL-6 signal inhibition in treating NMOSD,” said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. “The SAkuraSky study is the first clinical study to demonstrate the efficacy and safety of an investigational medicine for NMOSD regardless of AQP4-IgG expression.”

In SAkuraSky Study, only eight of 41 patients (20%) treated with satralizumab in combination with baseline immunosuppressant therapy experienced a protocol-defined relapse (PDR) compared to 18 of 42 patients (43%) treated with placebo in combination with baseline therapy (HR=0.38, 95% CI: 0.16-0.88; p=0.02 [stratified log-rank test]) in the overall population, representative of NMOSD patients (including anti-AQP4-IgG antibody seropositive and seronegative patients). Importantly, 89%, 78% and 74% of patients on satralizumab in combination with baseline therapy were relapse-free at weeks 48, 96 and 144 compared to 66%, 59% and 49% with placebo in combination with baseline therapy. The proportion of serious adverse events was similar between the satralizumab and placebo treatment groups.

SAkuraSky Study (NCT02028884)

Summary:

A phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of satralizumab added to baseline treatment in patients with NMOSD

[Primary Endpoint]

Time to first protocol-defined relapse adjudicated by an independent review committee in the double-blind period

Study Design:

  • 83 male and female patients aged from 13-73 years were randomized.
  • Patients were randomized to satralizumab or placebo in a 1:1 ratio. Satralizumab (120 mg) or placebo added to baseline treatment (azathioprine, mycophenolate mofetil and/or corticosteroids*) was subcutaneously administered at Week 0, 2, and 4. The subsequent treatment was continued at 4-week intervals.
  • The double-blind treatment period ended when the total number of PDR had reached 26. After experiencing a PDR or completion of the study, patients in both groups were offered treatment with satralizumab in an open-label extension period.
  • Patients with AQP4-IgG seropositive or seronegative neuromyelitis optica (NMO)** and those with AQP4-IgG seropositive NMOSD were enrolled.

    *Approved indication for Mycophenolate mofetil in Japan is treatment of refractory rejection after kidney transplant (If the patient cannot be treated with existing drugs because of a lack of response, adverse reactions, or another reason and refractory rejection has been diagnosed), suppression of rejection after the organ transplants (kidney, heart, liver, lung, or pancreas transplants), and lupus nephritis. For other drugs, please refer to the latest package insert of each drug.

    **NMO defined in 2006

Main Results:

  • In a prespecified primary analysis, only eight of 41 patients (20%) treated with satralizumab in combination with baseline immunosuppressant therapy experienced a protocol-defined relapse (PDR) compared to 18 of 42 patients (43%) treated with placebo in combination with baseline therapy (HR=0.38, 95% CI: 0.16-0.88; p=0.02 [stratified log-rank test]) in the overall population, representative of NMOSD patients (including anti-AQP4-IgG antibody seropositive and seronegative patients). Satralizumab also showed stable results in a post hoc analyses using multiple imputation for censored data.
  • 89%, 78% and 74% of patients on satralizumab in combination with baseline therapy were relapse-free at weeks 48, 96 and 144 compared to 66% and 59% and 49% with placebo in combination with baseline therapy.
  • In a prespecified AQP4-IgG seropositive subgroup analysis for time to relapse, three of 27 patients (11%) treated with satralizumab experienced a PDR compared to 12 of 28 patients (43%) treated with placebo (HR=0.21, 95% CI: 0.06-0.75). In the AQP4-IgG seronegative subgroup analysis, five of 14 patients (36%) treated with satralizumab experienced a PDR compared to six of 14 patients (43%) receiving placebo (HR= 0.66, 95% CI: 0.20-2.24).
  • The proportion of serious adverse events was similar between the satralizumab and placebo treatment groups. A lower rate of infections (including serious infections) was observed in patients treated with satralizumab compared with the placebo group. The most common adverse events in the satralizumab group were upper respiratory tract infection, nasopharyngitis (common cold) and headache.

About neuromyelitis optica spectrum disorder (NMOSD)

NMOSD is an autoimmune disease of the central nervous system characterized by inflammatory lesions in the optic nerves and spinal cord, and cause continual and significant decrease in quality of life due to permanent neurologic disorders Patients with NMOSD frequently experience a relapsing disease course with repeated attacks leading to accumulating neurological damage and disability. Symptoms may include visual impairment, motor disability, and loss of quality of life. In some cases, attacks of NMOSD result in death. Aquaporin-4 antibodies (AQP4-IgG), pathogenic antibodies, are detected in at least two-thirds of NMOSD patients. AQP4-IgG is known to target and damage a specific central nervous cell type called astrocytes, resulting in inflammatory lesions of the optic nerve(s), spinal cord and brain 1-4. The inflammatory cytokine IL-6 is now emerging as an important factor in NMOSD pathogenesis 5-9.

Diagnostic criteria introduced in 2006 for NMO were characterized by inflammation of the optic nerve (optic neuritis) and the spinal cord (myelitis). These were revised in 2007 with the definition of NMOSD, proposed for diseases with either optic neuritis or myelitis. In 2015, the definition of NMOSD further revised to include a broader spectrum of disease. The diagnostic term NMOSD is now widely used 10.

About satralizumab

Satralizumab, created by Chugai, is an anti-IL-6 receptor recycling antibody. The drug is expected to suppress relapse of NMOSD by inhibiting IL-6 signal transduction which is deeply related to the pathology. In two global phase III clinical studies in NMO and NMOSD patients, the primary endpoint was achieved with satralizumab either as an add-on therapy to baseline immunosuppressant treatment (NCT02028884) or as monotherapy (NCT02073279). These studies represent one of the largest clinical trial programs undertaken for this rare disease. Satralizumab is designated as an orphan drug for the treatment of NMO and NMOSD in Japan, and for the treatment of the same disease group in Europe and the U.S. In addition, it has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in December 2018. The application was accepted for review by EMA and FDA, and filed to MHLW in 2019.

Sources

1. Jarius S, Ruprecht K, Wildemann B et al. Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: A multicentre study of 175 patients. J Neuroinflammation 2012;9:14.

2. Lennon VA, Wingerchuk DM, Kryzer TJ et al. A serum autoantibody marker of neuromyelitis optica: distinction from multiple sclerosis. Lancet 2004;364:2106-12.

3. Marignier R, Bernard-Valnet R, Giraudon P et al. Aquaporin-4 antibody-negative neuromyelitis optica: Distinct assay sensitivity-dependent entity. Neurology 2013;80:2194-200.

4. Takahashi T, Fujihara K, Nakashima I et al. Anti-aquaporin-4 antibody is involved in the pathogenesis of NMO: a study on antibody titre. Brain 2007;130:1235-43.

5. Chihara N, Aranami T, Sato W et al. Interleukin 6 signaling promotes anti-aquaporin 4 autoantibody production from plasmablasts in neuromyelitis optica. Proc Natl Acad Sci USA 2011;108:3701-6.

6. Kimura A, Kishimoto T. IL-6: regulator of Treg/Th17 balance. Eur J Immunol 2010;40:1830-5.

7. Lin J, Li X, Xia J. Th17 cells in neuromyelitis optica spectrum disorder: a review. Int J Neurosci2016;126:1051-60.

8. Takeshita Y, Obermeier B, Cotleur AC, et al. Effects of neuromyelitis optica-IgG at the blood-brain barrier in vitro. Neurol Neuroimmunol Neuroinflamm. 2016;4(1):e311.

9. Obermeier B, Daneman R, Ransohoff RM. Development, maintenance and disruption of the blood-brain barrier. Nat Med 2013;19:1584-96.

10. Wingerchuk DM, Banwell B, Bennett JL et al. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology 2015;85:177-89.

Contacts

For Media

Chugai Pharmaceutical Co., Ltd.

Media Relations Group, Corporate Communications Dept.,

Tomoko Shimizu

Tel: +81-3-3273-0881

E-mail: pr@chugai-pharm.co.jp

For US media

Chugai Pharma USA Inc.

Casey Astringer

Tel: +1-908-516-1350

E-mail: pr@chugai-pharm.com

For European media

Chugai Pharma U.K. Ltd.

Carter Westwood

Tel: +44-20-8987-5680

E-mail: pr@chugai.eu

For Taiwanese media

Chugai Pharma Taiwan Ltd.

Susan Chou

Tel: +886-2-2715-2000

E-mail: pr@chugai.com.tw

For Investors

Chugai Pharmaceutical Co., Ltd.

Investor Relations Group, Corporate Communications Dept.,

Toshiya Sasai

Tel: +81-3-3273-0554

E-mail: ir@chugai-pharm.co.jp

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Shortages of Low-Skill, Middle-Skill, and High-Skill Workers Causing Revenue Declines and Other Headaches for Employers, TrueBlue’s Latest Study Finds

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TACOMA, Wash.–(BUSINESS WIRE)–While there has been a lot of discourse around the shortage of high-skill workers in the U.S., a new study by staffing giant TrueBlue shows a significant percentage of employers are also struggling with deficits in low-skill and middle-skill workers – and dealing with a host of business challenges as a result.

According to TrueBlue’s nationwide survey, which included nearly 1,500 managers (HR, operational, and business), skills shortages are widening across skills categories:

  • 32% of managers can’t find workers to fill low-skill positions (generally classified as those that may or may not require a high school diploma and require little to no experience)
  • 46% can’t find workers for middle-skill jobs (typically require some experience and continuing education such as college courses, an apprenticeship or certification, but don’t necessarily require a four-year college degree)
  • 35% can’t find workers for high-skill jobs (typically require a four-year degree or higher and specialized experience)

Low unemployment coupled with globalization, accelerated technology advancement, and evolving work models are creating talent deficits across all skill levels within organizations,” said Patrick Beharelle, CEO of TrueBlue. “The skills supply is not keeping up with demand, which is fueling a greater intensity in an already competitive labor market and adversely impacting productivity, service quality, and revenue growth for businesses.”

Impact of Talent Shortages on Businesses

The top three business challenges managers are experiencing due to prolonged job vacancies within their organizations include:

  • Quality – More than a third of managers (35%) reported that extended job vacancies have caused lower product or service quality.
  • Turnover – 25% have seen higher employee turnover.
  • Revenue – 23% said their companies experienced a decline in revenue.

To address talent shortages and minimize associated business impact, 2 in 5 companies (41 percent) reported that they plan to raise compensation for entry-level workers and nearly half (46 percent) plan to train and hire the long-term unemployed in the coming year.

Survey Methodology

This SurveyMonkey survey was conducted online in the U.S. by TrueBlue between September 23 and October 15, 2019. It included 1,499 managers (HR, operations and general). The survey was across regions, industries, and company sizes.

About TrueBlue

TrueBlue (NYSE: TBI) is a global leader in specialized workforce solutions that help clients achieve business growth and improve productivity. In 2018, the company connected approximately 730,000 people with work. TrueBlue’s PeopleReady segment offers on-demand industrial staffing services, PeopleManagement offers contingent and productivity-based, on-site industrial staffing and driver staffing services, and PeopleScout offers recruitment process outsourcing (RPO) and managed service provider (MSP) solutions to a wide variety of industries. Learn more at www.trueblue.com.

Contacts

Jennifer Grasz

Vice President, Corporate Communications

jgrasz@trueblue.com
(312) 840-6327

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Law Firm of Estey & Bomberger Reports: Uber Says Nearly 6,000 Rapes, Sexual Assaults Occurred in Two-year Period

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SAN DIEGO–(BUSINESS WIRE)–The law firm of Estey & Bomberger reported today that Uber’s long-awaited sexual assault report was released Dec. 5, with the ride-hailing company admitting that 5,981* passengers and drivers were raped or sexually assaulted between 2017-2018.

“I applaud Uber for releasing the data that acknowledges there is a problem with sexual assaults occurring in rideshare. While we believe these assaults were preventable, Uber’s report represents a tremendous step for ride-hailing safety,” said Estey & Bomberger attorney Mike Bomberger. “I think there are many positive measures Uber is taking. However, Uber still has an obligation to help the victims who have been raped and assaulted and facing a lifetime of emotional pain. They will need ongoing therapy.”

Estey & Bomberger represents more than 100 ride-hailing sexual assault victims.

“It’s important to remember when reading this report that only one in three women report their sexual assault,” Bomberger said. “Therefore, the number of women who have been sexually assaulted is certainly much higher than reported here.”

Bomberger reiterated his call for all ride-hailing trips to be digitally recorded.

“We’re pleased that Uber is now testing cameras in Texas. That’s the real solution to this problem – if drivers know they’re being recorded they won’t rape and assault,” Bomberger said.

Estey & Bomberger is asking Lyft and Uber sexual assault victims, along with former employees of the ride-sharing firms, to contact its office by calling 866-964-1708 or emailing info@lyftsexualassaultlawyers.com.

*statistic courtesy NPR “Uber Received Nearly 6,000 U.S. Sexual Assault Claims in Past 2 Years,” Dec. 5, 2019.

Contacts

for Estey & Bomberger

Ed Vasquez, 408-420-6558

ed@ejvcommunications.com

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Best’s Market Segment Report: AM Best Maintains Global Reinsurance Market Outlook at Stable

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OLDWICK, N.J.–(BUSINESS WIRE)–AM Best has maintained a market segment outlook of stable on the global reinsurance industry for 2020, citing a stabilized pricing environment — albeit at levels below long-term adequacy — the continuing alignment between traditional and third-party capital and ongoing stability in the global life reinsurance segment.

A new Best’s Market Segment Report, titled, “Market Segment Outlook: Global Reinsurance,” states that although rates in the non-life reinsurance market have improved modestly, pricing has not kept adequate pace with the changing risk dynamics, as illustrated by loss development from events such as hurricanes Irma and Maria and Typhoon Jebi, and potential losses from more-recent events (e.g., Hurricane Dorian). Property catastrophe pricing still is being driven by the availability of third-party capital; however, the increasing interdependence between traditional capacity and third-party capital through joint ventures, retrocession and direct ownership should serve to more closely align return objectives for the market overall. Third-party capital also represents a benefit in the form of stabilized earnings of rated balance sheets, due to tail risk being assumed by this capital.

Overall market conditions are improving, but AM Best remains concerned about insufficient rate adequacy relating to certain U.S. casualty lines, a steady decline in the benefit of favorable reserve releases and the pervasive low interest rate environment. The collective effect of these factors requires underwriting discipline, and failure to react to these pressures could adversely affect the segment.

The report outlines other factors that are driving the stable market segment outlook, including:

  • AM Best believes alternative third-party capital will hold the line on future return expectations following the recent heavy catastrophe loss years;
  • A decline in capital consumption and earnings volatility, due in part to the increased utilization of third-party capital in retrocessionaire programs;
  • Greater emphasis on underwriting discipline due to pressure on interest rates and potential slower economic growth globally;
  • Improving pricing momentum driven by higher loss costs, coupled with lower loss reserve redundancies;
  • Increased demand for non-life reinsurance due to primary companies’ recent loss experience, as well as new risk transfer opportunities and mergers and acquisitions;
  • Stable operating performance among life reinsurers, which continue to maintain defensible market positions and offer services beyond risk transfer that create hurdles for new entrants.

To access the full copy of the overall global reinsurance briefing, please visit http://www3.ambest.com/bestweek/purchase.asp?record_code=292334.

Separate briefings on the non-life and life reinsurance segments can be viewed at:

To view a video with AM Best Associate Director Scott Mangan about the global reinsurance market segment outlook, please visit http://www.ambest.com/v.asp?v=globalreoutlook1219.

AM Best is a global credit rating agency, news publisher and data provider specializing in the insurance industry. The company does business in more than 100 countries. Headquartered in Oldwick, NJ, AM Best has offices in cities around the world, including London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2019 by A.M. Best Company, Inc. and/or its affiliates.

ALL RIGHTS RESERVED.

Contacts

Robert DeRose
Senior Director
+1 908 439 2200, ext. 5435
robert.derose@ambest.com

Greg Carter
Managing Director
+44 20 7397 0288
greg.carter@ambest.com

Michael Porcelli, FSA
Director
+1 908 439 2200, ext. 5548
michael.porcelli@ambest.com

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

Jim Peavy
Director, Public Relations
+1 908 439 2200, ext. 5644
james.peavy@ambest.com

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