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KB Home Announces the Grand Opening of Palmetto Bluff, a New-Home Community in the Intracoastal West Area of Jacksonville, Priced From the Low $300,000s

Homebuilder’s latest community offers personalized, new homes in a desirable location near beaches.

JACKSONVILLE, Fla.–(BUSINESS WIRE)–
KB Home (NYSE: KBH) today announced the grand opening of Palmetto Bluff, a new single-family home community in the Intracoastal West area of Jacksonville. Palmetto Bluff is conveniently located near Interstate 295 and provides easy access to downtown Jacksonville. Residents will also enjoy the community’s proximity to Naval Station Mayport, Atlantic Beach, Neptune Beach and Hanna Park, which offers a variety of outdoor activities, including camping, biking, hiking and fishing.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210407005098/en/

The homes at Palmetto Bluff showcase popular design characteristics like spacious lofts, gourmet kitchens overlooking expansive great rooms, and master suites with walk-in closets. The community offers one- and two-story floor plans that feature up to six bedrooms and three baths, and range in size from approximately 1,400 to 3,000 square feet. Palmetto Bluff also offers the KB Home Office, a dedicated room that homebuyers can personalize for the way they work.

“Palmetto Bluff’s convenient location provides easy access to major highways for a short drive to area beaches and downtown Jacksonville,” said Todd Holder, President of KB Home’s Jacksonville division. “As with other KB Home communities, Palmetto Bluff provides home shoppers the opportunity to purchase a new KB home that can be personalized to reflect their lifestyle and needs.”

KB Home stands out from other homebuilders as the company gives homebuyers exceptional choice and control. KB Home starts by offering a wide variety of homes at an affordable price. From there, the builder gives buyers the ability to personalize their homes from floor plans to exterior elevations, from design options to where they live in the community. The KB Home team works hand in hand with homeowners every step of the way so they have a real partner in the process.

Every KB home is designed to be ENERGY STAR^® certified thanks to the quality construction techniques and materials utilized that ultimately deliver significant savings on utility bills compared to used homes. Additionally, all new KB homes are designed to deliver an enhanced indoor environment and include high performance ventilation systems, low- or zero-VOC products and other features guided by the Environmental Protection Agency’s (EPA) Indoor airPLUS standards.

The Palmetto Bluff sales office and model homes are open for private in-person tours by appointment, and walk-in visits are welcome. Homebuyers also have the flexibility to arrange a live video tour with a sales counselor. Pricing begins from the low $300,000s and no CDD fees.

For more information on KB Home, call 888-KB-HOMES or visit kbhome.com.

About KB Home

KB Home is one of the largest and most recognized homebuilders in the United States and has been building quality homes for over 60 years. Today, KB Home operates in 45 markets across eight states, serving a wide array of buyer groups. What sets us apart is how we give our customers the ability to personalize their homes from homesites and floor plans to cabinets and countertops, at a price that fits their budget. We are the first builder to make every home we build ENERGY STAR^® certified. In fact, we go beyond the EPA requirements by ensuring every ENERGY STAR certified KB home has been tested and verified by a third-party inspector to meet the EPA’s strict certification standards, which help to lower the cost of ownership and to make our new homes healthier and more comfortable than new ones without certification. We also work with our customers every step of the way, building strong personal relationships so they have a real partner in the homebuying process, and the experience is as simple and easy as possible. Learn more about how we build homes built on relationships by visiting kbhome.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210407005098/en/

Cara Kane, KB Home

321-299-6844

[email protected]

KEYWORDS: Florida United States North America

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KB Home announces the grand opening of Palmetto Bluff, a new-home community in the Intracoastal West area of Jacksonville, from the low $300,00s. (Photo: Business Wire)

Analog Devices and MDA Collaborate to Provide Electronic Beam Forming Technology for the Telesat Lightspeed Constellation, Enhancing Global Connectivity

WILMINGTON, Mass.–(BUSINESS WIRE)–Analog Devices, Inc. (Nasdaq: ADI) announced today a collaboration with MDA to deliver the beam forming integrated circuit (BFIC) to be used in MDA’s sophisticated phased array antenna for the Telesat Lightspeed low earth orbit (LEO) satellite constellation. Telesat Lightspeed, initially comprised of 298 next-generation satellites, is planned to launch in the second half of 2023 and will redefine global broadband connectivity for commercial, government, and defense markets.

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LEO satellites, rather than operating from a fixed position, move across the sky and must dynamically steer communication beams to maintain uninterrupted and high-speed connectivity to ground terminals. The new BFIC solution is highly reliable while performing under extreme temperatures and cosmic radiation for the full 10- to 12-year lifespan of each satellite.

“Electronically steered array technology is a necessity for the builders and operators of the next generation of LEO constellations. This technology provides MDA and Telesat with the ability to simultaneously steer multiple beams and allows beams to be rapidly repositioned at speeds that are not possible with mechanical systems,” said Bryan Goldstein, Vice President of Aerospace and Defense at Analog Devices. “We are excited to collaborate with MDA to support the Telesat Lightspeed constellation.”

“The collaboration with ADI has enabled MDA to develop the critical solutions required to perform electronic beam steering on the Telesat Lightspeed antennas,” said Amer Khouri, Vice President of Satellite Systems, MDA. “We look forward to continuing this journey together and producing the large quantity of antennas required for this groundbreaking program.”

About Analog Devices

Analog Devices (Nasdaq: ADI) is a leading global high-performance semiconductor technology company dedicated to solving the toughest engineering challenges. We enable our customers to interpret the world around us by intelligently bridging the physical and digital with unmatched technologies that sense, measure, power, connect and interpret. Visit http://www.analog.com

About MDA

Serving the world from its Canadian home and global offices, MDA is an international space mission partner and a robotics, satellite systems and geointelligence pioneer with a 50-year story of firsts on and above the Earth. With over 2,000 employees across Canada, the US and the UK, MDA is leading the charge towards viable Moon colonies, enhanced Earth observation, communication in a hyper-connected world, and more. With a track record of making space ambitions come true, MDA enables highly skilled people to continually push boundaries, tackle big challenges, and imagine solutions that inspire and endure to change the world for the better, on the ground and in the stars. http://www.mda.space

Forward Looking Statements

This press release contains forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among other things, statements by Messrs. Goldstein and Khouri and other statements regarding the expected opportunities, benefits, and performance improvements associated with the above-described beam forming integrated circuit, that are based on current expectations, beliefs, assumptions, estimates, forecasts, and projections about the industry and markets in which the referenced companies operate. The statements contained in this release are not guarantees of future performance, are inherently uncertain, involve certain risks, uncertainties, and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements, and such statements should not be relied upon as representing Analog Devices’ expectations or beliefs as of any date subsequent to the date of this press release. Important factors that could cause actual results to differ materially from the results described, implied or projected in any forward-looking statements include difficulty or delay in our design, development, production and marketing of products, technologies and solutions, including those associated with the course, impacts and uncertainty of the COVID-19 global pandemic, and other risk factors described in the most recent filings of Analog Devices with the Securities and Exchange Commission. Analog Devices does not undertake any obligation to update forward-looking statements made by us.

(ADI-Web)

View source version on businesswire.com: https://www.businesswire.com/news/home/20210407005055/en/

Linda Kincaid

Analog Devices, Inc.

[email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Satellite Hardware Engineering Technology Aerospace Semiconductor Manufacturing Other Technology

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Analog Devices and MDA Collaborate to Provide Electronic Beam Forming Technology for the Telesat Lightspeed Constellation, Enhancing Global Connectivity (Graphic: Business Wire)

Yamaha Expands ADECIA Family With Tabletop Microphone Option

The Easy-to-Install, Customizable Product Suite Adds More Flexibility to Hybrid Conferencing and Learning Use Cases

HAMAMATSU, Japan–(BUSINESS WIRE)–Yamaha has added the new RM-TT wired tabletop array microphone as a microphone option to ADECIA, a complete family of easy-to-install products designed to work seamlessly together to provide complete and customizable communications solutions for meetings or learning spaces. The ADECIA tabletop solution, like the ADECIA Ceiling System, integrates the RM-CR remote conference processor, VXL1-16P Dante/PoE-compatible line array speaker, and SWR2311P-10G Yamaha’s long-trusted PoE network switch, providing comfortable and effortless remote conferencing experience.

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“With the hybrid style of working and learning now becoming commonplace, high-quality conferencing systems are more vital than ever to ensure a seamless and engaging communication experience,” said Nobuo Ikematsu, senior general manager of information & communication division, Yamaha. “With the additional option of Yamaha’s RM-TT tabletop microphone, users have more flexibility to customize ADECIA to their use case.”

Included within the ADECIA solution family, the new offering features the same easy setup and auto configuration features available through the RM-CR audio processor. Installation of the wired tabletop microphones is done through a LAN cable to the PoE switch. Up to eight microphone pods (four microphones per pod) can be added for scalability.

Packing into RM-TT’s low-profile form factor is all of Yamaha’s powerful sound technologies, including automatic voice tracking, auto gain control, adaptive echo cancellation, noise reduction, and reverberation suppression for optimal collaboration experiences. When the RM-CR processor and RM-TT tabletop microphones are combined, the unique voice tracking function automatically selects the microphone closest to the person speaking for optimal voice capture. For example, a meeting participant who is moving from the conference table to a white board or interactive display in the room can ensure that the voice will be captured and delivered to the far end in crisp, clear quality. In a classroom, the microphones can be setup around the room to capture every student as well as the teacher who may be presenting lessons from different areas or checking on individual progress or questions. The innovative technology also allows installers to dictate each microphone pod’s directional mode for customized room capture. Available mic options include unidirectional, super-cardioid, hyper-cardioid, omnidirectional, bidirectional, or toroidal.

The complete solution automatically detects all components of the system and configures them to be optimized for the room environment, accounting for the location of speakers and microphones, reverberation, and echo behavior. Setting up a room is done through the system’s configurator in four effortless steps. With USB, Bluetooth^®, Dante, and analog connections, this flexible system can fit a variety of enterprise or meeting spaces and classrooms.

The ADECIA tabletop model, including RM-TT, will be available in summer 2021. The ADECIA ceiling solution is now shipping

About Yamaha Corporation

Since its founding in 1887, the Yamaha Corporation (TOKYO:7951) has developed its business activities focusing on musical instruments, audio products, Yamaha music schools, semiconductors, and other products and services related to sound and music. With its unique expertise and sensibilities, gained from our devotion to sound and music, Yamaha is committed to creating excitement and cultural inspiration together with people around the world. With 15 years of history in the Japan market, Yamaha’s dedicated unified communications department focuses on solutions that enhance communication and help organizations reach their business goals.

www.yamaha.com

Product and company names and logos that appear in this news release are trademarks of their respective owners.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210407005041/en/

For media inquiries:

Yamaha Corporation

Kei Sato

Media Relations Group

Corporate Communications Division

Contact Form: https://inquiry.yamaha.com/contact/?act=55&lcl=en_WW

Tel: +81 3 5488 6605 (Japanese correspondence only)

For customers / general public

Yamaha Corporation

Takeshi Senoo

Marketing Group Marketing & Sales Department

Information & Communication Division

Email: [email protected]

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The ADECIA Ceiling System: left, The ADECIA tabletop solution: right (Photo: Business Wire)

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RM-TT wired tabletop array microphone product image (Photo: Business Wire)

Evoqua Water Technologies Announces Credit Facilities Refinancing

Highlights include:

• Extends maturities
• Lowers weighted average cost of debt
• Increases liquidity
• Reduces debt levels by $100 million

PITTSBURGH–(BUSINESS WIRE)–
Evoqua Water Technologies Corp. (NYSE: AQUA), an industry leader in mission-critical water treatment solutions, today announced the refinancing of the company’s credit facilities on April 1, 2021.

Wholly-owned subsidiaries of the company entered into a credit agreement, which provides for a $475 million term loan maturing on April 1, 2028 and a revolving credit facility of up to $350 million maturing on April 1, 2026, and a receivables financing agreement, which provides for a receivables finance facility of up to $150 million maturing on April 1, 2024. The net proceeds of these facilities, together with cash on hand, was used to repay all outstanding indebtedness under the company’s previous credit facilities, in an aggregate principal amount of approximately $815 million. The reduction of approximately $340 million to the first lien term loan outstanding under the previous credit facilities was funded by draws on the new revolving credit facility, the new receivables finance facility and $100 million of cash on hand.

In addition to extending the maturities of the previous term loan and revolver, Evoqua reduced the weighted average cash borrowing cost by approximately 0.50% from the December 31, 2020 level. Liquidity also improved as a result of the overall financing.

JP Morgan Chase Bank serves as the administrative agent and collateral agent under the credit agreement. PNC Bank serves as the administrative agent under the receivables financing agreement.

Mr. Ron Keating, CEO commented, “We are very pleased to have the new credit facilities in place which provides attractive market rates and extended maturities. This new structure allowed us to reduce total debt while increasing liquidity and provides flexibility for continued investments in our organic and inorganic growth strategies. We appreciate the continued support from the high-quality financial institutions who participated in the underwriting.”

About Evoqua Water Technologies

Evoqua Water Technologies is a leading provider of mission-critical water and wastewater treatment solutions, offering a broad portfolio of products, services and expertise to support industrial, municipal and recreational customers who value water. Evoqua has worked to protect water, the environment and its employees for more than 100 years, earning a reputation for quality, safety and reliability around the world. Headquartered in Pittsburgh, Pennsylvania, the company operates in more than 160 locations across ten countries. Serving more than 38,000 customers and 200,000 installations worldwide, our employees are united by a common purpose: Transforming Water. Enriching Life.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210407005183/en/

Investors

Dan Brailer

Vice President, Investor Relations

Evoqua Water Technologies

Telephone: 724-720-1605

Email: [email protected]

Media

Sarah Brown

Media

Evoqua Water Technologies

Telephone: 506-454-5495

Email: [email protected]

KEYWORDS: United States North America Pennsylvania

INDUSTRY KEYWORDS: Energy Environment Other Construction & Property Construction & Property Utilities

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Posted on April 7, 2021 8:03 am

Avaya OneCloud CCaaS Brings Digital Contact Center Capabilities into New Markets, Enabling Businesses Worldwide to Compose Effortless Customer and Employee Experiences

Avaya OneCloud CCaaS Brings Digital Contact Center Capabilities into New Markets, Enabling Businesses Worldwide to Compose Effortless Customer and Employee Experiences

RALEIGH-DURHAM, N.C.–(BUSINESS WIRE)–Avaya (NYSE: AVYA), a global leader in solutions to enhance and simplify communications and collaboration, has expanded the availability of its Avaya OneCloud^TM CCaaS contact center solution into forty countries¹, providing organizations globally with digital capabilities that better connect customers and employees across any touchpoint, modality, device, and channel. Avaya OneCloud CCaaS is a key part of the AI-powered Avaya OneCloud experience platform that includes workstream collaboration, unified communications and communications platform as a service solutions with OneCloud UCaaS and OneCloud CPaaS.

According to IDC, 84 percent of consumers consider “experience” as important as a company’s product or service, and 92 percent say customer experience has a great influence on future purchase decisions.² Avaya OneCloud CCaaS enables organizations to create true customer experience centers, by easily expanding their digital capabilities to benefit from everything cloud has to offer. This includes the flexibility, efficiency and innovation-on-demand of a multi-cloud ecosystem that delivers real-time insight, analytics and context, enhancing each customer interaction, across whatever touchpoint they choose, with speed and agility. Avaya OneCloud CCaaS also provides effortless composability enabled by Avaya OneCloud CPaaS, which is a force multiplier delivering even more value for the customer experience center. This enables organizations to easily leverage prebuilt apps to extend existing capabilities, as well as use build-your-own apps to create unique solutions to meet specific, customized needs.

Avaya OneCloud CCaaS gives organizations the power to:

• Connect digital touchpoints throughout the entire customer journey — from email, messaging, chat, social, and the ability for organizations to Bring Your Own Channel (BYOC).
• Intelligently match customers with the best employees based on business rules, internal and external context and desired business outcomes.
• Personalize employee experiences with a customizable, modern workspace that easily brings customer insights from different applications and systems into a single pane of glass.
• Get ahead of every customer interaction by predicting needs and proactively engaging customers with journey intelligence.
• Quickly and easily layer-on innovative cloud technologies to deliver the exact experience that provides their customers more options, faster responses, and a more personalized approach

“With OneCloud CCaaS, Avaya is combining expanded digital capabilities with a full-range of deployment options across public, private and hybrid cloud, to enhance the total experience for customer and employee engagement,” said Mary Wardley, Vice President, CRM Applications, IDC. “Their use of AI, orchestration, bots, the integration between voice and digital – all make for a compelling solution designed to be flexible and agile. And Avaya’s extensive ecosystem of technology partners and developers brings additional, proven capabilities that are continually integrated into the Avaya OneCloud CCaaS solution, delivering further value to customers. ”

Avaya OneCloud CCaaS helps organizations make each interaction effortless, seamless, and context driven—creating memorable experiences for customers and the employees who serve them. Avaya intelligently pairs customers and employees with the right resources at the right time, and AI-powered workflows give employees context and virtual assistance to create more rewarding engagement, while management tools deliver organizational-level insights.

“Avaya understands that today’s ‘everything customer’ wants to consume services the way they do things, and an on-demand, Work from Anywhere workforce needs in-the-moment collaboration to provide customers with what they want, when they want it, and how they want it,” said Anthony Bartolo, Executive Vice President and Chief Product Officer, Avaya. “Success depends on having an ‘always-on’ business that can deliver personalized, cloud-based experiences quickly and easily. Avaya OneCloud CCaaS enables our customers to realize the power of a cloud application ecosystem that’s multiplied by CPaaS and workstream collaboration. It powers an organization-wide customer engagement advantage that will be essential to remain competitive. And just as important, it is focused, flexible, comprehensive and fast.”

Additional Resources

• Learn how to create an effortless experience for customers with Avaya OneCloud CCaaS.
• Download the report, Four Ways Contact Center as a Service (CCaaS) Delivers a Better Employee and Customer Experience in 2021.
• Find out the Six Ways to Put Avaya OneCloud™ CCaaS to Work for Your Business.
• Read our blog, Not All Cloud Contact Center Solutions Are Created Equal: The Top Three Considerations When Moving to the Cloud.

About Avaya

Businesses are built by the experiences they provide, and everyday millions of those experiences are delivered by Avaya Holdings Corp. (NYSE: AVYA). Avaya is shaping what’s next for the future of work, with innovation and partnerships that deliver game-changing business benefits. Our cloud communications solutions and multi-cloud application ecosystem power personalized, intelligent, and effortless customer and employee experiences to help achieve strategic ambitions and desired outcomes. Together, we are committed to help grow your business by delivering Experiences that Matter. Learn more at http://www.avaya.com.

¹Avaya OneCloud CCaaS is available in the following countries, with more being added continually: USA, Canada, Mexico, Argentina, Brazil, Chile, Colombia, Costa Rica, Jamaica, Panama, Peru, Austria, Belgium, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom

²“Emotional Customer Intelligence and Digital Resiliency: Optimizing CX and NPS with Data and AI,” IDC 2021

Cautionary Note Regarding Forward-Looking Statements

This document contains certain “forward-looking statements.” All statements other than statements of historical fact are “forward-looking” statements for purposes of the U.S. federal and state securities laws. These statements may be identified by the use of forward-looking terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “our vision,” “plan,” “potential,” “preliminary,” “predict,” “should,” “will,” or “would” or the negative thereof or other variations thereof or comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond its control. The factors are discussed in the Company’s Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) available at www.sec.gov, and may cause the Company’s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements. The Company cautions you that the list of important factors included in the Company’s SEC filings may not contain all of the material factors that are important to you. In addition, in light of these risks and uncertainties, the matters referred to in the forward-looking statements contained in this press release may not in fact occur. The Company undertakes no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as otherwise required by law.

All trademarks identified by ®, TM, or SM are registered marks, trademarks, and service marks, respectively, of Avaya Inc. All other trademarks are the property of their respective owners.

Source: Avaya Newsroom

View source version on businesswire.com: https://www.businesswire.com/news/home/20210407005070/en/

For media inquiries:

Alex Alias

[email protected]

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RECIPE Randomized Controlled Trial Data Published in Arthritis & Rheumatology Show Higher Response Rates Using KRYSTEXXA^® (pegloticase injection) with the Immunomodulator Mycophenolate Mofetil

— Primary study endpoint demonstrates 86 percent response rate for patients receiving co-therapy of KRYSTEXXA and mycophenolate mofetil —

DUBLIN–(BUSINESS WIRE)–
Horizon Therapeutics plc (Nasdaq: HZNP) announced the publication of data from the first randomized controlled clinical trial (RCT) of KRYSTEXXA (pegloticase injection) concomitantly used with an immunomodulator, mycophenolate mofetil, in Arthritis & Rheumatology [doi.org/10.1002/art.41731].

The Reducing Immunogenicity of Pegloticase (RECIPE) trial demonstrated that 86 percent of patients (19 of 22) receiving co-therapy of KRYSTEXXA with the immunomodulator mycophenolate mofetil achieved serum uric acid (sUA) ≤ 6 mg/dL at 12 weeks, the primary study endpoint, compared to 40 percent of patients (4 of 10) receiving KRYSTEXXA monotherapy. The safety and efficacy of KRYSTEXXA co-prescribed with mycophenolate mofetil has not been established by any health authorities.

“Our focus on urgently reducing the buildup of uric acid crystals and addressing the impact of uncontrolled gout on patients led us to explore how to curtail the development of anti-drug antibodies with pegloticase through the RECIPE trial,” said Puja Khanna, M.D., M.P.H., associate professor and rheumatologist at the University of Michigan, and co-primary investigator for the RECIPE trial. “This trial adds major insight to the evolving body of data – that co-treatment with immunomodulatory medications can mitigate antibody production, and thereby improve the response rates of pegloticase. We believe that this novel approach has the potential of meaningfully improving the patient’s response to urate lowering therapy and long-term outcomes as a result.”

Data from this investigator-initiated Phase 2, double-blind, placebo-controlled proof-of-concept trial led by the University of Alabama at Birmingham and University of Michigan funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and Horizon illustrate the effect of a concomitant regimen of KRYSTEXXA with mycophenolate mofetil. In the study, 35 adult patients with uncontrolled gout were randomized (3:1) to receive either mycophenolate mofetil or placebo for two weeks prior to starting KRYSTEXXA (12 infusions of 8 mg every two weeks). Thirty-two patients received at least one dose of KRYSTEXXA and were included in the analysis, with three patients discontinuing prior to the first KRYSTEXXA infusion. During the trial, patients continued to receive either mycophenolate mofetil (1g) twice daily or placebo with KRYSTEXXA for 12 weeks. After Week 12, all patients received only KRYSTEXXA 8 mg IV every two weeks for 12 weeks, providing six months of KRYSTEXXA therapy. The primary endpoint was the proportion of patients who reached and maintained response to therapy (defined as sUA levels ≤6 mg/dL at 12 weeks).¹

In total, 86 percent (19 of 22) of patients receiving co-therapy of KRYSTEXXA and mycophenolate mofetil achieved serum uric acid ≤ 6 mg/dL at Week 12 versus 40 percent (4 of 10) of patients in the KRYSTEXXA and placebo arm, with a sustained response at Week 24 in 68 percent (15 of 22) of patients versus 30 percent (3 of 10) of patients, respectively. In the KRYSTEXXA with mycophenolate mofetil arm, no (0 of 22 patients) infusion reactions were reported compared to 30 percent (3 of 10) of patients reporting infusion reactions in the KRYSTEXXA with placebo arm. The most commonly reported adverse events for the KRYSTEXXA with mycophenolate mofetil arm versus the KRYSTEXXA with placebo arm included musculoskeletal (41 percent versus 10 percent), gastrointestinal disorders (18 percent versus 10 percent), respiratory (18 percent versus 0 percent) and infections (9 percent versus 0 percent).¹

“This publication reflects a fundamental aspect of our collaborative research efforts with leading voices in the rheumatology community,” said Paul M. Peloso, M.D., M.Sc., vice president and therapeutic area head, rheumatology, Horizon. “As we listen to and learn from studies outside of Horizon, along with our clinical colleagues, we can refine strategies to best improve the utility of our medicines and optimize benefits to patients.”

About KRYSTEXXA

INDICATIONS AND USAGE

KRYSTEXXA^® (pegloticase injection) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.

Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Serum uric acid levels should be monitored prior to infusions, and healthcare providers should consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.

Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

In the event of anaphylaxis or infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.

Patients should be informed of the symptoms and signs of anaphylaxis and instructed to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Patients should be screened for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA should not be administered to these patients.

GOUT FLARES

An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.

CONGESTIVE HEART FAILURE

KRYSTEXXA has not been studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Caution should be exercised when using KRYSTEXXA in patients who have congestive heart failure, and patients should be monitored closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions in clinical trials with KRYSTEXXA were gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.

Please see Full Prescribing Information and Medication Guide for more information.

About Horizon

Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the potential benefits of combining immunomodulator (including mycophenolate mofetil) treatment with KRYSTEXXA. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, risks regarding whether results of additional clinical trials will be consistent with results of prior trials or other data or Horizon’s expectations, the risks associated with clinical development of drug candidates and risks related to competition or other factors that may change physician treatment strategies. For a further description of these and other risks facing Horizon, please see the risk factors described in Horizon’s filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in those filings. Forward-looking statements speak only as of the date of this press release and Horizon undertakes no obligation to update or revise these statements, except as may be required by law.

References

1. Khanna, P, et al. Reducing Immunogenicity of Pegloticase (RECIPE) with Concomitant Use of Mycophenolate Mofetil in Patients with Refractory Gout — a Phase II Double Blind Placebo Controlled Randomized Trial. Arthritis & Rheumatology. 2021. doi:10.1002/art.41731

 

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Tina Ventura

Senior Vice President, Investor Relations

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INDUSTRY KEYWORDS: Health Clinical Trials Research Pharmaceutical Science Biotechnology

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