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CORK, Ireland, May 3, 2021 /PRNewswire/ — Johnson Controls (NYSE: JCI) Executive Vice President and Chief Financial Officer Olivier Leonetti will speak at the Goldman Sachs Industrials & Materials Conference 2021 held virtually on Thursday, May 13, 2021 at 10:30a.m. EDT.  A live webcast of the presentation will be available on the company’s website at: http://investors.johnsoncontrols.com/news-and-events/events-and-presentations .

About Johnson Controls:
At Johnson Controls (NYSE:JCI) we transform the environments where people live, work, learn and play. As the global leader in smart, healthy and sustainable buildings, our mission is to reimagine the performance of buildings to serve people, places and the planet. 

With a history of more than 135 years of innovation, Johnson Controls delivers the blueprint of the future for industries such as healthcare, schools, data centers, airports, stadiums, manufacturing and beyond through its comprehensive digital offering OpenBlue. With a global team of 100,000 experts in more than 150 countries, Johnson Controls offers the world`s largest portfolio of building technology, software as well as service solutions with some of the most trusted names in the industry. For more information, visit www.johnsoncontrols.com or follow us @johnsoncontrols on Twitter.

 

 

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SOURCE Johnson Controls International plc

DUBLIN, May 3, 2021 /PRNewswire/ — Mallinckrodt plc (OTCMKTS: MNKKQ), a global biopharmaceutical company, today announced data from its Phase 4, multi-center, open-label study to assess the efficacy and safety of Acthar^® Gel (repository corticotropin injection) in adult patients with treatment-resistant, severe non-infectious keratitis, a disease which involves painful inflammation of the cornea.¹ The full results were presented in a poster at The Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, and further data will be shared at the upcoming virtual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting. The poster can be accessed here on the company’s website.

Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.² Please see Important Safety Information for Acthar Gel below.

The primary efficacy endpoint of the study was the proportion of patients who improved by 12 points or more in the symptom bother module of the Impact of Dry Eye on Everyday Life (IDEEL) score at week 12. The IDEEL is a patient-reported outcome assessment with three modules—impact on daily life, treatment satisfaction and symptom bother—and six dimensions. After 12 weeks of treatment with Acthar Gel, 50.0 percent (n=17) of patients experienced improvements in their symptom bother score by at least 12 points, a clinically important change³ (95% CI 33.2, 66.8).⁴

“As ophthalmologists, we rely heavily on patient-reported symptoms when evaluating severe keratitis, especially for those who require alternative treatments,” said one of the study authors David Wirta, M.D., Ophthalmologist, Eye Research Foundation, Newport Beach. “The clinically important improvement in the symptom bother module is very encouraging and helps us better understand the potential impact for Acthar Gel to effectively treat appropriate patients with severe keratitis who are in need of additional treatment options.”

Exploratory endpoints included the change from baseline to week 12 in each item of the Visual Analog Scale (VAS), and corneal fluorescein staining and conjunctival lissamine green staining as measured by Ora Calibra™ scales. After 12 weeks of treatment with Acthar Gel, all symptoms assessed by the VAS had improved from baseline, with the most pronounced improvements observed for eye dryness and discomfort. Additionally, improvements from baseline in corneal fluorescein staining and conjunctival lissamine green staining were observed as early as week four and were sustained through week 12. Additionally, the proportions of patients who experienced greater than or equal to 20, 30 or 50 percent improvement in the IDEEL symptom bother score at week 12 were 50.0 percent (95% CI 33.2, 66.8), 44.1 percent (95% CI 27.4, 60.8) and 14.7 percent (95% CI 2.8, 26.6), respectively.⁴ 

Safety was assessed regarding treatment-emergent adverse events (TEAEs) and serious TEAEs collected throughout the study. Of patients in the safety population (n=36), 33.3 percent experienced ≥1 TEAE after initiation of Acthar Gel treatment; most TEAEs were single incidences. In the study, the most commonly reported TEAE was hypertension (n=2). No serious TEAEs were related to the study drug.⁴ 

“These data provide meaningful evidence to support Acthar Gel’s potential role in improving outcomes for patients with severe keratitis that persists after the use of one or more standard treatments,” said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. “We are pleased to be able to share these important data broadly with the healthcare community with the hopes of helping physicians better understand which individuals may benefit from the drug as a treatment alternative.” 

About the Study

⁴

:

• The study was designed to evaluate the efficacy and safety of Acthar Gel in adult patients with treatment-resistant, severe non-infectious keratitis.
• In the 16-week study period, 36 patients were enrolled at eight sites across the United States.
• To ensure inclusion of moderate to severe dry eye patients, eligibility criteria included all of the following in at least one eye (the same eye) at screening and baseline:
• Inferior corneal fluorescein staining score of at least two points in any field in at least one eye.
• Sum corneal fluorescein staining score ≥4.
• Sum lissamine green conjunctival score of ≥2.
• Conjunctival redness score ≥1 (0-4 scale).
• Schirmer score ≥1 mm and ≤10 mm/5 min in at least one eye.
• Ocular Discomfort Score of ≥2.
• After a 28-day screening, subjects who met entry criteria were treated with Acthar Gel 1 mL (80 units) subcutaneously twice per week for 12 weeks, followed by a tapering period of four weeks.
• The mean age of the study population was 63.3 years, and most patients were female (71.4 percent), White (80.0 percent) and not of Hispanic or Latino ethnicity (94.3 percent).

Find out more information about the study here on the ClinicalTrials.gov website.

About Severe Keratitis
Keratitis is a painful inflammation of the cornea and is a significant cause of ocular morbidity around the world.¹ It can result from infectious agents (e.g., microbes including bacteria, fungi, amebae and viruses) or from noninfectious causes (e.g., eye trauma, chemical exposure and ultraviolet exposure).⁵ Non-infectious severe keratitis may be associated with various collagen vascular or other autoimmune diseases, sometimes as the presenting sign of the disease.⁶

IMPORTANT SAFETY INFORMATION

Contraindications

Acthar is contraindicated:

• For intravenous administration
• In infants under 2 years of age who have suspected congenital infections
• With concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar
• In patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin

Warnings and Precautions

• The adverse effects of Acthar are related primarily to its steroidogenic effects
• Acthar may increase susceptibility to new infection or reactivation of latent infections
• Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g., trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA axis suppression after stopping treatment
• Cushing’s syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms
• Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Monitor blood pressure and sodium and potassium levels
• Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy
• Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain GI disorders. Monitor for signs of perforation and bleeding
• Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression to psychosis. Existing conditions may be aggravated
• Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis
• Prolonged use of Acthar may produce cataracts, glaucoma, and secondary ocular infections. Monitor for signs and symptoms
• Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Acthar activity
• There may be an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver
• Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients
• Decrease in bone density may occur. Bone density should be monitored in patients on long-term therapy
• Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Adverse Reactions

• Commonly reported postmarketing adverse reactions for Acthar include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia, and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased
• The most common adverse reactions for the treatment of infantile spasms (IS) are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. Some patients with IS progress to other forms of seizures; IS sometimes masks these seizures, which may become visible once the clinical spasms from IS resolve

Other adverse events reported are included in the full Prescribing Information.

Please see full Prescribing Information for additional Important Safety Information.

ABOUT MALLINCKRODT 
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company’s Specialty Brands reportable segment’s areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning Acthar Gel including its potential impact on patients and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the “Risk Factors” section of Mallinckrodt’s most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

CONTACT

Media Inquiries


Caren Begun

Green Room Communications
201-396-8551
[email protected]

Investor Relations


Daniel J. Speciale

Vice President, Finance and Investor Relations Officer
314-654-3638
[email protected]

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2021 Mallinckrodt. US-2001768 04/21

References

¹ Sharma S. Keratitis. Bioscience Reports. 2001;21:419-444.
² Acthar® Gel (repository corticotropin injection) [prescribing information]. Mallinckrodt ARD LLC.
³ Fairchild CJ, et al. OptomVis Sci. 2008;85(8):699-707.
⁴ Grieco J, McLaurin E, Ousler G, Liu J, Kacmaz O, Wirta D. Results from a multicenter, open-label, Phase 4 study of repository corticotropin injection in patients with treatment-resistant severe non-infectious keratitis. Presented at: Association for Research in Vision and Ophthalmology Annual Meeting; May 1, 2021; San Francisco, CA.
⁵ Collier SA, Gronostaj MP, MacGurn, AK, Cope JR, Awsumb KL, Yoder JS, et al. Estimated burden of keratitis–United States, 2010. MMWR Morb Mortal Wkly Rep. 2014;63(45):1027–1030.
⁶ Donzis PB, Mondino BJ. Management of noninfectious corneal ulcers. Surv Ophthalmol. 1987;32:94–110.

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SOURCE Mallinckrodt plc

LONDON, May 3, 2021 /PRNewswire/ — International Game Technology PLC (IGT) (NYSE: IGT) announced that Walter Bugno, Executive Vice President of New Business and Strategic Initiatives, has resigned to pursue a new professional opportunity. Mr. Bugno will continue in his current position until May 14, 2021.

“I would like to thank Walter for his accomplishments over the course of more than 10 years of senior leadership at IGT. His efforts have made meaningful contributions to the strength of our global leadership,” said IGT CEO Marco Sala. “At every stage of his time with IGT, Walter successfully engaged teams across multiple regions, built significant customer relationships, fostered continued talent development and championed innovation throughout his organization. On behalf of everyone at IGT, I wish Walter well in his future endeavors.”

Following Mr. Bugno’s departure, IGT new business responsibilities will be divided among the Global Lottery and Global Gaming business units. Responsibilities for strategic initiatives will be assumed by the IGT Strategy and Corporate Development support function.

About IGT
IGT (NYSE:IGT) is the global leader in gaming. We deliver entertaining and responsible gaming experiences for players across all channels and regulated segments, from Gaming Machines and Lotteries to Sports Betting and Digital. Leveraging a wealth of compelling content, substantial investment in innovation, player insights, operational expertise, and leading-edge technology, our solutions deliver unrivalled gaming experiences that engage players and drive growth. We have a well-established local presence and relationships with governments and regulators in more than 100 countries around the world, and create value by adhering to the highest standards of service, integrity, and responsibility. IGT has approximately 11,000 employees. For more information, please visit www.IGT.com.

Cautionary Statement Regarding Forward-Looking Statements
This news release may contain forward-looking statements (including within the meaning of the Private Securities Litigation Reform Act of 1995) concerning International Game Technology PLC and its consolidated subsidiaries (the “Company”) and other matters. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, dividends, results of operations, or financial condition, or otherwise, based on current beliefs of the management of the Company as well as assumptions made by, and information currently available to, such management. Forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “plan,” “could,” “would,” “should,” “shall”, “continue,” “estimate,” “expect,” “forecast,” “future,” “guidance,” “intend,” “may,” “will,” “possible,” “potential,” “predict,” “project” or the negative or other variations of them. These forward-looking statements speak only as of the date on which such statements are made and are subject to various risks and uncertainties, many of which are outside the Company’s control. Should one or more of these risks or uncertainties materialize, or should any of the underlying assumptions prove incorrect, actual results may differ materially from those predicted in the forward-looking statements and from past results, performance, or achievements. Therefore, you should not place undue reliance on such statements. Factors that could cause actual results to differ materially from those in the forward-looking statements include (but are not limited to) the factors and risks described in the Company’s annual report on Form 20-F for the financial year ended December 31, 2020 and other documents filed from time to time with the SEC, which are available on the SEC’s website at www.sec.gov and on the investor relations section of the Company’s website at www.IGT.com. Except as required under applicable law, the Company does not assume any obligation to update these forward-looking statements. You should carefully consider these factors and other risks and uncertainties that affect the Company’s business. Nothing in this news release is intended, or is to be construed, as a profit forecast or to be interpreted to mean that the financial performance of International Game Technology PLC for the current or any future financial years will necessarily match or exceed the historical published financial performance or International Game Technology PLC, as applicable. All forward-looking statements contained in this news release are qualified in their entirety by this cautionary statement. All subsequent written or oral forward-looking statements attributable to International Game Technology PLC, or persons acting on its behalf, are expressly qualified in their entirety by this cautionary statement.

Contact:

Phil O’Shaughnessy, Global Communications, toll free in U.S./Canada +1 (844) IGT-7452; outside U.S./Canada +1 (401) 392-7452
Francesco Luti, +39 3485475493; for Italian media inquiries
James Hurley, Investor Relations, +1 (401) 392-7190

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SOURCE International Game Technology PLC

NEW YORK, May 3, 2021 /PRNewswire/ — The recent rise and influence of the individual investor has rippled across financial markets over the past 12 months, presenting companies with a unique opportunity to engage new investors like never before. A new survey from Broadridge Financial Solutions (NYSE: BR), the global Fintech leader, highlights how new and younger retail investors are thinking about investing and this year’s proxy season.

This new survey found that investors are specifically paying attention to ESG issues. Survey respondents said that social issues, such as diversity and environmental issues regarding how companies are managing climate change, are the two matters they are most interested in expressing their opinion on through proxy voting. Sixty-seven percent of investors surveyed believe that companies they invest in should take active steps to address environmental concerns, such as climate change, and 62% believe those companies should address social challenges, such as gender, ethnic, and racial diversity and inclusion. Additionally, the survey found that 46% of millennial investors (ages 25-40), the highest percentage of any generation, say they will vote their proxy in 2021.

Broadridge’s Proxy Season 2021 Investor Sentiment Study, conducted in collaboration with Engine Group, surveyed approximately 1,000 individual investors with investment or brokerage accounts about their proxy voting and investing habits, including their motivations for voting, the issues they are most interested in voting on, and their use of technology. The study sheds light on the sentiments of a new wave of retail investors, following a year that saw more than 10 million new brokerage accounts open, according to research from JMP Securities.

“The recent rise of the individual investor has been driven by technology, mobile and zero fee commissions,” said Martin Koopman, President, Bank Broker-Dealer, Investor Communication Solutions at Broadridge. “The survey data shows that newer and younger investors want their investments aligned with their values especially when it comes to ESG-related issues. We are also seeing these new investors look to their advisors, brokers and fund managers for technology solutions that make it easier for them to vote their proxies with their values.”

Supportive of ESG-Related Issues

Asked what issues they would be most interested in voicing their opinion on through proxy voting, respondents named social issues, such as diversity on the company board (43%) and environmental issues (41%), followed by approving or rejecting M&A (40%), executive/CEO compensation (35%), general corporate governance (33%) and appointing the Board of Directors (32%).

Tapping into the New Wave of Individual Investors

The Proxy Season 2021 Investor Sentiment Study showed that respondents with two years or less of investing experience are the most active traders, with 43% trading at least once a week. Their investment decisions largely stem from information they receive from reading or watching the news (35%), friends (34%), family (31%) and social media (30%).

This new wave of retail investors say they are going to be engaged in the proxy process this year. Thirty-nine percent of investors with two years of investing experience or fewer said they will definitely vote their proxy. Of the newer investors who plan to vote their proxy this year, 38% feel it’s their responsibility to vote while 42% say they plan to vote because they want to have a voice on issues that are important to them.

With mobile trading taking off, investors are also willing to vote their proxy on this platform. Seventy-five percent of investors would be more likely to vote their proxy if they knew they could do so through a mobile app, including 88% of Gen Z investors (ages 18-24), 92% of millennial investors, and 89% of investors with two years of experience or less.

New Tools for a New Generation

The Proxy Season 2021 Investor Sentiment Study found that investors are looking to their brokers, fund managers and advisors to educate them on the proxy voting process. Proxy voting provides a natural opportunity for brokers and financial advisors to further develop client relationships, a touchpoint where clients are seeking education and advice.

Brokers and financial advisors should note that 67% of respondents said they would like their advisor to spend time explaining the process of proxy voting and discussing the issues voted on at annual general meetings. Seventy-nine percent of respondents would be interested in pre-filling their voting preferences on certain issues, a process called Advanced Voting Instructions.

Investors are also seeking more ways to vote through their fund providers. Among surveyed investors who held mutual funds or ETFs:

• 65% of investors believe that as a mutual fund or ETF shareholder, they should have more of a say about how their fund votes at annual shareholder meetings, including 62% of Gen Z investors and 75% of millennials
• 72% of investors said they would be more likely to invest in a fund if they were given the option to vote on issues most important to them, including 77% of Gen Z investors and 89% of millennials

Investor Education

With the recent increase in stock record growth and newer and younger investors entering the market, Broadridge has updated https://www.shareholdereducation.com/ with bold new visuals and more user-friendly snackable content. The site educates investors on proxy voting, the impact it can have and the mechanics of voting.  

Along with providing educational information, Broadridge has a history of developing technology and solutions that enhance and ease the retail investor experience; from updating proxyvote.com to newly designed vote instruction forms to enhanced emails to a mobile app for proxy voting to virtual shareholder meeting technology. Broadridge enables better financial lives by providing investors with more ways to vote either online, by phone or mail, or with the ProxyVote app. 

Methodology
On behalf of Broadridge, Engine Group conducted an online survey of 1,002 investors ages 18 and older from March 11-16, 2021. All respondents currently have one or more investment or brokerage accounts where they can buy, sell, or hold stocks, bonds, mutual funds, or ETFs. The survey excluded investors who solely invest through a workplace-sponsored retirement account, such as a 401(k).

About Broadridge
Broadridge Financial Solutions (NYSE: BR), a global Fintech leader with over $4.5 billion in revenues, provides the critical infrastructure that powers investing, corporate governance, and communications to enable better financial lives. We deliver technology-driven solutions to banks, broker-dealers, asset and wealth managers and public companies. Broadridge’s infrastructure serves as a global communications hub enabling corporate governance by linking thousands of public companies and mutual funds to tens of millions of individual and institutional investors around the world. In addition, Broadridge’s technology and operations platforms underpin the daily trading of on average more than U.S. $10 trillion of equities, fixed income and other securities globally. A certified Great Place to Work^®, Broadridge is a part of the S&P 500^® Index, employing over 12,000 associates in 17 countries. For more information about us and what we can do for you, please visit www.broadridge.com.

Contact:

Sarah Rutledge

Prosek Partners for Broadridge
(212) 279-3115
[email protected] 

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SOURCE Broadridge Financial Solutions, Inc.