Market Newsdesk

FREMONT, Calif., Nov. 18, 2020 /PRNewswire/ — SYNNEX Corporation (NYSE: SNX), a leading business process services company, celebrates its founding 40 years ago today in 1980 by Bob Huang. Bob’s vision was to provide an environment of entrepreneurship, fostering strong, long-term relationships with associates, partners and clients, while always thinking strategically about what is next. The execution of this vision has allowed SYNNEX to continually lead the way over the past four decades by offering the most relevant technology solutions and services in the IT and BPO marketplaces.

Guided by the principles of visibility, velocity and value combined with a history of diversity, inclusiveness and respect for the individual, SYNNEX currently sits at #130 on the FORTUNE 500 listing of the largest US companies ranked by annual revenue.  Contributing to the success of SYNNEX has been the ability to continually innovate in its markets, adapt to changes and challenges, create new business units within the company and execute accretive strategic acquisitions.

“Today marks a significant milestone in our company history, and we would like to thank our associates, clients and partners for their trust, loyalty and support of the SYNNEX vision and strategy,” said Dennis Polk, President and CEO, SYNNEX Corporation. “As we reflect on 40 years in business, it’s important to recognize all of our constituents who have made this possible and reflect on all that has been achieved. Together we will continue to evolve as a business, remain relevant to our stakeholders and create value for who we serve across the globe.”

As previously announced, SYNNEX intends to complete its spin-off of Concentrix Corporation into its own publicly traded company on December 1, 2020. The separation is expected to unlock value for SYNNEX shareholders and allow both companies the enhanced agility to best serve associates, clients and partners.

About SYNNEX
SYNNEX Corporation (NYSE: SNX) is a Fortune 200 corporation and a leading business process services company, providing a comprehensive range of distribution, logistics and integration services for the technology industry and providing outsourced services focused on customer engagement to a broad range of enterprises.  SYNNEX distributes a broad range of information technology systems and products, and also provides systems design and integration solutions. Founded in 1980, SYNNEX Corporation operates in numerous countries throughout North and South America, Asia-Pacific and Europe. Additional information about SYNNEX may be found online at synnex.com.

Safe Harbor Statement
Statements in this news release regarding SYNNEX Corporation which are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, statements regarding the timing of the spin-off of Concentrix and the expected effects of the spin-off transaction, including unlocked shareholder value. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those discussed in the forward-looking statements. These risks and uncertainties include, but are not limited to: the impact of COVID-19 or coronavirus, or other pandemics, and the impact of related governmental, individual and business responses; general economic and market conditions; risks related to the satisfaction of closing conditions in the anticipated timeframe or at all; risks related to the ability to realize the anticipated benefits of the transaction; disruption from the transaction making it more difficult to maintain business, contractual and operational relationships; the unfavorable outcome of any legal proceedings that have been or may be instituted against SYNNEX or Concentrix; the ability to retain key personnel; negative effects of the transaction announcement or the consummation of the proposed spin-off on the market price of the capital stock of SYNNEX or Concentrix; significant transaction costs, fees, expenses and charges; unknown liabilities; the risk of litigation and/or regulatory actions related to the transaction; transaction-related financings; other business effects; future exchange and interest rates; changes in laws, regulations, and policies; and competitive developments; and other risks and uncertainties detailed in the Concentrix Form 10 registration statement, in our Form 10-K for the fiscal year ended November 30, 2019, and in subsequent SEC filings. Statements included in this press release are based upon information known to SYNNEX Corporation as of the date of this release, and SYNNEX Corporation does not intend to update information contained in this press release.

Copyright 2020 SYNNEX Corporation. All rights reserved. SYNNEX, the SYNNEX Logo, CONCENTRIX, and all other SYNNEX company, product and services names and slogans are trademarks or registered trademarks of SYNNEX Corporation. SYNNEX, the SYNNEX Logo, and CONCENTRIX Reg. U.S. Pat. & Tm. Off. Other names and marks are the property of their respective owners.

Investor Contact:

Vikram Sinha

Investor Relations
SYNNEX Corporation
[email protected]
510-668-3904

SNX-G

 

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SOURCE SYNNEX Corporation

SOUTH PLAINFIELD, N.J., Nov. 18, 2020 /PRNewswire/ — PTC Therapeutics, Inc. (NASDAQ: PTCT), today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted PTC596 both Orphan Drug Designation and Fast Track designation for the potential treatment of leiomyosarcoma (LMS), a rare type of cancer that affects smooth muscle tissue. Furthermore, the FDA has also granted PTC596 a Rare Pediatric Disease designation and Orphan Drug Designation for the potential treatment of Diffuse Intrinsic Pontine Glioma (DIPG), an ultra-rare childhood glioma. PTC596 is currently being studied in clinical trials in LMS and DIPG.  

“We are very pleased with the FDA’s decisions to grant PTC596 these designations,” said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics. “This brings us one step closer to providing truly novel therapeutic approaches to patients with devastating rare cancers seen in children and adults that do not have good treatment options.”

PTC596 is an orally bioavailable small molecule tubulin binding agent that arrests tumor cells in G2/M phase, including cancer stem cells, through the action of inhibiting tubulin polymerization. It is currently in a Phase 1b study for LMS, which accounts for approximately 10 to 28% of all soft tissue sarcomas.¹ Approximately 4000 patients are diagnosed with LMS annually in the US, the risk of developing metastases is approximately 40%, and the 5-year survival rate is estimated to be 13.6% for metastatic LMS.² PTC596 is also currently in a clinical study for DIPG, an ultra-rare glioma arising in the brainstem that makes up 10 to 15% of all brain tumors in children.³ Approximately 300 patients are diagnosed with DIPG annually in the US, and the median overall survival with the current standard of care of radiation therapy, is approximately 9 months with a two-year overall survival rate of less than 10%.⁴

About PTC Therapeutics, Inc.
PTC is a science-driven, global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders. PTC’s ability to globally commercialize products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines and our mission to provide access to best-in-class treatments for patients who have an unmet medical need.

For More Information:

Investors

Lisa Hayes

+1 (732) 354-8687
[email protected]

Media

Jane Baj

+1 (908) 912-9167
[email protected]

Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this release, other than statements of historic fact, are forward-looking statements, including statements regarding: the future expectations, plans and prospects for PTC; PTC’s strategy, future operations, future financial position, future revenues and projected costs; and the objectives of management. Other forward-looking statements may be identified by the words “guidance,” “plan,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions.

PTC’s actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties, including those related to: the outcome of pricing, coverage and reimbursement negotiations with third party payors for PTC’s products or product candidates that PTC commercializes or may commercialize in the future; significant business effects, including the effects of industry, market, economic, political or regulatory conditions; changes in tax and other laws, regulations, rates and policies; the eligible patient base and commercial potential of PTC’s products and product candidates; PTC’s scientific approach and general development progress; and the factors discussed in the “Risk Factors” section of PTC’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K, as well as any updates to these risk factors filed from time to time in PTC’s other filings with the SEC. You are urged to carefully consider all such factors.

As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that any product will receive or maintain regulatory approval in any territory or prove to be commercially successful.

The forward-looking statements contained herein represent PTC’s views only as of the date of this press release and PTC does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this press release except as required by law.

¹ Bessen, T., Caughey, G. E., Shakib, S., Potter, J. A., Reid, J., Farshid, G., Roder, D., & Neuhaus, S. J. (2019). A population-based study of soft tissue sarcoma incidence and survival in Australia: An analysis of 26,970 cases. Cancer epidemiology, 63, 101590. https://doi.org/10.1016/j.canep.2019.101590
² Ries LAG, Young JL, Keel GE, Eisner MP, Lin YD, Horner M-J (editors). SEER Survival Monograph: Cancer Survival Among Adults: U.S. SEER Program, 1988-2001, Patient and Tumor Characteristics. National Cancer Institute, SEER Program, NIH Pub. No. 07-6215, Bethesda, MD, 2007.
³ Raabe, E. H., & Cohen, K. (n.d.). What is DIPG? Retrieved November 9, 2020, from https://www.dipg.org/dipg-facts/what-is-dipg/
⁴ Jansen, M. H., Veldhuijzen van Zanten, S. E., Sanchez Aliaga, E., Heymans, M. W., Warmuth-Metz, M., Hargrave, D., van der Hoeven, E. J., Gidding, C. E., de Bont, E. S., Eshghi, O. S., Reddingius, R., Peeters, C. M., Schouten-van Meeteren, A. Y., Gooskens, R. H., Granzen, B., Paardekooper, G. M., Janssens, G. O., Noske, D. P., Barkhof, F., Kramm, C. M., … van Vuurden, D. G. (2015). Survival prediction model of children with diffuse intrinsic pontine glioma based on clinical and radiological criteria. Neuro-oncology, 17(1), 160–166. https://doi.org/10.1093/neuonc/nou104

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SOURCE PTC Therapeutics, Inc.

MONETT, Mo., Nov. 18, 2020 /PRNewswire/ — Jack Henry & Associates, Inc. (NASDAQ: JKHY) today announced its Board of Directors declared a regular quarterly cash dividend of $.43 per share.  The cash dividend on its common stock, par value $.01 per share, is payable on December 22, 2020, to stockholders of record as of December 2, 2020.  At November 12, 2020, there were 76,317,581 shares of the common stock outstanding. 

About Jack Henry & Associates, Inc.

Jack Henry (NASDAQ: JKHY) is a leading provider of technology solutions primarily for the financial services industry. We are a S&P 500 company that serves approximately 8,700 clients nationwide through three divisions: Jack Henry Banking^® supports banks ranging from community banks to multi-billion-dollar institutions; Symitar^® provides industry-leading solutions to credit unions of all sizes; and ProfitStars^® offers highly specialized solutions to financial institutions of every asset size, as well as diverse corporate entities outside of the financial services industry. With a heritage that has been dedicated to openness, partnership, and user centricity for more than 40 years, we are well-positioned as a driving market force in future-ready digital solutions and payment processing services. We empower our clients and consumers with the human-centered, tech-forward, and insights-driven solutions that will get them where they want to go. Are you future ready? Additional information is available at www.jackhenry.com.

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SOURCE Jack Henry & Associates, Inc.

LOS ANGELES, Nov. 18, 2020 /PRNewswire/ — B. Riley Financial, Inc. (NASDAQ: RILY) (“B. Riley” or the “Company”), a leading business advisory and financial services company, today announced the launch of B. Riley Financial Sponsors Group. The team will focus on developing and maintaining relationships with alternative capital managers, including private equity firms, family offices, sovereign wealth, credit funds and hedge funds. Dan Kraft and Tim Bottrell recently joined B. Riley to lead the group as Co-Directors of Financial Sponsors Coverage.

“The launch of our Financial Sponsors Group is a key milestone for B. Riley enabling us to dedicate the right resources to drive value for middle market sponsors and alternative capital managers. With each assignment, we will deliver the broad service offering and benefits of B. Riley Financial,” said Tom Kelleher, co-Chief Executive Officer, B. Riley Financial. “We’re thrilled to have Dan and Tim leading the effort. Their deep relationships and expertise will help ensure we’re delivering superior results to our clients.”

In their new roles, Dan and Tim will be focused on developing relationships with sponsors, collaborating with B. Riley Senior Management and coordinating with personnel who routinely interact with sponsors.

“I’m excited to be a part of a firm with so much to offer,” said Mr. Kraft. “I look forward to bringing B. Riley’s robust range of capabilities to the sponsor community.”

“I’m thrilled to support the Company’s rapid growth with a creative and differentiated approach that will help the firm continue to expand and strengthen its sponsor relationships,” said Mr. Bottrell.

Mr. Kraft joins the firm with over seven years of investment banking experience where most recently he served as a Vice President in the Financial Sponsors Group at J.P. Morgan. During his tenure, Dan assisted with dozens of M&A advisory assignments, debt and equity capital fundraises for both public and private companies. Earlier in his career, he was at Bank of America serving large-cap investment grade clients. Dan holds a BS in Finance and Economics from The University of New Hampshire. He will be based in B. Riley’s Los Angeles office.

Mr. Bottrell comes aboard from Goldman Sachs’ Global Markets Division where he led the Multi-Asset Originations effort. During his tenure, he originated dozens of public and private investment, lending, and co-investment opportunities across Investment Banking, Merchant Banking, Private Wealth Management and Global Markets. Tim began his career at Bloomberg LP, where he was an original member of the Bloomberg Mandates platform. He holds a BS in Economics from Rutgers University and will be based in B. Riley’s New York office.

About B. Riley Financial, Inc.
B. Riley Financial (NASDAQ: RILY) provides collaborative financial services solutions tailored to fit the capital raising, business, operational, and financial advisory needs of its clients and partners. B. Riley operates through several subsidiaries that offer a diverse range of complementary end-to-end capabilities spanning investment banking and institutional brokerage, private wealth and investment management, corporate advisory, restructuring, due diligence, forensic accounting and litigation support, appraisal and valuation, and auction and liquidation services. Certain registered affiliates of B. Riley originate and underwrite senior secured loans for asset-rich companies. B. Riley also makes proprietary investments in companies and assets with attractive return profiles. For the latest Company news and developments, follow B. Riley on Twitter @BRileyFinancial and LinkedIn. For more information about B. Riley, visit our website at www.brileyfin.com.

Forward-Looking Statements
Statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management’s current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. You should not place undue reliance on such forward-looking statements, which are based on the information currently available to us and speak only as of the date of this press release. Factors that could cause such actual results to differ materially from those contemplated or implied by such forward-looking statements include, without limitation, the risks associated with the unpredictable and ongoing impact of the COVID-19 pandemic and other risks described from time to time in B. Riley Financial, Inc.’s periodic filings with the SEC, including, without limitation, the risks described in B. Riley Financial, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Forms 10-Q for the quarters ended March 31, 2020, June 30, 2020, and September 30, 2020 under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. All information is current as of the date this press release is issued, and B. Riley Financial, Inc. undertakes no duty to update this information.

 

 

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SOURCE B. Riley Financial

SEATTLE, Nov. 18, 2020 /PRNewswire/ — Zillow Group, Inc. (NASDAQ: Z) (NASDAQ: ZG), which is transforming the way people buy, sell, rent and finance homes, today announced that it will present at two upcoming financial conferences.

• Zillow Group CFO Allen Parker will participate in a fireside chat at 11:00 a.m. ET on Tuesday, Dec. 1, 2020 as part of the Nasdaq Virtual Investor Conference.
• President of Zillow, Jeremy Wacksman will participate in a fireside chat at 5:30 p.m. ET on Tuesday, Dec. 1, 2020 as part of the Credit Suisse 24th Annual Technology Conference.

Both live and replay versions of the webcasts will be available under the Events & Presentations section on the company’s Investor Relations website.

About Zillow Group:

Zillow Group, Inc. (NASDAQ: Z and ZG) is reimagining real estate to make it easier to unlock life’s next chapter.

As the most visited real estate website in the U.S., Zillow® and its affiliates offer customers an on-demand experience for selling, buying, renting or financing with transparency and nearly seamless end-to-end service. Zillow Offers® buys and sells homes directly in dozens of markets across the country, allowing sellers control over their timeline. Zillow Home Loans™, our affiliate lender, provides our customers with an easy option to get pre-approved and secure financing for their next home purchase. Zillow recently launched Zillow Homes, Inc., a licensed brokerage entity, to streamline Zillow Offers transactions. 

Zillow Group’s affiliates and subsidiaries include Zillow®, Zillow Offers®, Zillow Premier Agent®, Zillow Home Loans™, Zillow Closing Services™, Zillow Homes, Inc., Trulia®, Out East®, StreetEasy® and HotPads®.  Zillow Home Loans, LLC is an Equal Housing Lender, NMLS #10287 (www.nmlsconsumeraccess.org).

(ZFIN)

 

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SOURCE Zillow

SAN JOSE, Calif., Nov. 18, 2020 /PRNewswire/ — Harmonic (NASDAQ: HLIT) today announced that Medianet, the largest independent pay TV and cable television provider in the Maldives, is using Harmonic’s EyeQ™ content-aware encoding (CAE) to optimize video streaming and television service delivery. Powered by the latest developments in AI, EyeQ CAE significantly reduces Medianet’s CDN costs while enabling the operator to deliver consistent, high-quality video experiences to subscribers on all screens.

“In the Maldives, bandwidth is expensive. We needed a solution that would immediately and effectively reduce our content delivery costs,” said Ahmed Shafeeu, CEO at Medianet. “With Harmonic’s EyeQ technology, we’ve been able to save a dramatic percentage of our CDN usage while maintaining an outstanding quality of experience for our viewers.”

Harmonic’s EyeQ CAE reduces streaming congestion by cutting bandwidth requirements up to 50% compared to traditional encoding methods, allowing Medianet to optimize video quality over any delivery network. EyeQ technology is 100% standards-compliant with all formats, codecs, encoding schemes and resolutions, future-proofing Medianet’s video delivery workflow. Medianet has been a longtime user of Harmonic HEVC encoding for its cable and satellite delivery.

“A common challenge for operators is sacrificing quality for bandwidth efficiency,” said Tony Berthaud, vice president of sales and video services, APAC, at Harmonic. “Bandwidth use and quality are no longer a tradeoff. EyeQ technology creates variable bit rate profiles so that Medianet can provide constant video quality, improving viewers’ quality of experience on every screen. We’re pushing the boundaries of innovation with EyeQ content-aware encoding, enabling unrivaled video quality and cost savings.”

Further information about Harmonic and the company’s solutions is available at www.harmonicinc.com.

About Harmonic
Harmonic (NASDAQ: HLIT), the worldwide leader in virtualized cable access and video delivery solutions, enables media companies and service providers to deliver ultra-high-quality video streaming and broadcast services to consumers globally. The company revolutionized cable access networking via the industry’s first virtualized cable access solution, enabling cable operators to more flexibly deploy gigabit internet service to consumers’ homes and mobile devices. Whether simplifying OTT video delivery via innovative cloud and software platforms, or powering the delivery of gigabit internet cable services, Harmonic is changing the way media companies and service providers monetize live and on-demand content on every screen. More information is available at www.harmonicinc.com.  

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements concerning Harmonic’s business and the anticipated capabilities, advantages, reliability, efficiency, market acceptance, market growth, specifications and benefits of Harmonic products, services and technology are forward-looking statements. These statements are based on our current expectations and beliefs and are subject to risks and uncertainties, including the
risks and uncertainties
more fully described in Harmonic’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended Dec. 31, 2019, its Quarterly Reports on Form 10-Q and its Current Reports on Form 8-K. The forward-looking statements in this press release are based on information available to Harmonic as of the date hereof, and Harmonic disclaims any obligation to update any forward-looking statements.

Harmonic, the Harmonic logo and other Harmonic marks are owned by Harmonic Inc. or its affiliates. All other trademarks referenced herein are the property of their respective owners.

 

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SOURCE Harmonic Inc.

RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 18, 2020 /PRNewswire/ — Jardiance^® (empagliflozin) reduced the risk of total (first plus recurrent) cardiovascular events compared with placebo, when both were given on top of standard of care, in adults with type 2 diabetes and established cardiovascular disease over the three years of the EMPA-REG OUTCOME^® trial, according to results of a new post-hoc analysis. Total cardiovascular events included 3P-MACE (a composite of non-fatal heart attack, non-fatal stroke and cardiovascular death), hospitalization for heart failure and all-cause hospitalization. The findings, announced by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), were published in The Lancet Diabetes & Endocrinology.

“People with type 2 diabetes and established atherosclerotic cardiovascular disease are at an increased risk of cardiovascular complications often requiring recurrent admissions to hospital, imposing a significant burden on quality of life for patients and on healthcare systems,” said Darren McGuire, M.D., M.H.Sc., lead author of the analysis and Professor of Medicine at the University of Texas Southwestern Medical Center and Parkland Health and Hospital System. “Considering the totality of hospitalization events, as opposed to just the first event that is most commonly analyzed in clinical trials, better reflects the net effect of beneficial therapies. These new findings help us understand the impact of long-term treatment with Jardiance for adults who may experience recurrent events due to these debilitating conditions.”

Previously, the landmark EMPA-REG OUTCOME trial showed that, in adults with type 2 diabetes and established cardiovascular disease, Jardiance reduced the relative risk of 3P-MACE by 14%, driven by a 38% reduction in the relative risk of cardiovascular death.

These new exploratory analyses show that, when added to standard of care, Jardiance reduced the relative risk of the following total (first plus recurrent) events versus placebo:

• 3P-MACE by 22%
• Hospitalizations for heart failure by 42%
• All-cause hospitalizations by 17%
• Fatal or non-fatal myocardial infarction, commonly known as heart attack, by 21%
• Coronary heart disease events (a composite of myocardial infarction and coronary revascularization) by 20%.

“These new results support the early and sustained cardiovascular benefits for Jardiance noted previously throughout the three-year EMPA-REG OUTCOME trial,” said Mohamed Eid, M.D., M.P.H, M.H.A, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “Reducing risk beyond the first event for important heart-related outcomes is critical for people living with type 2 diabetes and established cardiovascular disease, which are complicated, life-long conditions.”

“Boehringer Ingelheim and Lilly will continue to explore how Jardiance can potentially improve health outcomes and fill treatment gaps for adults with type 2 diabetes and heart disease,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. “We look forward to presenting further results from our EMPOWER program, which is one of the largest cardiovascular clinical programs for an SGLT2 inhibitor to date with more than 377,000 adults studied worldwide.”

About EMPA-REG OUTCOME (NCT01131676)
EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established cardiovascular disease.

The study assessed the effect of Jardiance (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (including medication for the treatment of hypertension and hypercholesteremia). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.

The overall safety profile of Jardiance was consistent with that of previous trials.

About the EMPOWER Program
The Alliance has developed the EMPOWER program to explore the impact of Jardiance on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually. Through the EMPOWER program, Boehringer Ingelheim and Lilly are working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of nine clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With more than 377,000 adults estimated to have enrolled worldwide upon completion of the studies, it is one of the broadest and most comprehensive clinical programs for an SGLT2 inhibitor to date.

The development program encompasses:

• EMPEROR-Reduced, in adults with chronic heart failure with reduced ejection fraction to reduce the risk of cardiovascular death or hospitalization due to heart failure
• EMPEROR-Preserved, in adults with chronic heart failure with preserved ejection fraction to reduce the risk of cardiovascular death or hospitalization due to heart failure
• EMPULSE, in adults hospitalized for acute heart failure and stabilized to improve clinical and patient reported outcomes
• EMPACT-MI, to evaluate all-cause mortality and hospitalization for heart failure in adults with and without type 2 diabetes who have had an acute myocardial infarction, with the aim to prevent heart failure and improve outcomes
• EMPA-KIDNEY, in adults with established chronic kidney disease to reduce the progression of kidney disease and the occurrence of cardiovascular death
• EMPERIAL-Reduced, in adults with chronic heart failure with reduced ejection fraction to evaluate functional ability and patient reported outcomes
• EMPERIAL-Preserved, in adults with chronic heart failure with preserved ejection fraction to evaluate functional ability and patient-reported outcomes
• EMPA-REG OUTCOME, in adults with type 2 diabetes and established cardiovascular disease to reduce the risk of major adverse cardiovascular events, including cardiovascular death
• EMPRISE, two non-interventional studies (U.S. and EU-Asia) of the effectiveness, safety, healthcare utilization and cost of care of empagliflozin in routine clinical practice in adults with type 2 diabetes across the cardiovascular risk continuum

About Type 2 Diabetes and Cardiovascular Disease
Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin. More than 463 million people worldwide have diabetes, of which 232 million are estimated to be undiagnosed. By 2045, the number of people with diabetes is expected to rise to 700 million people worldwide. Type 2 diabetes is the most common form of diabetes.

Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, cardiovascular disease is a major complication and the leading cause of death associated with diabetes. One in two people with type 2 diabetes worldwide die from a cardiovascular event.

About Cardio-Renal-Metabolic Conditions
Boehringer Ingelheim and Lilly are driven to transform care for people with cardio-renal-metabolic conditions, a group of interconnected disorders that affect more than one billion people worldwide and are a leading cause of death.

The cardiovascular, renal and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum. Dysfunction in one system may accelerate the onset of others, resulting in progression of interconnected diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to an increased risk of cardiovascular death. Conversely, improving the health of one system can lead to positive effects throughout the others.

Through our research and treatments, our goal is to support people’s health, restoring the harmony between the interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardio-renal-metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps.

Wh
a
t is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.

JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

IMPORTANT SAFETY INFORMATION

Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE.

Do not take JARDIANCE if you have severe kidney problems or are on dialysis.

J
A
RDIANCE can cause serious side effects, including:

• Dehydration. JARDIANCE can cause some people to have dehydration (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up.

You may be at a higher risk of dehydration if you:

• have low blood pressure
• take medicines to lower your blood pressure, including water pills (diuretics)
• are on a low salt diet
• have kidney problems
• are 65 years of age or older.
• Va
  ginal yeast infection. Women who take JARDIANCE may get vaginal yeast infections. Talk to your doctor if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.
   
• Y
  east infection of the penis. Men who take JARDIANCE may get a yeast infection of the skin around the penis, especially uncircumcised males and those with chronic infections. Talk to your doctor if you experience redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and/or pain in the skin around penis.
   
• Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition and may need to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking JARDIANCE, even if blood sugar is less than 250 mg/dL. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with JARDIANCE. Stop taking JARDIANCE and call your doctor right away if you get any of the following symptoms, and if possible, check for ketones in your urine:
• nausea                  
• vomiting
• stomach-area (abdominal) pain
• tiredness
• trouble breathing
   
• Kidney problems. Sudden kidney injury has happened in people taking JARDIANCE. Talk to your doctor right away if you reduce the amount you eat or drink, or if you lose liquids; for example, from vomiting, diarrhea, or being in the sun too long.
   
• Serious urinary tract infections. Serious urinary tract infections can occur in people taking JARDIANCE and may lead to hospitalization. Tell your doctor if you have symptoms of a urinary tract infection, such as a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or pelvis, or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
   
• Low blood sugar (hypoglycemia): If you take JARDIANCE with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Symptoms of low blood sugar may include:
• headache
• drowsiness
• weakness
• dizziness
• confusion
• irritability
• hunger
• fast heartbeat
• sweating
• shaking or feeling jittery
   
• Necrotizing fasciitis. A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum). This bacterial infection has happened in women and men who take JARDIANCE, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have fever or are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, and redness of skin (erythema).
   
• Allergic (hypersensitivity) reactions. Symptoms of serious allergic reactions to JARDIANCE may include:
• swelling of your face, lips, throat and other areas of your skin
• difficulty with swallowing or breathing
• raised, red areas on your skin (hives)

If you have any of these symptoms, stop taking JARDIANCE and contact your doctor or go to the nearest emergency room right away.

• Increased fats in your blood (cholesterol).

T
h
e most common side effects of JARDIANCE include urinary tract infections and yeast infections in females.

These are not all the possible side effects of JARDIANCE. For more information, ask your doctor or pharmacist.

Before taking JARDIANCE, tell your doctor if you:

• have kidney problems. Your doctor may do blood tests to check your kidneys before and during your treatment with JARDIANCE
• have liver problems
• have a history of urinary tract infections or problems with urination
• are going to have surgery. Your doctor may stop your JARDIANCE before you have surgery. Talk to your doctor if you are having surgery about when to stop taking JARDIANCE and when to start it again
• are eating less or there is a change in your diet
• have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
• drink alcohol very often, or drink a lot of alcohol in the short term (“binge” drinking)
• have any other medical conditions
• are pregnant or plan to become pregnant. JARDIANCE may harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with JARDIANCE
• are breastfeeding or are planning to breastfeed. JARDIANCE may pass into your breast milk and may harm your baby. Do not breastfeed while taking JARDIANCE

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take water pills (diuretics) or medicines that can lower your blood sugar, such as insulin.

Y
o
u are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, please see Prescribing Information and Medication Guide.

CL-JAR-100057 01.27.2020

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the alliance. The alliance leverages the strengths of two of the world’s leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. Clinical trials have been initiated to evaluate the impact of Jardiance on people living with heart failure or chronic kidney disease.

About Boehringer Ingelheim
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.

For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.

About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance and reflects Lilly’s current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that Jardiance will receive additional regulatory approvals. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly’s expectations, please see Lilly’s most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

Jardiance® and EMPA-REG OUTCOME® are registered trademarks of Boehringer Ingelheim.

P-LLY
MPR-US-101338

CONTACT:


Jennifer Forsyth

Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: [email protected]
Phone: (203) 791-5889

Stephan Thalen

Global Business Communications
Lilly Diabetes and Lilly USA
Email: [email protected]
Phone: (317) 903-5640

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SOURCE Eli Lilly and Company