Soliqua®Phase 3 results significantly lowered blood sugar levels compared to GLP-1 receptor agonist treatments

Soliqua®Phase 3 results significantly lowered blood sugarlevels compared to GLP-1 receptor agonist treatmentsPatients switched to Soliqua reached anaverage blood sugarbelowthe American Diabetes Association recommendedlevel of 7%FullPhase 3 data presentedtodayat the American Diabetes Association(ADA)79th Scientific Sessions PARIS–June 9, 2019–In a Phase 3 study1evaluating adults with type 2 diabetes inadequately controlled by GLP-1 receptor agonist (GLP-1 RA) treatments, Soliqua®/Suliqua®2(insulin glargine 100 Units/mL and lixisenatide) met the primary study objectivebydemonstrating astatistically superior reduction of average blood sugar level (HbA1c)after26weeks, compared with continuing GLP-1 RA treatment.The LixiLan-G study included either a daily or once-weekly GLP-1 RA treatmentas comparator. Morepatientswho switched to Soliqua achieved HbA1clevelsbelow 7%, a target recommended by the ADA, compared with those who stayed on previous GLP-1 RA therapy. More patients who switched to Soliqua also achieved the composite endpoint of HbA1cbelow 7% without documented symptomatichypoglycemia(low blood sugar levels).The study showed a safety profile consistent with the established profiles of the treatments studied: the most common classes of adverse event were gastrointestinal events (i.e., nausea, diarrhea and or vomiting) and hypoglycemia.1Blonde L et al, Presentation #149 OR, American Diabetes Association 79th Scientific Sessions, June 9, San Francisco, CA, U.S.2Soliqua®is an injectable prescription medicine that contains two diabetes medicines, insulin glargine and lixisenatide.Soliqua®is marketed in the EU as Suliqua®, where it is indicated in combination with metformin for the treatment of adults with type 2 diabetesmellitus to improve glycemic control when this has not been provided by metformin alone ormetformin combined with another oral glucose lowering medicinal product or with basal insulin. It is marketed in the U.S. as Soliqua®100/33, where it is indicatedas an adjunct to diet and exercise to improve glycemiccontrol in adults with type 2 diabetes mellitus.It is marketedas Soliqua®in other geographies where it is approved

The full Phase 3 data results were presented today for the first time as an oral presentation at the 79thScientific Sessions of theADAin San Francisco.“We are committed to providing people living with diabetes a broad range of options thatcan help support personalized care,”said Rachele Berria, Global Head of Diabetes Medical Affairs at Sanofi. “As the first comparison between Soliqua and both daily and weekly GLP-1 RA treatments, this study provides physicians with new data that they could use when consideringSoliqua as a part of a personalizedtreatment plan.”About the studyThe LixiLan-G study included 514 adults with type 2 diabetes who were inadequately controlled on a GLP-1 RA (either once-daily liraglutide or twice-daily exenatide, or once-weekly exenatide extended release, albiglutide or dulaglutide) and metformin (with or without pioglitazone, with or without a sodium-glucose transport protein 2 inhibitor [SGLT2i]).Participants were randomized to either switch to Soliqua or continue theirprevious GLP-1 RA treatment, while maintaining their other pre-trial anti-diabetic medication. Adherence to allocated treatment was monitored and reinforced throughout the study.The primary objective was to demonstrate superior reduction of HbA1cwith Soliqua versus continuation ofthe previousGLP-1 RA after 26 weeks. Secondary objectivesincludedcomparison of the overall efficacy and safety ofSoliqua to continued GLP-1 RA treatment. After 26 weeks, patients who switched to Soliqua saw a 0.6% greater reduction in HbA1cversus continuing treatment with a GLP-1RA:SoliquaGLP-1 RAMean HbA1cat baseline7.86%7.88%Mean HbA1cat Week 266.7%7.4%Reduction in HbA1c-1.02%-0.38%Least squares mean difference-0.64%95% Confidence interval-0.77to -0.51p-value<0.0001More patients who switched to Soliqua achieved HbA1cbelow the 7%target recommended by the ADAversus those treated with GLP-1RA(difference: 36%, p<0.0001).The study also evaluated compositetargets

of HbA1cbelow 7% without documented symptomatic hypoglycemia(<54mg/dL or ≤70mg/dL, respectively):SoliquaGLP-1 RA% of patientsachieving HbA1c< 7%62%26%% of patients achieving HbA1c<7% with no documented (≤70 mg/dL) symptomatic hypoglycemia43%25%% of patients achieving HbA1c<7% with no documented(<54 mg/dL) symptomatic hypoglycemia57%25%The study showed a safety profile consistent with previous studies:22% of patients who switched to Soliqua experienced gastrointestinal events (nausea, diarrheaor vomiting), compared with 10% of patients who continued previoustreatment with GLP-1 RA. Rates of hypoglycemiawere also consistent with the established safety profiles of thetreatments: 9% of patients who treated with Soliqua experienced at least one event, compared with <1% who remained on previous GLP-1 RA therapy.Participants treated with Soliqua were followed for a further 26 weeks. Data from this extension period will be presented at a later date.About SanofiSanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.Sanofi, Empowering LifeMedia Relations ContactAshleigh KossTel.: +1 908-981-8745Ashleigh.Koss@sanofi.comInvestor Relations ContactGeorge GrofikTel.: +33 (0)1 53 77 45 45ir@sanofi.comSanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actualresults and developments to differ materially fromthose expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or

government regulation generally, that could affect the availability or commercial potential of the product, the absence of guarantee that the product will be commercially successful, the uncertainties inherent in research and development, includingfuture clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2018. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise anyforward-looking information or statements.

department of justice news

Press Release: U.S. Attorney’s Office Promotes Elder Justice Initiative with Live Interactive Telephone Town Hall

FOR IMMEDIATE RELEASE
Thursday, May 30, 2019

U.S. Attorney’s Office Promotes Elder Justice Initiative with Live Interactive Telephone Town Hall

GREENSBORO, N.C. — The United States Attorney’s Office for the Middle District of North Carolina is promoting the Department of Justice’s Elder Justice Initiative throughout the Piedmont Triad area, announced U.S. Attorney Matthew G.T. Martin. On May 28, 2019, the Middle District partnered with the FBI and the AARP to conduct outreach and raise awareness to educate older adults about the latest scams so they do not fall victim. More than 4000 seniors in North Carolina dialed in to an interactive telephone town hall to learn about the latest financial scams. A recording of the town hall is available online here.

Scammers are targeting seniors at an alarming rate. Across the country, victims of all ages lost $2.71 billion dollars to fraud in 2018, according to statistics collected by the FBI’s Internet Crime Complaint Center. Victims over the age of 60 account for $649,227,724 of those losses. According to the same statistics, in North Carolina, more than 7,500 people lost more than $137 million dollars.

The DOJ Elder Justice Initiative aims to combat elder financial exploitation by expanding efforts to investigate and prosecute financial scams that target seniors; educating older adults on how to identify scams and avoid getting ripped off by scammers; and promoting greater coordination with law enforcement partners.

Some examples of financial fraud targeting seniors discussed during the seminar are:

  • Lottery phone scams – in which the callers convince seniors that a large fee or taxes must be paid before they can receive lottery winnings.
  • Grandparent scams – which convince seniors that their grandchildren are in trouble and need money to make rent, repair a car, or even money for bail.
  • Romance scams – which lull victims to believe that their online paramour needs funds for a U.S. visit or some other purpose.
  • IRS imposter scams – which defraud victims by posing as IRS agents and claiming that victims owe back taxes.
  • Sham business opportunities – which convince victims to invest in lucrative business opportunities or investments.

Below are some tips shared with participants during the seminar on how to avoid falling victim to a financial scam:

  • Don’t share personal information with anyone you don’t know.
  • Don’t pay a fee for a prize or lottery winning.
  • Don’t click on pop-up ads or messages.
  • Delete phishing emails and ignore harassing phone calls.
  • Don’t send gift cards, checks, money orders, wire money, or give your bank
  • account information to a stranger.
  • Don’t fall for a high-pressure sales pitch or a lucrative business deal.
  • If a scammer approaches you, take the time to talk to a friend or family member.
  • Keep in mind that if you send money once, you’ll be a target for life.
  • Remember, it’s not rude to say, “NO.”
  • A good rule of thumb is, if it sounds too good to be true, it’s likely a scam.

In March of this year, Attorney General William P. Barr and multiple law enforcement partners, including the FBI, announced the largest coordinated sweep of elder fraud cases in history. The Department took action in every federal district across the country, through the filing of criminal or civil cases. The cases brought during this sweep involved more than 260 defendants from around the globe who victimized more than two million Americans, most of them older adults. As part of the sweep, the Middle District of North Carolina charged, and obtained the guilty plea of, a woman who embezzled around $370,000 from an older person for whom she was a caretaker, using the money to pay for spa treatments, travel, college tuition, dining, and expensive shopping sprees. She will be sentenced in July 2019.

In another matter, Assistant U.S. Attorney Frank Chut secured the conviction of a woman who obtained credit card numbers and personal information from older residents of Davidson County, by calling victims and pretending to be calling from a hospital or pharmacy. The defendant was sentenced to fourteen months imprisonment, and was ordered to pay restitution to her victims for the more than $69,000 that she obtained through her scheme.

Attacking exploitation and fighting fraud are two priorities of the Middle District, and the U.S. Attorney’s office is committed to aggressively pursuing individuals who engage in such acts.

Elder abuse includes physical abuse, caregiver neglect, financial exploitation, psychological abuse, sexual abuse, and abandonment. Elder fraud complaints may be filed with the FTC at www.ftccomplaintassistant.gov or at 877-FTC-HELP. You can also contact the Victim Connect Hotline between 9am-6pm, Monday through Friday, at: 1- 855-4VICTIM (1-855-4842846), or email the U.S. Attorney’s Office for the Middle District of North Carolina at USANCM.CivilRights@usdoj.gov.

For more information about the Elder Justice Initiative, please visit: https://www.justice.gov/elderjustice.