News Release

INDIANAPOLIS, May 22, 2019 /PRNewswire/ -- Eli Lilly and Company's (NYSE: LLY) Insulin Lispro Injection is now available for order in pharmacies for people who use Lilly's rapid-acting insulin and need a lower-cost option. Lilly's Insulin Lispro Injection has a 50 percent lower list price than its identical medicine, Humalog^® U-100 (insulin lispro injection) and is available in both a vial and KwikPen^®. Because they are the same insulin, pharmacists will be able to substitute Insulin Lispro Injection for Humalog.

In March, Lilly announced plans to introduce Insulin Lispro Injection, which fills another gap in the healthcare system. The people who are most likely to benefit from Insulin Lispro Injection are Medicare Part D beneficiaries, people with high-deductible health plans and the uninsured who use Humalog.

"The availability of Lilly's Insulin Lispro Injection is important progress that helps more people afford their insulin," said Mike Mason, senior vice president, Connected Care and Insulins. "Lilly will continue to work with health plans, wholesalers, employers and the government to work toward permanent solutions that will help every person with diabetes afford their medicines."

Currently, about 95 percent of people in the U.S. pay $95 or less a month for their Humalog prescription and 43 percent pay $0 at the retail pharmacy. With the launch of Insulin Lispro Injection, even more people will pay lower amounts at the pharmacy. Because most insurance plans provide affordable copays for chronic medicines that are much lower than list price, people should ask their pharmacist whether Insulin Lispro Injection or Humalog is the lower-cost option for them. People with additional questions can also contact the Lilly Diabetes Solution Center at (833) 808-1234 from 9 am to 8 pm EST Monday through Friday to speak with a live representative.

Insulin Lispro Injection has a list price of $137.35 per vial and $265.20 for a package of five KwikPens. In addition to wholesaler contracts that have been secured, Lilly is working with payers to gain broad insurance coverage for Insulin Lispro Injection.

"The current healthcare system isn't working for everyone, causing a growing number of people with chronic conditions to struggle to afford their medicine," Mason said. "But even one person with diabetes who can't afford insulin is too many, which is why we introduced Insulin Lispro Injection. It adds to our suite of solutions that help significantly lower the amount people pay until a more sustainable solution is achieved."

Indication for Humalog® (insulin lispro) and Insulin Lispro Injection
Humalog and Insulin Lispro Injection are used to treat people with diabetes for the control of high blood sugar.

Important Safety Information for Humalog® (insulin lispro) and Important Safety Information for Insulin Lispro Injection

What is the most important information I should know about Humalog and Insulin Lispro Injection?

• Do not share your Humalog or Insulin Lispro Injection KwikPen or syringe with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
• Do not change the insulin you use without talking to your healthcare provider. Changes may make you more likely to experience low or high blood sugar. Changes should be made cautiously under the supervision of your healthcare provider.
• Test your blood sugar levels as your healthcare provider instructs.
• Your insulin dose may need to change because of illness, stress, other medicines you take, change in diet, or change in physical activity or exercise.
• When used in a pump, do not mix or dilute Humalog or Insulin Lispro Injection with any other insulin or liquid.

Who should not take Humalog or Insulin Lispro Injection?

• Do not take Humalog or Insulin Lispro Injection if your blood sugar is too low (hypoglycemia) or if you are allergic to Humalog or Insulin Lispro Injection or any of the ingredients in Humalog or Insulin Lispro Injection.

Before using Humalog or Insulin Lispro Injection, what should I tell my healthcare providers?

• About all of your medical conditions, including liver, kidney, or heart failure or other heart problems.
• If you are pregnant, planning to become pregnant, or are breastfeeding.
• About all the medicines you take, including prescription (especially ones commonly called TZDs [thiazolidinediones]) and nonprescription medicines, vitamins, and herbal supplements.

How should I use Humalog or Insulin Lispro Injection?

• Humalog and Insulin Lispro Injection are rapid-acting insulins. Take Humalog or Insulin Lispro Injection within fifteen minutes before eating or right after eating a meal.
• Always make sure you receive the correct type of Humalog or Insulin Lispro Injection from the pharmacy.
• Do not use Humalog or Insulin Lispro Injection if it is cloudy, colored, or has solid particles or clumps in it.
• Inject Humalog or Insulin Lispro Injection under your skin (subcutaneously). Never inject into a vein or muscle. Change (rotate) your injection site with each dose. Make sure you inject the correct insulin and dose.
• Do not re-use needles. Always use a new needle for each injection. Re-use of needles can cause you to receive the wrong dose of Humalog or Insulin Lispro Injection and result in infection.
• Do not drive or operate heavy machinery until you know how Humalog or Insulin Lispro Injection affects you. Do not use alcohol while using Humalog or Insulin Lispro Injection.

What are the possible side effects of Humalog or Insulin Lispro Injection?

• Severe low blood sugar can cause unconsciousness (passing out), seizures, and death. Low blood sugar is the most common side effect. There are many causes of low blood sugar, including taking too much Humalog or Insulin Lispro Injection. It is important to treat it quickly. You can treat mild to moderate low blood sugar by drinking or eating a quick source of sugar right away. Symptoms may be different for each person. Be sure to talk to your healthcare provider about low blood sugar symptoms and treatment.
• Severe life-threatening allergic reactions (whole-body reactions) can happen. Get medical help right away if you develop a rash over your whole body, have trouble breathing, have a fast heartbeat, or are sweating.
• Humalog or Insulin Lispro Injection can cause life-threatening low potassium in your blood (hypokalemia), which can cause severe breathing problems, irregular heartbeat, and death.
• Serious side effects can include swelling of your hands and feet and heart failure when taking certain pills called thiazolidinediones or "TZDs" with Humalog or Insulin Lispro Injection. This may occur in some people even if they have not had heart problems before. Tell your healthcare provider if you have shortness of breath, swelling of your ankles or feet, or sudden weight gain, which may be symptoms of heart failure. Your healthcare provider may need to adjust or stop your treatment with TZDs or Humalog or Insulin Lispro Injection.
• Failure of your insulin pump or infusion set or degradation of the insulin in the pump can cause hyperglycemia and ketoacidosis. Always carry an alternate form of insulin administration in case of pump failure.
• The most common side effects of Humalog or Insulin Lispro Injection include low blood sugar, allergic reactions, including reactions at your injection site, skin thickening or pits at the injection site (lipodystrophy), itching, and rash. These are not all of the possible side effects. Ask your healthcare provider for more information or for medical advice about side effects.

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

Humalog and Insulin Lispro Injection are available by prescription only.

For additional information, talk to your healthcare providers and please click to access Humalog Full Prescribing Information and Patient Prescribing Information.

For additional information, talk to your healthcare providers and click to access Insulin Lispro Injection Full Prescribing Information and Patient Prescribing Information.

Please see Instructions for Use included with Humalog and Insulin Lispro Injection products.

HI IL CON ISI 04MAR2019

About Diabetes
Approximately 30 million Americans¹ and an estimated 425 million adults worldwide have diabetes.² Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone.¹ Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.

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. We offer a wide range of therapies and a continued determination to provide real 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 healthcare leader that unites caring with discovery to 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 www.lilly.com and www.lilly.com/newsroom/social-channels. P-LLY

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Insulin Lispro Injection and reflects Lilly's current beliefs. As with any pharmaceutical product, there are risks and uncertainties related to the commercialization and regulation of Insulin Lispro Injection and authorized generics. Among other things, there can be no guarantee that individual patient experiences will be consistent with intended results or that Lilly will realize the benefits described in this press release. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Humalog^® and KwikPen^® are registered trademarks of Eli Lilly and Company, its subsidiaries, or affiliates.

1. Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept of Health and Human Services; 2017.
2. International Diabetes Federation. IDF Diabetes Atlas, 8th edn. Brussels, Belgium: International Diabetes Federation, 2017. http://www.diabetesatlas.org.

PP-SP-US-0061 05/2019 ©Lilly USA, LLC 2019. All rights reserved.

Refer to: 
Greg Kueterman; kueterman_gregory_andrew@lilly.com; 317.277.4021 (Lilly Diabetes Communications)
Dani Barnhizer; dbarnhizer@lilly.com; 317.276.3598 (Lilly Diabetes Communications)
Kevin Hern; hrn_kevin_r@lilly.com; 317.277.1838 (Investor Relations)

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SOURCE Eli Lilly and Company