INDIANAPOLIS , April 7, 2020 /PRNewswire/ -- In response to the crisis caused by COVID-19, Eli Lilly and Company (NYSE: LLY) is introducing the Lilly Insulin Value Program, allowing anyone with commercial insurance and those without insurance at all to fill their monthly prescription of Lilly insulin for $35 . The program is effective today and covers most Lilly insulins including all Humalog® (insulin lispro injection 100 units/mL) formulations.

The savings can be obtained by calling the Lilly Diabetes Solution Center at (833) 808-1234. The Solution Center is open 8 am to 8 pm (EDT) Monday through Friday . Representatives at the Solution Center will help people with diabetes obtain a card in the most convenient way for them, including through email or the U.S. mail. A card can typically be received within 24 hours by email. If you already have a co-pay card from the Lilly Diabetes Solution Center for an amount higher than $35 , no action is necessary. Active co-pay cards have been re-set to a $35 co-pay.

Representatives at the Solution Center can also direct people to affordability options that may reduce their out-of-pocket costs further – such as free insulin for people with minimal income, or no income at all, that has been donated by Lilly to non-profit organizations.

"Too many people in the U.S. have lost their jobs because of the COVID-19 crisis, and we want to make sure no one goes without their Lilly insulin," said Mike Mason , president, Lilly Diabetes. "We've been providing affordability solutions for a long time, but more is needed to help people during this unprecedented period. People with commercial insurance, as well as those without insurance at all, are eligible, and the process is quick and simple. We want people who need help to call us."

"It's critical that people with diabetes can reliably access insulin at a low, consistent out-of-pocket cost. Enabling a $35 per month insulin co-pay regardless of employment status will help many Americans in this difficult time," said CEOs Aaron Kowalski and Thom Scher on behalf of the JDRF-Beyond Type 1 Alliance.

The program is one of several affordability options that can be accessed through the Solution Center. Because of federal guidelines, seniors with Medicare Part D plans are not eligible for a co-pay card, but they can call the Solution Center to see if they are eligible for another option, such as donated insulin for people with lower incomes or Insulin Lispro Injection (100 units/mL), a non-branded version of Humalog U-100 with a 50 percent lower list price. People with an urgent need for insulin and nowhere else to turn can contact the Solution Center for an immediate supply. Additionally, people with commercial insurance who use Baqsimi® (glucagon) nasal powder 3 mg can pay as little as $25 for up to two devices with a co-pay card, which was first made available last summer.

A separate co-pay card for Humulin® R U-500 (insulin human injection, 500 units/mL) allows for a monthly prescription fill for as little as $25 for people with commercial insurance and can be accessed at Humulin.com.

"The Lilly Insulin Value Program is meant to help address the needs of people in this crisis, but we also remain committed to exploring additional solutions that provide meaningful impact for those living with diabetes beyond the current crisis," said Mason.

Lilly has introduced several solutions in recent years to help meet the individual financial circumstances of people living with diabetes, including three non-branded versions of Humalog insulin options with list prices 50 percent lower than the branded versions. In January, the company announced plans to donate at least 200,000 KwikPens® to relief agencies over the next three years.

As we announced on March 3 , Lilly does not currently anticipate shortages of any forms of our insulin during the COVID-19 crisis. All forms of Lilly insulin are available in U.S. pharmacies, and pharmacies that don't stock certain medicines can order them from wholesalers, with delivery in 1-2 days. Lilly is committed to manufacturing medicines that meet global safety, quality, value and environmental expectations and is committed to public health and the needs of people with chronic conditions, including diabetes, who depend on our medicines around the world.

Terms, conditions, and limitations apply to the co-pay cards. Not available to those patients with government insurance such as Medicaid, Medicare, Medicare Part D, TRICARE®/CHAMPUS, Medigap, DoD , or any State Patient or Pharmaceutical Assistance Program .

PURPOSE and SAFETY SUMMARY

Important Facts About Humalog® (HU-ma-log) and Insulin Lispro Injection

Humalog is also known as insulin lispro injection.

Humalog and Insulin Lispro Injection are fast-acting insulins. They are used to control high blood sugar in adults and children with diabetes. They are available only with a prescription.

Humalog comes in two strengths: U-100 (100 units per milliliter) and U-200 (200 units per milliliter). The Humalog U-200 prefilled pen contains 2 times as much insulin per 1 milliliter as standard (U-100) insulin. The dose window on the pen shows your insulin dose.

per 1 milliliter as standard (U-100) insulin. The dose window on the pen shows your insulin dose. It is not known if Humalog or Insulin Lispro Injection are safe and effective for children with type 2 diabetes or for children younger than 3 years of age with type 1 diabetes. There were no studies done with these insulins in these groups of children. If your doctor decides to give your child one of these insulins, he or she may give you special instructions.

Important Facts about Humalog® Mix50/50™, Humalog® Mix75/25™, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25

Humalog Mix50/50 and Humalog Mix75/25 are known as insulin lispro protamine and insulin lispro injectable suspension.

Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 are mixed U-100 insulins. This means they contain a mix of fast-acting and intermediate-acting insulins. They are used to control high blood sugar in people with diabetes. They are available only with a prescription.

It is not known if Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 are safe and effective for children younger than 18 years of age. There were no studies done with these insulins in children younger than 18. If your doctor decides to give your child one of these insulins, he or she may give you special instructions.

All Humalog and Insulin Lispro Injection products contain insulin lispro. Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 contain insulin lispro protamine mixed with insulin lispro.

Warnings

Do not take Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 if you have:

symptoms of low blood sugar (hypoglycemia)

an allergy to insulin lispro products or any of their ingredients.

Do not reuse needles or share your insulin injection supplies with other people. This includes your:

prefilled pen for use by a single patient

cartridges

reusable pen that works with Lilly 3mL cartridges

3mL cartridges needles

syringes

You or the other person can get a serious infection. This can happen even if you change the needle.

Do not change the type of insulin you take or your dose, unless your doctor tells you to. This could cause low or high blood sugar, which could be serious.

Do not use a syringe to remove Humalog from your prefilled pen. This can cause you to take too much insulin. Taking too much insulin can lead to severe low blood sugar. This may result in seizures or death.

Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 may cause serious side effects. Some of these can lead to death. The possible serious side effects are:

Low blood sugar. This can cause:







- dizziness or light-headedness - sweating - confusion





- headache - blurred vision - slurred speech





- shakiness - fast heartbeat - anxiety





- irritability - mood change - hunger

If you are at risk of having severely low blood sugar, your doctor may prescribe a glucagon emergency kit. These are used when your blood sugar becomes too low and you are unable to take sugar by mouth. Glucagon helps your body release sugar into your bloodstream.

Severe allergic reaction.

Get emergency help right away if you have:







- a rash over your whole body - trouble breathing - a fast heartbeat





- sweating - a faint feeling - shortness of breath





- extreme drowsiness - dizziness - confusion





- swelling of your face, tongue,

or throat

Low potassium in your blood. This can lead to severe breathing problems, irregular heartbeat, and death.

Heart failure. Taking diabetes pills called thiazolidinediones (thIE-uh-zOH-li-dEEn-dIE-OHns), or "TZDs," with insulin lispro products may cause heart failure in some people. This includes people who do not have any heart problems. If you have heart failure, it may get worse if you take TZDs with these insulin lispro products. Tell your doctor if you have any new symptoms of heart failure, or if they get worse. Some symptoms of heart failure include: shortness of breath, swelling of ankles and feet, and sudden weight gain. Your doctor may need to change or stop treatment with TZDs and your insulin lispro product.

High blood sugar and ketoacidosis. You can have these serious problems when your insulin pump or infusion set stops working. They can also happen if your insulin is no longer effective. For these reasons, always keep extra insulin injection supplies with you.

Common side effects

The most common side effects of Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 are:

- low blood sugar - allergic reactions - reactions where you have injected insulin - changes in fat tissue where you have injected insulin - swelling of your hands or feet - weight gain - itching - rash

These are not all of the possible side effects. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

Talk with your doctor about low blood sugar and how to manage it. Also tell your doctor:

about all of the medicines you take, including over-the-counter medicines, vitamins, and herbal supplements.

about any other prescription medicines you take, especially ones called TZDs.

about all of your medical conditions, including if you have heart failure or other heart, liver, or kidney problems.

if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed.

How to take

Read the Instructions for Use that come with your Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25. Be sure to take your insulin lispro product and check your blood sugar levels exactly as your doctor tells you to. Your doctor may tell you to change your dose because of illness, increased stress, or changes in your weight, diet, or physical activity level. He or she may also tell you to change the amount or time of your dose because of other medicines or different types of insulin you take.

Before injecting your insulin lispro product

You can inject your insulin dose yourself, or you can have a trained caregiver inject it for you. Make sure you or your caregiver:

Check the insulin label before each injection. This will help you make sure that you are taking the correct insulin.

Use a new needle for each injection. You can get a serious infection or the wrong dose of insulin if you re-use needles.

Change (rotate) where you inject your insulin with each dose. This can reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin. Do not inject your insulin into the exact same spot or where the skin has pits or lumps. Avoid injecting into thickened, tender, bruised, scaly, hard, scarred, or damaged skin.

When you are ready to inject

If you are taking Humalog or Insulin Lispro Injection, inject it under your skin within 15 minutes before or right after you eat a meal.

If you are taking Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, inject it under your skin within 15 minutes before you eat a meal.

Staying safe while taking your insulin lispro product

To stay safe while taking your insulin, be sure to never inject Humalog U-200, Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 in your vein, muscle, or with an insulin pump. Also be sure not to:

mix Humalog U-200, Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 with other insulins or liquids.

drive or use heavy machinery until you know how your insulin lispro product affects you.

drink alcohol or use other medicines that contain alcohol when taking your insulin lispro product.

Learn more

For more information, call 1-800-545-5979 or go to www.humalog.com or www.lillyinsulinlispro.com.

This summary provides basic information about Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25. It does not include all information known about these medicines. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other health care provider about your insulin lispro product and how to take it. Your doctor is the best person to help you decide if these medicines are right for you.





HI BOI SP U100 75/25 CON BS 10JAN2020

For additional information, talk to your healthcare providers and please click to access Humalog Full Prescribing Information, Humalog U-100 Patient Information, Humalog U-200 Patient Information, Humalog Mix75/25 Full Prescribing Information, Humalog Mix75/25 Patient Information, Humalog Mix50/50 Full Prescribing Information, Humalog Mix50/50 Patient Information, Insulin Lispro Injection Full Prescribing Information, Insulin Lispro Injection Patient Information, Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 Full Prescribing Information, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 Patient Information.

Please see Instructions for Use included with the product.

PURPOSE and SAFETY SUMMARY

Important Facts About BAQSIMI™ (BAK-see-mee). It is also known as glucagon nasal powder.

BAQSIMI is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 4 years and above.

It is not known if BAQSIMI is safe and effective in children under 4 years of age.

Warnings

Do not use BAQSIMI if:

you have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma.

you have a tumor in your pancreas called insulinoma.

you are allergic to glucagon, or any other ingredient in BAQSIMI.

BAQSIMI may cause serious side effects, including:

High blood pressure. BAQSIMI can cause high blood pressure in certain people with tumors in their adrenal glands.

Low blood sugar. BAQSIMI can cause certain people with tumors in their pancreas to have low blood sugar.

Serious allergic reaction. Call your doctor or get medical help right away if you have a serious allergic reaction including:

rash

difficulty breathing

low blood pressure

Common side effects

The most common side effects of BAQSIMI include:

nausea

vomiting

headache

runny nose

discomfort in your nose

stuffy nose

redness in your eyes

itchy nose, throat, and eyes

watery eyes

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

Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Before using

Before getting BAQSIMI, tell your health care provider about all your medical conditions, including if you:

have a tumor in your pancreas.

have not had food or water for a long time (prolonged fasting or starvation).

are pregnant or plan to become pregnant.

are breastfeeding or plan to breastfeed. It is not known if BAQSIMI passes into your breast milk. You and your doctor should decide if you can use BAQSIMI while breastfeeding.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How to use

Read the detailed Instructions for Use that comes with BAQSIMI.

Use BAQSIMI exactly how your doctor tells you to use it.

Make sure your caregiver knows where you keep your BAQSIMI and how to use BAQSIMI the right way before you need their help.

you need their help. Your doctor will tell you how and when to use BAQSIMI.

BAQSIMI contains only 1 dose of medicine and cannot be reused.

be reused. BAQSIMI should be given in one side of your nose (nostril) but does not need to be inhaled.

BAQSIMI will work even if you have a cold or are taking cold medicine.

After giving BAQSIMI, the caregiver should call for emergency medical help right away.

If the person does not respond after 15 minutes, another dose may be given, if available.

Tell your doctor each time you use BAQSIMI.

Store BAQSIMI at temperatures up to 86°F (30°C).

Keep BAQSIMI in the shrink wrapped tube until you are ready to use it.

Keep BAQSIMI and all medicines out of the reach of children.

Learn more

For more information, call 1-800-545-5979 or go to www.baqsimi.com.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BAQSIMI for a condition for which it was not prescribed. Do not give BAQSIMI to other people, even if they have the same symptoms that you have. It may harm them.

This summary provides basic information about BAQSIMI but does not include all information known about this medicine. You can ask your pharmacist or doctor for information about BAQSIMI that is written for health professionals. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other health care provider about BAQSIMI and how to take it. Your doctor is the best person to help you decide if BAQSIMI is right for you.





Please click to access the Baqsimi full Prescribing Information and Patient Information.

GN CON BS 24JUL19

PURPOSE and SAFETY SUMMARY

Important Facts About Humulin® (HUE-mu-lin) R U-500. It is also known as insulin human injection (500 units/mL).

Humulin R U-500 is a prescription insulin used in adults and children who need more than 200 units of insulin a day to control high blood sugar for their diabetes mellitus. It is more concentrated than standard insulin. It has 5 times as much insulin in each mL as standard insulin.

It is not known if Humulin R U-500 is safe and effective when used with other insulins, when used in an insulin pump, or in children. There were no studies done in children, so your doctor will give you special instructions for use in children.

Warnings

Humulin R U-500 may cause serious side effects, including:

Severe low blood sugar, which can lead to seizures, unconsciousness, and death.

Severe allergic reactions. Get medical help right away if you develop a rash over your whole body, have trouble breathing, have a fast heartbeat, or are sweating.

Swelling of your hands and feet. Tell your doctor if you are short of breath, have swelling in your ankles, or have gained weight suddenly.

Heart failure when taking a medication from a class of drugs called thiazolidinediones (TZDs) with Humulin R U-500. This may occur in some people even if they have not had heart problems before.

Low potassium in your blood (hypokalemia). This can lead to severe breathing problems, irregular heartbeat, and death.

Do not share your Humulin R U-500 KwikPen® or U-500 syringe with anyone. Even if you have changed the needle, you or the other person can get a serious infection.

When using the Humulin R U-500 KwikPen: The Humulin R U-500 KwikPen is made to dial and deliver the correct dose of Humulin R U-500 insulin. Do not remove Humulin R U-500 from the KwikPen to inject with any syringe. This could cause severe overdose and may lead to death.

When using the Humulin R U-500 vial: There is a special syringe to measure Humulin R U-500 called the "U-500 insulin syringe." Only use the U-500 insulin syringe to inject Humulin R U-500. If you do not use the right syringe, you may take the wrong dose of Humulin R U-500. This could cause severe overdose and may lead to death.

Do NOT perform dose conversion when using the Humulin R U-500 KwikPen or U-500 insulin syringe.

Do not use Humulin R U-500 in an insulin pump or inject it into your vein or muscle.

Do not take this medicine if you have low blood sugar.

Do not change the insulin you use without talking to your doctor. Changing insulin may lead to low or high blood sugar.

Do not drive or use heavy machinery until you know how Humulin R U-500 affects you. Do not drink alcohol while using Humulin R U-500.

Common side effects

The most common side effects of Humulin R U-500 include:

Low blood sugar (hypoglycemia). Talk to your doctor about low blood sugar symptoms and treatment. Symptoms may be different for each person.

Allergic reactions, such as redness and swelling at the site where you inject.

Skin thickening or pits at the injection site (lipodystrophy).

Itching and rash.

These are not all the possible side effects of Humulin R U-500.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

Tell your doctor if you are pregnant or plan to become pregnant. Also tell your doctor about:

Any allergies you have. Your doctor can check if the medicine has ingredients that may cause a reaction.

Any medical conditions, including problems with your liver, kidney, or heart.

All the medicines you take, especially a class of drugs called thiazolidinediones, or TZDs. Be sure to include the over-the-counter medicines, vitamins, and herbal supplements you take.

How to take





Read the instructions that come with your Humulin R U-500 carefully. Take it exactly the way your doctor tells you.

Know how much Humulin R U-500 you are supposed to take. Do not change your dose unless your doctor tells you to.

change your dose unless your doctor tells you to. Check the label of your insulin each time you use it. This will help you make sure you are using the right one.

Test your blood sugar before you take Humulin R U-500. Do not take it if your blood sugar is too low.

before you take Humulin R U-500. Do not take it if your blood sugar is too low. Do not mix Humulin R U-500 with any other insulin.

mix Humulin R U-500 with any other insulin. Always use a new needle when injecting Humulin R U-500. This will help you avoid infection.

Inject Humulin R U-500 under your skin. Change (rotate) where you inject your insulin with each dose. Do not inject your insulin into the exact same spot. Avoid injecting your insulin into areas where the skin has pits or lumps, or is thickened, tender, bruised, scaly, hard, scarred, or damaged. This will help reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin.

Learn more

For more information, call 1-800-545-5979 or go to humulin.com.

This summary provides basic information about Humulin R U-500 but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Humulin R U-500 and how to take it. Your doctor is the best person to help you decide if Humulin R U-500 is right for you.

Please click to access the Humulin R U-500 full Prescribing Information and Patient Information.

Humulin® , Humalog®, Humalog® Mix50/50TM, and Humalog® Mix75/25TM KwikPen® and Baqsimi® are trademarks and registered trademarks of Eli Lilly and Company , its subsidiaries, or affiliates.

HM CON BS 15NOV2019

About Diabetes

Approximately 34 million Americans1 (just over 1 in 10) and an estimated 463 million adults worldwide2 have diabetes. 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 alone1. 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 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. P-LLY

This press release contains forward-looking statements about insulin supply, the Lilly Insulin Value Program, and other insulin and glucagon affordability programs, and reflects Lilly 's current beliefs. There is no guarantee that we will be able to continue uninterrupted insulin supply or that our insulin and/or glucagon affordability programs will significantly lower or cap monthly out-of-pocket costs for people who use these medicines. 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.

PP-LD-US-2098 04/2020 ©Lilly USA , LLC 2020. All rights reserved.

References

Centers for Disease Control and Prevention . National Diabetes Statistics Report, 2020. Atlanta, GA : Centers for Disease Control and Prevention , U.S. Dept. of Health and Human Services ; 2020. International Diabetes Federation . IDF Diabetes Atlas, 9th edn. Brussels, Belgium : International Diabetes Federation , 2019. Available at: http://diabetesatlas.org.

Refer to: Greg Kueterman ; kueterman_gregory_andrew@lilly.com; +1 (317) 432-5195 (Media)

Kevin Hern ; hern_kevin_r@lilly.com; +1 (317) 277-1838 (Investors)

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