Lilly plans donation of 200,000 insulin KwikPens over next three years to support lower-income communities

Insulin donation, along with $2 million in grants to relief agencies, extends program launched in 2018

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Jan 28, 2020, 06:45 ET

INDIANAPOLIS, Jan. 28, 2020 /PRNewswire/ -- Starting this month, Eli Lilly and Company (NYSE: LLY) will donate at least 200,000 KwikPens^® to three relief organizations – Americares, Direct Relief and Dispensary of Hope – to stock insulin at nearly 200 U.S. free clinics through 2022. These donations will directly support lower-income people living with diabetes who qualify for free clinic services.

Separately, Lilly is providing $2 million to fund grants that relief agencies will distribute to a wide range of eligible free clinics. The grants will fund programs intended to help people with diabetes understand and access resources that can help them obtain medicine and supplies, medical care, insurance coverage and more.

The insulin donations include KwikPens of Humalog^® (insulin lispro injection 100 units/mL), Humalog^® Mix75/25^™ (insulin lispro protamine and insulin lispro injectable suspension), and Basaglar^® (insulin glargine injection 100 units/mL). Shipments to relief agencies have already started, giving lower-income people another option for accessing insulin.

"Dispensary of Hope is excited to expand the ongoing effort with Lilly's insulin donation program," said Chris Palombo, Dispensary of Hope CEO. "Insulin saves lives, and the addition of donated Humalog and Basaglar KwikPens is important for the nation's uninsured, low-income community."

In 2018, Lilly announced plans to donate insulin vials to stock approximately 150 U.S. free clinics. Since then, Lilly has donated 120,000 vials that have been used by people who qualify for free clinic services. Lilly is now sending KwikPens to the relief agencies for distribution to nearly 200 free clinics.

"This donation of KwikPens will help many people across the U.S. get the treatment they need," said Mike Mason, president, Lilly Diabetes. "With the help of the relief agencies, Lilly insulin will now be available in many free clinics that are equipped to properly store it. These clinics help people find comprehensive care such as medicine, devices, and physician support, and are very important to people who live with diabetes and use these services. We will continue to evaluate the needs of these communities and enhance our insulin donations as necessary.

"Lilly is committed to offering the broadest suite of solutions for people who need help affording their insulin," Mason continued. "But real change to our reimbursement system is needed. Insurance coverage should ensure no one with diabetes is forced to ration or skip doses for financial reasons."

These donations are part of a broader suite of solutions that Lilly is providing to people who need help affording their insulin. These options include lower-priced versions of branded insulins, out-of-pocket price caps at pharmacies for people with commercial insurance plans and help for people with immediate needs. Anyone who uses a Lilly insulin can call the Lilly Diabetes Solution Center at (833) 808-1234 (9 a.m. to 8 p.m. EST Monday through Friday) to see whether there is an option that reduces their out-of-pocket costs, including information about how to receive free insulin through a free clinic if they meet income requirements.

More information about the grants that relief agencies will receive can be found on our blog.

Important Safety Information for Basaglar, Humalog (Humalog U-100 and Humalog U-200), Insulin Lispro Injection, Humalog Mix75/25, and Humalog Mix50/50

Contraindications
Basaglar, Humalog (Humalog U-100 and Humalog U-200), Insulin Lispro Injection, Humalog Mix50/50, and Humalog Mix75/25 are contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine, insulin lispro, or any of their excipients.

Warnings and Precautions
Never share a prefilled pen, cartridge, reusable pen compatible with Lilly 3 mL cartridges, or syringe between patients, even if the needle is changed. Patients using vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

Changes in insulin strength, manufacturer, type, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Any changes in insulin regimen should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. Due to reports of hypoglycemia and hyperglycemia, advise patients who repeatedly inject into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to the unaffected areas and to closely monitor blood glucose. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

Hypoglycemia is the most common adverse reaction associated with insulins, including Basaglar, Humalog, Insulin Lispro Injection, Humalog Mix75/25, and Humalog Mix50/50. Severe hypoglycemia can cause seizures, may be life threatening, or cause death.

Accidental mix-ups between insulin glargine (100 units/mL), basal insulin products, Humalog Mix75/25, Humalog Mix50/50, and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between insulins, instruct patients to always check the insulin label before each injection to confirm that the correct insulin is injected, including the correct insulin brand and concentration.

Do not transfer concentrated insulins (Humalog U-200) from the KwikPen to any syringe as overdosage and severe hypoglycemia can occur.

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Basaglar, Humalog, Insulin Lispro Injection, Humalog Mix75/25, and Humalog Mix50/50. If hypersensitivity reactions occur, discontinue use; treat per standard of care and monitor until symptoms and signs resolve.

All insulin products, including Basaglar, Humalog, Insulin Lispro Injection, Humalog Mix75/25, and Humalog Mix50/50, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated.

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including Basaglar, Humalog, Insulin Lispro Injection, Humalog Mix75/25, or Humalog Mix50/50, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, dosage reduction or discontinuation of TZD must be considered.

Malfunction of an insulin pump device, infusion set, or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Patients using Humalog U-100 or Insulin Lispro Injection in subcutaneous insulin infusion pumps must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Adverse Reactions
Adverse reactions commonly associated with insulin glargine products, Humalog, Insulin Lispro Injection, Humalog Mix75/25, and Humalog Mix50/50 are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash.

Other adverse reactions commonly associated with insulin glargine products, Humalog Mix75/25, and Humalog Mix50/50 are weight gain and edema.

Drug Interactions
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with Basaglar, Humalog, Insulin Lispro Injection, Humalog Mix75/25, or Humalog Mix50/50.

Click to access Basaglar Full Prescribing Information, Humalog Full Prescribing Information, Insulin Lispro Injection Full Prescribing Information, Humalog Mix75/25 Full Prescribing Information and Humalog Mix50/50 Full Prescribing Information.

See Instructions for Use provided with pen/vial/syringe.

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About Diabetes
Approximately 30 million Americans¹ and an estimated 463 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 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 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 (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Humalog® (insulin lispro injection 100 units/mL), Basaglar® (insulin glargine injection 100 units/mL), and Humalog® Mix75/25™ (insulin lispro protamin and insulin lispro injectable suspension) as a treatment for patients with diabetes and reflects Lilly's current belief. 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.

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.
International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels, Belgium: International Diabetes Federation, 2019. http://www.diabetesatlas.org.

Refer to:	Dani Barnhizer; [email protected]; 317.607.6119 (Lilly Diabetes Communications)
	Kevin Hern; [email protected]; 317.277.1838 (Investor Relations)