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Kaléo Donates 250,000th EVZIO® (naloxone HCl injection) Auto-injector to Help Fight Opioid Overdose Epidemic

— More than 3,600 lives reported saved with the help of EVZIO–

Richmond, Va. (June 22, 2017) – Kaléo, a privately-held pharmaceutical company, today announced that 250,000 EVZIO^® (naloxone HCl injection) Auto-injectors have been donated since launching the Kaléo Cares Product Donation Program in October 2014. More than 250 first responder agencies, public health departments and qualifying non-profit community groups across 35 states, have received donated EVZIO Auto-injectors through Kaléo’s charitable program. More than 3,600 lives have been reported saved with the help of EVZIO Auto-injectors, an average of approximately 26 lives saved per week, since the start of the program.

The 250,000th EVZIO Auto-injector was donated earlier this month to the Connecticut Department of Health. “Like so many other states across the country, Connecticut is experiencing the terrible effects of opioid addiction and overdose. We are grateful for the donation of EVZIO Auto-injectors to aid in our efforts to help save lives,” said Governor Dannel P. Malloy of the State of Connecticut.

Kaléo, an innovative pharmaceutical company headquartered in Richmond, Virginia, was founded by identical twin brothers with life-threatening conditions. From their initial concept of a compact auto-injector with innovative features, all the way to FDA approval, it took years of hard work and many millions of dollars invested in research and development. Kaléo is proud to have more than 100 domestic and international issued patents and FDA approvals for three products in the last four years. Kaléo’s products have all been internally developed and are manufactured in the United States in custom state-of-the-art robotic assembly processes with more than 100 quality checks run on every product.

EVZIO was the first naloxone product specifically designed, FDA approved and labeled for the emergency treatment of opioid overdose by individuals without medical training. It is the first and only intelligent naloxone auto-injector with voice and visual guidance.

“We have been fortunate enough to have received several donations of EVZIO from Kaléo since 2015,” said Eliza Wheeler, of the Drug Overdose Prevention and Education (DOPE) Project, a program of the Harm Reduction Coalition in San Francisco, California. “To date, our trained participants have used EVZIO nearly 500 times to reverse opioid overdoses experienced by their peers.”

EVZIO was designed to be prescribed by a health care practitioner to patients at risk for a potential opioid overdose, and was not invented for the bulk purchase market that includes public entities or non-profit organizations. To address the needs of such entities, Kaléo created the Kaléo Cares Product Donation Program which ensures that qualifying organizations, such as first-responders, health departments, and non-profits serving patients in need, can access EVZIO at zero cost.

“The opioid epidemic is killing about 91 people, on average, each day. We can’t stand by and hope that things change on their own,” said Spencer Williamson, President and CEO of Kaléo. “By increasing access to this potentially life-saving medicine, EVZIO is helping to reduce the number of needless deaths from opioid overdose in the United States.”

For more information about the Kaléo Cares Product Donation Program, please visit www.kaleo.com/who-we-are/kaleo-cares.

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About Opioid-Induced Respiratory Depression (OIRD) and Overdose

Opioid emergencies, such as an accidental overdose, are a growing public health epidemic. On average, 79 people die from opioids, including prescription opioid analgesics and heroin, every day in the United States; most occur outside of medical settings, such as in a home.¹,² Approximately 136,000 opioid overdose emergency department visits occur each year.³ Many communities throughout the United States are facing a devastating heroin epidemic. Additionally, there are nearly two times the number of prescription opioid-related deaths as compared to heroin-related deaths.¹

Life-threatening opioid emergencies result in respiratory and/or central nervous system depression. Opioid-Induced Respiratory Depression (OIRD) is the most important serious adverse effect of opioids as it can be immediately life-threatening.⁴ In addition to the risk of an opioid overdose associated with an opioid use disorder, there may be an increased risk of life-threatening OIRD even when patients take a prescribed dose of an opioid as directed. For example, taking high doses of opioids, taking an opioid in combination with other drugs (e.g., benzodiazepines) or alcohol, or if there is a history of certain medical conditions (e.g., COPD, severe asthma) places individuals at significantly higher risk for life-threatening OIRD.⁵, ⁶, ⁷ Seconds count when a life-threatening OIRD event occurs. Without rapid intervention, brain injury or death can occur in as little as 4 minutes.⁸ Most life-threatening OIRD emergencies occur in the home and are witnessed by family and friends who may be in the best position to intervene quickly.⁹

Naloxone is an opioid antagonist that displaces opioids from the receptors in the brain, temporarily reversing the life-threatening breathing problems that can occur during an opioid emergency.¹⁰

About EVZIO (EVV-zee-oh)

EVZIO (naloxone HCl injection) Auto-injector is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. EVZIO is intended for immediate administration as emergency therapy in settings where opioids may be present. EVZIO is not a substitute for emergency medical care. EVZIO is an intelligent auto-injection system that provides simple, on-the- spot voice and visual guidance. EVZIO is small, easy-to-carry and easy-to-use to help patients and caregivers keep it on hand so they can take fast, confident action administering EVZIO during an opioid emergency.^[11] Each EVZIO pre-filled, single-use, hand-held Autoinjector delivers a single dose of naloxone. Each EVZIO prescription comes with two Autoinjectors and a Trainer. For more information on EVZIO, including full Prescribing Information, visit www.EVZIO.com.

EVZIO INDICATION

EVZIO is a prescription medicine used in adults and children for the treatment of an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond.

EVZIO is to be given right away and does not take the place of emergency medical care. Get emergency medical help right away after the first dose of EVZIO, even if the person wakes up.

EVZIO is safe and effective in children for known or suspected opioid overdose.

EVZIO IMPORTANT SAFETY INFORMATION

What is the most important information I should know about EVZIO?

EVZIO is used to temporarily reverse the effects of opioid medicines. The medicine in EVZIO has no effect in people who are not taking opioid medicines. Always carry EVZIO with you in case of an opioid emergency.

• Use EVZIO right away if you or your caregiver think signs or symptoms of an opioid emergency are present, even if you are not sure, because an opioid emergency can cause severe injury or death. Signs and symptoms of an opioid emergency may include:
  • unusual sleepiness and you are not able to awaken the person with a loud voice or rubbing firmly on the middle of their chest (sternum)
  • breathing problems including slow or shallow breathing in someone difficult to awaken or they look like they are not breathing
  • the black circle in the center of the colored part of the eye (pupil) is very small, sometimes called “pinpoint pupils” in someone difficult to awaken
• Family members, caregivers, or other people who may have to use EVZIO in an opioid emergency should know where EVZIO is stored and how to give EVZIO before an opioid emergency happens.
• Get emergency medical help right away after using the first dose of EVZIO. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.
• The signs and symptoms of an opioid emergency can return within several minutes after EVZIO is given. If this happens, give additional injections using new EVZIO autoinjectors every 2 to 3 minutes, and continue to closely watch the person until emergency help is received.

Who should not use EVZIO?

Do not use EVZIO if you are allergic to naloxone hydrochloride or any of the ingredients in EVZIO.

What are the ingredients in EVZIO?

Active ingredient: naloxone hydrochloride
Inactive ingredients: sodium chloride, hydrochloric acid to adjust pH, and water

What should I tell my healthcare provider before using EVZIO?

Tell your healthcare provider about all of your medical conditions, including if you:

• Have heart problems
• Are pregnant or plan to become pregnant. Use of EVZIO may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you are given EVZIO.

Tell your healthcare provider about the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements.

What are the possible side effects of EVZIO?

EVZIO may cause serious side effects, including:

• Sudden opioid withdrawal symptoms. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving EVZIO and may include: body aches, fever, sweating, runny nose, sneezing, goose bumps, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, stomach cramping, increased blood pressure, and increased heart rate.
• In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include: seizures, crying more than usual, and increased reflexes.

Common side effects of EVZIO include dizziness and injection site redness.

These are not all of the possible side effects of EVZIO. Call your doctor 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.

Please see full Prescribing Information at EVZIO.com.

About Kaléo (kuh-LAY-oh)

Kaléo is a pharmaceutical company dedicated to building innovative solutions for serious and life-threatening medical conditions. Our mission is to provide innovative solutions that empower patients to confidently take control of their medical conditions. We believe patients and caregivers are the experts on how their medical condition impacts their lives, and are an integral part of our product development process. Each Kaléo product combines an established drug with an innovative delivery platform with the goal of achieving superiority and cost effectiveness. Kaléo is a privately-held company headquartered in Richmond, Virginia. For more information, visit www.kaleo.com.

^{[1] Centers for Disease Control and Prevention. Increase in Drug and Opioid Overdose Deaths—United States, 2000-2014. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6450a3.htm?s_cid=mm6450a3_w. Accessed 01/04/2015.}

^{[2] World Health Organization. Community Management of Opioid Overdose. Geneva, Switzerland: WHO, 2014.}

^{[3] Yokell et al. Presentation of Prescription and Nonprescription Opioid Overdoses to US Emergency Departments. JAMA Int. Med. 2014; 174(12):2034-7.}

^{[4] Food and Drug Administration. FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics, 2014.}

^{[5] Zedler B, Xie L, Wang L, et al. Risk factors for serious prescription opioid-related toxicity or overdose among Veterans Health Administration patients. Pain Med. 2014; 15:1911-1929.}

^{[6] Bohnert A, Valenstein M, Bair MJ, et al. Association between Opioid Prescribing Patterns and Opioid Overdose-Related Deaths. 2011; 305(13):1315-1321.}

^{[7] Gudin JA, Mogali S, Jones JD, Comer SD. Risks, Management, and Monitoring of Combination Opioid, Benzodiazepines, and/or Alcohol Use. Postgrad Med J. 2013; 125(4):115-130.}

^{[8] Caplan LR, Hurst JW, Chimowitz MI. Cardiac arrest and other hypoxic-ischemic insults. In: Clinical Neurocardiology. New York, NY: CRC Press; 1999.}

^{[9] World Health Organization. Community Management of Opioid Overdose. Geneva, Switzerland: WHO, 2014.}

^{[10] Straus M, Ghitza U, Tai B. Preventing deaths from rising opioid overdose in the US – the promise of naloxone antidote in community-based naloxone take-home programs. Subst Abuse Rehabil. 2013:65-72.}