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Kaléo Donates Thousands of AUVI-Q® (epinephrine injection, USP) and EVZIO® (naloxone HCl injection) Auto-injectors to Hurricane Harvey Relief Efforts

— Direct Relief to distribute 25,000 auto-injectors to partner clinics serving storm-impacted communities   —

Richmond, VA (September 1, 2017) Kaléo, a privately-held pharmaceutical company, today announced a donation of 20,000 AUVI-Q^® (epinephrine injection, USP) Auto-injectors and 5,000 EVZIO^® (naloxone HCl injection) Auto-injectors to medical aid organization Direct Relief in support of Hurricane Harvey relief efforts in Texas, Louisiana and other affected states.

“Tens of thousands of people have had to flee their homes with little more than the clothes on their backs,” said Spencer Williamson, President and CEO of Kaléo. “We are proud to work with Direct Relief to ensure that our epinephrine and naloxone products are available to patients in need.”

“We are deeply appreciative for the donation by Kaléo and are pleased to work with them to help support the medical needs of the victims of Hurricane Harvey along the Gulf Coast,” said Pat Bacuros, Direct Relief’s Director of Philanthropic Investment. “As the only non-profit medical aid organization to obtain Verified-Accredited Wholesale Distributor status from the National Association of Boards of Pharmacy, Direct Relief is a natural partner for Kaléo to get these potentially life-saving medications to those in the greatest need.”

AUVI-Q (0.15 mg and 0.3 mg) is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions. EVZIO was the first naloxone product specifically designed, approved and labeled for the emergency treatment of opioid overdose by individuals without medical training. The products are both FDA-approved and have innovative features such as voice instructions that help guide users with step-by-step instructions through the delivery process of the medications. The products also feature an automatic retractable needle system that injects the medication and retracts the needle back into the device within seconds.

“One out of every 13 children in the U.S. has at least one food allergy,” said Dr. James R. Baker, Jr., CEO of Food Allergy Research and Education (FARE). “Therefore, it is likely that there are many children with life-threatening allergies among the flood victims. We are pleased to see efforts to ensure replacement epinephrine to patients who may have lost their auto-injectors in this emergency.”

“I commend Direct Relief and Kaléo for taking bold action to help victims of Hurricane Harvey obtain the medicines they need in this crisis,” said Mark Kinzly, Co-founder of the Texas Overdose Naloxone Initiative. “The opioid overdose crisis will not recede during this natural disaster. Having access to naloxone in the affected areas will help save lives.”

“With the devastating situation in Texas and Louisiana due to Hurricane Harvey, and many families there affected by food allergies and life-threatening anaphylaxis, it’s imperative for individuals to have immediate access to potentially life-saving medications, including epinephrine,” said Eleanor Garrow-Holding, President and CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT). “Thank you to our partner, Kaléo, and to Direct Relief, for providing these auto-injectors for those most in need.”

To learn more about AUVI-Q (0.15 mg and 0.3 mg), please visit www.auvi-q.com. For information about EVZIO, please visit www.evzio.com.

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About Anaphylaxis

Anaphylaxis (pronounced ana-fuh-lak-sis) is a serious allergic reaction that happens quickly and may cause death. Anaphylaxis can occur as a result of exposure to allergens including tree nuts, peanuts, milk, eggs, fish, shellfish, soy, wheat, insect bites, latex and medication, among other allergens.

About AUVI-Q (0.15 mg and 0.3 mg)

AUVI-Q (epinephrine injection, USP) Auto-injector is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or who have a history of serious allergic reactions. AUVI-Q contains epinephrine, a well-established, first-line treatment for severe, life-threatening allergic reactions that occur as a result of exposure to allergens including food such as peanuts, tree nuts, fish, shellfish, dairy, eggs, soy and wheat; insect stings or bites; latex and medication, among other allergens and causes.

AUVI-Q is the only compact epinephrine auto-injector with a voice instruction system that helps guide patients and caregivers step-by-step through the injection process, and a needle that automatically retracts following administration. In anaphylaxis emergencies, it is often individuals without medical training who need to step in and deliver potentially life-saving epinephrine. AUVI-Q was designed through careful analysis of the situations where epinephrine auto-injectors are used and with significant input from the allergy community that relies on it incorporating Human Factors Engineering (HFE). HFE is about designing products or systems that are easy to operate and, most importantly, support correct use, with the goal to remove the potential for error. For more information about AUVI-Q (0.15 mg and 0.3 mg) visit www.auvi-q.com.

AUVI-Q Indication

AUVI-Q (epinephrine injection, USP) is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions.

AUVI-Q Important Safety Information

AUVI-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after use. Each AUVI-Q contains a single dose of epinephrine. AUVI-Q should only be injected into your outer thigh, through clothing if necessary. If you inject a young child with AUVI-Q, hold their leg firmly in place before and during the injection to prevent injuries. Do not inject into veins, buttocks, fingers, toes, hands, or feet. If you accidentally inject AUVI-Q into any other part of your body, seek immediate medical treatment.

Rarely, patients who use AUVI-Q may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following symptoms at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.

If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use AUVI-Q. Be sure to tell your healthcare provider about all the medicines you take, especially medicines for asthma. Also tell your healthcare provider about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, heart problems or high blood pressure, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

Common side effects include fast, irregular or ‘pounding’ heartbeat, sweating, shakiness, headache, paleness, feelings of over excitement, nervousness, or anxiety, weakness, dizziness, nausea and vomiting, or breathing problems. These side effects usually go away quickly, especially if you rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Please click here to see the full Prescribing Information and the Patient Information at www.auvi-q.com.

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.

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. 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-the-counter 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.

Please click here to see the full Prescribing Information and the Patient Information at www.evzio.com.

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.

About Direct Relief 
Direct Relief is a leading medical relief organization, active in all 50 states and in 70 countries and is the only U.S. nonprofit to obtain Verified Accredited Wholesale Distributor (VAWD)© certification by the National Association of Boards of Pharmacy.  The organization has been among the world’s largest medical suppliers in Haiti after the 2010 earthquake, has top charity ratings, including four-star and “top-notch” rating from Charity Navigator, and a 100% fundraising efficiency rating from Forbes magazine. Among other distinctions, Direct Relief was the 2011 winner of the Peter F. Drucker Award for Nonprofit Innovation and received the 2013 President’s Award from ESRI. For more information visit www.DirectRelief.org.

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. Kaléo is a privately-held company headquartered in Richmond, Virginia. For more information, visit www.kaleo.com.