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Kaléo Announces AUVI-Q® (epinephrine injection, USP) Charitable Donation Program for All Public Elementary Schools in the United States

— More than 67,000 Schools Eligible for the “Q Your School^TM” Program   —

Richmond, VA (August 7, 2017) Kaléo, a privately-held pharmaceutical company, today announced a new charitable product donation program, offering AUVI-Q^® (epinephrine injection, USP) Auto-injectors free of charge to all public elementary schools in the United States. The new program, “Q Your School,” provides up to four AUVI-Q cartons (each carton contains two epinephrine auto-injectors and a Trainer) per school per academic year, as well as access to educational materials on how to identify and respond to life-threatening allergic emergencies.

AUVI-Q (0.15 mg and 0.3 mg) is a FDA-approved 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. It is an epinephrine auto-injector (EAI) with innovative features such as voice instructions that help guide a user with step-by-step instructions through the epinephrine delivery process and an automatic retractable needle system, a first for epinephrine auto-injectors, that injects the epinephrine and retracts the needle back into the device within seconds. AUVI-Q is not a substitute for emergency medical care.

“There are nearly 6 million children, under 18, living with life-threatening allergies,” said Spencer Williamson, President and CEO of Kaléo. “We are proud to offer the “Q Your School” charitable donation program offering free AUVI-Q Auto-injectors to all public elementary schools across the nation.”

According to the National Center for Education Statistics, there are approximately 67,000 public elementary schools in America[i]. Through the Kaléo Cares Product Donation Program, qualified applicants may apply to receive up to four AUVI-Q cartons (each carton contains two epinephrine auto-injectors and a Trainer) per school per academic year, free of charge. There are no obligations, such as marketing or product exclusivity requirements, attached to the “Q Your School” program.

“Schools play an important role in helping to keep kids with food allergies safe,” said Melanie Carver, Vice President of Community Services at the Asthma and Allergy Foundation of America (AAFA). “This is an exciting program because it helps schools be better prepared to recognize and respond to life-threatening allergic emergencies.”

Identical twin brothers, Evan and Eric Edwards, the inventors of AUVI-Q, know what it is like to live with life-threatening allergies, both as patients themselves and parents of food-allergic children. Their goal was to develop an epinephrine auto-injector that contained innovative features, such as a voice instruction system that helps guide patients and caregivers step-by-step through the injection process. Evan and Eric Edwards believe and trust in AUVI-Q, not only for themselves, but also for their children and other families who may have to depend on it to administer epinephrine during an allergic emergency.

“Not all kids with food allergies are the same. They may have different needs and preferences,” said Tonya Winders, President & CEO of the Allergy and Asthma Network (AAN). “This is an exciting announcement because it helps schools to be more aware of the various epinephrine auto-injector options now available to students at risk for a life-threatening allergic emergency and know how to use them in an emergency.”

For information and an application for the “Q Your School” program, please visit https://kaleo.com/who-we-are/kaleo-cares/.

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

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.

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 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.

[i] https://nces.ed.gov/fastfacts/display.asp?id=84