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 News Release - July 27, 2017

U.S. FDA Grants Priority Review for an Epinephrine Auto-Injector in Development by Kaléo Specifically for Infants and Small Children

AUVI-Q® (epinephrine injection, USP) 0.1 mg could be the first auto-injector approved with a needle length and dose specifically designed for infants and small children

Emergency room visits due to anaphylaxis are increasing in children


RICHMOND, Va., July 27, 2017 -- (Healthcare Sales & Marketing Network) -- Kaléo, a privately-held pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review of its supplemental New Drug Application (sNDA) for AUVI-Q 0.1 mg, the first known epinephrine auto-injector specifically designed for the treatment of life-threatening allergic reactions in infants and small children weighing 16.5 to 33 pounds. The new 0.1 mg dose epinephrine auto-injector has a shorter needle length and lower dose than existing 0.15 mg and 0.3 mg epinephrine auto-injectors.

Priority Review designation by the FDA is given to drugs that, if approved, may provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to available therapies.

Children are increasingly being treated for anaphylaxis. There was a 129.8 percent increase in emergency room visits for anaphylaxis among children four years old and younger between 2005 and 2014.¡ According to a study published in Allergy, Asthma & Clinical Immunology, 43 percent of children weighing 16.5 pounds (7.5 kg) to 33 pounds (15 kg) treated with a 0.15 mg auto-injector having a standard 12.7 mm needle length are at risk of having the needle strike the bone, therefore potentially impacting the administration of epinephrine during a life-threatening emergency.¡¡ The needle length in AUVI-Q 0.1 mg was specifically designed for use with infants and small children to help mitigate this safety concern.

"National Institutes of Health (NIH) guidelines now recommend that certain infants be evaluated for potential peanut allergy and early peanut introduction as young as four to six months old," said Eleanor Garrow-Holding, President and CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT). "We applaud the development of the first epinephrine auto-injector (EAI) specifically designed to treat infants and small children who may be at risk for peanut or other life-threatening allergies. As there is currently no EAI on the market specifically designed for this precious population, we hope that the AUVI-Q 0.1 mg is approved as soon as possible."

"Children continue to be diagnosed with life-threatening allergies at an earlier age, some as young as a few months," said Dr. Vivian Hernandez-Trujilloiii, a pediatric allergist, and fellow of the American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; and American Academy of Pediatrics specializing in the management of life-threatening allergies or anaphylaxis. "Until now, the needle length and dose of available epinephrine auto-injectors have given caregivers pause — wary of injecting too much epinephrine or hitting bone with a needle that may be too long for small children. This newly designed and developed epinephrine auto-injector fulfills an important and timely unmet medical need for these infants and young children."

AUVI-Q 0.1 mg builds upon kaléo's continued commitment to innovation. "Kaléo is proud to be taking a leadership role in helping to fulfill this unmet medical need that has been identified for over a decade by parents of young children and the pediatric allergy healthcare practitioner community," said Spencer Williamson, President and CEO of kaléo.

"The AUVI-Q 0.1 mg Auto-injector in development not only contains a dose of epinephrine tailored to infants and small children, but contains important product features such as an optimized needle length designed to help mitigate the risk of striking bone in this population," said Eric S. Edwards, MD, PhD, Vice President of Innovation and Research & Development at kaléo.

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 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.

The approval and launch of AUVI-Q was initially delayed due to a patent lawsuit filed by the makers of EpiPen®. The lawsuit was resolved in 2012 allowing for the commercialization and launch of AUVI-Q. Therefore, kaléo does not expect a similar legal delay in approval of AUVI-Q 0.1 mg.

Identical twin brothers, Evan and Eric Edwards, the inventors of AUVI-Q, grew up with life-threatening allergies. They know what it is like to live with life-threatening allergies, both as patients 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.

If approved, the new AUVI-Q 0.1 mg Auto-injector is projected to be available for patients in the first half of 2018.

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

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 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.kaleopharma.com.

¡ Motosue M., et al. J Allergy Clin Immunol Pract. 2017;5:171-175.

¡¡ Kim H., et al. Ann Allergy Asthma Immunol. 2017 Jun;118(6):719-725.

iii Dr. Vivian Hernandez-Trujillo is a scientific medical consultant for kaléo, Inc. and other private companies.


Source: Kaléo

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