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Kaléo Announces ALLERJECT® (epinephrine injection, USP) Auto-Injector Will Be Available for Canadians at Risk for Anaphylaxis Starting May 19, 2020



ALLERJECT provides the life-threatening allergy community with an alternative epinephrine auto- injector option with innovative features

RICHMOND, VA (May 12, 2020) – Kaléo, a privately held U.S. pharmaceutical company, today announced that ALLERJECT® (epinephrine injection, USP), will be widely available in pharmacies across Canada beginning May 19, 2020. People interested in obtaining ALLERJECT should speak to their healthcare provider and are encouraged to check with their local pharmacy for additional availability details.

ALLERJECT is a portable epinephrine auto-injector with an innovative voice instruction system that helps guide patients and caregivers step-by-step through the injection process and has a retractable needle system. ALLERJECT is available in a 0.15 mg dose (for patients who weigh 15 to 30 kg (33 lbs to 66 lbs)) and a 0.3 mg dose (for patients who weigh 30 kg or more (66 lbs or more)).

“The importance of being prepared for a life-threatening allergic reaction, including recognizing the signs and symptoms of anaphylaxis and knowing how to administer epinephrine, cannot be overstated,” said Dr. Susan Waserman, Professor of Medicine, and Director, Division of Clinical Immunology & Allergy at McMaster University. “In a situation in which delayed epinephrine administration could be the difference between life and death, ALLERJECT’s voice instruction system can help guide even untrained users through a successful injection.”

ALLERJECT is indicated for the emergency treatment of serious allergic reactions (anaphylaxis) and is intended for people who are at risk and for people with a history of serious allergic reactions (anaphylaxis). Anaphylaxis is the term for a severe, life-threatening allergic reaction that some people have to foods (like peanuts and shellfish), insect stings, certain medicines, latex, or other allergens.

These reactions can also be triggered by exercise or even by unknown causes. A severe allergic reaction occurs when a person is exposed to an allergen (an allergy-causing substance). When the allergen enters the body it triggers the release of chemicals that can lead to life-threatening symptoms.2

“Over the last two years, we have been strongly advocating to have a minimum of two suppliers of epinephrine auto-injectors available for the over 2 million Canadians impacted by food allergy,” said Jennifer Gerdts, executive director of Food Allergy Canada. “Everyone should always be able to access life-saving medication. With the availability of ALLERJECT, Canadian families now have a different option for an epinephrine auto-injector, providing them with choice that comes from no longer being vulnerable in a single-source market. It’s a significant step for the food allergy community.”

As many as 2.6 million Canadians may have at least one food allergy.1 Up to 740,000 people are estimated to be at risk for anaphylaxis due to food or insect stings alone at least once in their lifetime.2 A potentially life-threatening allergic reaction can happen anywhere – and can happen quickly – reinforcing the importance of patients, families and caregivers having timely and reliable access to an epinephrine auto-injector.

“At kaléo, we understand the uncertainties patients at risk for anaphylaxis face each day,” said Omar Khalil, general manager of Allergy and Pediatrics at kaléo. “Anaphylactic reactions to food or other allergens can happen anywhere, at any time. It’s critical that people at-risk – and those close to them – have and will carry a device like ALLERJECT to help them respond on a moment’s notice.”

ALLERJECT is manufactured on a high-tech, fully automated robotic production line with more than 100 automated quality checks on each device. Clinical significance is unknown.

Kaléo is committed to providing access to potentially life-saving epinephrine to patients at risk for anaphylaxis and their caregivers, and supporting the needs of those at risk for severe allergic reactions. For more information, please visit www.Allerject.ca.

About Anaphylaxis
3, 4
Anaphylaxis (pronounced anna-fill-axis) is the most serious type of allergic reaction. During anaphylaxis, a person may have trouble breathing or experience a drop in blood pressure. These symptoms can lead to death if not treated. Health Canada, the Canadian Food Inspection Agency (CFIA), allergy associations, and the medical community have identified the key substances most frequently associated with food allergies and allergic-type reactions, including: eggs, milk, mustard, peanuts, crustaceans and molluscs, fish, sesame seeds, soy, sulphites, tree nuts, wheat and triticale.

Clinical use:

ALLERJECT should be used immediately to treat yourself or your child when experiencing a severe allergic reaction. This is emergency treatment. It does not replace seeing a doctor or going to the hospital. After injection, seek immediate medical attention. Even if you have sought medical help, you must stay within close proximity to a hospital or where you can easily call 911 for the next 48 hours.

Safety information:

Talk to your doctor or pharmacist about all of your medical conditions, especially if you:

Have heart disease, irregular heartbeat, or high blood pressure
Have diabetes
Have thyroid conditions
Have narrow-angle glaucoma
Have depression or other mental disease
Have Parkinson’s disease
Have asthma
Have previously had an allergic reaction
Are pregnant or breastfeeding
Have any allergies to this drug or its ingredients or components
ALLERJECT remains the essential treatment for anaphylaxis even if you have the above conditions.

Talk to your doctor or pharmacist to discuss treatment options for anaphylaxis and whether ALLERJECT is right for you. Always read and follow the patient information leaflet that comes with your ALLERJECT device for warnings and precautions, side effects, and complete dosing and administration information.

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About kaléo (kuh-LAY-oh)

Kaléo is a pharmaceutical company dedicated to building innovative solutions that can help empower patients with certain serious and life-threatening medical conditions. We believe patients and caregivers are the experts on how medical conditions impact their lives, and so we include them as an integral part of our development process and consider their needs foremost. Kaléo products combine established drugs with innovative delivery platforms. Kaléo is a privately-held company headquartered in Richmond, Virginia in the United States. For more information, visit www.kaleo.com.###

FOR MEDIA INQUIRIE PLEASE CONTACT

Lauren Hayes
Lauren.Hayes@cohnwolfe.ca
(416) 924-5700 Ext. 4015

Caryn Durham
Caryn.Durham@kaleo.com
(804) 545-6360 Ext. 476

1 AllerGen. Estimated Food Allergy Prevalence Among Canadian Children and Adults. Available at: https://allergen- nce.ca/wp-content/uploads/Canadian-food-allergy-prevalence-Jul-2017.pdf. Accessed April 2020.

2 ALLERJECT Product Monograph. November 2019.

3 Health Canada. Common food allergens. https://www.canada.ca/en/health- canada/services/food-nutrition/food-safety/food-allergies-intolerances/food-allergies.html. Accessed April 2020.

4 Food Allergy Canada. Reaction signs and symptoms. https://foodallergycanada.ca/food-allergy-basics/preventing- and-treating-allergic-reactions/reaction-signs-and-symptoms/. Accessed April 2020.