News

Kaléo and the pan-Canadian Pharmaceutical Alliance (pCPA) Complete Negotiations for ALLERJECT® (epinephrine injection, USP) Auto-Injector for the Treatment of Serious Allergic Reactions Across Canadian Provinces

• Kaléo and the pan-Canadian Pharmaceutical Alliance (pCPA) complete negotiations for ALLERJECT® (epinephrine injection, USP) auto-injector
• Ontario* and Quebec* public drug plans are first to list ALLERJECT with other provinces expected to follow soon
• ALLERJECT is also covered by the largest private insurance plans across Canada

 RICHMOND, VA (August 10,2020) – Kaléo, a privately held U.S. pharmaceutical company, today announced that it has completed negotiations with the pan Canadian Pharmaceutical Alliance (pCPA) for a Letter of Intent regarding ALLERJECT® (epinephrine injection, USP) auto-injector for the treatment of serious allergic reactions. In addition to these public programs, the largest private insurance plans, covering more than eighteen million Canadians, now also list ALLERJECT as a covered benefit.

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)).

“This is welcome news for the more than thirteen million Canadians1 who rely on public insurance to access their prescription medications,” said Omar Khalil, General Manager of Allergy and Pediatrics at Kaléo. “The Ontario and Quebec public drug plans were the first to list ALLERJECT with additional provinces expected to follow soon. We are excited this will allow patients and families the option to access ALLERJECT for their epinephrine auto-injector needs.”

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

“It is so important that every Canadian at risk of anaphylaxis has affordable and consistent access to an epinephrine auto-injector,” said Jennifer Gerdts, executive director of Food Allergy Canada. “The news that ALLERJECT will be broadly covered increases the access patients have to a device, helping to ensure they are prepared in case of a serious allergic reaction.

Understanding what to do in case of an allergic emergency is particularly important as families are getting ready for back-to-school and reviewing their Anaphylaxis Emergency Plans.”

As many as 2.6 million Canadians may have at least one food allergy.3 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.1 A potentially life-threatening allergic reaction can happen anywhere – and can happen quickly4-6– reinforcing the importance of patients, families and caregivers having timely and reliable access to an epinephrine auto-injector.

ALLERJECT became widely available in pharmacies across Canada on May 19, 2020. Patients interested in obtaining ALLERJECT should speak to their healthcare provider and are encouraged to check with their local pharmacy for additional availability and pricing details.

For more information, please visit www.Allerject.ca.

*Ontario: Coverage under the Ontario Public Drug Programs is available for patients with a valid prescription for ALLERJECT

*Quebec: Codes assigned by RAMQ (Official Mark of the Régie de l’assurance maladie du Québec) are as follows: 0.15 mg is 98069 and 0.3 mg is 98070

About Anaphylaxis7,8

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.

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.

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¹ Sutherland, Greg and Thy Dinh. Understanding the Gap: A Pan-Canadian Analysis of Prescription Drug Insurance Coverage. Published in Canada | All rights reserved | Agreement No. 40063028 | *Incorporated as AERIC Inc.”

² ALLERJECT Product Monograph. November 2019.

³; 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 July 2020.

⁴ Bock SA, Munoz-Furlong A, Sampson HA. Further fatalities caused by anaphylactic reactions to food, 2001-2006. J Allergy Clin Immunol. 2007;119:1016–8.

⁵ Fleming JT, Clark S, Camargo CA, Rudders SA. Early treatment of food-induced anaphylaxis with epinephrine is associated with a lower risk of hospitalization. J Allergy Clin Immunol Pract. 2015;3:57–62.

⁶ Robinson M, Greenhawt M, Stukus D. Factors associated with epinephrine administration for anaphylaxis in children before arrival to the emergency department. Ann Allergy Asthma Immunol. 2017;119:164-169.

⁷ Health Canada. Common food allergens. http://www.canada.ca/en/health-canada/services/food-nutrition/food- safety/food-allergies-intolerances/food-allergies.html. Accessed July 2020.

⁸ Food Allergy Canada. Reaction signs and symptoms. https://foodallergycanada.ca/food-allergy-basics/preventing- and-treating-allergic-reactions/reaction-signs-and-symptoms/. Accessed July 2020.