Richmond-based kaléo announces auto-injector availability for Canadians

RICHMOND, VA– 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.

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.

The official press release is available here.