November 24, 2017 4:01 PM ET

Pharmaceuticals

Company Overview of kaleo, Inc.

Company Overview

kaleo, Inc. develops, markets, and sells pharmaceutical and medical products. The company offers drug and device development and human factors engineering (HFE) services. Its product includes AUVI-Q 0.1 mg, an epinephrine auto-injector specifically designed for the treatment of life-threatening allergic reactions in infants and small children weighing 16.5 to 33 pounds. kaleo, Inc. was formerly known as Intelliject, Inc. and changed its name to kaleo, Inc. in January 2014. The company was founded in 2008 and is based in Richmond, Virginia.

111 Virginia Street

Suite 300

Richmond, VA 23219

United States

Founded in 2008

Phone:

804-545-6360

Fax:

804-545-6219

Key Executives for kaleo, Inc.

Chief Executive Officer, President and Director
Co-founder and Vice President of Product Development
Chief Financial Officer
Age: 50
Chief Operating Officer
Age: 56
Vice President and General Counsel
Compensation as of Fiscal Year 2017.

kaleo, Inc. Key Developments

U.S. FDA Approves Kaléo's AUVI-Q® 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children

kaléo announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for AUVI-Q® (epinephrine injection, USP) 0.1 mg, the first and only epinephrine auto-injector (EAI) specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5 to 33 pounds (7.5 to 15 kilograms) who are at risk for or have a history of serious allergic reactions. The sNDA for the AUVI-Q 0.1 mg Auto-injector was granted Priority Review by the FDA, an expedited regulatory pathway reserved for products that may provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to available therapies. AUVI-Q is a compact epinephrine auto-injector with industry-first features, including a voice prompt system that guides a user with step-by-step instructions through the delivery process, and a needle that automatically retracts following administration. The new 0.1 mg-dose epinephrine auto-injector has a shorter needle length and lower dose of epinephrine than current FDA approved 0.15 mg and 0.3 mg epinephrine auto-injectors. Children are increasingly being treated for anaphylaxis. There was a 129.8% 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% of children weighing 16.5 pounds (7.5 kilograms) to 33 pounds (15 kilograms) treated with a 0.15 mg EAI 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. Only AUVI-Q 0.1 mg has a dose and needle length designed specifically for treating anaphylaxis in infants and small children weighing 16.5 - 33 pounds. AUVI-Q 0.1 mg includes the innovative AUVI-Q electronic voice instruction system as well as visual cues to help guide users step-by-step through the administration.

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

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

Express Scripts Sues Kaleo over Rebate Contract Breaches

Express Scripts Holding Co. Inc. sued kaleo Inc. for allegedly breaching two rebate agreements involving Evzio, an auto-injector meant to be used in instances of opioid overdose. The complaint, filed in the U.S. District Court for the Eastern District of Missouri, claims that kaleo failed to fully pay amounts invoiced under two contracts over $13 million under the PSG Rebate Agreement and over $1.5 million under the Medicare Rebate Agreement. Under the contracts, which the companies entered into in October 2014, kaleo must pay the pharmacy benefit manager various rebates for its clients' use of Evzio prescriptions, as well as administrative fees for Express Scripts' services. Express Scripts is seeking at least $14.5 million in compensation, which covers unpaid invoices from April 2016 to January 2017, plus amounts kaleo has accrued since then.

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