Rx News

More than 600 Lives Reported Saved Since Launch of the "kaleo Cares" EVZIO® (naloxone HCl injection) Auto-injector Donation Program

January 12, 2016

RICHMOND, Va., Jan. 12, 2016 kaléo, a privately-held pharmaceutical company, today announced that EVZIO^® (naloxone HCl injection) Auto-Injectors -- donated through their kaléo Cares Product Donation Grants program -- have been administered to help save more than 600 lives since inception of the charitable program.

EVZIO was the first take-home naloxone product approved for immediate administration as emergency therapy in settings where opioids may be present, such as in a home where most opioid overdose emergencies occur.

While the exact number of lives saved with the help of EVZIO auto-injectors is unknown because there are no mandatory reporting requirements as part of the kaléo Cares Product Donation Program, reports from grantees indicate that EVZIO has been used to treat more than 600 suspected opioid overdoses between October 1, 2014 and December 31, 2015.

"Since we started handing out the donated product, the auto-injectors have been used to help save at least 314 people," said Chloe Blalock, Program Coordinator for Homeless Health Care Los Angeles (HHCLA). "More than one-third of the auto-injectors we have distributed have been used to successfully reverse an opioid overdose." Since November, 2014, kaléo has donated more than 1000 EVZIO auto-injectors and 500 Trainers for EVZIO to HHCLA.

"At kaléo, our goal has always been to get our potentially life-saving products into the hands of anybody who might need them. The kaléo Cares Product Donation program is one of many tools we utilize to get EVZIO into the hands of those who might not otherwise have access," said Spencer Williamson, President and CEO of kaléo. "Since initiating the program in October 2014, our donated EVZIO Auto-injectors have helped save an average of nearly 10 lives per week. We take great pride in the program and are committed to continuing it as we enter a new year."

"Thanks to kaléo's donation, we have more than 75 people who have been treated to date with the EVZIO auto-injectors and are alive today," said Robert Child, executive director of the North Carolina Harm Reduction Coalition. "EVZIOs are helping to give our sons and daughters a second chance on life."

The kaléo Cares Product Donation Program is intended for qualifying public interest organizations, such as first responder groups for use in the field or for qualifying non-profits, harm reduction groups and health departments who intend to distribute product to patients facing financial hardships who do not have insurance coverage for prescription medicines. Since the implementation of the program in October, 2014 kaléo has donated EVZIO to more than 200 organizations in 33 states, including more than 120 law enforcement and other first responder organizations.

Police in Fayetteville, Georgia received EVZIO in May of 2015. "Since that time, our officers have helped save ten people from possible death as a result of an opioid overdose," said Fayetteville Police Captain, Lars Paul. "Officers hold the EVZIO auto-injector in high regard because of its ease of use. We cannot thank kaléo enough for their generous donation of this lifesaving equipment."

"Drug overdose has become a huge problem in our area," acknowledged Chief Gary Yandura of the Brookhaven Police Department in Brookhaven, Georgia."Anytime there is a chance for a police officer to save a life they should have the tools to help make them successful," he added."EVZIO has been that tool. We use it to help save lives and give second chances."

For more information about kaléo Cares or to apply for a charitable product donation of EVZIO, please visit www.kaleopharma.com/who-we-are/kaleo-cares/.

About Opioid-Induced Respiratory Depression (OIRD) and Overdose
Opioid emergencies, such as an accidental overdose, are a growing public health epidemic. On average, eighty (80) people die from opioids, including prescription opioid analgesics and heroin, everyday in the United States; most occur outside of medical settings, such as in a home.¹ Approximately 136,000 opioid overdose emergency department visits occur each year.² Many communities throughout the United States are facing a devastating heroin epidemic. Additionally, there are nearly two times the number of prescription opioid-related deaths as compared to heroin-related deaths. On average, 3,300 children five years old and younger are admitted to emergency departments each year due to accidental opioid exposure.³

Life-threatening opioid emergencies result in respiratory and/or central nervous system depression. Opioid-Induced Respiratory Depression (OIRD) is the most important serious adverse effect of opioids as it can be immediately life-threatening. In addition to the clear risk of an opioid overdose associated with an opioid use disorder, there may be an increased risk of life-threatening OIRD, even when patients take a prescribed dose of an opioid as directed. For example, taking high doses, taking an opioid in combination with other drugs (e.g., benzodiazepines) or alcohol, or if there is a history of certain medical conditions (e.g., COPD, severe asthma) places individuals at significantly higher risk for life-threatening OIRD. Seconds count when a life-threatening OIRD event occurs. Without rapid intervention, brain injury or death can occur within minutes. Most life-threatening OIRD emergencies occur in the home and are witnessed by family and friends who may be in the best position to intervene quickly.

Naloxone is an opioid antagonist that displaces opioids from the receptors in the brain, temporarily reversing the life-threatening breathing problems that can occur during an opioid emergency.

About EVZIO (EVV-zee-oh)
EVZIO is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. EVZIO is intended for immediate administration as emergency therapy in settings where opioids may be present. EVZIO is not a substitute for emergency medical care. EVZIO is the only naloxone product with an intelligentvoice and visual instruction systemdesigned to help guidea caregiver or family memberconfidently through a highly stressful opioid emergency. Results averaged across two independent studies demonstrate more than 94% of users can correctly administer EVZIO without training, and 100% with training.⁴ Each EVZIO pre-filled, single-use, hand-held auto-injector delivers a single 0.4 mg dose of naloxone HCl injection. Each EVZIO prescription comes with two auto-injectors and a Trainer. For more information on EVZIO, visit www.EVZIO.com.

Three out of four insured Americans are covered for EVZIO. Based on the latest information, the median out of pocket cost for patients who have received EVZIO is under $20 for a prescription that includes two auto-injectors and a Trainer.²Individuals with commercial insurance may be eligible to have EVZIO mailed directly to their home for a $0 copay. EVZIO is also covered broadly by government insurance plans including the U.S. Veterans Administration, Tricare and the majority of state Medicaid programs.²For details on specific plans, please visithttp://evzio.com/hcp/resources/insurance-coverage.php.

Uninsured individuals who are not qualified for Medicare or Medicaid, and are experiencing financial difficulties, may be eligible to receive EVZIO at no cost through the kaléo Cares Patient Assistance Program. For more information, please visithttp://EVZIO.com/patient/savings-support/patient-assistance-program.php.

EVZIO IMPORTANT SAFETY INFORMATION
EVZIO is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the ingredients in EVZIO.

The following warnings and precautions should be taken when administering EVZIO:

The following adverse reactions have been identified during use of naloxone hydrochloride in the postoperative setting: hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone hydrochloride in postoperative patients have resulted in significant reversal of analgesia and have caused agitation.

Abrupt reversal of opioid effects in persons who were physically dependent on opioids has precipitated signs and symptoms of opioid withdrawal including: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying, and hyperactive reflexes.

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. For full Prescribing Information visit http://evzio.com/pdfs/Evzio PI.PDF.

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. Each kaléo product combines an established drug with an innovative delivery platform with the goal of achieving superiority and cost effectiveness. Kaléo is a privately-held company headquartered in Richmond, Virginia. For more information, visit www.kaleopharma.com.

¹ Centers for Disease Control and Prevention. Increase in Drug and Opioid Overdose Deaths—United States, 2000-2014. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6450a3.htm?s_cid=mm6450a3_w. Accessed 01/04/2015
² Yokell et al. Presentation of Prescription and Nonprescription Opioid Overdoses to US Emergency Departments. JAMA Int. Med. 2014; 174(12):2034-7.
³ Burghardt L, et al. Adult Prescription Drug Use and Pediatric Medication Exposures and Poisonings. Pediatrics. 2013; 132:18-27.
⁴ EVZIO (Naloxone Hydrochloride Injection) Auto-injector [Data on File]. Richmond, VA: Kaleo, Inc.

Contact: Mark Herzog
kaléo
mark.herzog@kaleopharma.com
804-545-6360 (office)

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