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More than 100 Lives Reported Saved Since Launch of the "kaleo Cares" EVZIO® (naloxone HCl injection) Donation Program

- Donated EVZIO® Auto-injectors Contribute to Lives Saved by First Responders and Community Organizations -

RICHMOND, Va., Aug. 31, 2015 /PRNewswire/ -- Kaléo, a privately-held pharmaceutical company, today announced that EVZIO® (naloxone HCl injection) Auto-Injectors—donated through their charitable donation program, "kaléo Cares,"—have been administered to help save more than 100 lives since inception of the charitable program. EVZIO is the only 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.

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Based on retrospective literature searches and reports from grantees, EVZIO Auto-injectors have helped save at least 126 lives between October 1, 2014 and August 28, 2015. The actual number of lives saved may be higher as there are no mandatory reporting requirements as part of the kaléo Cares program.

"We made it clear from day one that kaléo is determined to help make EVZIO available to all who may benefit, including people in need without traditional insurance coverage," 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 two lives every week." 

The "kaléo Cares Product Donation Program" is intended for certain qualifying non-profit community organizations and first responder agencies demonstrating need. Since the launch of the program, EVZIO Auto-injectors have been donated to 138 first responder agencies or non-profit community-based organizations. 

Since deploying EVZIO in the field on July 13, 2015, police officers in Madison, WI have already used the EVZIO auto-injectors on eight occasions to help save people experiencing opioid emergencies. "Thanks to the generous donation of the EVZIO talking naloxone auto-injectors provided through a grant process from kaléo, my line officers, supervisors, detectives and even command staff feel empowered to confidently administer a life-saving drug in a timely fashion," said Madison Police Chief, Joel Despain. "The ability for an officer to literally save a life-- could there be a better illustration of what a 'guardian' should be doing for the community?"

In opioid emergencies, such as an accidental overdose, seconds count, and immediate treatment can be the difference between life and death. "In the past, loved ones had few options during an opioid emergency other than to call 911 and hope EMS arrived in time," said Eric S. Edwards, MD, PhD, Chief Medical Officer of kaléo. "EVZIO is the only naloxone product that provides visual and voice instructions to help make it easy to administer naloxone during a stressful opioid emergency. Studies demonstrate, on average, 94 percent of users can correctly administer EVZIO without training, and 100 percent with training."

"After hearing about Live4Lali's work to fight the opioid overdose epidemic in the Chicago area, kaléo made a generous donation of EVZIO," said Chelsea Laliberte, the Executive Director of Live4Lali, Inc., a non-profit community group. "That donation has already helped save lives and means fewer mothers burying their children and fewer communities rocked by tragedy. The compassion and commitment kaléo has shown to those affected by the opioid overdose crisis is unparalleled." 

EVZIO, available in the United States by prescription, provides a proven injectable route of administration. The needle is not visible before, during or after injection. There is no generic equivalent to EVZIO.

For more information about "kaléo Cares" or to apply for a charitable product donation, 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. Sixty-seven (67) people die from opioids, including prescription opioid analgesics and heroin, every day 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 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 intelligent voice and visual instruction system designed to help guide a caregiver or family member confidently through a highly stressful opioid emergency. Results averaged across two independent studies demonstrate more than 94 percent of users can correctly administer EVZIO without training, and 100 percent 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.4 Based on the latest information, the median out of pocket cost for patients who have received EVZIO is $17 for a prescription that includes two auto-injectors and a trainer.2 Individuals 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.2 For details on specific plans, please visit http://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 visit http://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:

  • Due to the duration of action, keep the patient under continued surveillance and repeated doses of naloxone should be administered, as necessary, while awaiting emergency medical assistance.
  • Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
  • Reversal of respiratory depression by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete.
  • Use in patients who are opioid dependent may precipitate acute abstinence syndrome.
  • Patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects should be monitored in an appropriate healthcare setting.
  • In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated.

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%20PI.PDF.

About kaléo (kuh-LAY-oh)

Kaléo is a pharmaceutical company dedicated to building innovative solutions for serious and life-threatening medical conditions.  On April 3, 2014, the FDA approved EVZIO, the only naloxone product approved for immediate administration by family members or caregivers as emergency therapy for the treatment of known or suspected opioid overdose in settings where opioids may be present. The company's first product approval, Auvi-Q® (www.Auvi-Q.com) (Allerject® in Canada), was licensed to Sanofi which launched the product in early 2013. 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. Specific Drugs involved in Drug Poisoning Deaths, 2008-2013.http://www.cdc.gov/nchs/pressroom/heroin_deaths.pdf. Accessed July 21, 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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