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September 29, 2015


kaléo to Donate 50,000 EVZIO® (naloxone HCl injection) Auto-Injectors in Honor of the UNITE to Face Addiction Rally

– Donation Will Go to Local Public Health Departments in Greatest Need Nationwide

Richmond, Va. (September 29, 2015) – Kaléo, a privately-held pharmaceutical company, today announced that 50,000 EVZIO® (naloxone HCl injection) Auto-Injectors will be donated through the kaléo Cares Product Donation Program to local public health departments determined to be in greatest need across the United States. The donation, also announced today on The Dr. Oz Show, is made in honor of the UNITE to Face Addiction rally taking place October 4 on the National Mall in Washington, D.C.

“In the midst of a public health emergency surrounding addiction it is time for all of us to have improved resources. We are proud to be part of what we believe to be the largest donation of naloxone in history,” said Greg Williams, Co-Founder of Facing Addiction, the national non-profit group organizing the UNITE to Face Addiction rally. “It is time for all of us to collectively face addiction and this donation from kaléo will help save so many lives.”

EVZIO is the only naloxone product approved by the U.S. Food and Drug Administration (FDA) for immediate administration as emergency treatment of known or suspected opioid overdose in settings where opioids may be present, such as in a home where most opioid emergencies occur.

The local public health departments receiving donations will be determined based on publicly-available research provided by the U.S. Department of Health and Human Services (HHS). “Kaléo, the maker of the only FDA-approved naloxone product for use by laypersons, has launched the kaléo Cares Product Donation program,” said HHS Secretary Sylvia Mathews Burwell. “Our Department is proud to work with them, using our publicly-available data sets to get this life-saving product where it is needed most.”

“The daily death toll caused by opioid overdoses across the United States is a tragedy, and we need to use all available tools to act quickly to prevent as many of these deaths as possible,” said National Association of County and City Health Officials Executive Director LaMar Hasbrouck, M.D., M.P.H. “America’s 2,800 local health departments are playing an important role in this life-saving mission and appreciate the donation of EVZIO by kaléo and the work by the organizers of UNITE to Face Addiction to raise public awareness of the national opioid overdose epidemic.”

“This unprecedented donation is designed to help make EVZIO available to those without traditional insurance coverage who are being served by local public health departments determined to be in greatest need,” said Spencer Williamson, President and CEO of kaléo. “Since the launch of the kaléo Cares Product Donation Program last October, donated EVZIO have contributed to more than 135 reported lives saved. We believe this latest donation will help save hundreds of people in the months ahead.”

During an opioid emergency, such as an accidental overdose, seconds count, and immediate treatment can be the difference between life and death. “EVZIO provides visual and voice instructions to help make it easy to use by friends, family or caregivers with little to no training,” said Eric Edwards, M.D., Ph.D., Chief Medical Officer of kaléo. “In fact, studies demonstrate 94 percent of users can correctly administer EVZIO without training, and 100 percent with training.”

EVZIO, available in the United States by prescription, provides a proven injectable route of administration without the need for a user to see or handle the needle directly. There is no generic equivalent to EVZIO.

For more information about the UNITE to Face Addiction rally, visit www.facingaddiction.org.

The kaléo Cares Product Donation Program is intended for certain qualifying non-profit community organizations and first responder agencies demonstrating need. For more information about kaléo Cares, please visit kaleopharma.com/who-we-are/kaleo-cares/.

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About Overdose and Opioid-Induced Respiratory Depression (OIRD)

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 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. Based on the latest information, the median out of pocket cost for patients who have received EVZIO is less than $20 for a prescription that includes two Auto-injectors and a Trainer. Certain 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. 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 kaleopharma.com.

Media Contact:
Mark Herzog
kaléo
mark.herzog@kaleopharma.com
804-545-6360 ext. 318 (office)

  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.