News

Kaléo and the Clinton Foundation’s Health Matters Initiative
 Unite to Reduce Prescription Opioid-Related Deaths

— EVZIO® (naloxone HCl injection) and Clinton Health Matters Initiative 
in National Strategic Partnership —

Richmond, Va. (January 27, 2015) – Kaléo, a privately-held pharmaceutical company, today announced a national strategic partnership with the Clinton Health Matters Initiative (CHMI), an initiative of the Clinton Foundation, that will help support its goal of cutting prescription drug-related deaths in half, saving approximately 10,000 lives over five years. In partnership with CHMI, Kaléo will make EVZIO® (naloxone HCl injection) Auto-Injector, an emergency treatment for opioid overdose, available at a discount to colleges and universities, public safety organizations and community organizations placing this potentially life-saving medicine in the hands of those who can intervene quickly.

“I am pleased Kaléo has taken this important step with our Health Matters Initiative to create a nationwide expansion of this lifesaving medication by establishing a more predictable and affordable pricing arrangement for law enforcement professionals, community programs, and colleges and universities around the country,” said President Bill Clinton.

Opioid overdose is a growing public health epidemic.¹ Forty-four (44) people die from prescription opioids every day in the United States,² most occur in the home and are witnessed by family or friends.³ Approved by the U.S. Food and Drug Administration (FDA) in 2014, EVZIO is the only naloxone product approved for immediate use as emergency treatment of known or suspected opioid overdose in settings where opioids may be present, such as in a home or college dormitory.⁴ There is no generic equivalent to EVZIO.

The partnership between Kaléo and CHMI is an outcome of an April 2014 working meeting convened by CHMI, in which the FDA and key stakeholders in government, industry, and community groups met to identify opportunities to expand naloxone access in local communities.

The new endeavor, announced on Monday at the Clinton Foundation’s Health Matters Annual Activation Summit in California, will make EVZIO available at a discount close to federal pricing, such as the Federal Supply Schedule (FSS), to qualifying organizations that are not covered by insurance or eligible for FSS pricing.

“The Clinton Health Matters Initiative is interested in finding real solutions to a problem that is devastating our communities, and we are honored to be their partner in this effort,” said Spencer Williamson, the Chief Executive Officer of Kaléo. “As a company committed to saving lives, nothing makes us prouder than knowing our product is making a difference on the frontline of this epidemic.”

Seconds count during an opioid overdose; without rapid intervention, brain injury or death can occur within minutes.⁵ Visual and voice instructions that guide a person through the injection process make EVZIO easy to use by friends, caregivers or first responders during a suspected opioid emergency.⁶ Although not a substitute for emergency medical care, the immediate use of EVZIO may temporarily reverse the effects of the opioid to help keep the person breathing until emergency medical care arrives.⁴

Three out of four Americans now have insurance coverage for EVZIO. The typical out of pocket cost for an insured patient is less than $30 for a prescription that includes two auto-injectors and a trainer.⁶ EVZIO is also broadly covered by government insurance plans including the U.S. Veterans Administration and Tricare. Uninsured patients 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.

For downloadable information about EVZIO, opioid overdose and Kaléo, including visuals and video content, visit the media resource page at: www.evziomedia.com.

About Overdose and Opioid-Induced Respiratory Depression (OIRD)

Opioid overdose is a growing public health epidemic. Forty-four (44) people die from prescription opioids every day in the United States; most occur outside of medical settings, such as in a home.^2,3 Approximately 136,000 opioid overdose emergency department visits occur each year.⁷ On average, 3,300 children five years old and younger are admitted to emergency departments each year due to accidental opioid exposure.⁸

Opioid overdose results 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.⁹ There may be an increased risk of life-threatening OIRD, even when taking the prescribed dose of an opioid as directed, if taking high doses,¹⁰ 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, asthma).10 Seconds count when a life-threatening OIRD event occurs. Without rapid intervention, brain injury or death can occur within minutes.⁵ 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.¹²

About EVZIO (EVV-zee-oh)

EVZIO is a take-home naloxone auto-injector with visual and voice instructions to make it easy to use by family members and caregivers. EVZIO was approved by FDA in 2014 and is the only naloxone product approved for immediate administration as emergency treatment for opioid overdose in settings where opioids may be present, such as in a dormitory or home. The injectable form of naloxone HCl was first approved by FDA in 1971 and has been the standard of care for the treatment of opioid overdose in the hospital and by emergency medical services for over 40 years.^13,14

EVZIO is a prescription medicine used for the treatment of an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond. EVZIO is to be given right away by a caregiver and does not take the place of emergency medical care. Caregivers should get emergency medical help right away after the first dose of EVZIO, even if the person wakes up.⁴ Studies demonstrate 90% of users can correctly administer EVZIO without training, and 100% with training.⁶ 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.

EVZIO INDICATION

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.⁴

EVZIO IMPORTANT SAFETY INFORMATION⁴

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 www.EVZIO.com.

About the Clinton Health Matters Initiative

The Clinton Health Matters Initiative works to improve the health and well-being of people throughout the United States across all generations. CHMI builds strategic partnerships to implement evidence-based systems and environmental and investment strategies, with the goals of ultimately reducing the prevalence of preventable diseases, reducing healthcare costs associated with preventable diseases, and reducing health disparity and inequity gaps. CHMI builds scalable solutions to address the drivers of health and wellness, serves as a catalyst for community health transformation by convening local partners and commitment-makers, and leverages the digital platform to innovate and disseminate best practices.

About the Clinton Foundation

The Bill, Hillary & Chelsea Clinton Foundation convenes businesses, governments, NGOs, and individuals to improve global health and wellness, increase opportunity for women and girls, reduce childhood obesity, create economic opportunity and growth, and help communities address the effects of climate change. Because of our work, 26,000 American schools are providing kids with healthy food choices in an effort to eradicate childhood obesity; 36,000 farmers in Malawi and Tanzania have improved their incomes by more than 500 percent; 33,500 tons of greenhouse gas emissions being reduced annually across the U.S.; more than 5,000 people have been trained in marketable job skills in Colombia; 8.2 million people have access to lifesaving HIV/AIDS medications; $200 million in strategic investments have been made, impacting the health of 75 million people in the U.S.; and members of the Clinton Global Initiative have made nearly 3,100 Commitments to Action to improve more than 430 million lives around the world.

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 kaleo.com.

1. Centers for Disease Control and Progression. CDC Vital Signs: “Prescription Painkiller Overdoses” July 2013. http://www.cdc.gov/vitalsigns/PrescriptionPainkillerOverdoses/index.html. Accessed December 22, 2014.
2. Centers for Disease Control and Prevention (2015). Deaths: Final data for 2013. National vital statistics reports; vol 64 no 2. http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_02.pdf Accessed January 16, 2015.
3. Paulozzi LJ. Prescription drug overdoses: a review. J Safety Res. 2012 Sep;43(4):283-9.
4. EVZIO Prescribing Information. Kaléo. 2014.
5. Anoxic Brain Damage. http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/anoxic-brain-damage. Accessed December 22, 2014.
6. Data on file. Kaléo. 2014.
7. Yokell et al. Presentation of Prescription and Nonprescription Opioid Overdoses to US Emergency Departments. JAMA Intern Med. 2014; 174(12):2034-2037.
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9. Food and Drug Administration. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics, 2014.
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12. World Health Organization. Community management of opioid overdose. http:// apps.who.int/iris/bitstream/10665/137462/1/9789241548816_eng.pdf. Accessed January 20, 2015.
13. Green TC, Heimer R, Grau LE. Distinguishing signs of opioid overdose and indication for naloxone: an evaluation of six overdose training and naloxone distribution programs in the United States. Addiction. 2008;103(6):979-989.
14. Beletsky L, Ruthazer R, Macalino GE, et al. Physicians’ knowledge of and willingness to prescribe naloxone to reverse accidental opiate overdose: challenges and opportunities. J Urban Health. 2007;84(1):126-136.

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