EVZIO® (naloxone HCI injection, USP) Auto-
`1 njector Now Available to Patients in Select
`States Without a Prescription Through
`Kaleo·s New Virtual Standing Order Pilot
`Program and to Government Agencies at a
`Direct Purchase Price
`-- kaleo announces bold new initiatives in support of U.S. Surgeon General's Advisory
`on Naloxone and Opioid Overdose --
`
`NEWS PROVIDED BY
`Kaleo-+
`Apr 05, 2018, 08:36 ET
`
`RICHMOND, Va., April 5, 2018 /PRNewswire/ -- Kaleo, a privately-held pharmaceutical company,
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`today announced two new initiatives to help further expand access to EVZIO® (naloxone HCI
`
`injection, USP) Auto-Injector in support of the Surgeon General's Advisory on Naloxone and
`
`Opioid Overdose emphasizing the importance of naloxone:
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`• Effective today-Through kaleo's new "Virtual Standing Order" program, those with
`commercial insurance, without a prescription, can receive EVZIO at no cost by calling 1-
`877-883-8946 to talk to a pharmacist and arrange delivery of naloxone directly to their
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`home. The Virtual Standing Order is now available for patients in six states as part of the
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`initial pilot program: Arizona, California, Colorado, Missouri, Nevada and Ohio. Kaleo plans
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`to expand the Virtual Standing Order program to additional states.
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`Opiant Exhibit 2134
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00688
`Page 1
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`• Also effective today, kaleo is introducing a direct purchase price of $180 per auto-injector
`of EVZIO ($360 per pack of two auto-injectors and a trainer) to all federal and state
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`government agencies and tribes who purchase the product directly from kaleo, including
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`those agencies who receive federal grant funding to address the opioid overdose
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`epidemic. To obtain more information, please visit https://evzio.com/patient/direct(cid:173)
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`purchase/.
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`In addition, commercially-insured patients who are being treated by a healthcare provider and
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`receive a prescription can continue to obtain EVZIO for $0 out of pocket through kaleo's
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`EVZIO2YOU program. Kaleo will also continue to donate product through the kaleo Cares
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`Product Donation Program, which has donated, free of charge, more than 320,000 EVZIO
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`naloxone auto-injectors nationwide to qualifying non-profits and first responders
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`demonstrating need. For a complete summary of the comprehensive access program
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`(including the terms and conditions) for EVZIO, visit www.evzio.com/patient/evzio2you.
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`In speaking about naloxone today, the surgeon general stated, "It is time to make sure more
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`people have access to this lifesaving medication, because 77 percent of opioid overdose deaths
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`occur outside of a medical setting and more than half occur at home."
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`EVZIO-an auto-injector designed to be easy to use-provides simple, on-the-spot voice and
`visual guidance to help those with no medical training administer naloxone during an opioid
`overdose. EVZIO is not a substitute for emergency medical care.
`
`The two initiatives announced today expand upon kaleo's commitment to help ensure broad
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`access to EVZIO. In 2016, kaleo created a first-of-its-kind access program for EVZIO, which
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`allows the more than 200 million Americans with commercial insurance and a prescription(cid:173)
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`even those who have high-deductible health plans-to receive EVZIO for $0 out of pocket. Even
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`in cases where a patient's commercial insurance does not cover EVZIO, kaleo ensures that they
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`can obtain it for absolutely nothing out of pocket. Kaleo stands ready to work with government
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`agencies, physicians, advocacy groups, and managed care organizations to ensure broad,
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`affordable access to EVZIO.
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`"We are proud to support the Surgeon General's Advisory on Naloxone and Opioid Overdose,"
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`said Spencer Williamson, CEO of kaleo. "If we empower more patients to have access to this
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`potentially life-saving medicine, we believe that EVZIO may help reduce the number of tragic
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`Opiant Exhibit 2134
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00688
`Page 2
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`deaths from opioid overdose across the nation."
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`About kaleo (kuh-LAY-oh)
`
`Kaleo is a pharmaceutical company dedicated to building innovative solutions for serious and
`
`life-threatening medical conditions. Our mission is to provide innovative solutions that
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`empower patients to confidently take control of their medical conditions. We believe patients
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`and caregivers are the experts on how their medical condition impacts their lives and are an
`
`integral part of our product development process. Each kaleo product combines an
`
`established drug with an innovative delivery platform. Kaleo is a privately-held company
`
`headquartered in Richmond, Virginia. For more information, visit www.kaleopharma.com.
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`INDICATION
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`EVZIO is a prescription medicine used in adults and children for the treatment of an opioid
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`emergency such as an overdose or a possible opioid overdose with signs of breathing problems
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`and severe sleepiness or not being able to respond. EVZIO is to be given right away and does
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`not take the place of emergency medical care. Get emergency medical help right away after
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`the first dose of EVZIO, even if the person wakes up. EVZIO is safe and effective in children for
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`known or suspected opioid overdose.
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`IMPORTANT SAFETY INFORMATION
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`What is the most important information I should know about EVZIO?
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`EVZIO is used to temporarily reverse the effects of opioid medicines. The medicine in EVZIO has
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`no effect in people who are not taking opioid medicines. Always carry EVZIO with you in case
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`of an opioid emergency.
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`Use EVZIO right away if you or your caregiver think signs or symptoms of an opioid emergency
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`are present, even if you are not sure, because an opioid emergency can cause severe injury or
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`death. Signs and symptoms of an opioid emergency may include:
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`Opiant Exhibit 2134
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00688
`Page 3
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`• unusual sleepiness and you are not able to awaken the person with a loud voice or
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`rubbing firmly on the middle of their chest (sternum)
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`• breathing problems including slow or shallow breathing in someone difficult to awaken
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`or they look like they are not breathing
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`• the black circle in the center of the colored part of the eye (pupil) is very small, sometimes
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`called "pinpoint pupils" in someone difficult to awaken
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`Family members, caregivers, or other people who may have to use EVZIO in an opioid
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`emergency should know where EVZIO is stored and how to give EVZIO before an opioid
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`emergency happens.
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`Get emergency medical help right away after using the first dose of EVZIO. Rescue breathing or
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`CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.
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`The signs and symptoms of an opioid emergency can return within several minutes after EVZIO
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`is given. If this happens, give additional injections using new EVZIO auto-injectors every 2 to 3
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`minutes and continue to closely watch the person until emergency help is received.
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`Who should not use EVZIO?
`Do not use EVZIO if you are allergic to naloxone hydrochloride or any of the ingredients in
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`EVZIO.
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`What are the ingredients in EVZIO?
`Active ingredient: naloxone hydrochloride
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`Inactive ingredients: sodium chloride, hydrochloric acid to adjust pH, and water
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`What should I tell my healthcare provider before using EVZIO?
`Tell your healthcare provider about all of your medical conditions, including if you:
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`• have heart problems
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`• are pregnant or plan to become pregnant. Use of EVZIO may cause withdrawal symptoms
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`in your unborn baby. Your unborn baby should be examined by a healthcare provider right
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`away after you are given EVZIO.
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`Opiant Exhibit 2134
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00688
`Page 4
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`Tell your healthcare provider about the medicines you take, including prescription and over(cid:173)
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`the-counter medicines, vitamins, and herbal supplements.
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`What are the possible side effects of EVZIO?
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`EVZIO may cause serious side effects, including:
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`Sudden opioid withdrawal symptoms. In someone who has been using opioids regularly,
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`opioid withdrawal symptoms can happen suddenly after receiving EVZIO and may include:
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`body aches, fever, sweating, runny nose, sneezing, goose bumps, yawning, weakness, shivering
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`or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, stomach
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`cramping, increased blood pressure, and increased heart rate.
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`In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid
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`withdrawal may be life-threatening if not treated the right way. Signs and symptoms include:
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`seizures, crying more than usual, and increased reflexes.
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`Common side effects of EVZIO include dizziness and injection site redness.
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`These are not all of the possible side effects of EVZIO. Call your doctor for medical advice about
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`side effects. You are encouraged to report negative side effects of prescription drugs to the
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`FDA. Visit www.fda.gov/medwatch or call l-800-FDA-1088. Please click here to see the full
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`Prescribing Information and the Patient Information, or visit www.evzio.com.
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`SOURCE Kaleo
`
`Related Links
`
`http://www.ka leopha rma.com
`
`https://www.prnewswire.com/news-releases/evzio-naloxone-hcl-injection-usp-auto-injector-now-available-to-patients-in-select-states-without-a-prescrip... 5/5
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`Opiant Exhibit 2134
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00688
`Page 5
`
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