Kaleo Supports Opioid Overdose Emergency Treatment Efforts with EVZIO™ (naloxone hcl injection) Donations to Local Law Enforcement Agencies

RICHMOND, Va., Oct. 27, 2014 /PRNewswire/ -- Kaleo, a privately-held pharmaceutical company headquartered in Richmond, Virginia, today announced a new donation program that will allow qualifying local law enforcement agencies to receive EVZIO™ naloxone auto-injectors without charge as part of the kaleo Cares program. EVZIO, approved by the U.S. Food and Drug Administration (FDA) on April 3, 2014, 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 the first and only naloxone product approved for emergency therapy in any settings where opioids may be present, including outside of supervised medical settings. EVZIO is not a substitute for emergency medical care.

The first recipient of the kaleo Cares law enforcement donation program is the Henrico County Sheriff's Office. Located in the suburbs of Richmond, Virginia, the Sheriff's Office is comprised of more than 350 deputies and 44 civilian employees. It also maintains two nationally accredited correctional facilities with an average total population of more than 1,200 inmates.

"In an opioid overdose emergency, timing is very important and the ability of our deputies to administer naloxone with the EVZIO naloxone auto-injector, even before an ambulance arrives, can save precious time and potentially save lives," said the Honorable Michael L. Wade, Sheriff of Henrico County. "We are pleased to be the first local law enforcement agency to receive this generous donation."

"Sadly, the national opioid overdose epidemic has touched our county like hundreds across the United States," said Dianne Reynolds-Cane, M.D., Medical Director for the Henrico County Sheriff's Office, former president of the Virginia Board of Medicine and a past Fellow of the United States Federation of State Medical Boards. "It is critically important that our deputies be equipped with this potentially life-saving medicine, specifically approved by the FDA for emergency situations related to prescription opioid or heroin overdose. We are eager to deploy EVZIO as soon as possible."

"Kaleo is committed to saving lives. By having EVZIO on hand, local law enforcement officers will be able to intervene quickly during a suspected opioid overdose," said Spencer Williamson, CEO of kaleo. "We are proud to initiate this donation program that will make EVZIO, a potentially life-saving product, available to more people who may benefit from it."

Applications to receive product donation will be received and processed on a rolling submission basis for a limited time. Kaleo will provide a maximum of 200 EVZIO naloxone auto-injectors (100 cartons) per local law enforcement agency, along with training materials.

EVZIO is available in the United States by prescription. EVZIO should be administered as quickly as possible when an opioid overdose is suspected because prolonged respiratory depression may result in damage to the central nervous system or death. EVZIO has a retractable needle system that prevents user exposure to the needle before, during and after injection. The device has the ability to penetrate clothing including the seam of blue jeans. Additionally, EVZIO was successfully tested up to 6 months at temperatures as high as 104 degrees F (40 degrees C) and in studies in which temperatures cycled from 39 degrees F (4 degrees C) to 104 degrees F (40 degrees C).

For more information about kaleo Cares or to apply for donations, please visit www.kaleopharma.com/who-we-are/kaleo-cares/.

About EVZIO

EVZIO is a pre-filled, single-use, hand-held auto-injector that works by temporarily blocking the effect of an opioid, potentially reversing the life-threatening respiratory depression and to help keep a patient breathing. 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. Each EVZIO delivers a single 0.4 mg dose of naloxone HCl injection. Since the duration of action of most opioids may exceed that of naloxone, seek immediate emergency medical assistance, keep the patient under continued surveillance, and administer repeated doses of EVZIO as necessary. For more information on EVZIO, visit www.EVZIO.com.

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. Please click here for full Prescribing Information.

About kaleo Cares

To better serve communities and patients in need of access to EVZIO, kaleo offers patient assistance through its kaleo Cares program. For more information about the kaleo Cares program, please visit www.kaleopharma.com/who-we-are/kaleo-cares/.

About Opioid Overdose

According to the Institute of Medicine, chronic pain affects about 100 million American adults – more than the total affected by heart disease, cancer and diabetes combined.

Opioids are used to treat pain associated with a variety of acute and chronic medical conditions. Nearly 17,000 Americans die each year from prescription opioid overdose, and accidental drug poisoning has surpassed automobile collisions as the leading cause of accidental death in the U.S., driven largely by prescription opioids.^[1],[2] Opioid overdose can cause a person's breathing to severely slow down and even stop.^[3]

About kaleo

Kaleo is a pharmaceutical company dedicated to putting a new generation of life-saving personal medical products in patients' hands. On April 3, 2014, the FDA approved EVZIO, the first and only naloxone product labeled for immediate administration by family members or caregivers as emergency therapy for the treatment of known or suspected opioid overdose. 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 demonstrably superior medical products that empower patients and caregivers to confidently take control in potentially life-threatening situations. 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 kaleo product combines an established drug with an innovative delivery platform with the goal of achieving superiority and cost effectiveness. Kaleo is a privately-held company headquartered in Richmond, Virginia. For more information, visit www.kaleopharma.com.

©2014 kaleo, Inc. All rights reserved. PP-EVZ-US-0286 October 2014

[1] Paulozzi, L.J., Mack, K.A., and Hockenberry, J.M. Vital Signs: Variation Among States in Prescribing of Opioid Pain Relievers and Benzodiazepines — United States, 2012. July 4, 2014 / 63(26);563-568. Accessed July 1, 2014, this as an MMWR Early Release on http://www.cdc.gov/mmwr.

[2] Centers for Disease Control and Prevention. Opioid-related deaths continue to increase. http://media.jsonline.com/images/OPIOIDS20GFIX.jpg.

[3] Boyer, E. Management of Opioid Analgesic Overdose. N Engl J Med 2012; 367.

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