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January 25, 2016


kaléo Announces the Award of its 100th Patent

– Latest U.S. Patent is for Electronic Voice and Visual Instruction System used in EVZIO® (naloxone HCl injection) Auto-Injector –

Richmond, Va. (January 25, 2016) – kaléo, a privately-held pharmaceutical company dedicated to building innovative solutions for serious and life-threatening medical conditions, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. patent number 9,238,108, entitled “Medicament Delivery Device Having an Electronic Circuit System” that covers aspects of the electronic voice and visual instruction technology included in its FDA approved product EVZIO® (naloxone HCl injection) Auto-injector. 100 patents have now been awarded to kaléo by domestic and international patent authorities.

The 100 U.S. and foreign patents awarded to kaléo not only cover the company’s drug products and award-winning auto-injector platforms, but also unique demonstration devices, compliance tracking solutions, drug delivery devices, and other novel technologies.

“This will be the twentieth patent for our naloxone product, EVZIO, listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book,” said Evan Edwards, co-founder and Vice President of Product Development and Industrialization. “Our Human Factors Engineering product development process led to the invention of EVZIO, and other innovative products that are designed with the end user in mind.”

Human Factors Engineering (HFE) is central to kaléo’s collaborative approach to product development. Kaléo utilizes HFE, in which patients and caregivers are directly involved, in the development and design of potentially life-saving medical products intended to be used in emergency situations.

“Administering emergency medicines correctly, especially in stressful and potentially life-threatening situations, is a major concern for physicians, patients and their loved ones,” said Spencer Williamson, President and CEO of kaléo. “Our process of collaborating with patients helps ensure that every aspect of our product design and usability is evaluated through their real world experiences.”

The company has invested more than $100 million in the research, development and commercialization of EVZIO, the first take-home naloxone auto-injection system approved by the FDA for immediate administration in settings where opioids may be present, such as in a home where most opioid overdose emergencies occur.

Ron Gunn, Chief Operating Officer, said, “We are proud to achieve this important milestone and continue to invest in R&D for the next generation of innovative technologies that fulfill unmet medical needs.”

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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% of users can correctly administer EVZIO without training, and 100% with training.1 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 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 PI.PDF.

About kaléo (kuh-LAY-oh)

Kaléo is a pharmaceutical company dedicated to building innovative solutions for serious and life-threatening medical conditions. 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. Kaléo is a privately-held company headquartered in Richmond, Virginia. For more information, visit kaleopharma.com.

1 EVZIO (Naloxone Hydrochloride Injection) Auto-injector [Data on File]. Richmond, VA: Kaleo, Inc.