Adapt Pharma Names Mike Kelly President of U.S. Operations

April 11, 2016

Contributing Over 25 Years of Pharmaceutical Expertise to Adapt Executive Team

Dublin, Ireland – April 11, 2016 – Adapt Pharma, (www.adaptpharma.com) announced today that Mike Kelly has been appointed as President of U.S. Operations. In this role, Mike will have responsibility for all of the company’s U.S. operating activities. He will report to Eunan Maguire, Chief Operating Officer of Adapt Pharma.

Mike brings nearly three decades of pharmaceutical experience, playing an instrumental role in the creation, development and strengthening of specialty brands and businesses for a number of pharmaceutical companies. He joins Adapt Pharma from Covis Pharmaceuticals, Inc., where he served as Chief Executive Officer and Board member. Prior to Covis, Mike was a member of the founding management team of Azur Pharma and later, following a strategic merger, served as Senior Vice President of Sales and Marketing for Jazz Pharmaceuticals PLC. Mike earned his Master of Business Administration from Rider University in Lawrenceville, New Jersey.

“I am delighted to welcome Mike to Adapt Pharma. Mike has established a highly successful track record in leadership roles in specialty pharmaceuticals” said Seamus Mulligan, Chairman and Chief Executive Officer of Adapt Pharma. “His experience will be of great value as Adapt Pharma expands its commercial presence, starting with the launch of NARCAN® (naloxone HCl) Nasal Spray.”

“I am excited to take on this role and look forward to working with our talented senior leadership to grow Adapt Pharma in the U.S.,” said Mike. “Most immediately, I am proud to support a product like NARCAN® Nasal Spray and expand the opportunity to help Americans, impacted by opioid overdose in our country.”

For questions regarding NARCAN® Nasal Spray distribution, please call 1-844-4NARCAN® (462-7226)

For Media Inquiries

Thom Duddy, Adapt Pharma
Executive Director, Communications
Phone: 484-532-5470
Email: thomas.duddy@adaptpharma.com

Indications

NARCAN® (naloxone hydrochloride) Nasal Spray 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. NARCAN® Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. NARCAN® Nasal Spray is not a substitute for emergency medical care.

 

Important Safety Information

NARCAN® Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.

Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.

Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.

Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.

Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal characterized by 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 some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may also include convulsions, excessive crying, and hyperactive reflexes. Monitor for the development of opioid withdrawal.

Risk of Cardiovascular (CV) Effects: Abrupt postoperative reversal of opioid depression may result in adverse CV effects. These events have primarily occurred in patients who had pre-existing CV disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.

Adverse Reactions: The following adverse reactions were observed in a NARCAN® Nasal Spray clinical study: increased blood pressure, constipation, toothache, muscle spasms, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma.

To report SUSPECTED ADVERSE REACTIONS, contact ADAPT Pharma, Inc. at 1-844-4NARCAN (1-844-462-7226) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See Instructions for Use and full prescribing information in the use of this product, available here: https://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf .

Additional information, including full prescribing information for NARCAN® Nasal Spray, and important safety information and instructions for use, is also available at www.NARCAN.com.