Emergent BioSolutions Reinforces Commitment to Opioid Emergency Preparedness Efforts in Canada Through Multi-Year Contract with Ontario Ministry of Health

WINNIPEG, Manitoba, May 01, 2025 (GLOBE NEWSWIRE) -- Today, Emergent BioSolutions Inc. (NYSE:EBS) announced a maximum three-year agreement with a value of approximately $65 million to supply the Ontario Ministry of Health with NARCAN^® Nasal Spray for the Ontario Naloxone Program (ONP). Since 2018, Emergent has supported the Ontario Ministry of Health to provide access to NARCAN^® Nasal Spray across the province. NARCAN^® Nasal Spray is designed to reverse the effects of an opioid poisoning in minutes and is the only 4 mg, intranasal naloxone spray in Canada with a shelf life of four years (48 months).

From January through March 2025, there were 653 suspect drug-related fatalities in Ontario, which is an average of 7 lives lost per day.¹ Data show a promising 30 per cent decrease in overdose deaths from the same period last year.² Opioid poisonings continue to be a significant threat, and therefore, greater access to life-saving medications, such as NARCAN^® Nasal Spray, remain critically important.

"This agreement marks another important step in Emergent's ongoing commitment to addressing opioid poisoning deaths in Canada," said Paul Williams, SVP and products business head, Emergent. "We applaud the Ontario Ministry of Health for their commitment to continuing to ensure access to intranasal naloxone to meet demand. By providing Ontario with NARCAN^® Nasal Spray, we continue to put this life-saving tool in the hands of more people who will now be ready to act in an opioid emergency when every minute counts."

As part of the contract, Emergent will supply the ONP with NARCAN^® Nasal Spray to distribute across the province to individuals at risk of opioid overdose, and their friends and family via participating community-based organizations, including public health units, outreach programs, hospital emergency departments, urgent care and inpatient units, first responders, community health centers and more.

"Our government is helping more people get the treatment and support they need, when and where they need it," said Sylvia Jones, Ontario Deputy Premier and Minister of Health. "The Ontario Naloxone Program provides people at risk of opioid overdose with access to lifesaving naloxone. We're pleased to continue working with Emergent to provide intranasal naloxone to those at risk of opioid poisoning and to community members who may have a loved one at risk."

This announcement follows Health Canada's recent approval of KLOXXADO® Nasal Spray 8 mg. Emergent remains committed to bolstering the nation's efforts to combat the opioid epidemic. Learn more about Emergent's commitment in Canada via this National Impact Map resource.

About NARCAN^® Nasal Spray

NARCAN^® Nasal Spray is a pure opioid antagonist indicated for emergency use to reverse known or suspected opioid overdose, as manifested by respiratory and/or severe central nervous system depression.

While NARCAN^® Nasal Spray can be administered by a non-health care professional, it is not intended to be a substitute for professional medical care. Always call 911 as soon as an opioid overdose is suspected, before administering NARCAN^® Nasal Spray.

Always read the label and follow the directions for use.

Important Safety Information for KLOXXADO^® (naloxone HCl) Nasal Spray 8 mg

Contraindications

Hypersensitivity to naloxone hydrochloride or to any of the other ingredients in KLOXXADO^®

Warnings and Precautions

• KLOXXADO^® is used in adults to treat an opioid overdose. It can be used to reverse the effects of an
• overdose until medical help arrives. Use KLOXXADO^® right away if you suspect an opioid overdose emergency, even if you are not sure, because an opioid overdose emergency can cause severe injury or death. Signs and symptoms of an opioid overdose may include:
  • trouble breathing or not breathing
  • extreme drowsiness
  • pale and clammy skin
  • slow or no heartbeat
  • passing out
  • unable to be woken up by touch, shaking of shoulders or shouting
  • Very small pupils, like a pinpoint
• Family members, caregivers or other people who may have to use KLOXXADO^® in an opioid overdose emergency should know where KLOXXADO^® is stored and how to give KLOXXADO^® before an opioid overdose emergency happens.
• Always seek immediate medical help when using KLOXXADO^®. Rescue breathing or CPR (cardiopulmonary resuscitation) may be needed while waiting for emergency medical help.
• The signs and symptoms of an opioid overdose emergency can return after KLOXXADO^® is given. If this happens, give another dose after 2 to 3 minutes, using a new KLOXXADO^® device, in the other nostril, and watch the person closely until emergency medical help arrives.
• Do not use KLOXXADO^® if you are allergic to naloxone hydrochloride or any of the ingredients in KLOXXADO^®.
• KLOXXADO^® can cause sudden and severe opioid withdrawal, the symptoms of which may include body aches, diarrhea, rapid heartbeat, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramps, weakness and high blood pressure.
• KLOXXADO^® is not indicated for pediatric use. In an emergency, if KLOXXADO^® is administered to an infant because no other options are available, they may experience additional withdrawal symptoms such as: seizures, crying more than usual and overactive reflexes. These symptoms may be life-threatening if not treated right away. If KLOXXADO^® is given to an infant, seek immediate medical help.
• Tell your doctor about all of your medical conditions before using KLOXXADO^®, including if you have heart disease or any other heart problems, are pregnant or think you are pregnant, or are breastfeeding or plan to breastfeed.
• Tell your doctor about all of the medicines you take, including any prescription and over-the-counter medicines, drugs, vitamins, minerals, natural supplements and alternative medicines.
  
  

Side Effects

The following side effects are discussed in the full Patient Medication Information for KLOXXADO^®:

• Body aches, stomach cramps
• Diarrhea
• Rapid heartbeat
• Fever
• Runny nose, sneezing
• Goosebumps, shivering or trembling
• Sweating
• Yawning
• Nausea or vomiting
• Nervousness
• Restlessness or irritability
• High blood pressure

Infants may have seizures, cry more than normal and have overactive reflexes.

Some people may become aggressive after abrupt reversal of opioid overdose.

In two clinical studies, a total of 47 healthy adult volunteers were exposed to a single dose of KLOXXADO^®, one spray in one nostril. Side effects were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope. These are not all of the possible side effects of KLOXXADO^®. Contact your doctor for medical advice about side effects.

Pregnancy, Infancy and Breastfeeding, Children

Tell your doctor if you are pregnant or think you are pregnant. Use of KLOXXADO^® may cause distress to you and your unborn baby. A healthcare provider should monitor you and your unborn baby right away after you use KLOXXADO^®.

Tell your doctor if you are breast-feeding or plan to breastfeed. It is not known if KLOXXADO^® passes into breast milk.

If the primary concern is an infant at risk of an overdose, consider whether other naloxone-containing products may be more appropriate.

Dosage and Administration

Do not attempt to prime or test-fire the device. Each KLOXXADO^® Nasal Spray contains only 1 dose of medicine and cannot be reused. Read the "instructions for use" at the end of the Patient Medication Information and Medication Guide for detailed information about the right way to use KLOXXADO^® Nasal Spray.

Storage and Handling

Store KLOXXADO^® at room temperature between 59°F to 86°F (15°C to 30°C). Do not freeze KLOXXADO^®. KLOXXADO^® freezes at temperatures below -15°C. If this happens, KLOXXADO^® may be thawed by allowing it to sit at room temperature for 15 minutes. It may still be used if it has been thawed after being frozen.

Keep KLOXXADO^® in its box until ready to use. Protect from light. Replace KLOXXADO^® before the expiration date on the box. Keep KLOXXADO^® and all medicines out of the reach and sight of children.

For more information, please see the full Prescribing Information and Medication Guide, which you can find on our website at www.kloxxado.com.

• To report an adverse event or product complaint, please contact us at [email protected] or call 1-877-845-0689 or 1-800-962-8364.
• Adverse events may also be reported to the FDA directly at 1-800-FDA-1088 or www.fda.gov/medwatch.

KLOXXADO^® is a registered trademark of Hikma Pharmaceuticals USA Inc.

About Emergent BioSolutions

At Emergent, our mission is to protect and save lives. For over 25 years, we've been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today's health challenges and tomorrow's threats, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the three-year agreement to supply NARCAN^® Nasal Spray to ONP, are forward-looking statements. We generally identify forward-looking statements by using words like "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "future," "goal," "intend," "may," "plan," "position," "possible," "potential," "predict," "project," "should," "target," "will," "would," and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs and expectations regarding future events based on information that is currently available. We cannot guarantee that any forward-looking statements will be accurate. Readers should realize that if underlying assumptions prove inaccurate or if known or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake any obligation to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause the company's actual results to differ materially from those indicated by any forward-looking statements. Readers should consider this cautionary statement, as well as the risk factors and other disclosures included in our periodic reports filed with the U.S. Securities and Exchange Commission, when evaluating our forward-looking statements.

Investor Contact:

Richard S. Lindahl

Executive Vice President, CFO

[email protected]

Media Contact:

Assal Hellmer

Vice President, Communications

[email protected]

¹https://odprn.ca/occ-opioid-and-suspect-drug-related-death-data/

²https://odprn.ca/occ-opioid-and-suspect-drug-related-death-data/