Emergent BioSolutions Inc. (NYSE: EBS) announced today that it
has entered into an agreement to obtain exclusive commercial rights
in the U.S. and Canada to Hikma Pharmaceuticals’ KLOXXADO®
(naloxone HCl) Nasal Spray, an 8 mg naloxone agent that is approved
for the emergency treatment of known or suspected opioid overdose,
as manifested by respiratory and/or central nervous system
depression.1 This six-year agreement complements and strengthens
Emergent’s mission to protect, enhance, and save lives by helping
to reduce opioid overdose deaths —providing compelling product
options, combined with a commitment to increasing naloxone access,
awareness, and education.
There have been great strides in the fight against the opioid
epidemic since 2018 when Emergent first acquired its flagship
product, NARCAN® Nasal Spray, which is designed to rapidly reverse
the effects of a life-threatening opioid emergency.2 A recent
report from the Centers for Disease Control and Prevention confirms
the number of opioid overdose deaths in the U.S. decreased last
year – the first meaningful decline since 2018.3 There are a
variety of factors that contributed to this decline; and such
progress reinforces the positive impact of Emergent’s comprehensive
national strategy and ongoing efforts to increase access to and
awareness of available naloxone nasal spray.
“The initial signs of progress toward stemming the tide of lives
lost to opioid overdose are promising. Emergent’s relentless
dedication to working with those on the frontlines of the epidemic,
speaking with families and caregivers, and engaging with advocates
and other critical stakeholders in the fight, underscores that even
one death is too many and our commitment to doing what we can to
help remains steadfast,” said Joe Papa, president and chief
executive officer, Emergent. “Meeting the needs of our patients and
customers by now offering two nasal naloxone products at different
strengths – NARCAN® Nasal Spray 4 mg and KLOXXADO® Nasal Spray 8 mg
– allows Emergent to do its part to help save lives from this
devastating crisis.”
Distributing both NARCAN® Nasal Spray 4 mg and KLOXXADO® Nasal
Spray 8 mg through Emergent’s expansive distribution networks will
provide federal and state leaders, community-based organizations,
harm reduction groups, law enforcement and first responders with
the flexibility to tailor their approach to opioid overdose
reversal treatment for specific patients and communities. NARCAN®
Nasal Spray is widely available nationwide over the counter and
will continue to be a trusted 4 mg naloxone standard of care in the
community setting. With its 8 mg dosage, KLOXXADO® Nasal Spray is a
prescription option for those who choose to administer a higher
dose of naloxone.
“In the midst of responding to an opioid overdose, having access
to safe and effective naloxone treatment is paramount, and NARCAN®
Nasal Spray 4 mg and KLOXXADO® Nasal Spray 8 mg are proven tools to
help reverse the effects of an opioid overdose,” said Dr. Simon
Lowry, chief medical officer, Emergent. “Broadening public
awareness and expanding access to life-saving naloxone, the current
standard of care for opioid overdose reversal, is critical for
anyone who may be impacted by the opioid epidemic.”
Under the terms of the agreement, Hikma will continue to
manufacture KLOXXADO® Nasal Spray 8 mg to maintain distribution and
availability. KLOXXADO® Nasal Spray will soon be integrated into
Emergent’s proprietary NARCANDirect™ online distribution network
where qualified direct purchasers, such as emergency medical
services, law enforcement, fire departments, government agencies,
schools/universities, and community-based naloxone distribution
programs, can purchase and ship bulk quantities.
About
NARCAN® Nasal
SprayNARCAN® Naloxone HCl Nasal Spray 4 mg is the
first FDA-approved, over-the-counter (OTC) 4 mg naloxone product
for the emergency treatment of opioid overdose. NARCAN® Nasal
Spray is not a substitute for emergency medical care. Repeat dosing
may be necessary. Use as directed.
KLOXXADO® (naloxone HCl) Nasal Spray 8 mg
Contraindications Hypersensitivity to naloxone
hydrochloride or to any of the other ingredients
Warnings and Precautions
- 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 emergency may include: Unusual sleepiness; you
are not able to awaken the person with a loud voice or by rubbing
firmly on the middle of their chest (sternum).
- Breathing problems, including slow or shallow breathing in
someone difficult to awaken or who looks like they are not
breathing.
- The black circle in the center of the colored part of the eye
(pupil) is very small (sometimes called "pinpoint pupils") in
someone difficult to awaken.
- 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.
- Get emergency medical help right away after using the first
dose of 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, alternating
nostrils, 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, increased heart
rate, fever, runny nose, sneezing, goosebumps, sweating, yawning,
nausea or vomiting, nervousness, restlessness or irritability,
shivering or trembling, stomach cramps, weakness and increased
blood pressure.
- In infants under 4 weeks old who have been receiving opioids
regularly, sudden opioid withdrawal may be life-threatening if not
treated the right way. Signs and symptoms include: seizures, crying
more than usual, and increased reflexes.
- Tell your doctor about all of your
medical conditions before using KLOXXADO®, including if you have
heart problems, are pregnant or plan to become pregnant, are
breastfeeding or plan to breastfeed.
- Tell your doctor about all of the
medicines you take, including prescription and over-the-counter
medicines, drugs, vitamins and herbal supplements.
Side EffectsThe following serious side effect
is discussed in the full Prescribing Information for KLOXXADO®:
- Sudden and Severe Opioid Withdrawal
Symptoms of sudden and severe opioid withdrawal resulting from
the use of KLOXXADO® in someone regularly using opioids include:
body aches, diarrhea, increased heart rate, fever, runny nose,
sneezing, goosebumps, sweating, yawning, nausea or vomiting,
nervousness, restlessness or irritability, shivering or trembling,
stomach cramps, weakness and increased blood pressure.
Infants may have seizures, cry more than normal and have
increased 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 plan to become pregnant. If
you are pregnant and opioid dependent, use of KLOXXADO® may cause
withdrawal symptoms in you and your unborn baby. A healthcare
provider should monitor you and your unborn baby right away after
you use KLOXXADO®.
There is no information regarding the presence of naloxone in
human milk, the effects of naloxone on the breastfed infant or on
milk production.
If the primary concern is an infant at risk of an overdose,
consider whether other naloxone-containing products may be more
appropriate.
KLOXXADO® nasal spray is safe and effective in children for
known or suspected opioid overdose.
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 Prescribing 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 68°F to 77°F (20°C to 25°C). Do not expose to
temperatures below 41°F (5°C) or above 104°F (40°C). Do not freeze
KLOXXADO®. 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 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 us.hikma@primevigilance.com
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.
Trademarks and logos are the property of their respective
owners.
About Emergent BioSolutions At Emergent,
our mission is to protect and enhance life. For over 25 years,
we’ve been at work defending people from things we hope will never
happen—so we are prepared just in case they ever do. We provide
solutions for complex and urgent public health threats through a
portfolio of vaccines and therapeutics that we develop and
manufacture for governments and consumers. We also offer a range of
integrated contract development and manufacturing services for
pharmaceutical and biotechnology customers. To learn more about how
we plan to protect or enhance 1 billion lives by 2030, visit our
website and follow us on LinkedIn, X, Instagram, Apple Podcasts and
Spotify. Safe Harbor StatementThis 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, 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. LindahlExecutive
Vice President, CFOlindahlr@ebsi.com
Media Contact:Assal HellmerVice President,
Communicationsmediarelations@ebsi.com
1KLOXXADO® (Naloxone HCl) Nasal Spray [prescribing
information]. Columbus, OH: Hikma Specialty USA, Inc.; 20212
NARCAN® Nasal Spray [drug facts label]. Plymouth Meeting, PA:
Emergent Devices; 2023 3 Centers for Disease Control and
Prevention. Provisional Drug Overdose Death Counts.
Updated May 15,
2024. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
Emergent Biosolutions (NYSE:EBS)
Historical Stock Chart
From Dec 2024 to Jan 2025
Emergent Biosolutions (NYSE:EBS)
Historical Stock Chart
From Jan 2024 to Jan 2025