Emergent BioSolutions Gains Exclusive Commercial Rights to KLOXXADO® (naloxone HCI) Nasal Spray from Hikma Pharmaceuticals
Emergent BioSolutions (NYSE: EBS) has secured exclusive commercial rights to KLOXXADO® (naloxone HCl) Nasal Spray in the U.S. and Canada from Hikma Pharmaceuticals through a six-year agreement. This 8 mg naloxone product complements EBS's existing NARCAN® Nasal Spray 4 mg, expanding their portfolio of opioid overdose emergency treatments.
The agreement comes as CDC reports the first meaningful decline in U.S. opioid overdose deaths since 2018. NARCAN® will continue to be available over-the-counter as a 4 mg standard treatment, while KLOXXADO®'s 8 mg dosage will be available by prescription for those requiring higher doses.
Hikma will continue manufacturing KLOXXADO®, which will be integrated into Emergent's NARCANDirect™ online distribution network. This platform serves qualified direct purchasers including emergency services, law enforcement, government agencies, and community-based programs.
Emergent BioSolutions (NYSE: EBS) ha ottenuto i diritti commerciali esclusivi per KLOXXADO® (naloxone HCl) Spray Nasale negli Stati Uniti e in Canada da Hikma Pharmaceuticals tramite un accordo di sei anni. Questo prodotto di naloxone da 8 mg integra l'attuale NARCAN® Spray Nasale 4 mg di EBS, ampliando il loro portfolio di trattamenti d'emergenza per overdose da oppioidi.
L'accordo arriva mentre i CDC riportano il primo significativo calo delle morti per overdose da oppioidi negli Stati Uniti dal 2018. NARCAN® continuerà a essere disponibile senza ricetta come trattamento standard da 4 mg, mentre il dosaggio da 8 mg di KLOXXADO® sarà disponibile solo su prescrizione per coloro che necessitano di dosi più elevate.
Hikma continuerà a produrre KLOXXADO®, che sarà integrato nella rete di distribuzione online NARCANDirect™ di Emergent. Questa piattaforma serve acquirenti diretti qualificati, tra cui i servizi di emergenza, le forze dell'ordine, le agenzie governative e i programmi basati sulla comunità.
Emergent BioSolutions (NYSE: EBS) ha obtenido los derechos comerciales exclusivos para KLOXXADO® (naloxona HCl) Spray Nasal en EE. UU. y Canadá de Hikma Pharmaceuticals a través de un acuerdo de seis años. Este producto de naloxona de 8 mg complementa el existente NARCAN® Spray Nasal 4 mg de EBS, ampliando su cartera de tratamientos de emergencia para sobredosis de opioides.
El acuerdo se produce mientras los CDC informan la primera disminución significativa en las muertes por sobredosis de opioides en EE. UU. desde 2018. NARCAN® seguirá estando disponible sin receta como tratamiento estándar de 4 mg, mientras que la dosis de 8 mg de KLOXXADO® estará disponible solo con receta para quienes necesiten dosis más altas.
Hikma continuará fabricando KLOXXADO®, que se integrará en la red de distribución en línea NARCANDirect™ de Emergent. Esta plataforma atiende a compradores directos calificados, incluidos servicios de emergencia, fuerzas del orden, agencias gubernamentales y programas comunitarios.
Emergent BioSolutions (NYSE: EBS)는 Hikma Pharmaceuticals로부터 6년 계약을 통해 미국과 캐나다에서 KLOXXADO® (날록손 HCl) 코 스프레이에 대한 독점 상업적 권리를 확보했습니다. 이 8mg 날록손 제품은 EBS의 기존 NARCAN® 코 스프레이 4mg을 보완하며, 그들의 오피오이드 과다복용 응급 치료 포트폴리오를 확장합니다.
이 계약은 CDC가 2018년 이후 미국에서 오피오이드 과다복용 사망자의 첫 번째 의미 있는 감소를 보고하면서 체결되었습니다. NARCAN®은 4mg 표준 치료제로 계속해서 처방전 없이 구매할 수 있으며, KLOXXADO®의 8mg 용량은 더 높은 용량이 필요한 경우에 한해 처방전으로만 구매할 수 있습니다.
Hikma는 KLOXXADO®의 제조를 계속할 것이며, 이는 Emergent의 NARCANDirect™ 온라인 배급 네트워크에 통합될 것입니다. 이 플랫폼은 응급 서비스, 법 집행기관, 정부 기관 및 지역 사회 기반 프로그램 등 자격이 있는 직접 구매자를 대상으로 합니다.
Emergent BioSolutions (NYSE: EBS) a obtenu les droits commerciaux exclusifs pour KLOXXADO® (naloxone HCl) Spray Nasal aux États-Unis et au Canada de Hikma Pharmaceuticals par le biais d'un accord de six ans. Ce produit de naloxone de 8 mg complète le NARCAN® Spray Nasal 4 mg existant d'EBS, élargissant leur portefeuille de traitements d'urgence pour les overdoses aux opioïdes.
L'accord intervient alors que les CDC annoncent la première baisse significative des décès par overdose aux opioïdes depuis 2018 aux États-Unis. NARCAN® continuera d'être disponible sans ordonnance comme traitement standard de 4 mg, tandis que la posologie de 8 mg de KLOXXADO® sera disponible sur ordonnance pour ceux qui nécessitent des doses plus élevées.
Hikma continuera de fabriquer KLOXXADO®, qui sera intégré dans le réseau de distribution en ligne NARCANDirect™ d'Emergent. Cette plateforme sert des acheteurs directs qualifiés, y compris les services d'urgence, les forces de l'ordre, les agences gouvernementales et les programmes communautaires.
Emergent BioSolutions (NYSE: EBS) hat sich die exklusiven Vertriebsrechte für KLOXXADO® (Naloxon HCl) Nasenspray in den USA und Kanada von Hikma Pharmaceuticals durch einen sechsjährigen Vertrag gesichert. Dieses 8 mg Naloxon Produkt ergänzt das bestehende NARCAN® Nasenspray 4 mg von EBS und erweitert deren Portfolio an Notfallbehandlungen bei Opioidüberdosierungen.
Das Abkommen kommt, während die CDC einen ersten signifikanten Rückgang der Opioidüberdosis-Todesfälle in den USA seit 2018 berichten. NARCAN® wird weiterhin rezeptfrei als Standardbehandlung von 4 mg erhältlich sein, während die 8 mg Dosis von KLOXXADO® rezeptpflichtig sein wird für diejenigen, die höhere Dosen benötigen.
Hikma wird die Herstellung von KLOXXADO® fortsetzen, das in Emergents NARCANDirect™ Online-Vertriebsnetz integriert wird. Diese Plattform dient qualifizierten Direktkäufern, einschließlich Notdiensten, Strafverfolgungsbehörden, Regierungsagenturen und gemeinnützigen Programmen.
- Obtained exclusive rights to KLOXXADO® 8 mg nasal spray in US and Canada
- Expands product portfolio with complementary naloxone treatment option
- Integration into existing NARCANDirect™ distribution network
- Market timing aligns with first decline in opioid deaths since 2018
- None.
Insights
This strategic acquisition of KLOXXADO® commercial rights represents a significant market expansion for Emergent BioSolutions in the opioid overdose treatment space. By adding an 8mg prescription naloxone option alongside their OTC NARCAN® 4mg spray, EBS has effectively cornered both segments of the naloxone market. The six-year agreement with Hikma Pharmaceuticals creates a dual-product portfolio that should drive revenue growth and market share gains.
The timing is particularly strategic given the recent CDC report showing the first meaningful decline in opioid deaths since 2018. This market consolidation positions EBS to capitalize on continued government and healthcare initiatives to expand naloxone access. The integration of KLOXXADO® into their NARCANDirect™ distribution network will create operational synergies and strengthen relationships with institutional buyers.
This deal enhances public health response capabilities by providing flexible dosing options through a unified distribution channel. The combination of OTC and prescription naloxone products under one company streamlines procurement for government agencies and healthcare organizations while potentially reducing costs through economies of scale.
The strategic importance lies in EBS's expanded ability to serve different market segments - from community-based harm reduction programs requiring OTC options to medical facilities needing higher-dose prescription formulations. This positions EBS as an essential partner in addressing the opioid crisis, likely leading to stronger relationships with federal and state agencies, which could translate to more stable, long-term contracts.
With a market cap of
For investors, this represents a clear catalyst for growth, expanding EBS's addressable market and diversifying revenue streams within their core competency. The integration with their existing distribution infrastructure should drive operational efficiencies and improve profitability metrics over the agreement's six-year term.
- Alongside over-the-counter NARCAN® Nasal Spray 4 mg, prescription KLOXXADO® (naloxone HCl) Nasal Spray 8 mg will expand Emergent’s ability to distribute multiple life-saving opioid overdose emergency treatments to patients, customers and communities in need
- Focus remains on increasing access, raising awareness and ensuring strong supply to meet the ongoing demand of naloxone nasal spray
GAITHERSBURG, Md., Jan. 14, 2025 (GLOBE NEWSWIRE) -- 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 Spray
NARCAN® 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 Effects
The 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 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, 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
lindahlr@ebsi.com
Media Contact:
Assal Hellmer
Vice President, Communications
mediarelations@ebsi.com
1KLOXXADO® (Naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA, Inc.; 2021
2 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
FAQ
What are the terms of EBS's agreement for KLOXXADO® nasal spray rights?
How does KLOXXADO® differ from EBS's NARCAN® nasal spray?
How will EBS distribute KLOXXADO® nasal spray?
What is the market context for EBS's KLOXXADO® acquisition?
