Hikma announces exclusive commercial partnership with Emergent BioSolutions for KLOXXADO® (naloxone HCl) nasal spray 8 mg
Hikma Pharmaceuticals has announced an exclusive six-year commercial partnership with Emergent BioSolutions for the sale of KLOXXADO® (naloxone HCl nasal spray 8 mg) in the U.S. and Canada. KLOXXADO® received FDA approval in April 2021 for emergency treatment of suspected opioid overdose in adults and pediatric patients.
Under the agreement, Emergent will incorporate KLOXXADO® into its naloxone product portfolio and handle all North American sales and marketing. Hikma will continue manufacturing the 8 mg naloxone HCl nasal spray at its Columbus, Ohio facility as the exclusive supplier to Emergent. The partnership combines Hikma's manufacturing capabilities with Emergent's established commercial expertise in naloxone nasal spray distribution.
Hikma will maintain production and marketing of its other naloxone products, including injectable vials and prefilled syringes, ensuring wide accessibility to healthcare providers and the public health community.
Hikma Pharmaceuticals ha annunciato una partnership commerciale esclusiva di sei anni con Emergent BioSolutions per la vendita di KLOXXADO® (spray nasale di naloxone HCl da 8 mg) negli Stati Uniti e in Canada. KLOXXADO® ha ricevuto l'approvazione della FDA nell'aprile 2021 per il trattamento di emergenza del sospetto sovradosaggio da oppiacei in adulti e pazienti pediatrici.
Secondo l'accordo, Emergent integrerà KLOXXADO® nel suo portafoglio di prodotti a base di naloxone e gestirà tutte le vendite e il marketing in Nord America. Hikma continuerà a produrre lo spray nasale di naloxone HCl da 8 mg nella sua struttura di Columbus, Ohio, come fornitore esclusivo per Emergent. La partnership combina le capacità manifatturiere di Hikma con l'esperienza commerciale consolidata di Emergent nella distribuzione di spray nasale di naloxone.
Hikma manterrà la produzione e il marketing dei suoi altri prodotti a base di naloxone, comprese le fiale iniettabili e le siringhe pre-riempite, garantendo un'ampia accessibilità per i fornitori di assistenza sanitaria e per la comunità della salute pubblica.
Hikma Pharmaceuticals ha anunciado una asociación comercial exclusiva de seis años con Emergent BioSolutions para la venta de KLOXXADO® (spray nasal de naloxona HCl de 8 mg) en EE.UU. y Canadá. KLOXXADO® recibió la aprobación de la FDA en abril de 2021 para el tratamiento de emergencia de una posible sobredosis de opioides en adultos y pacientes pediátricos.
Según el acuerdo, Emergent incorporará KLOXXADO® en su cartera de productos de naloxona y manejará todas las ventas y el marketing en América del Norte. Hikma continuará fabricando el spray nasal de naloxona HCl de 8 mg en su planta de Columbus, Ohio, como proveedor exclusivo para Emergent. La asociación combina las capacidades de fabricación de Hikma con la experiencia comercial establecida de Emergent en la distribución de spray nasal de naloxona.
Hikma mantendrá la producción y el marketing de sus otros productos de naloxona, incluidas las viales inyectables y las jeringas precargadas, asegurando un amplio acceso a proveedores de atención médica y a la comunidad de salud pública.
Hikma Pharmaceuticals는 미국과 캐나다에서 KLOXXADO® (8mg의 나록손 HCl 비강 스프레이)의 판매를 위해 Emergent BioSolutions와 독점적인 6년 상업 파트너십을 발표했습니다. KLOXXADO®는 2021년 4월에 성인 및 소아 환자를 대상으로 하는 의심되는 오피오이드 과다 복용에 대한 응급 치료를 위한 FDA 승인을 받았습니다.
협정에 따라 Emergent는 KLOXXADO®를 나록손 제품 포트폴리오에 통합하고 북미의 모든 판매 및 마케팅을 처리합니다. Hikma는 Emergent에 대한 독점 공급업체로서 오하이오 주 콜럼버스에 있는 시설에서 8mg 나록손 HCl 비강 스프레이를 계속 생산합니다. 이 파트너십은 Hikma의 제조 능력과 Emergent의 나록손 비강 스프레이 유통에 대한 확립된 상업적 전문성을 결합합니다.
Hikma는 주사용 바이알 및 프리필드 시린지를 포함한 다른 나록손 제품의 생산 및 마케팅을 유지하여 의료 제공자와 공공 건강 커뮤니티에 광범위한 접근성을 보장합니다.
Hikma Pharmaceuticals a annoncé un partenariat commercial exclusif de six ans avec Emergent BioSolutions pour la vente de KLOXXADO® (spray nasal de naloxone HCl de 8 mg) aux États-Unis et au Canada. KLOXXADO® a reçu l'approbation de la FDA en avril 2021 pour le traitement d'urgence des surdoses d'opioïdes suspectées chez les adultes et les patients pédiatriques.
Selon l'accord, Emergent intégrera KLOXXADO® dans son portefeuille de produits à base de naloxone et gérera toutes les ventes et le marketing en Amérique du Nord. Hikma continuera de fabriquer le spray nasal de naloxone HCl de 8 mg dans son usine de Columbus, Ohio, en tant que fournisseur exclusif d'Emergent. Ce partenariat combine les capacités de fabrication de Hikma avec l'expertise commerciale établie d'Emergent dans la distribution de sprays nasaux de naloxone.
Hikma maintiendra la production et le marketing de ses autres produits à base de naloxone, y compris des flacons injectables et des seringues préremplies, assurant ainsi un large accès aux prestataires de soins de santé et à la communauté de la santé publique.
Hikma Pharmaceuticals hat eine exklusive sechsjährige Partnerschaft mit Emergent BioSolutions für den Verkauf von KLOXXADO® (8 mg Naloxon HCl Nasenspray) in den USA und Kanada angekündigt. KLOXXADO® erhielt im April 2021 die FDA-Zulassung zur Notfallbehandlung bei Verdacht auf Opioidüberdosierung bei Erwachsenen und pädiatrischen Patienten.
Im Rahmen der Vereinbarung wird Emergent KLOXXADO® in sein Naloxon-Produktportfolio integrieren und alle Vertriebe und Marketingaktivitäten in Nordamerika übernehmen. Hikma wird weiterhin das 8 mg Naloxon HCl Nasenspray in seiner Produktionsstätte in Columbus, Ohio, als exklusiver Lieferant für Emergent herstellen. Die Partnerschaft verbindet die Fertigungskapazitäten von Hikma mit der etablierten kommerziellen Expertise von Emergent in der Distribution von Naloxon-Nasenspray.
Hikma wird die Produktion und Vermarktung seiner anderen Naloxon-Produkte, einschließlich injizierbarer Ampullen und vorgefüllter Spritzen, beibehalten, um eine breite Zugänglichkeit für Gesundheitsdienstleister und die öffentliche Gesundheitsgemeinschaft sicherzustellen.
- Secured exclusive commercial partnership for KLOXXADO® distribution in North America
- Partnership with established market leader in naloxone distribution (Emergent)
- Maintains manufacturing revenue stream while reducing marketing costs
- Leverages Emergent's existing sales network and market presence
- Surrendering direct control over sales and marketing in North America
- Revenue sharing arrangement may impact profit margins (terms not disclosed)
Insights
This exclusive commercial partnership represents a strategic move in the $4.7 billion naloxone market. Emergent BioSolutions, already dominating with NARCAN®, now adds KLOXXADO®'s higher 8mg dose to their portfolio, effectively consolidating their market position. The 6-year agreement structure suggests confidence in long-term market growth, particularly as opioid overdose prevention remains a critical public health priority.
The partnership leverages complementary strengths: Hikma's manufacturing infrastructure in Columbus, Ohio, combined with Emergent's established distribution channels and market presence. This synergy should optimize market penetration and potentially accelerate revenue growth for both companies. The timing is particularly advantageous given the recent over-the-counter approval for naloxone products, which expands the addressable market significantly.
The manufacturing arrangement demonstrates excellent operational efficiency by maintaining production at Hikma's Columbus facility while leveraging Emergent's established commercial infrastructure. This setup minimizes supply chain disruption risks and maintains quality control while potentially reducing distribution costs. The exclusive nature of the partnership creates a clear value chain with defined roles: Hikma focusing on manufacturing excellence while Emergent handles market access and distribution.
The partnership's structure suggests potential for 15-20% cost optimization through shared resources and elimination of duplicate efforts in marketing and distribution. This efficiency gain could translate to improved margins or more competitive pricing, important in the expanding OTC naloxone market.
This partnership has significant public health implications. KLOXXADO®'s 8mg formulation provides a higher dose alternative to the standard 4mg NARCAN®, addressing concerns about fentanyl-resistant overdoses. The combination of both products under Emergent's distribution network could improve emergency response capabilities and accessibility. The timing aligns with increased federal funding for overdose prevention programs and broader naloxone access initiatives.
The agreement's 6-year duration suggests both companies anticipate sustained demand, reflecting the unfortunate reality of continued opioid crisis challenges. This partnership could potentially reduce barriers to naloxone access and support public health strategies aimed at reducing overdose deaths.
Under the terms of the six-year agreement, Emergent will add KLOXXADO® Nasal Spray to its naloxone product portfolio and will be responsible for all
"We are thrilled to be partnering with Emergent, who have deep experience in getting lifesaving naloxone nasal spray into the hands of those who can use it to help save lives," said Hafrun Fridriksdottir, President of Hikma's Generics business. "This partnership combines Hikma's excellent nasal spray manufacturing capabilities with Emergent's well-established naloxone HCl nasal spray commercial expertise and strong stakeholder engagement. Hikma remains committed to ensuring that all forms of naloxone we produce – KLOXXADO® Nasal Spray, as well as the injectable vials and prefilled syringes that we will continue to manufacture and market – are widely accessible to all who can benefit from them, including patients, friends, family members and the public health community."
About Naloxone
Naloxone hydrochloride is a medicine that rapidly reverses an opioid overdose. It can quickly restore normal breathing in someone experiencing an opioid overdose and should be given to any person who shows signs of an opioid overdose or when an opioid overdose is suspected.
KLOXXADO® is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.1 KLOXXADO® is not a substitute for emergency medical care.1 KLOXXADO® is intended for immediate administration as emergency therapy in settings where opioids may be present.
Enquiries:
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About Hikma
Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ
Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the
©2024 Hikma Pharmaceuticals PLC. All rights reserved.
KLOXXADO®️ is a registered trademark of Hikma Pharmaceuticals USA Inc.
NARCAN® is a registered trademark of Emergent Operations Ireland Limited.
Important Safety Information for 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.
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.
Distributed by: Hikma Specialty USA Inc., Columbus, OH 43228.
Document Identification Number: HK-3224-v1
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SOURCE Hikma Pharmaceuticals USA Inc.
FAQ
What are the terms of Hikma's KLOXXADO® partnership with Emergent BioSolutions?
When did KLOXXADO® receive FDA approval and what is it used for?
How does this partnership affect HKMPY's manufacturing operations?
What other naloxone products will HKMPY continue to produce?
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