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Emergent BioSolutions Gains Exclusive Commercial Rights to KLOXXADO (Naloxone HCI) Nasal Spray From Hikma Pharmaceuticals

Emergent BioSolutions Gains Exclusive Commercial Rights to KLOXXADO (Naloxone HCI) Nasal Spray From Hikma Pharmaceuticals

Emergent BioSolutions獲得Hikma Pharmaceuticals公司KLOXXADO(納洛酮鹽酸鹽)鼻用噴霧劑的獨家商業權利
GlobeNewswire ·  01/14 12:30
  • 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
  • 除了4毫克的場外交易NARCAN鼻用噴霧,處方KLOXXADO(氯氮平HCl)鼻用噴霧8毫克將擴大Emergent在需要的患者、客戶和社區中分發多種挽救生命的阿片類超量急救治療的能力。
  • 重點仍然是增加獲取途徑,提高意識,並確保強有力的供應以滿足對氯氮平鼻用噴霧的持續需求。

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.

馬里蘭州蓋瑟斯堡,2025年1月14日(全球新聞稿)——Emergent BioSolutions Inc.(紐交所:EBS)今天宣佈已達成協議,以獲得在美國和加拿大獨家商業權利,生產Hikma Pharmaceutical的KLOXXADO(氯氮平HCl)鼻用噴霧,該藥物爲8毫克氯氮平劑,經過批准用於已知或疑似阿片類藥物過量的緊急治療,該情況表現爲呼吸和/或中樞神經系統抑制。此項六年的協議補充並加強了Emergent的使命,即通過幫助減少阿片類藥物過量死亡,保護、改善和挽救生命——提供引人注目的產品選擇,並承諾增加氯氮平的獲取、意識和教育。

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.

自2018年Emergent首次收購其旗艦產品NARCAN鼻用噴霧以來,在抗擊阿片類藥物流行方面取得了重大進展。最近來自疾病控制與預防中心的報告確認,去年美國的阿片類藥物過量死亡人數有所減少——這是自2018年以來的首次顯著下降。有多種因素導致了這一下降;這樣的進展強化了Emergent全面國家策略的積極影響,以及持續努力增加對氯氮平鼻用噴霧的獲取和意識。

"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."

「阻止阿片類藥物過量造成的生命損失的初步進展跡象令人鼓舞。Emergent對與抗擊流行的前線工作者合作的堅持,傾聽家庭和護理人員的聲音,與倡導者及其他關鍵利益相關者溝通的努力,強調即使是一條生命的喪失也是太多,我們的承諾將始終如一。」Emergent總裁兼首席執行官Joe Papa表示。「通過現在提供兩種不同強度的鼻用氯氮平產品——4毫克的NARCAN鼻用噴霧和8毫克的KLOXXADO鼻用噴霧,滿足患者和客戶的需求,使Emergent能夠爲幫助挽救生命在這場毀滅性的危機中盡一份力。」

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.

通過Emergent的廣泛分銷網絡,分發NARCAN鼻用噴霧劑4毫克和KLOXXADO鼻用噴霧劑8毫克,將爲聯邦和州領導人、社區組織、減害團體、執法機構和急救人員提供靈活性,以根據特定患者和社區量身定製阿片類藥物過量逆轉治療的方法。NARCAN鼻用噴霧劑在全國範圍內廣泛提供,無需處方,並將繼續是社區護理中值得信賴的4毫克 Naloxone 標準。憑藉其8毫克的劑量,KLOXXADO鼻用噴霧劑是選擇給予更高劑量 Naloxone 的處方選項。

"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."

「在應對阿片過量的過程中,獲得安全有效的 Naloxone 治療至關重要,而NARCAN鼻用噴霧劑4毫克和KLOXXADO鼻用噴霧劑8毫克是幫助逆轉阿片過量影響的有效工具,」Emergent首席醫療官Simon Lowry博士表示。「擴大公衆意識和增加生命救助的 Naloxone 的可獲得性,對於任何可能受到阿片藥物危機影響的人來說都是至關重要的。」

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.

根據協議條款,Hikma將繼續製造KLOXXADO鼻用噴霧劑8毫克,以維持分銷和可用性。KLOXXADO鼻用噴霧劑將很快被整合到Emergent自主研發的NARCANDirect在線分銷網絡中,合格的直接購買者,如緊急醫療服務、執法機構、消防部門、政府機構、高校、和社區基礎的Naloxone分發項目,可以購買和交通大宗商品。

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.

關於NARCAN鼻用噴霧劑
NARCAN 納洛酮鹽酸鹽鼻用噴霧劑 4 毫克是首個 FDA 批准的場外交易 4 毫克納洛酮產品,用於緊急治療阿片類藥物過量。NARCAN 鼻用噴霧劑不能替代緊急醫療保健。可能需要重複給藥。請按指示使用。

KLOXXADO (naloxone HCl) Nasal Spray 8 mg
Contraindications
Hypersensitivity to naloxone hydrochloride or to any of the other ingredients

KLOXXADO(納洛酮鹽酸鹽)鼻用噴霧劑 8 毫克
禁忌症
對納洛酮鹽酸鹽或其他成分的超敏感反應

Warnings and Precautions

警告和注意事項

  • 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.
  • 如果您懷疑出現阿片類藥物過量緊急情況,請立即使用KLOXXADO,即使您不確定,因爲阿片類藥物過量緊急情況可能導致嚴重傷害或死亡。阿片類藥物過量緊急情況的跡象和症狀可能包括:異常嗜睡;您無法用大聲呼喊或用力擦摩他們胸口中央(胸骨)的方式叫醒此人。
  • 呼吸問題,包括在難以喚醒或看起來像是沒有呼吸的人身上出現緩慢或淺表的呼吸。
  • 在難以喚醒的人身上,眼睛(瞳孔)彩色部分中心的黑色圓圈非常小(有時稱爲「針尖瞳孔」)。
  • 家庭成員、護理人員或其他可能在阿片類藥物過量緊急情況下需要使用KLOXXADO的人,應知道KLOXXADO存放在哪裏以及如何在阿片類藥物過量緊急情況發生之前使用KLOXXADO。
  • 在使用第一劑KLOXXADO後,請立即尋求緊急醫療幫助。在等待緊急醫療幫助時,可能需要進行人工呼吸或心肺復甦(CPR)。
  • 在給予KLOXXADO後,阿片類藥物過量緊急情況的跡象和症狀可能會重新出現。如果發生這種情況,請在2到3分鐘後給予另一劑,使用新的KLOXXADO裝置,交替使用鼻孔,並密切觀察直到緊急醫療幫助到達。
  • 如果您對氟鎖那定鹽酸鹽或KLOXXADO中的任何成分過敏,請不要使用KLOXXADO。
  • KLOXXADO可能會導致突然和嚴重的阿片類藥物戒斷,症狀可能包括身體疼痛、腹瀉、心率增加、發熱、流鼻涕、打噴嚏、雞皮疙瘩、出汗、打哈欠、噁心或嘔吐、焦慮、不安或易怒、顫抖或抖動、腹痛、虛弱和血壓升高。
  • 對於4周以下的嬰兒,如果定期服用阿片類藥物,突然停藥可能會危及生命,尤其如果未得到正確治療。症狀包括:癲癇發作、哭鬧比平常多、反射增強。
  • 在使用KLOXXADO之前,請告訴您的醫生您所有的醫療狀況,包括您是否有心臟問題,是否懷孕或計劃懷孕,以及您是否在哺乳或計劃哺乳。
  • 請告訴您的醫生您正在服用的所有藥物,包括處方藥和非處方藥、藥物、維生素和草藥補充劑。

Side Effects
The following serious side effect is discussed in the full Prescribing Information for KLOXXADO:

副作用
以下嚴重副作用在KLOXXADO的完整處方信息中有討論:

  • Sudden and Severe Opioid Withdrawal
  • 突然和嚴重的阿片類藥物撤退

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.

由於使用KLOXXADO而導致的突然和嚴重的阿片類藥物撤退的症狀包括:身體疼痛、腹瀉、心率加快、發燒、流鼻涕、打噴嚏、雞皮疙瘩、出汗、打哈欠、噁心或嘔吐、緊張、不安或易怒、顫抖、腹部絞痛、乏力和血壓升高。

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

嬰兒可能會有抽搐、哭鬧超過正常水平,且反射增強。

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

一些人在突然而劇烈的阿片類藥物 overdose 逆轉後可能會變得具有攻擊性。

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.

在兩項臨牀研究中,總共有47名健康成年志願者接受了一劑 KLOXXADO 的噴霧,一次噴入一個鼻孔。每一種以下副作用在兩名受試者中都有報告:腹痛、無力、頭暈、頭痛、鼻部不適和前暈厥。

These are not all of the possible side effects of KLOXXADO. Contact your doctor for medical advice about side effects.

這些並不是 KLOXXADO 所有可能的副作用。如需就副作用獲取醫療建議,請聯繫您的醫生。

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.

懷孕、嬰兒期和母乳餵養,兒童
如果您懷孕或計劃懷孕,請告訴您的醫生。如果您懷孕且對阿片類藥物依賴,使用KLOXXADO可能會導致您和未出生的寶寶出現戒斷症狀。醫療服務提供者應在您使用KLOXXADO後立即監測您和您的未出生寶寶。

There is no information regarding the presence of naloxone in human milk, the effects of naloxone on the breastfed infant or on milk production.

目前沒有關於納洛酮在母乳中存在的相關信息,也沒有關於納洛酮對哺乳嬰兒或對乳汁生產的影響的信息。

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

如果主要關注的是有過量風險的嬰兒,請考慮其他含納洛酮的產品是否更合適。

KLOXXADO nasal spray is safe and effective in children for known or suspected opioid overdose.

KLOXXADO鼻用噴霧劑對於已知或懷疑的阿片藥物過量在兒童中是安全有效的。

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.

劑量和使用方法
請勿嘗試啓動或測試設備。每個KLOXXADO鼻用噴霧劑僅含有1劑藥物,無法重複使用。請閱讀處方信息和藥物指南末尾的「使用說明」,了解如何正確使用KLOXXADO鼻用噴霧劑的詳細信息。

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.

存儲和處理
將KLOXXADO存放在室溫下,溫度在68°F到77°F(20°C到25°C)之間。請勿暴露在41°F(5°C)以下或104°F(40°C)以上的溫度中。請勿冷凍KLOXXADO。使用前請將KLOXXADO保留在其包裝盒中。防止光照。請在盒子上的到期日期之前更換KLOXXADO。將KLOXXADO和所有藥物放在兒童無法觸及的地方。

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

欲了解更多信息,請查看完整的處方信息和藥物指南,您可以在我們的網站找到。

  • 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 .
  • 如需報告不良事件或產品投訴,請聯繫我們,電子郵件地址是us.hikma@primevigilance.com,或者撥打1-877-845-0689或1-800-962-8364。
  • 不良事件也可以直接向FDA報告,電話號碼是1-800-FDA-1088或。

Trademarks and logos are the property of their respective owners.

商標和標識是其各自所有者的財產。

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.

關於Emergent BioSolutions
在Emergent,我們的使命是保護和提升生活。超過25年來,我們一直在努力保護人們免受我們希望永遠不會發生的事情的影響——所以我們已經做好準備,以防它們真的發生。我們通過一系列疫苗和治療方法爲複雜和緊急的公共衛生威脅提供解決方案,這些疫苗和治療方法是我們爲政府和消費者開發和製造的。我們還爲藥品和生物技術客戶提供一系列綜合的合同開發和製造服務。要了解我們計劃如何在2030年前保護或增強10億人生活的更多信息,請訪問我們的網站並在領英、X、Instagram、蘋果播客和Spotify上關注我們。
安全港聲明
本新聞稿包含1995年《私人證券訴訟改革法案》意義上的前瞻性陳述。除歷史事實的陳述外,所有陳述均爲前瞻性陳述。我們通常通過使用諸如「預期」、「信任」、「持續」、「可能」、「估計」、「期待」、「預測」、「未來」、「目標」、「打算」、「可能」、「計劃」、「定位」、「可能」、「潛在」、「預測」、「項目」、「應該」、「目標」、「將要」、「會」等類似詞彙或其中的變體,或其否定形式來識別前瞻性陳述,但這些術語並不是識別此類陳述的唯一方式。前瞻性陳述基於我們當前的意圖、信念和預計未來事件的期望,這些期望是基於當前可用的信息。我們無法保證任何前瞻性陳述都是準確的。讀者應意識到,如果基本假設被證明不準確,或者已知或未知的風險或不確定性出現,實際結果可能會與我們的預期顯著不同。因此,提醒讀者不應過度依賴任何前瞻性陳述。任何前瞻性陳述僅在本新聞稿發佈之日有效,除法律要求外,我們沒有義務更新任何前瞻性陳述以反映新的信息、事件或情況。

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.

有多個重要因素可能導致公司實際結果與任何前瞻性陳述所指示的結果顯著不同。讀者在評估我們的前瞻性陳述時,應考慮此警示性聲明,以及在我們定期向美國證券交易委員會提交的報告中包含的風險因素和其他披露。

Investor Contact:
Richard S. Lindahl
Executive Vice President, CFO
lindahlr@ebsi.com

投資者聯繫人:
理查德·S·林達爾
執行副總裁,財務長
lindahlr@ebsi.com

Media Contact:
Assal Hellmer
Vice President, Communications
mediarelations@ebsi.com

媒體聯繫人:
阿薩爾·赫爾默
副總裁,通訊
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.

1KLOXXADO(氯氮平鹽酸鹽)鼻用噴霧劑 [處方信息]. 哥倫布,俄亥俄州:Hikma Specialty 美國公司;2021
2 NARCAN鼻用噴霧劑 [藥物說明書]. 賓夕法尼亞州普利茅斯會議: Emergent Devices; 2023
3 疾病控制與預防中心. 臨時藥物過量死亡統計. 更新於2024年5月15日.


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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本頁的譯文內容由軟件翻譯。富途將竭力但卻不能保證翻譯內容之準確和可靠,亦不會承擔因任何不準確或遺漏而引起的任何損失或損害。