SCIENTURE to commercially launch REZENOPY®, a life-saving opioid overdose emergency treatment through a collaboration with KINDEVA DRUG DELIVERY L.P.
Scienture Holdings (NASDAQ: SCNX) has announced a definitive agreement with Summit Biosciences (subsidiary of Kindeva Drug Delivery) for the exclusive U.S. rights to commercially launch REZENOPY®, a 10mg naloxone HCl nasal spray for opioid overdose treatment. The FDA-approved product represents the highest-strength naloxone HCl available in the market.
Under the agreement, Kindeva will manufacture and supply REZENOPY®, while Scienture will own the new drug application (NDA) and handle U.S. sales, marketing, and distribution. The product aims to combat the rising opioid-related fatalities through enhanced potency against powerful opioids.
According to IQVIA data (MAT December 2024), the US naloxone market shows annual sales of $189 million with a unit volume of 10.0 million. The collaboration aligns with Scienture's mission to provide innovative treatment solutions and expand patient access across therapeutic areas.
Scienture Holdings (NASDAQ: SCNX) ha annunciato un accordo definitivo con Summit Biosciences (sussidiaria di Kindeva Drug Delivery) per i diritti esclusivi negli Stati Uniti per il lancio commerciale di REZENOPY®, uno spray nasale di naloxone HCl da 10 mg per il trattamento delle overdose da oppioidi. Il prodotto, approvato dalla FDA, rappresenta il naloxone HCl con la massima concentrazione disponibile sul mercato.
In base all'accordo, Kindeva produrrà e fornirà REZENOPY®, mentre Scienture possiederà la nuova domanda di registrazione del farmaco (NDA) e gestirà le vendite, il marketing e la distribuzione negli Stati Uniti. Il prodotto mira a combattere l'aumento delle morti legate agli oppioidi attraverso una potenza potenziata contro oppioidi potenti.
Secondo i dati di IQVIA (MAT dicembre 2024), il mercato del naloxone negli Stati Uniti mostra vendite annuali di 189 milioni di dollari con un volume unitario di 10,0 milioni. La collaborazione è in linea con la missione di Scienture di fornire soluzioni terapeutiche innovative e ampliare l'accesso dei pazienti in diverse aree terapeutiche.
Scienture Holdings (NASDAQ: SCNX) ha anunciado un acuerdo definitivo con Summit Biosciences (filial de Kindeva Drug Delivery) para los derechos exclusivos en EE. UU. para lanzar comercialmente REZENOPY®, un spray nasal de naloxona HCl de 10 mg para el tratamiento de sobredosis de opioides. El producto, aprobado por la FDA, representa la naloxona HCl de mayor concentración disponible en el mercado.
Bajo el acuerdo, Kindeva fabricará y suministrará REZENOPY®, mientras que Scienture será propietaria de la nueva solicitud de medicamento (NDA) y se encargará de las ventas, el marketing y la distribución en EE. UU. El producto tiene como objetivo combatir el aumento de las muertes relacionadas con opioides a través de una potencia mejorada contra opioides potentes.
Según los datos de IQVIA (MAT diciembre 2024), el mercado de naloxona en EE. UU. muestra ventas anuales de 189 millones de dólares con un volumen unitario de 10,0 millones. La colaboración se alinea con la misión de Scienture de proporcionar soluciones de tratamiento innovadoras y ampliar el acceso de los pacientes en diversas áreas terapéuticas.
Scienture Holdings (NASDAQ: SCNX)는 Kindeva Drug Delivery의 자회사인 Summit Biosciences와 독점적인 미국 출시 권한을 위한 최종 계약을 발표했습니다. REZENOPY®는 10mg의 나록손 HCl 비강 스프레이로, 오피오이드 과다복용 치료에 사용됩니다. FDA의 승인을 받은 이 제품은 시장에서 가장 높은 농도의 나록손 HCl을 제공합니다.
계약에 따라 Kindeva는 REZENOPY®를 제조 및 공급하고, Scienture는 새로운 약물 신청(NDA)을 소유하며 미국 내 판매, 마케팅 및 유통을 담당합니다. 이 제품은 강력한 오피오이드에 대한 향상된 효능을 통해 증가하는 오피오이드 관련 사망자를 줄이는 것을 목표로 합니다.
IQVIA 데이터에 따르면(2024년 12월 기준), 미국의 나록손 시장은 연간 1억 8,900만 달러의 판매와 1,000만 개의 단위 볼륨을 보여줍니다. 이 협력은 혁신적인 치료 솔루션을 제공하고 다양한 치료 분야에서 환자의 접근성을 확대하려는 Scienture의 사명과 일치합니다.
Scienture Holdings (NASDAQ: SCNX) a annoncé un accord définitif avec Summit Biosciences (filiale de Kindeva Drug Delivery) pour les droits exclusifs aux États-Unis pour le lancement commercial de REZENOPY®, un spray nasal de naloxone HCl de 10 mg pour le traitement des overdoses d'opioïdes. Le produit, approuvé par la FDA, représente la naloxone HCl de la plus forte concentration disponible sur le marché.
Dans le cadre de l'accord, Kindeva fabriquera et fournira REZENOPY®, tandis que Scienture possédera la nouvelle demande de médicament (NDA) et gérera les ventes, le marketing et la distribution aux États-Unis. Le produit vise à lutter contre l'augmentation des décès liés aux opioïdes grâce à une puissance accrue contre les opioïdes puissants.
Selon les données d'IQVIA (MAT décembre 2024), le marché de la naloxone aux États-Unis affiche des ventes annuelles de 189 millions de dollars avec un volume unitaire de 10,0 millions. La collaboration est en accord avec la mission de Scienture de fournir des solutions de traitement innovantes et d'élargir l'accès des patients dans divers domaines thérapeutiques.
Scienture Holdings (NASDAQ: SCNX) hat eine endgültige Vereinbarung mit Summit Biosciences (Tochtergesellschaft von Kindeva Drug Delivery) über die exklusiven US-Rechte zum kommerziellen Launch von REZENOPY® bekannt gegeben, einem 10 mg Naloxon HCl Nasenspray zur Behandlung von Opioidüberdosierungen. Das von der FDA genehmigte Produkt stellt das stärkste Naloxon HCl dar, das auf dem Markt erhältlich ist.
Im Rahmen der Vereinbarung wird Kindeva REZENOPY® herstellen und liefern, während Scienture die neue Arzneimittelzulassung (NDA) besitzen und den Verkauf, das Marketing und die Distribution in den USA übernehmen wird. Das Produkt zielt darauf ab, die steigenden opioidbedingten Todesfälle durch eine verbesserte Potenz gegenüber starken Opioiden zu bekämpfen.
Laut IQVIA-Daten (MAT Dezember 2024) zeigt der US-Naloxon-Markt jährliche Verkäufe von 189 Millionen US-Dollar mit einem Stückvolumen von 10,0 Millionen. Die Zusammenarbeit steht im Einklang mit der Mission von Scienture, innovative Behandlungslösungen bereitzustellen und den Zugang für Patienten in verschiedenen Therapiegebieten zu erweitern.
- Exclusive U.S. rights for high-potency naloxone product
- Entry into $189M annual market
- FDA-approved status reduces regulatory risk
- Partnership with established manufacturer reduces operational risk
- Competitive market with existing naloxone products
- Revenue potential dependent on market penetration against established products
Insights
Scienture Holdings' announcement of its exclusive commercial rights to REZENOPY® represents a potentially transformative opportunity for this micro-cap pharmaceutical company. The agreement with Kindeva Drug Delivery positions Scienture to enter the
The collaboration structure appears strategically advantageous for Scienture. By securing ownership of the New Drug Application while leveraging Kindeva's manufacturing capabilities, Scienture can focus on commercialization activities through its existing infrastructure. This asset-light approach could optimize resource allocation for the
From a market perspective, REZENOPY's positioning as the most potent naloxone formulation available addresses a critical need in combating increasingly potent synthetic opioids like fentanyl. With 10 million units of naloxone sold annually according to IQVIA data, even capturing a modest market share could substantially impact Scienture's revenue trajectory.
The timing is particularly relevant amid the ongoing opioid crisis. While the article doesn't specify pricing strategy or exact launch timeline, the FDA approval (April 2024) suggests commercial availability could be imminent. The public health implications of a higher-potency emergency treatment option align with increasing government and healthcare system focus on overdose prevention.
For investors, this development represents Scienture's execution against its stated strategy of delivering specialty products for unmet needs. Success in commercializing REZENOPY could potentially reposition Scienture from a developmental-stage company to one with meaningful commercial revenue - a transition that typically drives significant valuation reassessment.
TAMPA, FL, March 06, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce that its wholly owned subsidiary, Scienture, LLC (“Scienture”), has entered into a definitive agreement with SUMMIT BIOSCIENCES INC. (a wholly owned subsidiary of Kindeva Drug Delivery L.P. (“Kindeva”)), for the exclusive U.S. rights to commercially launch REZENOPY® (naloxone HCl) Nasal Spray 10mg, an opioid antagonist that was approved by the FDA on April 19, 2024.
Under the terms of the collaboration, Kindeva will manufacture and commercially supply REZENOPY® (naloxone HCl) Nasal Spray 10mg. Scienture will own the new drug application (NDA) for REZENOPY® in its name and be responsible for the sales, marketing and distribution of the product in the U.S. through Scienture’s commercial operations infrastructure.
REZENOPY® is the most potent (highest strength) version of naloxone HCl available in the market. The product leverages the proven use of the active ingredient and form factor, with increased effectiveness against potent opioids.
The addition of REZENOPY® to Scienture’s product portfolio aligns with Scienture’s mission to provide innovative treatment solutions across therapeutic areas and expand access to patients. This product collaboration represents a strategic step in advancing public health initiatives and ensuring that life-saving interventions are readily available to those at risk of opioid overdose. As opioid-related fatalities continue to rise, Scienture is dedicated to collaborating with healthcare professionals, policymakers, and advocacy groups to enhance awareness, education, and distribution efforts.
Nasal delivery of Naloxone HCl has been widely recognized for its efficacy, ease of use, and accessibility, making it an essential tool for first responders, healthcare providers, and community programs. IQVIA data (MAT December 2024) indicates a total annual sales of
“We are proud to take this significant step in strengthening our commitment to combating the opioid epidemic,” said Narasimhan Mani, Ph.D., MBA, President of Scienture, LLC. “Through this collaboration with a well established and strong partner like Kindeva, we now offer REZENOPY®, a higher dose naloxone HCl option for communities, reinforcing our mission to deliver impactful healthcare solutions.”
“This collaboration is not just about expanding our portfolio; it’s about making a real difference in the fight against opioid addiction,” added Shankar Hariharan, Ph.D., CEO of Scienture, LLC. “By working alongside public health agencies and community organizations, we will drive meaningful change and save lives.”
“As part of our commitment to fast-tracking healthier tomorrows, we are thrilled to be joining forces with Scienture to bring this life-saving device to market,” remarked Milton Boyer, CEO of Kindeva. “Our nasal drug delivery team has created a nasal spray that is quick and simple to administer, and which has the potential to prevent unnecessary overdoses across the United States. We are dedicated to ensuring this device reaches the people that need it most as quickly as possible and prevent more opioid related fatalities.”
About REZENOPY®
REZENOPY® (naloxone HCl) Nasal Spray 10mg, is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. It is intended for immediate administration as emergency therapy in settings where opioids may be present.
REZENOPY® nasal spray is for intranasal use only and is supplied as a carton containing two (2) blister packages each with a single spray device.
IMPORTANT SAFETY INFORMATION
- Administration: REZENOPY® nasal spray is for intranasal use only. Seek emergency medical care immediately after use. Administer a single spray into one nostril. If the patient does not respond within 2 to 3 minutes or responds and then relapses into respiratory depression, an additional dose may be given into the other nostril with a new device. Do not administer more than 2 sprays per day. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
- Contraindications: REZENOPY® nasal spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.
- Warnings and Precautions:
- Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer additional doses as necessary while awaiting emergency medical assistance.
- Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.
- Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid-dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal.
- Risk of Cardiovascular Effects: Abrupt postoperative reversal of opioid depression may result in adverse cardiovascular effects. These events have primarily occurred in patients who had pre-existing cardiovascular disorders or received other drugs that may have similar adverse cardiovascular effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.
- Adverse Reactions: The following adverse reactions were observed in a REZENOPY® nasal spray clinical study: upper abdominal pain, nasopharyngitis, and dysgeusia.
- Storage and Handling: Store REZENOPY® nasal spray in the blister and cartons provided. Store between 2°C to 25°C (36°F to 77°F). Excursions permitted up to 40°C (104°F). Do not freeze or expose to excessive heat above 40°C (104°F). Protect from light. REZENOPY® nasal spray may freeze at cold temperatures. If this happens, the device will not spray. If REZENOPY® nasal spray is frozen and is needed in an emergency, do NOT wait for it to thaw; get emergency medical help right away.
For more detailed information, please refer to the full prescribing information provided by the FDA.
About Scienture Holdings, Inc.
SCIENTURE HOLDINGS, INC. (NASDAQ: “SCNX”), through its wholly owned subsidiaries, Scienture, LLC and Integra Pharma Solutions, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Integra Pharma Solutions, LLC, is a licensed pharmaceutical wholesaler and sells brand, generic and non-drug products to healthcare markets including government organizations, hospitals, clinics and independent pharmacies nationwide. Scienture, LLC is a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit www.scienture.com.
About Kindeva Drug Delivery L.P.
Kindeva Drug Delivery is a leading global powerhouse CDMO for sterile injectable, pulmonary, nasal, transdermal, and intradermal finished dose. We are committed to manufacturing more tomorrows for our customers, colleagues, and patients around the world. We deliver unrivaled expertise across development, manufacturing, and comprehensive analytical services for a broad range of drug-delivery formats. Through strategic investments in cutting-edge technology, we proactively tackle critical industry challenges, including expanding aseptic injectable fill-finish capabilities and leading the way in green propellant initiatives. Combining forces with a diverse global client base, Kindeva operates state-of-the-art manufacturing, research, and development facilities across the U.S. and U.K. For more information please visit www.kindevadd.com
Cautionary Statements Regarding Forward-Looking Statements
This press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch and the success those products may have in the marketplace. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC.
Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.
Contacts:
SCIENTURE HOLDINGS, INC.
SCIENTURE HOLDINGS, INC.
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FAQ
What is the market size for naloxone products according to the SCNX press release?
How is REZENOPY different from other naloxone products in the market?
What are the roles of Scienture (SCNX) and Kindeva in the REZENOPY partnership?
When did REZENOPY receive FDA approval?
