Full Press Release Details
to commercially launch REZENOPY , a life-saving opioid overdose emergency treatment through a collaboration with KINDEVA DRUG DELIVERY
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.
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.
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.
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.
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 $189
million, unit volume of $10.0 million (eaches) for Naloxone in the US market.
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
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."
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."
(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.
nasal spray is for intranasal use only and is supplied as a carton containing two (2) blister packages each with a single spray
more detailed information, please refer to the full prescribing information provided by the FDA.
Scienture Holdings, Inc.
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.
Kindeva Drug Delivery L.P.
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
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