Aptar Announces CE Marking for LuerVax® and Accompanying Spray Divider, Strengthening Support for Vaccine Developers

Milestone strengthens Aptar Pharma’s support for intranasal vaccine development from clinical studies through commercialization

CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--Aptar Pharma, part of AptarGroup, Inc. (NYSE:ATR), a global leader in drug delivery, dosing and protection technologies, and consumer product dispensing, today announced that its LuerVax^® intranasal delivery device and accompanying Spray Divider have been CE marked under the EU Medical Device Regulation (MDR), indicating that they meet the European general safety and performance requirements for medical devices. This milestone expands Aptar Pharma’s support for customers developing innovative intranasal vaccine products.

LuerVax^® is an intranasal delivery device for administration of vaccines by a healthcare professional, when connected to a compatible LuerLock syringe. The optional Spray Divider is designed to enable the delivery of two sequential sprays, one per nostril. This gives vaccine developers access to a CE-marked intranasal delivery platform, to support development activities from early clinical studies through commercialization.

The CE marking demonstrates Aptar Pharma's continued commitment to delivering high-quality, compliant device solutions designed to help customers throughout vaccine development.

“Achieving CE marking for both LuerVax^® and the Spray Divider is an important step in strengthening our support of vaccine developers worldwide,” said Alex Theodorakis, President, Aptar Pharma Prescription. “Customers are increasingly seeking established device platforms that can support regulatory pathways and enable efficient clinical and commercial development. This CE marking reinforces Aptar's commitment to being a trusted partner throughout the vaccine development journey.”

Supporting Customers from Clinical Development to Commercialization

LuerVax^® and Spray Divider provide a flexible and reliable intranasal delivery platform intended to support a broad range of vaccine development programs.

Spray Divider is available in two sizes, 200 µL and 500 µL, for use with the corresponding LuerLock syringe, designed to enable the prepared syringe volume to be delivered as two sequential sprays, one per nostril.

Beyond access to a CE-marked intranasal delivery platform, customers can leverage Aptar Pharma's expertise in drug delivery, vaccine technologies, regulatory support, industrialization and manufacturing. This integrated approach helps vaccine developers navigate development activities from early clinical studies through commercialization while benefiting from a single partner that can support key stages of the development journey.

Advancing Intranasal Vaccine Delivery

As interest in non-invasive vaccine administration continues to grow, intranasal delivery offers the potential to improve patient acceptance and ease of administration while supporting innovative immunization strategies. With the CE marking of LuerVax^® and the Spray Divider, Aptar is well positioned to help customers capitalize on these opportunities through delivery technologies and development expertise.

"This achievement reflects Aptar's ongoing investment in innovative delivery solutions that address the evolving needs of vaccine developers," said Nektaria Karavas, Global Business Development Director - Vaccines and Antivirals, Aptar Pharma. "Our goal is to provide customers with the delivery technologies, expertise and regulatory support to bring the next generation of vaccines to market."

Regulatory Information

LuerVax^® is a Class I non-sterile, single use medical device under MDR intended for use by healthcare professionals, validated with compatible LuerLock syringe. The Spray Divider is an optional component intended to be used with LuerVax^® and the corresponding LuerLock syringe Refer to the Instructions for Use for the full intended use, warnings and precautions. LuerVax^® is a registered trademark of AptarGroup, Inc. or its affiliates.

About Aptar Pharma

Aptar Pharma is part of AptarGroup, Inc., a global leader in drug delivery, dosing and protection technologies, and consumer product dispensing. Aptar partners with the world’s top healthcare and consumer brands to deliver medicines and create exceptional user experiences. Serving diverse markets, from pharmaceutical to beauty to food and beverage, Aptar combines expertise with proprietary design, engineering and science to develop innovative solutions that help improve lives worldwide. Headquartered in Crystal Lake, Illinois, Aptar employs 14,000 dedicated people across 20 countries. For more information, visit www.aptar.com.

This press release contains forward-looking statements, including regarding the use of Aptar’s LuerVax^® intranasal delivery device and Spray Divider in vaccine development and commercialization, growth in intranasal vaccine delivery, and Aptar’s positioning and goals with respect to these opportunities. Forward-looking statements generally can be identified by the fact that they do not relate strictly to historical or current facts and by use of words such as “expects,” “anticipates,” “believes,” “estimates,” “future,” “potential,” “continues,” “goal,” “positioned” and other similar expressions or future or conditional verbs such as “will,” “should,” “would” and “could.” Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information currently available to us. Accordingly, our actual results or other events may differ materially from those expressed or implied in such forward-looking statements due to known or unknown risks and uncertainties that exist in our operations and business environment including, but not limited to: risks that vaccine developers may not adopt LuerVax^® or the Spray Divider for their programs; risks that the devices may not be compatible with, or perform as intended with, particular vaccine formulations; risks related to clinical development activities and regulatory approvals of vaccine candidates, which are conducted and obtained by third parties; risks related to maintaining CE marking and compliance with the EU Medical Device Regulation and other regulatory requirements; development, commercialization, manufacturing and supply risks; and competition, including technological advances. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-K and Form 10-Qs. We undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.