Aptar Pharma’s Bidose Nasal Drug Delivery Device Approved by U.S. FDA for Breakthrough Treatment of
Depression
Aptar Pharma, a leading drug delivery systems provider, is pleased to announce that its Bidose nasal spray device was recently
approved by the U.S. FDA for a breakthrough therapy in the field of depression. This marks the first FDA approval and U.S. launch
of a prescription drug using Aptar Pharma’s patented Bidose nasal spray delivery system.
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This approval again demonstrates Aptar Pharma’s expertise in developing patient-friendly drug delivery solutions for
breakthrough medicines. Aptar Pharma offers a broad portfolio of innovative technologies and wide array of services to meet the
highest quality standards of the pharmaceutical industry.
Ability to Build Long Term Collaborative Partnerships
Aptar Pharma’s key to success is its ability to build effective partnerships with pharma customers to deploy complex projects
requiring rigorous methodology and joint governance. This customized Bidose liquid device is produced in Aptar Pharma’s
state-of-the-art manufacturing facility in Congers, NY, which offers laboratory and other organizational capabilities to support
nasal and injectable drug delivery systems.
Patented Bidose Technology Platform
Aptar Pharma’s Bidose liquid system is designed for local or systemic delivery of drugs. As a robust, primeless, intuitive and
easy-to-use device with 360° functionality and precise spray characteristics, the Bidose system provides accurate two-shot nasal
drug delivery.
The Aptar Pharma Bidose and Unidose systems offer biotech and pharmaceutical companies effective and reliable intra-nasal
delivery platforms for a variety of medicines including potential life-saving treatments and treatments of severe conditions.
This nasal product platform can enhance brand image via an elegant and intuitive design while limiting the volume of drug
accessible to patients. The devices can also integrate wireless connectivity technologies.
Accelerated Development Support via Aptar Pharma Services
This breakthrough therapy approval is an example of a Combination Product, and benefited from Aptar Pharma’s Services offering,
a comprehensive portfolio of stage-specific packages designed to proactively address regulatory needs to accelerate approval.
Leveraging its extensive value-adding capabilities including lab and analytical services, proven regulatory expertise - with
dedicated Regulatory Affairs experts and fast approval data packages - and customized drug delivery solutions, Aptar Pharma’s
Services can enable an expedited approval and launch in the competitive pharmaceutical space.
“We are pleased that Aptar Pharma’s Bidose nasal delivery device has been approved by the FDA for this breakthrough therapy in
the field of depression,” explained Gael Touya, President, Aptar Pharma. “This project marks close to a 10-year customer
collaboration and once again demonstrates Aptar Pharma’s ability to develop and launch complex drug delivery systems
worldwide.”
About Aptar Pharma
Aptar Pharma is part of AptarGroup, Inc. (NYSE: ATR), a leading global supplier of a broad range of innovative dispensing,
sealing and active packaging solutions for the beauty, personal care, home care, prescription drug, consumer health care,
injectables, food and beverage markets. Aptar uses insights, design, engineering and science to create innovative packaging
technologies that build brand value for its customers, and, in turn, make a meaningful difference in the lives, looks, health and
homes of people around the world. Aptar is headquartered in Crystal Lake, Illinois and has over 14,000 dedicated employees in 18
different countries. For more information, visit
www.aptar.com/pharma.
This press release contains forward-looking statements. Words such as “future” and other similar expressions or future or
conditional verbs such as “will” are intended to identify such forward-looking statements. 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 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. Additionally, forward-looking statements include
statements that do not relate solely to historical facts, such as statements which identify uncertainties or trends, discuss the
possible future effects of current known trends or uncertainties or which indicate that the future effects of known trends or
uncertainties cannot be predicted, guaranteed or assured. 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-Ks and Form 10-Qs. We undertake no
obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Matt DellaMaria
matt.dellamaria@aptar.com
815-477-0424
Media Contact:
Carolyn Penot
carolyn.penot@aptar.com
+33 1 39 17 20 38
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