Latest news with #GaelTouya
Yahoo
17-07-2025
- Business
- Yahoo
Aptar acquires Mod3 Pharma's trial materials manufacturing capabilities
Aptar Pharma has announced the acquisition of Mod3 Pharma's clinical trial materials manufacturing capabilities from SWK Holdings. Mod3 Pharma was previously known as Enteris Biopharma. This acquisition is a strategic move aimed at strengthening Aptar Pharma's support for the early-stage development of drugs by providing formulation, fill, and finish services for Phase I and II clinical trials, and promoting the adoption of its devices in early-stage clinical programmes. It is said to build upon a previous partnership between the two companies, which focused on providing Phase I and II current good manufacturing practices (cGMP) fill and finish services for orally inhaled nasal drug products (OINDPs) to the customers of Aptar. Mod3 Pharma CEO Dr Paul Shields said: 'We are delighted to become part of the Aptar family. This acquisition reflects our shared commitment to accelerating the development of innovative therapies and bringing them to patients faster.' Aptar Pharma's expansion also aims to accelerate the adoption of new drug delivery technologies. Initially focusing on OINDPs, there is potential for growth into other areas, such as ophthalmic, dermal, injectable, and secondary packaging solutions, using Aptar's active material science solutions. Aptar Pharma president Gael Touya said: 'Our vision at Aptar Pharma is clear: from formulation to patient. 'By integrating Phase I and II clinical manufacturing capabilities, we're not just expanding our technical footprint, we're deepening our commitment to customers seeking a seamless and accelerated path to market.' Following the acquisition, Aptar Pharma will operate a US Food and Drug Administration (FDA)-inspected facility in New Jersey, US. The site is equipped with cGMP cleanrooms, fill-finish technologies, active pharmaceutical ingredient (API) suites, and biologics capabilities. "Aptar acquires Mod3 Pharma's trial materials manufacturing capabilities" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
15-07-2025
- Business
- Business Wire
Aptar Pharma Bolsters Clinical Trial Capabilities with Strategic Materials Manufacturing Acquisition
CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--Aptar Pharma, a global leader in drug delivery and active material science solutions and services, today announces its acquisition of the clinical trial materials manufacturing capabilities of Mod3 Pharma (formerly Enteris Biopharma) from SWK Holdings. This strategic move strengthens Aptar's support for early-stage drug development by offering formulation, fill and finish services for Phase 1 and 2 clinical trials and enhances adoption of its proprietary devices in early-stage clinical programs. This acquisition builds on a successful collaboration between Aptar Pharma and Mod3 Pharma, particularly in serving Aptar Pharma customers with Phase 1 and Phase 2 cGMP fill and finish services for orally inhaled nasal drug products (OINDPs), filling a largely unmet need in the market. The capabilities acquired also help Aptar address a growing market demand for agile, high-quality Current Good Manufacturing Practices (cGMP) clinical trial material supply services that complement the segment's existing service offerings. Additionally, the acquisition accelerates the adoption of new drug delivery technologies, initially focusing on OINDPs, with potential expansion into dermal, ophthalmic, injectable and secondary packaging solutions using Aptar's Active Material Science Solutions. Aptar Pharma will now operate an FDA-inspected, state-of-the-art facility in Boonton, New Jersey. The site includes cGMP cleanrooms, high-potency Active Pharmaceutical Ingredient (API) suites, biologics capabilities, and advanced fill-finish technologies - fully aligned with Aptar Pharma's drug delivery solutions portfolio. Gael Touya, President of Aptar Pharma, commented, 'Our vision at Aptar Pharma is clear: From formulation to patient. By integrating Phase 1 and 2 clinical manufacturing capabilities, we're not just expanding our technical footprint - we're deepening our commitment to customers seeking a seamless and accelerated path to market. This move reinforces our position as a trusted partner from molecule to delivery, and ultimately, to the patient.' Sai Shankar, President, M&A, Strategy, Business Development, Marketing, Drug Services, added, 'We're expanding our niche services to help customers move faster in areas of unmet need, and without duplicating the strengths of our trusted partners. This strategic expansion of our services builds on our legacy in drug dosing and dispensing systems by integrating deeper expertise as a drug delivery innovator, as well as product development and formulation, allowing us to offer more specialized and holistic support to our customers.' Dr. Paul Shields, CEO of Mod3 Pharma, remarked, 'We are delighted to become part of the Aptar family. This acquisition reflects our shared commitment of accelerating the development of innovative therapies and bringing them to patients faster.' About Aptar Pharma Aptar Pharma is part of AptarGroup, Inc. (NYSE:ATR), a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions. Aptar's innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, personal care, home, food and beverage. Using insights, proprietary design, engineering and science to create dispensing, dosing and protective technologies for many of the world's leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has 13,000 dedicated employees in 20 countries. For more information, visit
Yahoo
16-04-2025
- Business
- Yahoo
Aptar Announces Clinical Validation Study to Accelerate US FDA Approval of SmartTrack™ In-Vitro-in-Silico Platform for Pressurized Metered-Dose Inhalers
SmartTrack™ aims to reduce the need for clinical studies in generic drug product approvals CRYSTAL LAKE, Ill., April 16, 2025--(BUSINESS WIRE)--AptarGroup, Inc. (NYSE: ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies, today announces the commencement of a clinical study to validate its proprietary SmartTrack™ platform. The platform was developed by Aptar's drug services company, Nanopharm. If validated, SmartTrack™ aims to reduce the need for clinical studies in generic drug product approvals by proving it can accurately predict clinical outcomes – removing a major barrier for pharma companies and regulators and paving the way for wider patient access to medications. This validation would establish SmartTrack™ as a credible in-vitro-in-silico alternative to comparative clinical endpoint (CCEP) studies, and a reliable approach to derisking in vitro-pharmacokinetic (PK) only approaches, specifically for generic inhaled drug products. The study, which is expected to begin in Q2 2025, has been carefully designed based on detailed feedback from regulatory agencies to meet the requirements for obtaining a biowaiver of the CCEP for pharmaceutical companies working with Nanopharm as well as enabling the models to provide supportive data to the in vitro studies. The study will involve radio-labelling three different commercially available pressurized metered-dose inhaler (pMDI) drug products and imaging regional lung deposition. These results will be compared with regional deposition predictions from computational fluid dynamic (CFD) simulations conducted in collaboration with Fluidda, Medimprove and i2c Pharmaceutical Services. Additionally, pharmacokinetic (PK) data from subjects will be collected to validate predictions from Nanopharm's Simhalation™ platform, which uses physiologically based pharmacokinetic (PBPK) modeling. The resulting study data will be submitted to the U.S. FDA as one of the first Model Master Files (MMF), which would allow multiple companies to benefit from this data when partnering with Aptar, similar to the well-established Drug Master File (DMF) route. Gael Touya, President, Aptar Pharma, stated, "This clinical study marks a significant milestone in the evolution of Aptar's offerings. Providing clinically validated data to our pharmaceutical partners and regulatory bodies will be crucial in demonstrating the platform's viability, which could lead to accelerated approvals and broader access to generic inhaled medicines for more patients." In addition to supporting generic Abbreviated New Drug Application (ANDA)1 approvals, the study could also help accelerate and derisk other programs, such as the reformulation of pMDIs with new lower global warming potential (GWP) propellants, novel (drug product) combinations, developing drug products from other dosage forms, and New Chemical Entity (NCE) development into pMDIs. The study is expected to conclude by the end of 2025. Interested parties are encouraged to contact Nanopharm to explore how this package can support their product development and approval strategies. About Aptar Aptar is a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Nanopharm is a leading provider of tailored analytical, modelling and pharmaceutical development services, with a focus on orally inhaled and nasal drug products (OINDP). The company's unique analytical technologies and formulation development tools enable seamless translation of pre-clinical product development through to CMC, IVBE and cGMP manufacturing and release, whether for generic drug products or new molecular entities. This helps pharmaceutical companies to holistically understand how all properties of the combination drug products influence product functionality to accelerate and derisk product development in the niche field of OINDP. For more information, visit and This press release contains forward-looking statements, including the potential outcomes of the SmartTrack™ technology. 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" and other similar expressions or future or conditional verbs such as "will," "should," "would" and "could" 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 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: the successful integration of acquisitions; the regulatory environment; 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 Forms 10-Q. We undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as otherwise required by law. 1Abbreviated New Drug Application (ANDA) | FDA View source version on Contacts Aptar Investor Relations Contact:Mary Skafidas +1 347 351 6407 Aptar Pharma Media Contact: Ciara +49 151 1951 6502 Sign in to access your portfolio
