Aptar Expands Pharmaceutical Services; Announces Exclusive Collaboration Between Aptar Pharma and Fluidda

Nanopharm, an Aptar Pharma company and leader in contract research and development services for orally inhaled and nasal drug products (OINDPs), today announced an exclusive collaboration with Fluidda, a leader in the field of Functional Respiratory Imaging. The companies will leverage their respective proprietary technology platforms to help accelerate U.S. Food & Drug Administration (FDA) approvals for orally inhaled generic products (OIDPs) via the alternative bioequivalence pathway. Nanopharm was acquired by Aptar (NYSE: ATR) in 2019, as part of the company’s strategy to expand its services offerings and partner with pharmaceutical companies earlier in the drug development process.

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Photo: Aptar and Fluidda

Nanopharm has pioneered the development of the alternative bioequivalence regulatory pathway for U.S. FDA approval of generic OIDPs for Asthma and Chronic Obstructive Pulmonary Disease (COPD) using its proprietary in vitro and in silico service platform, SmartTrack. Fluidda’s proprietary in silico platform FRI (Functional Respiratory Imaging) delivers quantitative predictions of regional drug deposition in disease state lungs using Computational Fluid Dynamics (CFD). The FRI platform provides critical information to help understand the availability and activity of the drug at the site of action in the lungs, when complemented by Nanopharm’s local lung physiologically-based pharmacokinetic (PBPK) model platform and its in vitro data.

This novel approach is intended to allow pharma companies to file Abbreviated New Drug Application (ANDA) dossiers without the need to perform time-consuming, costly and often unpredictable clinical end-point studies. Similarly, it can support 505(b)(2) filings, by derisking and abbreviating clinical studies.

“We are pleased to solidify our relationship with Fluidda and its world-leading FRI technology. A company would have to spend several years to achieve the current combined expertise and experience of Nanopharm and Fluidda. The collaboration between Nanopharm and Fluidda has the potential to revolutionize this arduous regulatory pathway,” stated Dr. Jag Shur, Vice President, Science & Technology at Nanopharm.

Having already worked together closely for a number of years, Nanopharm and Fluidda have gained a unique insight into the complex and continually evolving regulatory requirements. This exclusive collaboration deepens the relationship between Fluidda and Nanopharm, benefiting both patients and customers with an uncompromised and holistic approach in developing the scientific rationale to demonstrate bioequivalence using only in vitro and in silico methodologies. The first potential approval of an OIDP using the alternative bioequivalence approach is pending, and, when approved, will further validate Nanopharm’s SmartTrack as the go-to solution for alternative bioequivalence studies and should accelerate demand for the companies’ collective services.