CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--Apr 16, 2025--
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.
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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 www.nanopharm.co.uk and www.aptar.com.
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.
Nanopharm’s SmartTrack™ for Generic Inhalation Products
WASHINGTON (AP) — A day after the audacious U.S. military operation in Venezuela, President Donald Trump on Sunday renewed his calls for an American takeover of the Danish territory of Greenland for the sake of U.S. security interests, while his top diplomat declared the communist government in Cuba is “in a lot of trouble.”
The comments from Trump and Secretary of State Marco Rubio after the ouster of Venezuela's Nicolás Maduro underscore that the U.S. administration is serious about taking a more expansive role in the Western Hemisphere.
With thinly veiled threats, Trump is rattling hemispheric friends and foes alike, spurring a pointed question around the globe: Who's next?
“It’s so strategic right now. Greenland is covered with Russian and Chinese ships all over the place," Trump told reporters as he flew back to Washington from his home in Florida. "We need Greenland from the standpoint of national security, and Denmark is not going to be able to do it.”
Asked during an interview with The Atlantic earlier on Sunday what the U.S.-military action in Venezuela could portend for Greenland, Trump replied: “They are going to have to view it themselves. I really don’t know.”
Trump, in his administration's National Security Strategy published last month, laid out restoring “American preeminence in the Western Hemisphere” as a central guidepost for his second go-around in the White House.
Trump has also pointed to the 19th century Monroe Doctrine, which rejects European colonialism, as well as the Roosevelt Corollary — a justification invoked by the U.S. in supporting Panama’s secession from Colombia, which helped secure the Panama Canal Zone for the U.S. — as he's made his case for an assertive approach to American neighbors and beyond.
Trump has even quipped that some now refer to the fifth U.S. president's foundational document as the “Don-roe Doctrine.”
Saturday's dead-of-night operation by U.S. forces in Caracas and Trump’s comments on Sunday heightened concerns in Denmark, which has jurisdiction over the vast mineral-rich island of Greenland.
Danish Prime Minister Mette Frederiksen in a statement that Trump has "no right to annex" the territory. She also reminded Trump that Denmark already provides the United States, a fellow member of NATO, broad access to Greenland through existing security agreements.
“I would therefore strongly urge the U.S. to stop threatening a historically close ally and another country and people who have made it very clear that they are not for sale,” Frederiksen said.
Denmark on Sunday also signed onto a European Union statement underscoring that “the right of the Venezuelan people to determine their future must be respected” as Trump has vowed to “run” Venezuela and pressed the acting president, Delcy Rodriguez, to get in line.
Trump on Sunday mocked Denmark’s efforts at boosting Greenland’s national security posture, saying the Danes have added “one more dog sled” to the Arctic territory’s arsenal.
Greenlanders and Danes were further rankled by a social media post following the raid by a former Trump administration official turned podcaster, Katie Miller. The post shows an illustrated map of Greenland in the colors of the Stars and Stripes accompanied by the caption: “SOON."
“And yes, we expect full respect for the territorial integrity of the Kingdom of Denmark,” Amb. Jesper Møller Sørensen, Denmark's chief envoy to Washington, said in a post responding to Miller, who is married to Trump's influential deputy chief of staff Stephen Miller.
During his presidential transition and in the early months of his return to the White House, Trump repeatedly called for U.S. jurisdiction over Greenland, and has pointedly not ruled out military force to take control of the mineral-rich, strategically located Arctic island that belongs to an ally.
The issue had largely drifted out of the headlines in recent months. Then Trump put the spotlight back on Greenland less than two weeks ago when he said he would appoint Republican Gov. Jeff Landry as his special envoy to Greenland.
The Louisiana governor said in his volunteer position he would help Trump “make Greenland a part of the U.S.”
Meanwhile, concern simmered in Cuba, one of Venezuela’s most important allies and trading partners, as Rubio issued a new stern warning to the Cuban government. U.S.-Cuba relations have been hostile since the 1959 Cuban revolution.
Rubio, in an appearance on NBC's “Meet the Press,” said Cuban officials were with Maduro in Venezuela ahead of his capture.
“It was Cubans that guarded Maduro,” Rubio said. “He was not guarded by Venezuelan bodyguards. He had Cuban bodyguards.” The secretary of state added that Cuban bodyguards were also in charge of “internal intelligence” in Maduro’s government, including “who spies on who inside, to make sure there are no traitors.”
Trump said that “a lot” of Cuban guards tasked with protecting Maduro were killed in the operation. The Cuban government said in a statement read on state television on Sunday evening that 32 officers were killed in the U.S. military operation.
Trump also said that the Cuban economy, battered by years of a U.S. embargo, is in tatters and will slide further now with the ouster of Maduro, who provided the Caribbean island subsidized oil.
“It's going down,” Trump said of Cuba. “It's going down for the count.”
Cuban authorities called a rally in support of Venezuela’s government and railed against the U.S. military operation, writing in a statement: “All the nations of the region must remain alert, because the threat hangs over all of us.”
Rubio, a former Florida senator and son of Cuban immigrants, has long maintained Cuba is a dictatorship repressing its people.
“This is the Western Hemisphere. This is where we live — and we’re not going to allow the Western Hemisphere to be a base of operation for adversaries, competitors, and rivals of the United States," Rubio said.
Cubans like 55-year-old biochemical laboratory worker Bárbara Rodríguez were following developments in Venezuela. She said she worried about what she described as an “aggression against a sovereign state.”
“It can happen in any country, it can happen right here. We have always been in the crosshairs,” Rodríguez said.
AP writers Andrea Rodriguez in Havana, Cuba, and Darlene Superville traveling aboard Air Force One contributed reporting.
In this photo released by the White House, President Donald Trump monitors U.S. military operations in Venezuela, with Secretary of State Marco Rubio at Mar-a-Lago in Palm Beach, Fla., Saturday, Jan. 3, 2026. (Molly Riley/The White House via AP)
