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
OMAHA, Neb. (AP) — Revered investor Warren Buffett shocked an arena full of his shareholders Saturday by announcing that he wants to retire at the end of the year.
Buffett said he will recommend to Berkshire Hathaway’s board on Sunday that Vice Chairman Greg Abel should replace him.
“I think the time has arrived where Greg should become the chief executive officer of the company at year end,” Buffett said.
Abel has been Buffett's designated successor for years, and he already manages all of Berkshire's noninsurance businesses. But it was always assumed that he would not take over until after Buffett's death. Previously the 94-year-old Buffett always said he had no plans to retire.
Buffett announced the news at the end of a five-hour question and answer period without taking any questions about it. He said the only board members who knew this was coming were his two children, Howard and Susie Buffett. Abel, who was sitting next to Buffett on stage, had no warning.
Abel returned an hour later without Buffett to conduct the company's formal business meeting, and he responded to the news.
“I just want to say I couldn’t be more humbled and honored to be part of Berkshire as we go forward,” Abel said.
Many investors have said they believe Abel will do a good job running Berkshire, but it remains to be seen how good he will be at investing Berkshire's cash. Buffett endorsed him Saturday by pledging to keep his fortune invested in the company.
“I have no intention — zero — of selling one share of Berkshire Hathaway. I will give it away eventually,” Buffett said. “The decision to keep every share is an economic decision because I think the prospects of Berkshire will be better under Greg’s management than mine.”
Thousands of investors in the Omaha arena gave Buffett a prolonged standing ovation after his announcement in recognition of his 60 years leading the company.
CFRA research analyst Cathy Seifert said it had to be hard for Buffett to reach this decision to step down.
“This was probably a very tough decision for him, but better to leave on your own terms,” Seifert said. “I think there will be an effort at maintaining a ‘business as usual’ environment at Berkshire. That is still to be determined.”
In many respects, Abel has already been running much of the company for years. But he hasn't been managing Berkshire's insurance operations or deciding where to invest all of its cash. He will now take those tasks on, but Vice Chairman Ajit Jain will remain to help oversee the insurance companies.
Investment manager Omar Malik of Hosking Partners in London said before Buffett’s announcement that he wasn’t worried about Berkshire’s future under Abel.
“Not really (worried). He’s had such a long time alongside Warren and a chance to know the businesses,” Malik said about Abel. "The question is will he allocate capital as dynamically as Warren? And the answer is no. But I think he’ll do a fine job with the support of the others.”
Cole Smead of Smead Capital Management said he wasn't surprised Buffett is stepping down after watching him Saturday because the 94-year-old wasn't as sharp as in past years. At one point, he made a basic math mistake in one of his answers. At other points, he got off track while telling stories about Berkshire and his investing without answering the question he was asked.
Abel is well regarded by Berkshire's managers and Buffett has praised his business acumen for years. But he will have a hard time matching Buffett's legendary performance, and since he doesn't control 30% of Berkshire's stock like Buffett does, he won't have as much leeway.
“I think the challenge he’s going to have is if anyone is going to give him Buffett or (former Vice Chairman Charlie) Munger’s pass card? Not a chance in God’s name," Smead said. Buffett always enjoyed a devoted following among shareholders.
Buffett has said that Abel might even be a more hands-on manager than he is and get more out of Berkshire’s companies. Managers within the company say they have to be well prepared before talking to Abel because they know he will ask tough questions.
Steven Check, president of Check Capital Management, said he never thought he would see Buffett retire.
“I didn't think he would retire while his mind is still working so well, nor did I think it'd happen at the annual meeting,” Check said. “But overall I'm very happy for him.”
Earlier Saturday, Buffett warned of dire global consequences from President Donald Trump's tariffs while telling the thousands of investors gathered at his annual meeting that “trade should not be a weapon” but "there's no question that trade can be an act of war.”
Buffett said Trump's trade policies have raised the risk of global instability by angering the rest of the world.
“It’s a big mistake in my view when you have 7.5 billion people who don’t like you very well, and you have 300 million who are crowing about how they have done,” Buffett said as he addressed the topic on everyone's mind at the start of the Berkshire Hathaway shareholders meeting.
While Buffett said it is best for trade to be balanced between countries, he doesn't think Trump is going about it the right way with his widespread tariffs. He said the world will be safer if more countries are prosperous.
Buffett said he just doesn't see many attractively priced investments that he understands these days, so Berkshire is sitting on $347.7 billion in cash, but he predicted that one day Berkshire will be “bombarded with opportunities that we will be glad we have the cash for.”
Buffett said the recent turmoil in the markets that generated headlines after Trump's tariff announcement last month “is really nothing.” He dismissed the recent drop as relatively small. He cited when the Dow Jones industrial average went from 240 on the day he was born in 1930 down to 41 during the Great Depression as a truly significant drop in the markets. Currently the Dow Jones Industrial Average sits at 41,317.43.
“This has not been a dramatic bear market or anything of the sort," he said.
Buffett said he hasn't bought back any of Berkshire's shares this year either because they don't seem to be a bargain either.
Investor Chris Bloomstran, who is president of Semper Augustus Investments Group, told the Gabelli investment conference Friday that a financial crisis might be the best thing for Berkshire because it would create opportunities to invest at attractive prices.
“Berkshire needs a crisis. I mean Berkshire thrives in crisis,” Bloomstran said.
The meeting attracts some 40,000 people every year who want to hear from Buffett, including some celebrities and well-known investors. This year, Hillary Rodham Clinton also attended. Clinton was the last candidate Buffett backed publicly because he has shied away from politics and any controversial topic in recent years for fear of hurting Berkshire’s businesses.
One investor even camped outside the arena overnight to be first in line.
Devan Bisher, 72, said he has faith in Berkshire's future and does not plan to sell the stock he started buying in the 1980s.
“It’s been a good train to ride,” Bisher said, “and I’m going to stay with it.”
FILE - Berkshire Hathaway Vice Chairman Greg Abel checks out the flight simulators offered by one of Berkshires companies, Flight Safety as he toured the exhibit hall Friday, May 3, 2024, in Omaha, Neb. ahead of Saturday's meeting. (AP Photo/Josh Funk, File)
FILE - Berkshire Hathaway shareholders line up to take selfies with Greg Abel Friday, May 3, 2024, in Omaha, Neb. (AP Photo/Josh Funk, File)
FILE - Berkshire Hathaway Vice Chairman Greg Abel poses for pictures with shareholders while touring the booths Berkshires companies set up, Friday, May 3, 2024, in Omaha, Neb. (AP Photo/Josh Funk, File)
FILE - Berkshire Hathaway Vice Chairman Greg Abel is seen at the CenturyLink Center in Omaha, Neb., on May 5, 2018. (AP Photo/Nati Harnik, File)
FILE - Berkshire Hathaway Chairman and CEO Warren Buffett speaks during an interview with Liz Claman on Fox Business Network's "Countdown to the Closing Bell," May 7, 2018, in Omaha, Neb. (AP Photo/Nati Harnik, File)
Nicolas Bustamante of San Francisco, CEO of fintool.com, holds a sign reading, "We miss Charlie Munger," alongside several others as shareholders arrive outside CHI Health Center Omaha for the Berkshire Hathaway annual meeting Saturday, May 3, 2025, in Omaha, Neb. (AP Photo/Rebecca S. Gratz)
Sean DeFendi of Virginia Beach, left, watches over the GEICO Gecko as he uses the Flight Safety International flight simulator in CHI Health Center Omaha for the Berkshire Hathaway annual meeting Saturday, May 3, 2025, in Omaha, Neb. (AP Photo/Rebecca S. Gratz)
Kevin Gao of San Francisco sorts through his bag of Squishmallows from the Jazwares booth in CHI Health Center Omaha for the Berkshire Hathaway annual meeting Saturday, May 3, 2025, in Omaha, Neb. (AP Photo/Rebecca S. Gratz)
Marcy Gomez of Pasadena, Cal., does yoga with fellow See's Candies employees before doors open to shareholders at CHI Health Center Omaha for the Berkshire Hathaway annual meeting Saturday, May 3, 2025, in Omaha, Neb. (AP Photo/Rebecca S. Gratz)
Boxes of See's Candies featuring an image of Warren Buffett at a campsite with See's Candies' namesake Mrs. See in CHI Health Center Omaha for the Berkshire Hathaway annual meeting Saturday, May 3, 2025, in Omaha, Neb. (AP Photo/Rebecca S. Gratz)
Squishmallows in the likeness of Warren Buffett, left, and Charlie Munger sit on display and for sale in the Jazwares booth at CHI Health Center Omaha for the Berkshire Hathaway annual meeting Saturday, May 3, 2025, in Omaha, Neb. (AP Photo/Rebecca S. Gratz)
Shareholders arrive outside CHI Health Center Omaha for the Berkshire Hathaway annual meeting Saturday, May 3, 2025, in Omaha, Neb. (AP Photo/Rebecca S. Gratz)
Shareholders wait in line outside CHI Health Center Omaha for the Berkshire Hathaway annual meeting Saturday, May 3, 2025, in Omaha, Neb. (AP Photo/Rebecca S. Gratz)
From front, shareholders Haibo Liu, Liyang Jiang and Cheng Guo of China rest in sleeping bags outside CHI Health Center Omaha for the Berkshire Hathaway annual meeting Saturday, May 3, 2025, in Omaha, Neb. The group arrived at 11 p.m. the night before to retain a spot at the front of the line. (AP Photo/Rebecca S. Gratz)
