Aptar Pharma and Fluidda | September 23, 2022
Nanopharm, an Aptar Pharma company and leader in contract research and development services for orally inhaled and nasal drug products 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 approvals for orally inhaled generic products via the alternative bioequivalence pathway. Nanopharm was acquired by Aptar 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.
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 using its proprietary in vitro and in silico service platform, SmartTrack™. Fluidda’s proprietary in silico platform FRI delivers quantitative predictions of regional drug deposition in disease state lungs using Computational Fluid Dynamics. 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 model platform and its in vitro data.
This novel approach is intended to allow pharma companies to file Abbreviated New Drug Application 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,”
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.
With momentum building for the transition to new lower global warming potential (GWP) propellants for pMDIs, SmartTrack™ will also help companies to understand and modulate the impact of these new propellants on drug deposition and dissolution in the lungs, giving confidence in the performance of the reformulated product before embarking on any necessary clinical studies.
Dr. Jan de Backer, CEO of Fluidda, stated, “Fluidda has already demonstrated the applicability of its FRI platform to provide more objective data for evaluating and administering inhaled drug products accurately. Nanopharm’s unique SmartTrack™ platform provides us with clinically-relevant input data without having to actually go into the clinic, which really adds another level of confidence to the models, and provides an integrated perspective.”
Guillaume Brouet, Vice President, Analytical, Regulatory and Scientific Affairs at Aptar Pharma, commented, “Aptar Pharma is delighted to collaborate with Fluidda on this important development, which reinforces our mission to help customers derisk and accelerate their drug product development programs.”
Aptar Pharma is part of AptarGroup, Inc., a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions and services. Aptar’s innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, personal care, home care, food and beverage. Aptar Pharma’s analytical, laboratory and regulatory services add value at every stage of the drug development process, accelerating and de-risking the program along the way. Nanopharm, an Aptar Pharma company, is a leading provider of specialized analytical and product development services, with a focus on orally inhaled and nasal drug products. Aptar is headquartered in Crystal Lake, Illinois and has 13,000 dedicated employees in 20 countries.
FLUIDDA, founded in 2005, is the world leader in the field of Functional Respiratory Imaging (FRI). This technique combines HRCT scans and Computational Fluid Dynamics technology (CFD), which offers vast improvements by making clinical trials shorter, faster and thus, more cost effective. FRI also helps patients and healthcare providers in offering a unique entry point in personalized medicine, by optimizing diagnosis, monitoring disease progression and the effects of therapy including accurate assessment of the deposition of inhalation medication. Fluidda’s mission is to optimize treatment pathways, reduce healthcare costs and to limit the go-to-market time of respiratory drugs, pulmonology medical devices and therapies. Fluidda has offices in Belgium, the United States and Portugal.
AllianceRx Walgreens Pharmacy | September 28, 2022
AllianceRx Walgreens Pharmacy has received exclusive access to Phospholine Iodide® from Fera Pharmaceuticals. Phospholine Iodide is used to help reduce elevated intraocular pressure of glaucoma and for accommodative esotropia in children.
"AllianceRx Walgreens Pharmacy is excited to be able to offer this invaluable therapeutic option to help correct these chronic and rare ophthalmologic conditions. These patients deserve access to this life-changing therapy that may actually preserve their vision. Our manufacturer partners know we offer resources to help patients stay on therapy and yield the best possible outcomes."
Lisa Mymo, vice president, pharma and financial services at AllianceRx Walgreens Pharmacy
As one of the nation's largest specialty and home delivery pharmacies, AllianceRx Walgreens Pharmacy has direct access to the majority of limited distribution drugs on the market. In addition to Phospholine Iodide, the following medications are also available through AllianceRx Walgreens Pharmacy:
Camzyos manufactured by Bristol Myers Squibb, treats adults with a rare heart condition known as symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms.
Vivjoa manufactured by Mycovia Pharmaceuticals, Inc., treats postmenopausal and permanently infertile women with recurrent vaginal yeast infections.
About AllianceRx Walgreens Pharmacy
AllianceRx Walgreens Pharmacy provides hope and care for better tomorrows to patients with rare diseases and chronic conditions by delivering medications from its specialty and home delivery pharmacies. Our advanced analytical capabilities, pharmacy expertise and technology solutions enable providers, pharmaceutical manufacturers, and health plans to deliver optimal health outcomes. Through personalized care and clinical programs, along with access to the leading number of limited distribution drugs, patients can get back to what matters most. Headquartered in Orlando, Florida, the company holds several national pharmacy accreditations and has team members across the United States.
Lexitas and QHP Capital | July 08, 2022
QHP Capital the management company for NovaQuest Private Equity announced its acquisition of Lexitas Pharma Services a full-service ophthalmology contract research organization supporting biopharmaceutical and medical device clinical trials.
Since 2011, Lexitas has provided clinical trial and medical strategy solutions to biopharmaceutical and medical device companies developing ophthalmic products. The Company provides end-to-end support and development expertise in the anterior and posterior segments of ophthalmology. Lexitas has conducted clinical trials for dry eye disease, glaucoma, cataract, uveitis, pediatric myopia, diabetic macular edema, age-related macular degeneration, and retinitis pigmentosa, among others. The Company’s therapeutic area expertise, relationships with ophthalmic KOLs, and network of high-performing research sites has led to strong outcomes for its international customer base.
“For the past decade, Lexitas has had the incredible opportunity and privilege to partner with talented companies with amazing science as they develop their ophthalmic drugs and devices. Partnering with the QHP team brings deep expertise and domain knowledge that is going to allow Lexitas to improve and increase the scope, quality, and efficiency of our capabilities. We couldn’t be more thrilled to be working with QHP and are excited at the prospect of getting safe and efficacious ophthalmic drugs to patients efficiently and quickly,”
George Magrath, M.D., CEO of Lexitas
“Lexitas is an excellent fit with QHP’s philosophy and strategy of providing strategic capital to growing clinical trial services providers in niche, specialized therapeutic areas,” said Vern Davenport and Jeff Edwards, Partners at QHP. “We look forward to supporting the Lexitas team as they continue to build out their capabilities and provide best-in-class ophthalmic drug development services.”
Additionally, Lexitas appointed Jeanne Hecht as Executive Chairwoman of the Board. Jeanne is a seasoned ophthalmology CRO industry executive having previously served as CEO of Ora, an ophthalmic CRO, where she expanded Ora’s international presence, introduced new lines of business, and furthered its goals along numerous strategic paths.
Lexitas is a full-service ophthalmic biopharmaceutical solutions company focused on providing end-to-end eyecare support and exceptional service to biopharma and medical device clients globally.
About QHP Capital
QHP Capital, L.P. is the management company for NovaQuest Private Equity NQPE is a private equity firm that invests in lower middle market healthcare companies primarily in North America. The Firm invests in services and technology companies where a strategic partner and operating resources can accelerate growth, targeting companies in healthcare and pharmaceutical services industries. NQPE invests in the form of buyouts, growth equity, and recapitalizations.