Mikart, LLC Nano and PharmaSolutions, Inc. | October 12, 2022
Mikart, LLC a comprehensive contract development and manufacturing organization announced that it has entered into a collaboration agreement with Nano PharmaSolutions, Inc. an innovative nanotechnology company that has a proprietary NanoTransformer™ that enhances the solubility of pharmaceutical active ingredients.
"We are excited to bring this new technology from preclinical stage to a GMP clinical phase manufacturing environment. This differentiated, solvent-free, nano-granulation process for drug development and manufacturing provides our customers with an alternative solubility enhancement technology."
Nazar Elkarim, PhD, Vice President of Pharmaceutical Development Services at Mikart
Kay Olmstead, PhD/MBA, Chief Executive Officer at NPS, added, "Nano PharmaSolutions is excited for this collaboration which will provide us with GMP manufacturing capabilities for development of nanomedicines, using our NanoTransformer™ technology at Mikart's facility."
Louis Weber, Vice President of Business Development at Mikart, added, "Mikart is committed to offering innovative options for enhancing solubility and bioavailability to our customers. We feel this nanotechnology will further enhance our development, clinical, and commercial capabilities designed to bring value to our growing customer base."
About Mikart, LLC
Mikart, LLC is a privately held contract development and manufacturing organization founded in 1975. Mikart focuses on small molecules, potent compounds, solid oral, combination products, suspensions, liquids and serialized packaging services. The company has a full range of formulation, analytical, packaging and manufacturing services with a seamless development solution that minimizes the time-to-market from clinical work through commercial supply.
About Nano PharmaSolutions, Inc.
Nano PharmaSolutions, Inc. developed a NanoTransformer™ technology that generates nanoparticles of active pharmaceutical ingredients with physical vapor deposition (PVD), a nanocoating method without using any polymers or solvents. This robust and high drug loading technology increases bioavailability of poorly soluble drugs. The NanoTransformer™ Technology produces patient-centric dosage forms while accelerating drug candidates to the clinic by shrinking development time and R&D costs.
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.
Citius Pharmaceuticals, Inc. | November 22, 2022
Citius Pharmaceuticals, Inc. a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the Company has been selected to participate in New Jersey's Technology Business Tax Certificate Transfer Program, more commonly known as the Net Operating Loss Program, and will receive $3.6 million in non-dilutive capital through the New Jersey Economic Development Authority. Citius expects to receive the funds by late 2022 or early 2023.
"This was the first year that Citius qualified for the program, and we are delighted to have been selected to participate in New Jersey's NOL Program. As a pre-revenue business, this program allows us to convert certain losses from operations into tangible working capital today, supporting our ongoing research and development efforts. We are thankful to the NJ Economic Development Authority for aiding our efforts in our initial year of participation. This non-dilutive funding will provide added cash runway as we advance a late-Phase 3 trial for Mino-Lok®, a Phase 2b trial for Halo-Lido, and a recently submitted biologics license application for I/ONTAK,"
Jaime Bartushak, Chief Financial Officer of Citius
About the Technology Business Tax Certificate Transfer Program
The NOL Program enables participants to sell their New Jersey net operating losses and unused R&D tax credits to unrelated profitable corporations for cash. The NJEDA and the New Jersey Department of Treasury's Division of Taxation jointly administer the NOL Program, which has routinely been hailed as a "lifeline" by entrepreneurs seeking capital for their companies. The average award for companies approved to sell their net operating losses through the program in 2022 was over $3.1 million. Thirty-six percent of program applicants are private businesses, while the remaining 64 percent are publicly traded companies. To date, more than $1.17 billion in funding has been distributed to over 570 technology and life sciences companies since the program's inception in the late 1990s.
About the New Jersey Economic Development Authority
The New Jersey Economic Development Authority serves as the State's principal agency for driving economic growth. The NJEDA is committed to making New Jersey a national model for inclusive and sustainable economic development by focusing on key strategies to help build strong and dynamic communities, create good jobs for New Jersey residents, and provide pathways to a stronger and fairer economy. Through partnerships with a diverse range of stakeholders, the NJEDA creates and implements initiatives to enhance the economic vitality and quality of life in the State and strengthen New Jersey's long-term economic competitiveness.
About Citius Pharmaceuticals, Inc.
Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The Company's diversified pipeline includes two late-stage product candidates, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma for which a BLA has been submitted. Mino-Lok® was granted Fast Track designation by the U.S. Food and Drug Administration. I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma. In the first half of 2022, Citius initiated a Phase 2b trial for Halo-Lido, a topical formulation for the relief of hemorrhoids.