Alchem International solves stability dilemma for micronized Digoxin

prnewswire | April 15, 2019

Alchem's molecule is the sole micronized digoxin available globally that resolves the challenge of micro dosage formulation and the long-term stability and impurity issues with this specialist heart drug.  Digoxin is commonly administered to treat various heart conditions including atrial fibrillation, atrial flutter, and heart failure.  Micronization of digoxin, normally made for formulation homogeneity, dissolution and bioavailability, had previously led to an impractical and short shelf life (12 to 24 months) and the formation of impurities.Speaking from Alchem's European offices in Geneva (Switzerland) Raman Mehta, Alchem CEO and President, commented "Our process innovations mean that, for the first time since Boehringer Ingelheim announced in 2014 an end to production and supply of micronized digoxin to the market, drugmakers can be sure of supply and sure of the stability of this niche but important API.  Raman Mehta continued "our customers are now able to formulate digoxin at the optimum particle size distribution (PSD) with a molecule that is stable for transport, stable for one-year storage at ambient temperatures (15 – 25 degrees Celsius) and stable for 4 years under cold storage (3 – 8 degrees Celsius). We fully expect the shelf life to be extended to 5 years in 2020 based on ongoing studies; our stability batches show Alchem manufactured digoxin to be stable with no change in the impurity profile and other properties either in long term stability or accelerated stability tests providing a clear advantage for handling and formulation".

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PHARMA TECH

AeroRx Partners with HCmed to Develop a Nebulized LABA/LAMA Combination Solution for the Treatment of Chronic Obstructive Pulmonary Disease

AeroRx Partners | October 03, 2022

AeroRx Therapeutics, LLC. and HCmed Innovations Co., Ltd. have initiated a collaboration, introducing a LABA/LAMA combination solution for delivery with a breath-actuated nebulizer. This collaboration sets forth the framework by which both companies will work together to develop a new nebulized combination formulation for the treatment of chronic obstructive pulmonary disease. According to market reports, it is estimated that there would be close to 34.5 million COPD patients worldwide by 2028, accounting for treatment global sales that could reach up to 19.3 billion USD. AeroRx is currently developing the first nebulized LABA/LAMA combination solution, which could benefit 7-19% of the COPD population. This population group is characterized for suffering from moderate to severe airflow obstruction, which creates difficulties to achieve the inspiratory flow rate required to use most dry powder inhalers optimally. Under this partnership, AeroRx will be responsible for the formulation development, clinical trials, and commercialization of the drug product, while HCmed will be responsible for the customization of the AdheResp breath-actuated nebulizer platform, analyzing and optimizing the formulation's aerosol characterization performance to accommodate the various stages of drug development process and the final combination product. The project will follow a 505(b)2 regulatory pathway, and the corresponding PK/PD study is expected to be conducted with HCmed's nebulizer in 2023. "We are excited to announce our partnership with AeroRx. The AeroRx team has extensive experience in the development of respiratory drugs, while at HCmed we can support our partners to develop drug-nebulizer combination products with our proprietary breath-actuated mesh nebulizer platform. The product of our collaboration will provide COPD patients with an effective inhaled LABA/LAMA combination drug, which will reinforce patients' treatment adherence and improve their quality of life." Jason Cheng, CEO and founder of HCmed Keith Ung, President and co-founder of AeroRx also commented, "We too are enthusiastic about this partnership. Breath-actuated vibrating mesh delivery of inhaled therapeutics is the wave of the future for many therapeutics and HCmed has become one of the leaders in this elegant inhaler device technology." About HCmed Founded in 2014, HCmed Innovations Co., Ltd. is a contract development and manufacturing organization that provides high-quality and cost-effective vibrating mesh nebulizer technology and services to support global pharmaceutical partners in the development of drug-nebulizer combination products for inhalation therapy. HCmed offers a mature customizable mesh nebulizer platform to enhance drug delivery. This technology enables efficient and reliable nebulization of different types of medication, ranging from small molecule synthetics to large molecule biologics, as either solutions, suspensions, or even difficult-to-deliver high viscosity drugs. About AeroRx Founded in 2022, AeroRx Therapeutics, LLC. is a spin-off of iPharma Lab's inhalation CDRO business which was recently acquired by Kindeva Drug Delivery. AeroRx is developing proprietary inhaled products for the treatment of COPD and asthma. The company is led by industry veterans with extensive expertise in inhaled drug delivery and development as well as a track record in building new pharmaceuticals organizations from the ground up.

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BUSINESS INSIGHTS

Saudi Ministry of Investment and Insilico Medicine sign agreement to expand region’s biotechnology capabilities

Insilico Medicine | September 15, 2022

Saudi Arabia’s Ministry of Investment and clinical stage artificial intelligence (AI)-driven drug discovery company Insilico Medicine have signed a memorandum of understanding (MoU) to support the development of a robust AI-driven biotech industry in the Kingdom. The agreement was signed during the Global AI Summit, held from the 13th through the 15th of September in Riyadh, which featured over 200 speakers representing 90 countries discussing the future of AI, including Insilico Medicine founder and CEO Alex Zhavoronkov, PhD. Sara Althari, PhD, senior researcher and MISA advisor, spearheaded the agreement. MISA and Insilico Medicine will work on shared initiatives that build on the capabilities of Insilico’s end-to-end AI-powered drug discovery platform, PharmaAI. Drawing on trillions of data points, the platform has three distinct but interconnected elements – novel AI target discovery novel AI drug design and AI clinical trial prediction. Under the terms of the MoU, Insilico will share its expertise and software platform with local biotech companies to support and accelerate their research and drug development efforts. Through the partnership, the MoU also seeks to spur the development of new biotech companies. Insilico will also work with Saudi companies on robotics-aided drug design and clinical trial design and best practices. The Company is launching a fully autonomous AI-run robotics lab that will perform experiments, capture data, and further validate its AI-discovered and designed drugs later this fall. The Company’s clinical trial prediction tool, InClinico, is designed to help researchers and companies plan trials with greater statistical likelihood of Phase 2 success. There will be additional partnership opportunities in other areas where Insilico’s AI platform has shown promise, including the support and initiation of projects related to healthy longevity and support for green chemistry initiatives, including the development of sustainable chemicals and crop protection solutions. “As someone who decided to dedicate his life to extending healthy productive longevity for everyone on the planet, I applaud Saudi Arabia’s new initiatives in this most impactful area of research. As a company, we are encouraged by Saudi Arabia’s vision to increase its digital economy and play a meaningful role in the future of drug discovery using AI and robotics. We look forward to working together to expand the region’s biotech sector and partnering with established and emerging companies as well as academic and research institutions in order to explore the full potential of our end-to-end AI platform.” Alex Zhavoronkov, PhD, founder and CEO of Insilico Medicine Over the past year, MISA has signed MoUs with a number of pharmaceutical and technology companies to grow its biotech sector, including Novartis, Janssen, AstraZeneca, GSK and Roche, as well as Amazon Saudi Arabia. Insilico Medicine, a company which bridges pharma and tech, is the first AI-driven drug discovery company to sign such an agreement in the region. About Insilico Medicine Insilico Medicine, a clinical stage end-to-end artificial intelligence (AI)-driven drug discovery company, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques to discover novel targets and to design novel molecular structures with desired properties. Insilico Medicine is delivering breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases and aging-related diseases.

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BUSINESS INSIGHTS

Cambrex to Acquire Snapdragon Chemistry, a Leader in Continuous Flow API Development Services

Cambrex | November 22, 2022

Cambrex, a leading global contract development and manufacturing organization providing drug substance, drug product, and analytical services across the entire drug lifecycle, today announced that it has entered into a definitive agreement to acquire Snapdragon Chemistry, a leading US-based provider of chemical process development services to a broad range of emerging and established biopharma customers. Snapdragon specializes in active pharmaceutical ingredient batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges. The team of scientists and engineers apply deep process understanding afforded by data-rich experimentation to design and rapidly execute efficient GMP and non-GMP manufacturing processes. With R&D and manufacturing headquartered in Waltham, Massachusetts, Snapdragon's 74 employees come with strong ties to the local scientific community, with 31 PhD scientists on staff. "The acquisition of Snapdragon will accelerate our growth in the area of continuous flow process development and manufacturing, complementing our recent organic investments in our High Point, North Carolina facility. With R&D and manufacturing capabilities in the heart of Boston's biopharma hub, Snapdragon will continue to focus on solving their customers' most difficult process development challenges." Tom Loewald, CEO of Cambrex "We are excited to be joining Cambrex, a company with over 40 years of drug substance development and manufacturing expertise," said Matt Bio, CEO of Snapdragon. "Partnering our best-in-class process development capabilities with Cambrex's larger scale manufacturing facilities in North America and Europe is a natural fit, both for our employees and our customers." Snapdragon recently opened its second facility, a new 51,000-square-foot facility to manufacture experimental pharmaceutical products for human clinical trials. The new facility expanded the company's capacity for supplying clinical intermediates and drug substances. The transaction is expected to close following the completion of customary regulatory approvals. This will be Cambrex's second acquisition within a year along with Q1 Scientific, consistent with its strategy to expand its portfolio of specialized solutions for pharmaceutical development and manufacturing. About Cambrex Cambrex is a leading global contract development and manufacturing organization that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,300 experts servicing global clients from North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and finished dosage form development and manufacturing. Cambrex offers a range of specialized drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid-state science, material characterization, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialty dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile, and non-sterile ointments.

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BUSINESS INSIGHTS

NanOlogy Publishes Review Article of Preclinical and Clinical Research Supporting LSAM-DTX

NanOlogy | September 21, 2022

NanOlogy LLC, a clinical-stage interventional oncology drug company, announced that a review article of preclinical and clinical research supporting its investigational drug, large surface area microparticle docetaxel has been published in Drug Delivery and Translational Research. The review article entitled Local administration of large surface area microparticle docetaxel to solid carcinomas induces direct cytotoxicity and immune‑mediated tumoricidal effects: preclinical and clinical studies provides a review of preclinical research that supports tumor-directed LSAM-DTX as well as promising results from the high-risk nonmuscle invasive bladder cancer arm of a clinical trial of local LSAM-DTX in urothelial carcinoma, which were published earlier this year in The Journal of Urology. The articles also follows an earlier review of preclinical and clinical research supporting another NanOlogy investigational drug, large surface area microparticle paclitaxel published in DDTR in 2020. In addition to LSAM-DTX, NanOlogy clinical programs have advanced tumor-directed LSAM-PTX in pancreas, lung, peritoneal, ovarian, prostate, and dermal cancers. The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts active ingredients into stable large surface area microparticles (LSAMs) of pure drug optimized for tumor-directed therapy and continuous drug release to maximize drug delivered to the tumor and minimize systemic toxicity. Taxane particles are covered by composition of matter patents issued in the US Canada, Europe, Japan, China, Hong Kong, South Korea, Australia, Indonesia, and Russia valid through June 2036. The composition patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, formulations, methods, and technology. About NanOlogy NanOlogy, LLC is a private clinical-stage interventional oncology drug company formed in 2015 to improve the treatment of solid tumors based on a proprietary particle engineering technology platform for tumor-directed drug therapy to maximize drug in tumor and minimize systemic toxicity.

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ABC delivers a broad array of GLP and CGMP-compliant product development and analytical testing services to the pharmaceutical, biotech, animal health, crop protection, consumer products and chemical industries. This cross-industry, cross-regulatory experience adds value to the process of product development--and will become increasingly important as public scrutiny and global regulations converge on the interrelationships between human, animal and environmental health.

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