Galenix

Core Activities and Services

Galenix operates as a full-service Contract Research Organization (CRO) and technology platform, covering the entire spectrum of pharmaceutical development from the initial feasibility study to the final submission of registration files.

Pharmaceutical Contract Services (Early Development Department)

The company provides a comprehensive range of pharmaceutical development services designed to secure a client's development program and optimize drug products. These services include: * Feasibility Studies and Preformulation: Initial studies to assess the Active Pharmaceutical Ingredient (API) compatibility, stability, and therapeutic potential with various formulation technologies. * Formulation Development: The creation of various dosage forms, from simple to complex, including immediate release, modified release, sustained release tablets, multilayer tablets, coated tablets, capsules, powders, granules, solutions, suspensions, gels, liposomes, microemulsions, and transdermal therapeutic systems. * Analytical Development and Validation: Developing and validating analytical methods essential for quality control and regulatory submission. * Process Transfer and Scale-up: Assisting with the transition from laboratory scale to industrial production, including clinical batches production. * Quality Control (QC) and Stability Studies: Performing Quality Control and conducting ICH (International Council for Harmonisation) stability studies. * Regulatory Services and Consulting: Providing support for the preparation and submission of registration files (e.g., NDA, CTD, MAA) in line with European and US FDA requirements, and strategic consulting on pharmaceutical development. * Clinical Supply Services Support: Providing necessary materials and support for clinical trials.

Drug Delivery Systems (DDS) Department and Technology Licensing

The DDS department is dedicated to developing innovative solutions for controlled-release and enhanced patient compliance, with a focus on suprabioavailability, delayed, extended, and immediate release profiles for oral, topical, or parenteral administrations. Galenix holds patents on several innovative DDS technologies and more than twenty drug product compositions and manufacturing processes, which are available for licensing out to pharmaceutical companies.

Proprietary Products and Technologies

Galenix's key proprietary Drug Delivery Systems (DDS) are the primary products it offers for licensing and integration into client development programs:

• MINEXTAB®: This technology is specifically designed for high-dosage solid forms (e.g., tablets). Its primary benefit is a drastic reduction in tablet size, often by at least 50%, by incorporating a high proportion of the active ingredient (at least 85% of the tablet mass) and minimizing excipients. This reduction improves patient compliance, particularly for drugs requiring large doses, and allows for tailored drug release profiles (immediate, modified, or bimodal) using conventional, scalable manufacturing processes.

• MINEXTAB® FLOATING: A variation of the MINEXTAB system intended for drugs that are primarily absorbed in the stomach. This formulation includes excipients that react with water to form CO2 bubbles, causing the tablet to float on gastric contents, thereby prolonging the drug's residence time in the stomach and potentially enhancing absorption.

• MICROGIX®: A versatile dispersed system designed to significantly improve the bioavailability and/or solubility of Active Pharmaceutical Ingredients (APIs). The API is first dispersed in a water/oil or oil/water preparation, which is then adsorbed onto a powder. This powder can be used to manufacture various dosage forms, including sachets, stick packs, capsules, tablets, or parenteral preparations.

• MUCOLYS® FILM: This technology involves a trademarked powder formulation intended for incorporation into spray-delivered medicines or stick packs. When it contacts a mucous membrane, such as inside the mouth, it forms a bioadhesive film. This film allows the drug to be released in a sustained manner through the mucous membrane for up to five hours, effectively reducing the "first-pass effect" metabolism in the liver.

• MUCOLYS® FLASH / ODTx®: These technologies are optimized for flash release formulations. MUCOLYS® FLASH is a powder formulation, often delivered via a spray or stick pack, that dissolves rapidly (in less than five seconds) in the saliva under the tongue for fast systemic absorption. ODTx® is also cited as an optimized flash release technology.

• LIPOGIX®: Mentioned as a DDS platform that focuses on improving the bioavailability and/or stability of the drug product.

By combining its extensive pharmaceutical contract services with its innovative, patented drug delivery systems, Galenix positions itself as a critical R&D partner, offering innovative integrated solutions from early-stage development through to European and US FDA registration.