TECHNOLOGIES

INHALATION:

The search for improved routes of administration and the desire for non-invasive delivery methods for self-medication of chronic conditions represent opportunities for developers of inhalation drug delivery based products. We believe that inhalation drug delivery is the fastest, non-injectable route of administration for many therapeutic agents. This makes it a preferred route of administration when a fast onset of action is required. In addition, for products that are orally unstable or undergo significant first-pass-metabolism, such as opioids, inhalation is a preferred route of administration.

TAIFUN® Inhalation Technology

TAIFUN® is AKELA Pharma’s proprietary multi-dose dry-powder inhaler (DPI) The device combines an integrated and patented desegregation system (vortex-chamber) and a unique humidity control system (desiccant capsule inside the drug reservoir), resulting in highly efficient fluid dynamics. The patented LURUX® wet suspension formulation method ensures excellent powder homogeneity. It also minimizes the formation of amorphous particles within the powder formulation, and ensures prolonged stability. In contrast to most marketed DPI products, the mechanical robustness and flexibility of TAIFUN, its functional strength and adaptability coupled with a low manufacturing cost position it as a very attractive dry powder inhalation platform. Salbutamol TAIFUN, the first TAIFUN product, has been approved in ten European countries.
 
 Advantages of Our TAIFUN® Technology

We believe that our TAIFUN® technology provides a number of technical improvements and clinical benefits, compared to current leading inhaled drug delivery systems. In particular, TAIFUN® enables reliable and efficient delivery of pharmaceuticals into patients' lungs in a wide range of clinical and environmental conditions. We believe that the unique combination of strong technical performance and user friendliness offers a competitive product platform for a variety of inhaled drugs.

In contrast to competing inhaler technologies that are being used or developed for the pulmonary administration of systemically active drugs, the TAIFUN® inhaler is a simple, all mechanical, small device that is inexpensive to manufacture. Despite its relative simplicity, the TAIFUN® inhaler incorporates advanced technology as well as meeting the regulatory requirements of modern dry powder inhalers. In particular, it can be adapted for a variety of small molecule drugs, economically manufactured, and introduced into market segments where pricing is competitive.

 We believe that the key advantages of TAIFUN® technology are:

• advanced powder formulations with high physical and chemical stability;

• high lung deposition of active drug independent of inhalation flow rate;

• high resistance to humidity;

• dose uniformity and accurate dose metering complying with FDA requirements;

• modern style and ease of use; and

• flexible dosing to accommodate varying patient needs.