New Start-up Enavail Applies Proprietary Particle Engineering Technologies To Increase Drug Solubility, Stability and Bioavailability

Key Market and Business Development

The U.S. drug delivery system industry is $80.2 billion and demand is expected to grow 10 percent annually through 2012 (1). One of the most challenging problems for the pharmaceutical industry in development of new drugs is poor solubility of lead compounds. Poorly water-soluble new chemical entities (NCE’s) exhibiting therapeutic activity is a major hurdle and can delay and even prevent commercialization. Development of compounds that are potentially very promising can be halted due to insolubility, and marketed drugs with poor or erratic bioavailability have a greater risk of adverse side effects.

“Promising drug candidates often fail in their early development due to poor bioavailability,” said Brian Windsor, President of Enavail. “Poor bioavailability even affects a large number of marketed drugs, so improving solubility can have a tremendous impact on NCE’s, reformulations, and even biologics. Whatever the case, Enavail’s proprietary particle design technologies provide solutions that get molecules off the shelf and back into the pipeline. Ultimately, this technology will allow healthcare patients worldwide to realize the benefits of new medications with decreased side effects.”

Enavail uses a suite of proprietary, proven and scalable technologies for generating amorphous or crystalline materials with greatly enhanced bioavailability and high potency. A highly controllable bottom up approach is taken, allowing for precise control of particle size and polydispersity. For proteins and peptides, this means high surface area, non-denatured powder forms of labile compounds. For small molecules, Enavail can generate crystalline or amorphous forms of poorly-soluble molecules, providing high potency and greatly enhanced dissolution.

The technology allows for a versatile approach that is amenable to multiple routes of administration – oral, pulmonary, intranasal, parenteral – offering the benefits of enhanced bioavailability and high potency to therapeutics across the spectrum. Enavail offers custom, economical solutions to partners from initial drug screening (even microgram quantities) through to cGMP manufacturing of materials for clinical trials.

Business Model

Utilizing its state-of-the-art lab and cGMP facilities in Austin, Texas, Enavail seeks collaborative partners in drug development interested in screening, product development and clinical scale manufacturing. Co-development projects usually begin with feasibility studies for development of customer-tailored solutions directed to their specific active ingredient. These are followed by cGMP clinical batch production and licensing of the Enavail technologies for commercialization of products.

About Enavail

Enavail is a particle engineering company founded on the pioneering research of Dr. Robert O. (Bill) Williams III, Dr. Keith Johnston and their teams. With state-of-the-art research and cGMP manufacturing facilities located in Austin, Texas, Enavail provides particle engineering expertise for pharmaceutical, biotech and nutraceutical companies. Enavail’s core technologies are focused on two key areas: a) generating crystalline or amorphous forms of poorly water-soluble compounds, providing high potency and greatly enhanced dissolution and bioavailability, and b) producing high surface area, non-degraded powder forms of labile proteins and peptides. Enavail is managed and funded by Emergent Technologies, Inc., a life sciences investment and management company. For more information, visit www.enavail.com

1. “Drug Delivery Systems to 2012 - Market Research, Market Share, Market Size, Sales, Demand Forecast, Market Leaders, Company Profiles, Industry Trends,” Fredonia Group Study, March 2008.

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