Pisgah Labs’ intellectual property is focused on the ability to provide modified release properties to drug substances possessing nitrogen functionality. The technology was designed to address a fully integrated business solution wherein unmet needs in the market place are matched with chemical solutions which are both patentable and capable of withstanding the regulatory approval process. In order to support a successful business proposition, a pharmaceutical product return on investment must not be compromised by “generic” competition. Further the investment required to develop and commercialize a new chemical entity is nearing a billion dollars and well outside the business plan of most pharmaceutical business units. Pisgah’s technology is truly enabling—both technically from the intellectual property perspective and as a business venture from a risk / reward perspective. Under appropriate confidentiality agreements, the full extent of Pisgah’s technology will be disclosed to qualified licensees. However, the technology essentially covers three areas: drug substance polymorphic stability, modified release properties imparted to drug substances and alternate product presentations. A particularly useful embodiment of the technology applies to imparting anti-abuse features to controlled drug substances. Pisgah’s technology demonstrates the utility of providing a drug dosage product which performs as expected in its intended application, however transformations to the drug product for the illegal or illicit purposes of abuse are drastically inhibited. Simply stated, the drug product is not absorbed through the mucosal membranes. Consequently, employing Pisgah’s technology converts any controlled substance containing a nitrogen functionality to its congener possessing the anti-abuse features. Clearly, safety of the drug is improved without diminishing its efficacy. Indeed, the drug’s efficacy via sustained release / extended release features may enhance the benefit desired from the product.

Related to the market’s paradigm shift and desire for products exhibiting anti-abuse properties is the regulatory and enforcement issues associated with controlled substances. Pisgah’s technology provides a means to perform unique and company specific cradle-to-grave tracking of active ingredient, the site of product formulation, the formulated product, and distribution channel.

Pisgah Labs is rapidly expanding the core technology and filing additional patent applications. Today, Pisgah is still exploring the scope of the technology and has conclusively determined that years of inventive discoveries are available to which the technology is commercially applicable. As applied technology, licensing opportunities are immediately available to provide product line extensions to patented products, the development of patented products via the 505(b)1 or 505(b)2 NDA process and to commercialize specialty branded products each covering a multitude of therapeutic categories. Currently, Pisgah Labs is prosecuting the following applications through the US PTO:

• Physical States of a Pharmaceutical Drug Substance
• Physical States of a Pharmaceutical Drug Substance, CIP
• Salts of Physiologically Active and Psychoactive Alkaloids and Amines Simultaneously Exhibiting Bioavailability and Abuse Resistance
• Improved Drug Safety with Intrinsic Markers
• Drug Release Properties of Pharmaceutical Drug Substances
• Improved Chemical and Physical Properties of Thyroid Hormone Organic Acid Addition Salts

Our R&D efforts are quickly expanding this set of filings to provide a valuable and enabling technology platform covered by an extensive patent portfolio.