A liquid system which enables rapid transmigration of therapeutic doses of up to large molecules

Transient disruption of skin barrier properties and engagement of physiology to actively transport medicaments.

TDS® is a liquid vehicle plus medicament system applied directly to the skin, not requiring a patch or other appliance. The medicament is delivered rapidly and in sufficient doses to accomplish a therapeutic outcome at one seventh to one tenth an equivalent oral dose. TDS® has been employed to deliver molecules of various sizes and HLB profiles, including molecules such as morphine HCL, heretofore considered undeliverable transdermally. The company has completed 15 trials of 12 various molecules including 3 successful human trials and successful delivery of a hydrophobic peptide. With TDS® the medicament traverses intact skin without a needle or significant irritation. Doses are typically compounded into one milliliter of the TDS® and measured with a metered pump or unit dose package. Clinical data has demonstrated that TDS® can be modified for sustained release, site-local applications or systemic absorption.

This system enables significant clinical and cost advantages versus alternative drug delivery modalities and has a broad array of potential applications and business opportunities Because of the high efficiency of the TDS® systems, effective flux of drug exceeding 90%, concetrated or dilute doses are enabled and consequently, titration of dosing specific to the patient is feasible. This is of particular interest in hormonal and pediatric applications. TransDermal Technologies Inc. has formed a research collaboration with The William Harvey Institute at St. Bartholomew's and the Royal London School of Medicine and Dentistry and can facilitate pre-clinical and clinical work on molecule applications. Research schedules are currently being negotiated for several molecules and development time lines are accelerated.

Phase I/II

Filings in place from Summer 1998, PCT applications complete and U.S. Nationalization issued U.S. Patent 6,444,234 in September 2002 and U.S. Patent 6,787,152 in September 2004 for the process and method for analyzing any particular medicament and creating an optimized TDS® for the medicament from the data developed. Delivery of all classes of medicaments is claimed. Additional technology and use patents are now pending.

TransDermal Technologies, Inc. is actively seeking companies interested in applying the TDS® technology to off-patent molecules, new compounds for which transdermal delivery would accelerate development and reduce costs and companies seeking to extend patent franchises. Typical transactions would include reimbursement for development expenses, progress milestone payments and royalties on product sales.

TransDermal may retain patents, but complete license of rights for products or product categories are negotiable. TransDermal will currently entertain proposals of limited options for license rights to hold applications off the market. The company is open to joint - venture transactions with value-added development companies as well as companies with existing sales and marketing forces.