TransPharma specializes in the development of transdermal drug-delivery systems. The systems enable the delivery, as well as improve the effectiveness, of small molecules, proteins, hormones, vaccines and other macromolecules. The company's proprietary technology creates microscopic passageways, known as RF MicroChannels, through the outer layer of the skin which enable even macromolecules to pass freely through the skin barrier and reach their destination. Administration of drugs can therefore be needle-free and pain-free.

PRODUCTS / TECHNOLOGIES

TECHNOLOGIES

TransPharma uses an array of microelectrodes, transmitting radio frequency (RF) energy under precise electronic control, to create microscopic passageways, known as RF-MicroChannels, through the tough outer layer of the skin. Creating an array of RF-MicroChannels takes a few seconds, using a pain-free, low cost, user-friendly system. The RF-MicroChannels enable controlled delivery of therapeutic doses of drugs from an adhesive patch directly into the systemic circulation, and allow constant drug levels to be maintained in the blood over prolonged periods.

These capabilities result in broad applicability characterized by:

• Highly precise dose and rate of drug delivery
• Delivery of molecules of a wide range of sizes, including macromolecules
• Transdermal delivery of molecules to prescribed depths
• Delivery of drugs in various forms including liquid, gel or powder

The company’s technology is said to differentiate from other transdermal drug delivery systems due to the following characteristics:

RF-MicroChannels are rapidly created (within milliseconds) resulting in no skin trauma or pain.

• The dimensions of the RF-MicroChannels are controllable and reproducible resulting in a precise rate of drug delivery.



• Uniformity of RF-MicroChannels through all skin types is fully controlled by a "unique" feedback mechanism.



• Size and density of RF-MicroChannels enable delivery of relatively high doses of drug, which could not previously be delivered by methods other than injection or orally.



• The long lifespan of RF-MicroChannels through the skin enables sustained-release delivery of drug molecules, leading to constant drug blood levels and enhanced safety.

TransPharma’s RF-MicroChannels drug delivery is ideally suited for certain drugs that must be injected and for many orally delivered drugs that are degraded either in the gastro-intestinal tract or by the liver, such that only a small fraction of the total administered dose is actually absorbed and therapeutically effective.

The company has established its skills not only in the device arena but also in patch technology innovations to match the device clinical opportunities. As part of these efforts, it has developed a specific method to enable production of a protein patch, which facilitates in reaching high bioavailability results.

PRODUCTS

ViaDerm

TransPharma’s first-generation product is the ViaDerm, which consists of a reusable handheld electronic control unit and a disposable micro-electrode array, which is designed to be used with standard drug patches. The micro-electrode arrays come individually packaged. The low-cost package is designed so that the array can be snapped onto the control unit without the user having to touch the array. Light pressure on the treatment site automatically initiates the RF MicroChannel ablation process. Within a few seconds, a blinking LED and beeping sound indicate that the RF-MicroChannels have been formed. After removing the ViaDerm from the treatment site, a quick release button ejects the used micro electrode array. The treatment site is now ready for drug patch application.

RESEARCH STRATEGY

A commercial ViaDerm prototype is currently in development. This prototype is battery operated, user-friendly and designed for home use. Several device configurations, with different drug-delivery capabilities, will be followed to meet the need of delivering different type of drugs in various therapeutic areas. A CE mark for the ViaDerm system is expected to be granted in the end of 2005. The company is also planning to expand the development of new types of patches, mainly for proteins.

TransPharma has completed the development of a fully-functional ViaDerm prototype. The company has demonstrated the capabilities of the RF MicroChannel Technology by conducting pre-clinical and clinical studies. A range of molecules of different size and nature (hydrophilic and hydrophobic) including large molecules such as peptides (insulin) and proteins (human growth hormone) were tested in animals. A set of experiments in rats and pigs carried out with human growth hormone, using the company’s ViaDerm system in combination with a patch developed in TransPharma, demonstrated the ability to deliver therapeutic levels of this molecule achieving up to 90% (in rats) and up to 17% (pigs) patch bioavailability, compared to subcutaneous injection. The macromolecule maintained its full bioactivity, following transdermal delivery.

Human clinical studies with the ViaDerm demonstrated its high safety standards and painless application. In a subsequent human study, Granisetron, an antiemetic drug administered to patients going under chemotherapy treatment was used. The study showed sustained-release delivery (constant blood levels over a period of 24 hours) of therapeutic levels of the hydrophilic Granisetron in comparison with the delivery of oral tablets which showed “peak and valley” profile levels. Furthermore, as an antiemetic drug, transdermal delivery of Granisetron has obvious advantage over the oral route. The method was found to be user friendly and convenient, when using a small patch containing no enhancers.

The company is planning to start Phase I trials of its first protein drug product in the coming year. The company has begun to set up a small scale manufacturing plant for production of ViaDerm systems (device plus patch) for clinical studies.

AGREEMENTS

In accordance with TransPharma’s strategy to co-develop products with pharmaceutical companies (drugs delivered with the ViaDerm system), five feasibility agreements exist with pharmaceutical and biotech companies. At this stage, the companies, as well as the drug-molecules, are undisclosed. Two feasibility studies are currently in process and three more are due to start at the beginning of 2005.

KEY FINANCIAL DATA

TransPharma is a privately-held company and so does not publish financial results.

TransPharma raised US$8.9 million in its second round of financing in April 2003. The round was led by Evergreen Partners and included an investor from Canada, T2C2/Bio and current investors Pitango Venture Capital, VitaLife and Biomedical Investments. The funds raised will allow the broadening of activity in three particular areas: business development, manufacturing process and clinical studies.

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