RF drug delivery device gains CE mark
Receipt of the CE mark confirms that the product is deemed to be safe, an approval that is required for a product to be sold to countries in the European Economic Area.
TransPharma has two propriety molecules that use ViaDerm in clinical development and has also done preclinical on an array of other molecules that would be suitable for use with the device.
Daphna Heffetz, CEO of TransPharma, said: "We are excited about receiving the European CE approval for our unique ViaDerm device. This achievement confirms the safety of the ViaDerm device and brings us closer to offering patients a method for the accurate delivery of biologics, thus avoiding the need for injections."
The device uses RF-MicroChannel Technology to create pores in the skin through which therapeutics can pass. This system provides a route for administering hydrophilic small molecules, peptides and proteins, which are formulated in patches and applied to the skin after use of the device.
TransPharma currently has propriety molecules for the treatment of osteoporosis and human growth hormone deficiency in clinical development.
The osteoporosis treatment, which is currently in Phase II trials, is subject to a licensing agreement between TransPharma and Eli Lilly for its commercialisation and development.
Under the terms of the agreement Lilly will obtain exclusive worldwide rights to the product, with TransPharma receiving $35m upfront and additional milestone payments. TransPharma is hoping to use ViaDerm in other strategic partnerships.
