The Needle-Free Injection System

PREJEX, INC. (“PREJEX” or the “Company”) is a spin-out of assets held by a German company Prejex GmbH. Frank Raymakers and Maarten Stuut, as the founders and directors of Prejex GmbH.

Here are some interesting facts…

There are nearly 100 scientific publications and abstracts of research and  development completed with the devices and substantial research have been published for the administration of intradermal, subcutaneous and intra-muscular medication delivery using the PREJEX device.

Management team in the US and EU are highly experienced in medical device, drug delivery and in the pharma-biotech industries.

The Company has improved, modern versions of the commercially-proven PREJEX™ needle-free device to market through a growing network of global distributors and directly-to-patients (direct-to-customers) through online sales.

New product mold and device improvements, new technical know-how, and new IP helps protect the market opportunity.

Single-use disposable and multi-use needle-free injectors are pre-filled with drugs and biologics for self-administration and at-home or at-work use – Needle-free is the future of patient care.

Business to Business and Business to Patient Applications
Supplemental NDAs – PREJEX will provide our N-jector systems to partners that have proprietary drugs approved under a New Drug Application (NDA) for a patented drug or under an Abbreviated New Drug Application (ANDA) for a generic drug. Combining a NDA drug with a novel delivery system can result in the extension of the patent life of the drug and life cycle of the product.  Combining a generic drug with a novel delivery system can differentiate one generic product from another because of the delivery system difference.  Such a partnership would involve completing a pharmacokinetic (PK) study in humans to show that the blood levels achieved and the “exposure” (AUC) parameters are bioequivalent or within 80%-125% of the reference drug NDA or ANDA data. Typically, for the submission of a Supplemental NDA on a partners NDA, PREJEX would receive milestone payments from our partner and a royalty on sales of the drug-device product.
Market and Sell our own Products – PREJEX can obtain active pharmaceutical ingredients (API) from several manufacturing sources, we can have the Needle-Free-ampules/syringes filled with drug at a contract manufacturing organization (CMO) providing such services, when appropriate, PREJEX can fund the PK study and the regulatory submission to regulatory authorities, and obtain market approvals to sell our own drug-device products. This would be more profitable to the Company as we would own all rights and the revenue stream will be higher than milestone and royalty payments on a SNDA partnership.